Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-01-10 @ 8:21 PM
Study NCT ID:
NCT04163458
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2019-10-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of MENOPUR Liquid and Powder in Women Undergoing Assisted Reproductive Technology (ART)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007267', 'term': 'Injections'}, {'id': 'D012997', 'term': 'Solvents'}, {'id': 'D012996', 'term': 'Solutions'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'DK0-Disclosure@ferring.com', 'phone': '-', 'title': 'Global Clinical Compliance', 'organization': 'Ferring Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were recorded from the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months).', 'eventGroups': [{'id': 'EG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration", 'otherNumAtRisk': 202, 'deathsNumAtRisk': 202, 'otherNumAffected': 101, 'seriousNumAtRisk': 202, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration", 'otherNumAtRisk': 199, 'deathsNumAtRisk': 199, 'otherNumAffected': 104, 'seriousNumAtRisk': 199, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 22.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 22.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 22.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 22.1'}, {'term': 'Corona virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 22.1'}, {'term': 'Vulvovaginal mycotic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 22.1'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 40, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 38, 'numAffected': 38}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 22.1'}, {'term': 'Post procedural discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 22.1'}, {'term': 'Procedural nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 22.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 22.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 22.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 22.1'}, {'term': 'Morning sickness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 22, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 26, 'numAffected': 22}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 22.1'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 22.1'}, {'term': 'Biochemical pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 22.1'}, {'term': 'Haemorrhage in pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 22.1'}, {'term': 'Subchorionic haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 22.1'}, {'term': 'Subchorionic haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 22.1'}, {'term': 'Uterine contractions during pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 22.1'}, {'term': 'Pelvic discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 22.1'}, {'term': 'Ovarian hyperstimulation syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 22.1'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 22.1'}, {'term': 'Breast tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 22.1'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 22.1'}], 'seriousEvents': [{'term': 'Ovarian hyperstimulation syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 22.1'}, {'term': 'Unresponsive to stimuli', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 22.1'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Fertilized (2 Pronuclei [2PN]) Oocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '4.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'On Day 1 after oocyte retrieval (up to 23 days after start of stimulation)', 'description': 'Fertilized oocytes with 2PN were regarded as correctly fertilized.', 'unitOfMeasure': 'Fertilized oocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Positive Beta Human Chorionic Gonadotropin (βhCG) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10-14 days after blastocyst transfer (up to approximately 6 weeks after start of stimulation)', 'description': "A blood serum βhCG test was obtained 10-14 days after blastocyst transfer. If the test was positive according to the local laboratory's reference ranges, this confirmed a positive βhCG.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Pregnancy Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5-6 weeks after blastocyst transfer (up to approximately 10 weeks after start of stimulation)', 'description': 'Clinical pregnancy was based on detection of at least 1 intrauterine gestational sac with fetal heart beat on transvaginal ultrasound.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ongoing Pregnancy Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8-9 weeks after blastocyst transfer (up to approximately 13 weeks after start of stimulation)', 'description': 'Ongoing pregnancy was based on detection of at least 1 intrauterine viable fetus by transvaginal or abdominal ultrasound', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Early Pregnancy Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8-9 weeks after blastocyst transfer (up to approximately 13 weeks after start of stimulation)', 'description': 'Number of participants with early pregnancy loss defined as a positive βhCG tests but no ongoing pregnancy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants who had a positive βhCG test were eligible.'}, {'type': 'SECONDARY', 'title': 'Follicular Development on Stimulation Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'title': 'Total number of follicles', 'categories': [{'measurements': [{'value': '17.0', 'spread': '9.4', 'groupId': 'OG000'}, {'value': '16.5', 'spread': '8.3', 'groupId': 'OG001'}]}]}, {'title': 'Follicles >= 12 mm', 'categories': [{'measurements': [{'value': '1.8', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Follicles >= 15 mm', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Follicles >= 17 mm', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At stimulation Day 6', 'description': 'The total number of follicles and the number of follicles per size category were reported.', 'unitOfMeasure': 'Follicles', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Follicular Development on Last Day of Stimulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'title': 'Total number of follicles', 'categories': [{'measurements': [{'value': '19.9', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '19.2', 'spread': '10.1', 'groupId': 'OG001'}]}]}, {'title': 'Follicles >= 12 mm', 'categories': [{'measurements': [{'value': '13.1', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '12.0', 'spread': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'Follicles >= 15 mm', 'categories': [{'measurements': [{'value': '8.5', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '3.2', 'groupId': 'OG001'}]}]}, {'title': 'Follicles >= 17 mm', 'categories': [{'measurements': [{'value': '5.4', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '2.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At last day of stimulation (up to 20 stimulation days)', 'description': 'The total number of follicles and the number of follicles per size category were reported.', 'unitOfMeasure': 'Follicles', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serum Follicle-stimulating Hormone (FSH) Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'title': 'Stimulation Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '14.1', 'upperLimit': '20.2'}, {'value': '14.9', 'groupId': 'OG001', 'lowerLimit': '12.8', 'upperLimit': '17.2'}]}]}, {'title': 'End of stimulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000', 'lowerLimit': '13.9', 'upperLimit': '22.5'}, {'value': '16.5', 'groupId': 'OG001', 'lowerLimit': '13.8', 'upperLimit': '20.5'}]}]}, {'title': 'Oocyte retrieval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000', 'lowerLimit': '7.1', 'upperLimit': '12.3'}, {'value': '8.4', 'groupId': 'OG001', 'lowerLimit': '6.7', 'upperLimit': '10.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Day 6, last day of stimulation (up to 20 stimulation days) and at oocyte retrieval (up to 22 days after start of stimulation)', 'description': 'The concentration of serum FSH was measured. The median and IQR of FSH levels on stimulation day 6, End of stimulation and Oocyte Retrieval visit are presented.', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Serum Anti-Müllerian Hormone (AMH) Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'title': 'End of stimulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000', 'lowerLimit': '5.4', 'upperLimit': '12.3'}, {'value': '8.7', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '12.9'}]}]}, {'title': 'End of trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.5', 'groupId': 'OG000', 'lowerLimit': '10.1', 'upperLimit': '24.0'}, {'value': '15.5', 'groupId': 'OG001', 'lowerLimit': '11.1', 'upperLimit': '22.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At the last day of stimulation (up to 20 stimulation days) and at end-of-trial (up to approximately 6 months from the start of screening)', 'description': 'The concentration of serum AMH was measured. The median and IQR of AMH levels on End of stimulation and End of Trial are presented.', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Human Chorionic Gonadotropin (hCG) Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'title': 'Stimulation Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '3.1'}, {'value': '2.4', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '2.9'}]}]}, {'title': 'End of stimulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '3.5'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '3.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Day 6 and last day of stimulation (up to 20 stimulation days)', 'description': 'The concentration of hCG was measured. The median and IQR of hCG levels on stimulation day 6 and End of stimulation are presented.', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Luteinizing Hormone (LH) Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'title': 'Stimulation Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '2.4'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '2.4'}]}]}, {'title': 'End of stimulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '4.3'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '4.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Day 6 and last day of stimulation (up to 20 stimulation days)', 'description': 'The concentration of LH was measured. The median and IQR of LH levels on stimulation day 6 and End of stimulation are presented.', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Progesterone (P4) Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'title': 'Stimulation Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '0.4'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '0.4'}]}]}, {'title': 'End of stimulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '1.1'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '1.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Day 6 and last day of stimulation (up to 20 stimulation days)', 'description': 'The concentration of P4 was measured. The median and IQR of P4 levels on stimulation day 6 and End of stimulation are presented.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Estradiol (E2) Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'title': 'Stimulation Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '518.1', 'groupId': 'OG000', 'lowerLimit': '236.7', 'upperLimit': '834.0'}, {'value': '336.4', 'groupId': 'OG001', 'lowerLimit': '167.5', 'upperLimit': '607.2'}]}]}, {'title': 'End of stimulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2720.0', 'groupId': 'OG000', 'lowerLimit': '1994.0', 'upperLimit': '3266.0'}, {'value': '2292.0', 'groupId': 'OG001', 'lowerLimit': '1694.0', 'upperLimit': '2887.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At stimulation Day 6 and last day of stimulation (up to 20 stimulation days)', 'description': 'The concentration of E2 was measured. The median and IQR of E2 levels on stimulation day 6 and End of stimulation are presented.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Oocytes Retrieved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '14.3', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '11.4', 'spread': '6.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'On day of oocyte retrieval (up to 22 days after start of stimulation)', 'description': 'The number of oocytes retrieved was recorded at the oocyte retrieval visit.', 'unitOfMeasure': 'Oocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Metaphase II (MII) Oocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '10.6', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '8.9', 'spread': '4.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'On day of oocyte retrieval (up to 22 days after start of stimulation)', 'description': 'Maturity stage was assessed prior to undergoing ICSI. Maturity stage was categorized as germinal vesicle, metaphase I, metaphase II, degenerated or other.', 'unitOfMeasure': 'MII Oocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with Oocytes retrieved were eligible.'}, {'type': 'SECONDARY', 'title': 'Fertilization Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '57.8', 'spread': '19.9', 'groupId': 'OG000'}, {'value': '60.0', 'spread': '20.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'On Day 1 after oocyte retrieval (up to 23 days after start of stimulation)', 'description': 'Fertilization rate(%) is the number of 2PN oocytes divided by the number of oocytes retrieved.', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with Oocytes retrieved were eligible.'}, {'type': 'SECONDARY', 'title': 'Number of Blastocysts and Number of Good-Quality Blastocysts 5 Days After Oocyte Retrieval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'title': 'Number of Blastocysts on Day 5', 'categories': [{'measurements': [{'value': '4.8', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '3.0', 'groupId': 'OG001'}]}]}, {'title': 'Number of Good-quality blastocysts on Day 5', 'categories': [{'measurements': [{'value': '3.0', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '2.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'On Day 5 after oocyte retrieval (up to 27 days after start of stimulation)', 'description': 'The number of blastocysts (total and good-quality) was reported. Blastocyst quality was assessed by blastocyst expansion and hatching status, blastocyst inner cell mass grading, and trophectoderm grading. The scoring was based on the classification system by Gardner and Schoolcraft, with additional categories for inner cell mass (degenerative or no inner cell mass) and trophectoderm (degenerative or very large cells)', 'unitOfMeasure': 'Blastocysts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Gonadotropin Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '2265.6', 'spread': '710.2', 'groupId': 'OG000'}, {'value': '2466.7', 'spread': '863.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 20 stimulation days', 'description': "The gonadotropin starting dose was 225 IU for the first 5 days, followed by individual adjustments according to the participant's follicular response. Dose adjustment should be 75 IU per adjustment. Gonadotropin was to be initiated within 3 days of confirmed downregulation.", 'unitOfMeasure': 'IU', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Stimulation Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '9.6', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '9.9', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 20 stimulation days', 'description': 'Calculated by start dates and end dates.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Ovarian Hyperstimulation Syndrome (OHSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'title': 'Early OHSS', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000'}, {'value': '3.5', 'groupId': 'OG001'}]}]}, {'title': 'Late OHSS', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000'}, {'value': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '≤9 days after triggering of final follicular maturation (early OHSS), >9 days after triggering of final follicular maturation until 21-28 days after last IMP dose or up to ongoing pregnancy 8-9 weeks after transfer in pregnant participants (late OHSS)', 'description': 'OHSS was defined as the total of early OHSS with onset ≤9 days after triggering of final follicular maturation, and late OHSS with onset \\>9 days after triggering of final follicular maturation.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Frequency of Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '52.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months)', 'description': 'Any AE occurring after start of IMP and before the end-of-trial visit, or a pre-treatment AE or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit was considered treatment-emergent, and is presented for this endpoint.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intensity of AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'title': 'Mild AEs', 'categories': [{'measurements': [{'value': '42.1', 'groupId': 'OG000'}, {'value': '40.7', 'groupId': 'OG001'}]}]}, {'title': 'Moderate AEs', 'categories': [{'measurements': [{'value': '23.8', 'groupId': 'OG000'}, {'value': '20.6', 'groupId': 'OG001'}]}]}, {'title': 'Severe AEs', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'The intensity of an AE was classified using the following 3-point scale: Mild = Awareness of signs or symptoms, but no disruption of usual activity. Moderate = Event sufficient to affect usual activity (disturbing). Severe = Inability to work or perform usual activities (unacceptable).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Alanine Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '14.2', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '12.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters.', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Aspartate Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '21.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters.', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Blood Urea Nitrogen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Calcium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Chloride', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '2.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '-5.498', 'spread': '10.896', 'groupId': 'OG000'}, {'value': '-5.032', 'spread': '8.849', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters.', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Gamma Glutamyl Transferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '-0.6', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '8.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters.', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '3.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Egfr African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'spread': '14.9', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '13.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters.', 'unitOfMeasure': 'mL/min/1.73m2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Egfr Non-afr. American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'spread': '13.1', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '11.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters.', 'unitOfMeasure': 'mL/min/1.73m2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Erythrocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '-0.169', 'spread': '0.293', 'groupId': 'OG000'}, {'value': '-0.199', 'spread': '0.256', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of haematology parameters.', 'unitOfMeasure': '10^12 cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Leukocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '1.17', 'spread': '2.25', 'groupId': 'OG000'}, {'value': '1.11', 'spread': '2.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of haematology parameters.', 'unitOfMeasure': '10^9 cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '-4.40', 'spread': '9.87', 'groupId': 'OG000'}, {'value': '-5.76', 'spread': '8.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of haematology parameters.', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Hematocrit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.03', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of haematology parameters.', 'unitOfMeasure': 'RATIO', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '22.6', 'spread': '38.6', 'groupId': 'OG000'}, {'value': '23.7', 'spread': '43.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of haematology parameters.', 'unitOfMeasure': '10^9 cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Basophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '54.0', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '60.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of haematology parameters.', 'unitOfMeasure': 'cells/uL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Basophils/Leukocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of haematology parameters.', 'unitOfMeasure': 'Basophils/leukocytes in Percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Eosinophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '-10.6', 'spread': '100.5', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '68.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of haematology parameters.', 'unitOfMeasure': 'cells/uL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Eosinophils/Leukocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of haematology parameters.', 'unitOfMeasure': 'Eosinophils/leukocytes in percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '-53.2', 'spread': '414.9', 'groupId': 'OG000'}, {'value': '-4.0', 'spread': '442.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of haematology parameters.', 'unitOfMeasure': 'cells/uL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Lymphocytes/Leukocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '-4.5', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '9.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of haematology parameters.', 'unitOfMeasure': 'Lymphocytes/leukocytes in percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Monocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '21.5', 'spread': '161.8', 'groupId': 'OG000'}, {'value': '36.7', 'spread': '148.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of haematology parameters.', 'unitOfMeasure': 'cells/uL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Monocytes/Leukocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of haematology parameters.', 'unitOfMeasure': 'Monocytes/leukocytes in percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '1206.4', 'spread': '2096.6', 'groupId': 'OG000'}, {'value': '1069.0', 'spread': '1966.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of haematology parameters.', 'unitOfMeasure': 'cells/uL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Neutrophils/Leukocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '10.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of haematology parameters.', 'unitOfMeasure': 'Neutrophils/leukocytes in percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects With Markedly Abnormal Changes of Clinical Parameters and Haematology Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'title': 'Calcium (mmol/L) (End of stimulation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Glucose (mmol/L) (End of stimulation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Erythrocytes (10^12 cells/L) (End of stimulation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Leukocytes (10^9 cells/L) (End of stimulation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin (g/L) (End of stimulation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hematocrit (RATIO) (End of stimulation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Platelets (10^9 cells/L) (End of stimulation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Basophils/leukocytes ratio (%) (End of stimulation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes/leukocytes ratio (%) (End of stimulation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase (IU/L) (End of trial)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Leukocytes (10^9 cells/L) (End of trial)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'The table represents the percentage of participants in each group with normal baseline values and markedly abnormal end-of-stimulation or end-of-trial visit values.\n\nIt is only parameters with markedly abnormal values at end of stimulation or end of trial visit which are represented. Parameters with normal baseline values and normal end of stimulation and end of trial values are not represented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. Participants who were evaluable had normal baseline values and markedly abnormal end-of-stimulation or end-of-trial visit values.'}, {'type': 'SECONDARY', 'title': 'Frequency of Injection Site Reactions (Redness, Pain, Itching, Swelling and Bruising) Assessed by the Participant During the Stimulation Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}, {'units': 'Total number of events', 'counts': [{'value': '29185', 'groupId': 'OG000'}, {'value': '29425', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '14.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 20 stimulation days', 'description': 'Assessed by the participant during the stimulation period. Participants assessed the injection site reactions (redness, pain, itching, swelling and bruising) three times daily: immediately after the injection, 30 minutes after the injection and 24 hours after the injection.\n\nTotal Number of events include all categories None, Mild, Moderate and Severe. Percentage of events with injection site reactions as a sum of the categories Mild, Moderate and Severe is presented.', 'unitOfMeasure': 'Percentage of events', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Total number of events', 'denomUnitsSelected': 'Total number of events'}, {'type': 'SECONDARY', 'title': 'Intensity of Injection Site Reactions (Redness, Pain, Itching, Swelling and Bruising) Assessed by the Participant During the Stimulation Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}, {'units': 'Total number of events', 'counts': [{'value': '29185', 'groupId': 'OG000'}, {'value': '29425', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'title': 'Mild injection site reaction', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000'}, {'value': '12.9', 'groupId': 'OG001'}]}]}, {'title': 'Moderate injection site reaction', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Severe injection site reaction', 'categories': [{'measurements': [{'value': '0.0069', 'groupId': 'OG000'}, {'value': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 20 stimulation days', 'description': 'Assessed by the participant during the stimulation period as mild, moderate or severe.\n\nParticipants assessed the injection site reactions (redness, pain, itching, swelling and bruising) three times daily: immediately after the injection, 30 minutes after the injection and 24 hours after the injection.', 'unitOfMeasure': 'Percentage of events', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Total number of events', 'denomUnitsSelected': 'Total number of events'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Treatment-induced Anti-MENOPUR Antibodies. Overall as Well as With Neutralizing Capacity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'title': 'Treatment-induced anti-MENOPUR antibodies (overall)', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '4.3'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '4.3'}]}]}, {'title': 'Treatment-induced anti-MENOPUR antibodies with neutralizing capacity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1.81'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1.84'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 28 days after end of the stimulation period (simulation period up to 20 days)', 'description': 'Measured by presence of anti-MENOPUR antibodies.\n\n95% Clopper-Pearson confidence interval has been reported in this endpoint.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Potential Technical Malfunctions of the Administration Pen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'OG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 20 stimulation days', 'description': 'Number of participants With Potential Technical malfunctions of the Administration Pen were recorded.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'FG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '204'}, {'groupId': 'FG001', 'numSubjects': '201'}]}, {'type': 'mITT', 'achievements': [{'groupId': 'FG000', 'numSubjects': '202'}, {'groupId': 'FG001', 'numSubjects': '199'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '180'}, {'groupId': 'FG001', 'numSubjects': '171'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Due to COVID-19 pandemic', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Participant withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Randomization failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'The trial was performed in 19 investigational sites in US between Oct 2019 and Jul 2021.', 'preAssignmentDetails': 'In total, 691 participants were screened. Of these, 97 participants were rescreened after the trial hold was lifted, leading to a total of 788 screening events. Of these, 383 were screening event failures while 405 screening events resulted in randomization. 401 participants were exposed to IMP: 202 participants exposed to MENOPUR liquid and 199 participants were exposed to MENOPUR powder.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MENOPUR Liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL: Solution for injection in pre-filled pen, subcutaneous administration\n\nPlacebo (for MENOPUR powder and solvent for solution for injection): Solution for injection in vials (powder and diluent); subcutaneous administration"}, {'id': 'BG001', 'title': 'MENOPUR Powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.\n\nMENOPUR powder and solvent for solution for injection, 75 IU: Solution for injection in vials (powder and diluent), subcutaneous administration\n\nPlacebo (for MENOPUR solution for injection in pre-filled pen): Solution for injection in pre-filled pen, subcutaneous administration"}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.9', 'spread': '3.9', 'groupId': 'BG000'}, {'value': '34.0', 'spread': '4.3', 'groupId': 'BG001'}, {'value': '34.0', 'spread': '4.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Age', 'categories': [{'title': '<35 years', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}, {'title': '>=35 years', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '183', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '202', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '341', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '158', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '318', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '202', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '26.1', 'spread': '4.6', 'groupId': 'BG000'}, {'value': '25.9', 'spread': '4.7', 'groupId': 'BG001'}, {'value': '26.0', 'spread': '4.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Primary Infertility', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '197', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of infertility', 'classes': [{'categories': [{'measurements': [{'value': '46.1', 'spread': '36.8', 'groupId': 'BG000'}, {'value': '44.5', 'spread': '31.4', 'groupId': 'BG001'}, {'value': '45.3', 'spread': '34.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Primary reason for infertility', 'classes': [{'categories': [{'title': 'Unexplained infertility', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}]}, {'title': 'Tubal infertility', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'Mild male factor', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Moderate male factor', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Severe male factor', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Endometriosis stage I/II', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-19', 'size': 1746308, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-10-12T07:17', 'hasProtocol': True}, {'date': '2021-08-17', 'size': 606230, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-08-28T04:08', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 405}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'dispFirstSubmitDate': '2022-05-16', 'completionDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-13', 'studyFirstSubmitDate': '2019-10-28', 'resultsFirstSubmitDate': '2023-08-28', 'studyFirstSubmitQcDate': '2019-11-12', 'dispFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-10-13', 'studyFirstPostDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Fertilized (2 Pronuclei [2PN]) Oocytes', 'timeFrame': 'On Day 1 after oocyte retrieval (up to 23 days after start of stimulation)', 'description': 'Fertilized oocytes with 2PN were regarded as correctly fertilized.'}], 'secondaryOutcomes': [{'measure': 'Positive Beta Human Chorionic Gonadotropin (βhCG) Rate', 'timeFrame': '10-14 days after blastocyst transfer (up to approximately 6 weeks after start of stimulation)', 'description': "A blood serum βhCG test was obtained 10-14 days after blastocyst transfer. If the test was positive according to the local laboratory's reference ranges, this confirmed a positive βhCG."}, {'measure': 'Clinical Pregnancy Rate', 'timeFrame': '5-6 weeks after blastocyst transfer (up to approximately 10 weeks after start of stimulation)', 'description': 'Clinical pregnancy was based on detection of at least 1 intrauterine gestational sac with fetal heart beat on transvaginal ultrasound.'}, {'measure': 'Ongoing Pregnancy Rate', 'timeFrame': '8-9 weeks after blastocyst transfer (up to approximately 13 weeks after start of stimulation)', 'description': 'Ongoing pregnancy was based on detection of at least 1 intrauterine viable fetus by transvaginal or abdominal ultrasound'}, {'measure': 'Early Pregnancy Loss', 'timeFrame': '8-9 weeks after blastocyst transfer (up to approximately 13 weeks after start of stimulation)', 'description': 'Number of participants with early pregnancy loss defined as a positive βhCG tests but no ongoing pregnancy.'}, {'measure': 'Follicular Development on Stimulation Day 6', 'timeFrame': 'At stimulation Day 6', 'description': 'The total number of follicles and the number of follicles per size category were reported.'}, {'measure': 'Follicular Development on Last Day of Stimulation', 'timeFrame': 'At last day of stimulation (up to 20 stimulation days)', 'description': 'The total number of follicles and the number of follicles per size category were reported.'}, {'measure': 'Serum Follicle-stimulating Hormone (FSH) Concentration', 'timeFrame': 'At Day 6, last day of stimulation (up to 20 stimulation days) and at oocyte retrieval (up to 22 days after start of stimulation)', 'description': 'The concentration of serum FSH was measured. The median and IQR of FSH levels on stimulation day 6, End of stimulation and Oocyte Retrieval visit are presented.'}, {'measure': 'Serum Anti-Müllerian Hormone (AMH) Concentration', 'timeFrame': 'At the last day of stimulation (up to 20 stimulation days) and at end-of-trial (up to approximately 6 months from the start of screening)', 'description': 'The concentration of serum AMH was measured. The median and IQR of AMH levels on End of stimulation and End of Trial are presented.'}, {'measure': 'Human Chorionic Gonadotropin (hCG) Concentration', 'timeFrame': 'At Day 6 and last day of stimulation (up to 20 stimulation days)', 'description': 'The concentration of hCG was measured. The median and IQR of hCG levels on stimulation day 6 and End of stimulation are presented.'}, {'measure': 'Luteinizing Hormone (LH) Concentration', 'timeFrame': 'At Day 6 and last day of stimulation (up to 20 stimulation days)', 'description': 'The concentration of LH was measured. The median and IQR of LH levels on stimulation day 6 and End of stimulation are presented.'}, {'measure': 'Progesterone (P4) Concentration', 'timeFrame': 'At Day 6 and last day of stimulation (up to 20 stimulation days)', 'description': 'The concentration of P4 was measured. The median and IQR of P4 levels on stimulation day 6 and End of stimulation are presented.'}, {'measure': 'Estradiol (E2) Concentration', 'timeFrame': 'At stimulation Day 6 and last day of stimulation (up to 20 stimulation days)', 'description': 'The concentration of E2 was measured. The median and IQR of E2 levels on stimulation day 6 and End of stimulation are presented.'}, {'measure': 'Number of Oocytes Retrieved', 'timeFrame': 'On day of oocyte retrieval (up to 22 days after start of stimulation)', 'description': 'The number of oocytes retrieved was recorded at the oocyte retrieval visit.'}, {'measure': 'Number of Metaphase II (MII) Oocytes', 'timeFrame': 'On day of oocyte retrieval (up to 22 days after start of stimulation)', 'description': 'Maturity stage was assessed prior to undergoing ICSI. Maturity stage was categorized as germinal vesicle, metaphase I, metaphase II, degenerated or other.'}, {'measure': 'Fertilization Rate', 'timeFrame': 'On Day 1 after oocyte retrieval (up to 23 days after start of stimulation)', 'description': 'Fertilization rate(%) is the number of 2PN oocytes divided by the number of oocytes retrieved.'}, {'measure': 'Number of Blastocysts and Number of Good-Quality Blastocysts 5 Days After Oocyte Retrieval', 'timeFrame': 'On Day 5 after oocyte retrieval (up to 27 days after start of stimulation)', 'description': 'The number of blastocysts (total and good-quality) was reported. Blastocyst quality was assessed by blastocyst expansion and hatching status, blastocyst inner cell mass grading, and trophectoderm grading. The scoring was based on the classification system by Gardner and Schoolcraft, with additional categories for inner cell mass (degenerative or no inner cell mass) and trophectoderm (degenerative or very large cells)'}, {'measure': 'Total Gonadotropin Dose', 'timeFrame': 'Up to 20 stimulation days', 'description': "The gonadotropin starting dose was 225 IU for the first 5 days, followed by individual adjustments according to the participant's follicular response. Dose adjustment should be 75 IU per adjustment. Gonadotropin was to be initiated within 3 days of confirmed downregulation."}, {'measure': 'Number of Stimulation Days', 'timeFrame': 'Up to 20 stimulation days', 'description': 'Calculated by start dates and end dates.'}, {'measure': 'Proportion of Participants With Ovarian Hyperstimulation Syndrome (OHSS)', 'timeFrame': '≤9 days after triggering of final follicular maturation (early OHSS), >9 days after triggering of final follicular maturation until 21-28 days after last IMP dose or up to ongoing pregnancy 8-9 weeks after transfer in pregnant participants (late OHSS)', 'description': 'OHSS was defined as the total of early OHSS with onset ≤9 days after triggering of final follicular maturation, and late OHSS with onset \\>9 days after triggering of final follicular maturation.'}, {'measure': 'Frequency of Adverse Events (AEs)', 'timeFrame': 'From the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months)', 'description': 'Any AE occurring after start of IMP and before the end-of-trial visit, or a pre-treatment AE or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit was considered treatment-emergent, and is presented for this endpoint.'}, {'measure': 'Intensity of AEs', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'The intensity of an AE was classified using the following 3-point scale: Mild = Awareness of signs or symptoms, but no disruption of usual activity. Moderate = Event sufficient to affect usual activity (disturbing). Severe = Inability to work or perform usual activities (unacceptable).'}, {'measure': 'Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Alanine Aminotransferase', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters.'}, {'measure': 'Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Aspartate Aminotransferase', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters.'}, {'measure': 'Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Blood Urea Nitrogen', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters.'}, {'measure': 'Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Calcium', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters.'}, {'measure': 'Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Chloride', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters.'}, {'measure': 'Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Creatinine', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters.'}, {'measure': 'Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Gamma Glutamyl Transferase', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters.'}, {'measure': 'Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Glucose', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters.'}, {'measure': 'Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Potassium', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters.'}, {'measure': 'Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Sodium', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters.'}, {'measure': 'Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Egfr African American', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters.'}, {'measure': 'Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Egfr Non-afr. American', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters.'}, {'measure': 'Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Erythrocytes', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of haematology parameters.'}, {'measure': 'Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Leukocytes', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of haematology parameters.'}, {'measure': 'Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Hemoglobin', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of haematology parameters.'}, {'measure': 'Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Hematocrit', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of haematology parameters.'}, {'measure': 'Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Platelets', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of haematology parameters.'}, {'measure': 'Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Basophils', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of haematology parameters.'}, {'measure': 'Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Basophils/Leukocytes', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of haematology parameters.'}, {'measure': 'Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Eosinophils', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of haematology parameters.'}, {'measure': 'Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Eosinophils/Leukocytes', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of haematology parameters.'}, {'measure': 'Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Lymphocytes', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of haematology parameters.'}, {'measure': 'Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Lymphocytes/Leukocytes', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of haematology parameters.'}, {'measure': 'Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Monocytes', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of haematology parameters.'}, {'measure': 'Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Monocytes/Leukocytes', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of haematology parameters.'}, {'measure': 'Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Neutrophils', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of haematology parameters.'}, {'measure': 'Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Neutrophils/Leukocytes', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'Blood samples were collected for the analysis of haematology parameters.'}, {'measure': 'Proportion of Subjects With Markedly Abnormal Changes of Clinical Parameters and Haematology Parameters', 'timeFrame': 'From the start of screening until the end-of-trial (up to approximately 6 months)', 'description': 'The table represents the percentage of participants in each group with normal baseline values and markedly abnormal end-of-stimulation or end-of-trial visit values.\n\nIt is only parameters with markedly abnormal values at end of stimulation or end of trial visit which are represented. Parameters with normal baseline values and normal end of stimulation and end of trial values are not represented.'}, {'measure': 'Frequency of Injection Site Reactions (Redness, Pain, Itching, Swelling and Bruising) Assessed by the Participant During the Stimulation Period', 'timeFrame': 'Up to 20 stimulation days', 'description': 'Assessed by the participant during the stimulation period. Participants assessed the injection site reactions (redness, pain, itching, swelling and bruising) three times daily: immediately after the injection, 30 minutes after the injection and 24 hours after the injection.\n\nTotal Number of events include all categories None, Mild, Moderate and Severe. Percentage of events with injection site reactions as a sum of the categories Mild, Moderate and Severe is presented.'}, {'measure': 'Intensity of Injection Site Reactions (Redness, Pain, Itching, Swelling and Bruising) Assessed by the Participant During the Stimulation Period', 'timeFrame': 'Up to 20 stimulation days', 'description': 'Assessed by the participant during the stimulation period as mild, moderate or severe.\n\nParticipants assessed the injection site reactions (redness, pain, itching, swelling and bruising) three times daily: immediately after the injection, 30 minutes after the injection and 24 hours after the injection.'}, {'measure': 'Proportion of Participants With Treatment-induced Anti-MENOPUR Antibodies. Overall as Well as With Neutralizing Capacity', 'timeFrame': 'Up to 28 days after end of the stimulation period (simulation period up to 20 days)', 'description': 'Measured by presence of anti-MENOPUR antibodies.\n\n95% Clopper-Pearson confidence interval has been reported in this endpoint.'}, {'measure': 'Number of Participants With Potential Technical Malfunctions of the Administration Pen', 'timeFrame': 'Up to 20 stimulation days', 'description': 'Number of participants With Potential Technical malfunctions of the Administration Pen were recorded.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Controlled Ovarian Stimulation', 'Assisted Reproductive Technology'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'Development of multiple follicles and pregnancy in ovulatory women undergoing controlled ovarian stimulation as part of an assisted reproductive technology (ART) cycle.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed informed consents, prior to any trial-related procedure.\n* Females between the ages of 18 and 42 years. The participants must be at least 18 years (including the 18th birthday) when they sign the informed consent and no more than 42 years (up to the day before the 43rd birthday) at the time of randomization who desire pregnancy.\n* Body mass index (BMI) between 17.5 and 38.0 kg/m\\^2 (both inclusive) at screening.\n* Regular menstrual cycles of 24 to 35 days, presumed to be ovulatory.\n* Documented history of infertility for at least 12 months before randomization for women ≤35 years or for at least 6 months for women ≥36 years. Women with documented bilateral tubal occlusion or male factor infertility requiring the use of donor sperm established as a cause of infertility are eligible at diagnosis.\n* Early follicular phase (cycle day 2-4) serum FSH level between 1 and 12 IU/L (results obtained within 3 months prior to randomization).\n* Male partner with semen analysis that is at least adequate for intracytoplasmic sperm injection (ICSI) at screening or within 6 months prior to the screening date. Partners with severe male factors requiring invasive or surgical sperm retrieval may not be used. Use of donor sperm is allowed.\n* At least 1 cycle with no fertility medication immediately prior to screening.\n* Hysterosalpingography, hysteroscopy, or saline hysterosonogram documenting uterine anatomy appropriate for ART at screening or within 12 months prior to screening.\n* Transvaginal ultrasound documenting presence and adequate visualization of both ovaries, without evidence of clinically significant abnormality (e.g., endometrioma ≥3 cm, no dermoid cysts) and normal adnexa (e.g., no hydrosalpinx) at screening. Both ovaries must be accessible for oocyte retrieval.\n\nExclusion Criteria:\n\n* More than two previous controlled ovarian stimulation cycles for in vitro fertilization (IVF)/ICSI\n* Known stage III-IV endometriosis (American Society for Reproductive Medicine, 2012).\n* Oocyte donor or embryo recipient; gestational or surrogate carrier.\n* Known history of recurrent miscarriage (defined as three consecutive losses after ultrasound confirmation of pregnancy \\[excluding ectopic pregnancy\\] and before week 24 of pregnancy).\n* Participant's male partner, with obvious leukospermia (\\>2 million white blood cells/mL) or signs of infection in semen sample within 6 months of the participant's screening. If either of these conditions exists, the male should be treated with antibiotics and retested prior to the participant's randomization.\n* Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events.\n* Any known endocrine (total testosterone, prolactin and TSH) or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) with the exception of controlled thyroid function disease.\n* Known tumors of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus which would contraindicate the use of gonadotrophins.\n* Any abnormal finding of clinical chemistry, hematology and vital signs at screening, which is judged clinically significant by the investigator.\n* Pregnancy (negative urine pregnancy test must be documented at screening and prior to the first investigational medicinal product \\[IMP\\] administration), or contraindication to pregnancy.\n* Hypersensitivity to any active ingredient or excipients in the medicinal products used in this trial."}, 'identificationModule': {'nctId': 'NCT04163458', 'acronym': 'CLARA', 'briefTitle': 'Comparison of MENOPUR Liquid and Powder in Women Undergoing Assisted Reproductive Technology (ART)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'A Randomized, Double-blind Double-dummy Trial Comparing MENOPUR Solution for Injection in a Pre-filled Pen and MENOPUR Powder and Solvent for Solution for Injection (Menotropins for Injection) in a GnRH Agonist Cycle in Women Aged 18-42 Years Undergoing an Assisted Reproductive Technology Program', 'orgStudyIdInfo': {'id': '000303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MENOPUR liquid', 'description': "MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.", 'interventionNames': ['Drug: MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL', 'Other: Placebo (for MENOPUR powder and solvent for solution for injection)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MENOPUR powder', 'description': "MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.", 'interventionNames': ['Drug: MENOPUR powder and solvent for solution for injection, 75 IU', 'Other: Placebo (for MENOPUR solution for injection in pre-filled pen)']}], 'interventions': [{'name': 'MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL', 'type': 'DRUG', 'otherNames': ['Highly purified menotropin'], 'description': 'Solution for injection in pre-filled pen, subcutaneous administration', 'armGroupLabels': ['MENOPUR liquid']}, {'name': 'MENOPUR powder and solvent for solution for injection, 75 IU', 'type': 'DRUG', 'otherNames': ['Highly purified menotropin'], 'description': 'Solution for injection in vials (powder and diluent), subcutaneous administration', 'armGroupLabels': ['MENOPUR powder']}, {'name': 'Placebo (for MENOPUR solution for injection in pre-filled pen)', 'type': 'OTHER', 'description': 'Solution for injection in pre-filled pen, subcutaneous administration', 'armGroupLabels': ['MENOPUR powder']}, {'name': 'Placebo (for MENOPUR powder and solvent for solution for injection)', 'type': 'OTHER', 'description': 'Solution for injection in vials (powder and diluent); subcutaneous administration', 'armGroupLabels': ['MENOPUR liquid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85284', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Fertility Treatment Center', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Fertility Specialists Medical Group - San Diego Center for Reproductive Surgery', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '06032', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Center for Advanced Reproductive Services PC', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}, {'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Fertility Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Fertility and IVF Center of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32789', 'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Center for Reproductive Medicine', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '83702', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Idaho Center for Reproductive Medicine', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '60610', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Fertility Centers of Illinois', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60169', 'city': 'Hoffman Estates', 'state': 'Illinois', 'country': 'United States', 'facility': 'InVia Fertility Specialists, SC', 'geoPoint': {'lat': 42.04281, 'lon': -88.0798}}, {'zip': '70817', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Fertility Answers, LLC', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '89118', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'SIRM Fertility Center', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Reproductive Endocrinology Associates of Charlotte', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina Conceptions', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '45209', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Institute for Reproductive Health', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'OU Physicians Reproductive Medicine', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19046', 'city': 'Abington', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abington Reproductive Medicine', 'geoPoint': {'lat': 40.12067, 'lon': -75.11795}}, {'zip': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Fertility Associates of Memphis, PLLC', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '76022', 'city': 'Bedford', 'state': 'Texas', 'country': 'United States', 'facility': 'Center for Assisted Reproduction', 'geoPoint': {'lat': 32.84402, 'lon': -97.14307}}, {'zip': '77063', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Fertility Institute', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77598', 'city': 'Webster', 'state': 'Texas', 'country': 'United States', 'facility': 'Center of Reproductive Medicine', 'geoPoint': {'lat': 29.53773, 'lon': -95.11826}}], 'overallOfficials': [{'name': 'Global Clinical Compliance', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ferring Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ferring Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}