Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT01146418
Status:
COMPLETED
Last Update Posted:
2024-06-20
First Post:
2010-06-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Frozen-thawed Embryo Transfer (FTET) Cycle Follow-up Protocol (P06031)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}, {'id': 'D006379', 'term': 'Helping Behavior'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C437186', 'term': 'follicle stimulating hormone, human, with HCG C-terminal peptide'}, {'id': 'C571802', 'term': 'follitropin beta'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication (including, without limitation, slides and texts of oral or other public presentations and texts of any transmission through any electronic media, eg, any computer access system such as the Internet, World Wide Web, etc) that report any results of the trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)', 'eventGroups': [{'id': 'EG000', 'title': 'Corifollitropin Alfa 150 μg Participants With ET', 'description': 'Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.', 'otherNumAtRisk': 151, 'otherNumAffected': 64, 'seriousNumAtRisk': 151, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'recFSH 300 IU Participants With ET', 'description': 'Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.', 'otherNumAtRisk': 147, 'otherNumAffected': 45, 'seriousNumAtRisk': 147, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Corifollitropin Alfa 150 μg Expectant Mothers', 'description': 'Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.', 'otherNumAtRisk': 52, 'otherNumAffected': 26, 'seriousNumAtRisk': 52, 'seriousNumAffected': 34}, {'id': 'EG003', 'title': 'recFSH 300 IU Expectant Mothers', 'description': 'Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.', 'otherNumAtRisk': 50, 'otherNumAffected': 19, 'seriousNumAtRisk': 50, 'seriousNumAffected': 29}, {'id': 'EG004', 'title': 'Corifollitropin Alfa 150 μg Follow-up Fetuses/Infants', 'description': 'Infants born to eligible participants who received a single injection of 150 μg corifollitropin alfa in Base Study P06029 (NCT01144416) were followed for safety and efficacy in Follow-Up Study P06031 according to standard practice.', 'otherNumAtRisk': 61, 'otherNumAffected': 18, 'seriousNumAtRisk': 61, 'seriousNumAffected': 15}, {'id': 'EG005', 'title': 'recFSH 300 IU Follow-up Fetuses/Infants', 'description': 'Infants born to eligible participants who received daily 300 IU recFSH in Base Study P06029 (NCT01144416) were followed for safety and efficacy in Follow-Up Study P06031 according to standard practice', 'otherNumAtRisk': 56, 'otherNumAffected': 21, 'seriousNumAtRisk': 56, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Jaundice neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vomiting in pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vomiting neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Sepsis neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Premature baby', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hyperbilirubinaemia neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Neonatal respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Perineal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Procedural nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Afterbirth pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gestational diabetes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Labour pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vaginal discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abortion missed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 38, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 24, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Haemorrhage in pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 18, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'seriousEvents': [{'term': 'Tachycardia foetal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Congenital coronary artery malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Congenital hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Congenital torticollis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Congenital umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}, {'groupId': 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1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Uterine leiomyosarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With ≥1 Vital Pregnancy (Cumulative Vital Pregnancy Rate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '694', 'groupId': 'OG000'}, {'value': '696', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Corifollitropin Alfa 150 μg Women/Expectant Mothers', 'description': 'Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.'}, {'id': 'OG001', 'title': 'recFSH 300 IU Women/Expectant Mothers', 'description': 'Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.1', 'groupId': 'OG000', 'lowerLimit': '27.7', 'upperLimit': '34.7'}, {'value': '33.0', 'groupId': 'OG001', 'lowerLimit': '29.6', 'upperLimit': '36.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-6.5', 'ciUpperLimit': '3.0', 'statisticalMethod': 'Clopper-Pearson method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Difference calculated using generalized linear model including covariates for treatment group and age class as stratified (≤38 yrs vs \\>38 yrs)'}], 'paramType': 'NUMBER', 'timeFrame': 'Assessed at least 35 days after ET in COS cycle in Base Study P06029 or an FTET cycle in Follow-Up Study P06031 (up to 2 years)', 'description': 'The cumulative vital pregnancy rate was defined as the number of participants with at least 1 vital pregnancy in a controlled ovarian stimulation (COS) cycle in Base Study P06029 or a frozen-thawed embryo transfer (FTET) in Follow Up Study P06031, divided by the total number of participants in each Full Analysis Set (FAS) treatment group. A vital pregnancy was defined as an intrauterine pregnancy with fetal heart tones assessed at least 35 days (≥5 weeks) after embryo transfer (ET).', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) population consisted of all randomized participants who received corifollitropin alfa or recFSH in Base Study P06029.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ≥1 Live Birth (Cumulative Live-Birth Rate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '694', 'groupId': 'OG000'}, {'value': '696', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Corifollitropin Alfa 150 μg Women/Expectant Mothers', 'description': 'Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.'}, {'id': 'OG001', 'title': 'recFSH 300 IU Women/Expectant Mothers', 'description': 'Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.2', 'groupId': 'OG000', 'lowerLimit': '24.9', 'upperLimit': '31.8'}, {'value': '29.5', 'groupId': 'OG001', 'lowerLimit': '26.1', 'upperLimit': '33.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-5.7', 'ciUpperLimit': '3.4', 'statisticalMethod': 'Clopper-Pearson method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Difference calculated using generalized linear model including covariates for treatment group and age class as stratified (≤38 yrs vs \\>38 yrs)'}], 'paramType': 'NUMBER', 'timeFrame': 'From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to time of delivery (up to 2 years)', 'description': 'The cumulative live-birth rate was defined as the number of participants with at least 1 live birth after ET in a COS cycle in Base Study P06029 or an FTET in Follow-Up Study P06031, divided by the total number of participants in each FAS treatment group.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population consisted of all randomized participants who received corifollitropin alfa or recFSH in Base Study P06029.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Corifollitropin Alfa 150 μg Women/Expectant Mothers', 'description': 'Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.'}, {'id': 'FG001', 'title': 'recFSH 300 IU Women/Expectant Mothers', 'description': 'Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.'}, {'id': 'FG002', 'title': 'Corifollitropin Alfa 150 μg Live-Born Infants', 'description': 'Infants born to eligible participants who received a single injection of 150 μg corifollitropin alfa in Base Study P06029 (NCT01144416) were followed for safety and efficacy in Follow-Up Study P06031 according to standard practice.'}, {'id': 'FG003', 'title': 'recFSH 300 IU Live-Born Infants', 'description': 'Infants born to eligible participants who received daily 300 IU recFSH in Base Study P06029 (NCT01144416) were followed for safety and efficacy in Follow-Up Study P06031 according to standard practice.'}], 'periods': [{'title': 'Base Study P06029 (NCT01144416)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '694'}, {'groupId': 'FG001', 'numSubjects': '696'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Participants who underwent ET in base study', 'groupId': 'FG000', 'numSubjects': '632'}, {'comment': 'Participants who underwent ET in base study', 'groupId': 'FG001', 'numSubjects': '647'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '49'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Women/Expectant Mother Follow Up', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants from Base Study P06029 with at least one embryo thawed for use in FTET cycle.', 'groupId': 'FG000', 'numSubjects': '157'}, {'comment': 'Participants from base study P06029 with at least one embryo thawed for use in FTET cycle.', 'groupId': 'FG001', 'numSubjects': '150'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Participants With Embryo Transfer (ET)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}, {'groupId': 'FG001', 'numSubjects': '147'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Participants With an Ongoing Pregnancy', 'achievements': [{'comment': 'Ongoing pregnancy defined as intra-uterine pregnancy with fetal heart beat on USS 10 weeks after ET', 'groupId': 'FG000', 'numSubjects': '52'}, {'comment': 'Ongoing pregnancy defined as intra-uterine pregnancy with fetal heart beat on USS 10 weeks after ET', 'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Participants with ET transfer who completed follow-up study', 'groupId': 'FG000', 'numSubjects': '113'}, {'comment': 'Participants with ET transfer who completed follow-up study', 'groupId': 'FG001', 'numSubjects': '110'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Live-Born Infant Follow Up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '61'}, {'groupId': 'FG003', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'Infants who completed follow up', 'groupId': 'FG002', 'numSubjects': '55'}, {'comment': 'Infants who completed follow up', 'groupId': 'FG003', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '5'}]}]}], 'preAssignmentDetails': 'Period 1 consists of participants from Base Study P06029 (NCT01144416) randomized to treatment groups corifollitropin alfa or recombinant follicle stimulating hormone (recFSH). Period 2 consists of participants from base study enrolled in Follow-Up Study P06031. Period 3 consists of infants born to expectant mothers in Follow-Up Study P06031.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '298', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Corifollitropin Alfa 150 μg Women/Expectant Mothers', 'description': 'Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.'}, {'id': 'BG001', 'title': 'recFSH 300 IU Women/Expectant Mothers', 'description': 'Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.5', 'spread': '2.1', 'groupId': 'BG000'}, {'value': '38.3', 'spread': '2.2', 'groupId': 'BG001'}, {'value': '38.4', 'spread': '2.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '151', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '298', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All Subjects Evaluable, restricted to subjects with ET'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 307}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2014-04-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-05', 'studyFirstSubmitDate': '2010-06-11', 'resultsFirstSubmitDate': '2015-10-01', 'studyFirstSubmitQcDate': '2010-06-16', 'lastUpdatePostDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-01-04', 'studyFirstPostDateStruct': {'date': '2010-06-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With ≥1 Vital Pregnancy (Cumulative Vital Pregnancy Rate)', 'timeFrame': 'Assessed at least 35 days after ET in COS cycle in Base Study P06029 or an FTET cycle in Follow-Up Study P06031 (up to 2 years)', 'description': 'The cumulative vital pregnancy rate was defined as the number of participants with at least 1 vital pregnancy in a controlled ovarian stimulation (COS) cycle in Base Study P06029 or a frozen-thawed embryo transfer (FTET) in Follow Up Study P06031, divided by the total number of participants in each Full Analysis Set (FAS) treatment group. A vital pregnancy was defined as an intrauterine pregnancy with fetal heart tones assessed at least 35 days (≥5 weeks) after embryo transfer (ET).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With ≥1 Live Birth (Cumulative Live-Birth Rate)', 'timeFrame': 'From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to time of delivery (up to 2 years)', 'description': 'The cumulative live-birth rate was defined as the number of participants with at least 1 live birth after ET in a COS cycle in Base Study P06029 or an FTET in Follow-Up Study P06031, divided by the total number of participants in each FAS treatment group.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Reproductive Techniques, Assisted', 'Follicle Stimulating Hormone, Human', 'Fertilization In Vitro'], 'conditions': ['Infertility']}, 'referencesModule': {'references': [{'pmid': '27090863', 'type': 'RESULT', 'citation': 'Boostanfar R, Gates D, Guan Y, Gordon K, McCrary Sisk C, Stegmann BJ. Efficacy and safety of frozen-thawed embryo transfer in women aged 35 to 42 years from the PURSUE randomized clinical trial. Fertil Steril. 2016 Aug;106(2):300-305.e5. doi: 10.1016/j.fertnstert.2016.03.041. Epub 2016 Apr 16.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this follow-up study is to collect the outcome and safety of FTET cycles after the embryos are cryopreserved in P06029 (NCT01144416). P06029 was a study in which a single injection of corifollitropin alfa (SCH 900962) was compared with daily recombinant follicle stimulating hormone (recFSH) injections in women aged 35 to 42 years undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant must have provided written informed consent for the trial.\n* Participant must have cryopreserved embryo(s) in trial P06029 (NCT01144416) of which at least one embryo is thawed for use in a subsequent FTET cycle.'}, 'identificationModule': {'nctId': 'NCT01146418', 'briefTitle': 'Frozen-thawed Embryo Transfer (FTET) Cycle Follow-up Protocol (P06031)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'Follow-up Protocol to Collect the Outcome and Safety of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Study P06029 (Phase 3; Protocol No. P06031)', 'orgStudyIdInfo': {'id': 'P06031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Corifollitropin alfa 150 μg', 'description': 'Participants in Base Study P06029 received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. No medication or investigational product was administered in Follow-Up Study P06031.', 'interventionNames': ['Biological: Corifollitropin alfa']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'recFSH 300 IU', 'description': 'Participants in the reference group in Base Study P06029 received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. No medication or investigational product was administered in Follow-Up Study P06031.', 'interventionNames': ['Biological: recFSH (follitropin beta)']}], 'interventions': [{'name': 'Corifollitropin alfa', 'type': 'BIOLOGICAL', 'description': 'Single injection of 150 μg corifollitropin alfa administered under protocol P06029', 'armGroupLabels': ['Corifollitropin alfa 150 μg']}, {'name': 'recFSH (follitropin beta)', 'type': 'BIOLOGICAL', 'otherNames': ['Follistim® AQ Cartridge'], 'description': 'Daily recFSH 300 IU administered under protocol P06029.', 'armGroupLabels': ['recFSH 300 IU']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}