Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:58 PM
Study NCT ID:
NCT00257556
Status:
COMPLETED
Last Update Posted:
2010-02-26
First Post:
2005-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of the Efficacy and Safety of Highly Purified Menotrophin Versus Recombinant Follitropin Alfa
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008596', 'term': 'Menotropins'}, {'id': 'C571801', 'term': 'follitropin alfa'}], 'ancestors': [{'id': 'D006065', 'term': 'Gonadotropins, Pituitary'}, {'id': 'D006062', 'term': 'Gonadotropins'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'DK0-Disclosure@ferring.com', 'title': 'Clinical Development Support', 'organization': 'Ferring Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'The only disclosure restiction 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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': "The 'all patients treated' population is the same as the safety population in this study.", 'eventGroups': [{'id': 'EG000', 'title': 'Menotrophin', 'description': 'Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)', 'otherNumAtRisk': 37, 'otherNumAffected': 18, 'seriousNumAtRisk': 37, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Follitropin Alfa', 'description': 'A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).', 'otherNumAtRisk': 39, 'otherNumAffected': 21, 'seriousNumAtRisk': 39, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Abdominal Pain Lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Injection Site Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Injection Site Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Injection Site Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Injection Site Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Injection Site Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Breast Tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Ovarian Hyperstimulation Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Vaginal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Skin Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}], 'seriousEvents': [{'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Abdominal Pain Lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Abortion Spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 3}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Abortion Imminent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Ovarian Hyperstimulation Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Uterine Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Vaginal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With an Ongoing Pregnancy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Menotrophin', 'description': 'Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)'}, {'id': 'OG001', 'title': 'Follitropin Alfa', 'description': 'A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Approx week 13; 9 weeks or more after the 1st positive pregnancy test', 'description': 'Number of participants who met human chorionic gonadotrophin (hCG) criterion, received an embryo transfer, tested positive with a serum pregnancy test 11-14 days after embryo transfer and had an ongoing pregnancy (defined as positive fetal heart action) at ≥ 9 weeks after the first positive pregnancy test.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients treated population'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With an Ongoing Pregnancy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Menotrophin', 'description': 'Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)'}, {'id': 'OG001', 'title': 'Follitropin Alfa', 'description': 'A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).'}], 'classes': [{'categories': [{'measurements': [{'value': '37.8', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.045', 'ciLowerLimit': '-0.170', 'ciUpperLimit': '0.260', 'estimateComment': 'A two-sided 95% continuity-corrected confidence interval for the difference in percentages, based on the normal approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Approx week 13; 9 weeks or more after the first positive pregnancy test', 'description': 'Percentage of participants who had an ongoing pregnancy ≥ 9 weeks after the first positive pregnancy test, as indicated by positive fetal heart action.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients treated population. Two menotrophin patients did not have pregnancy outcome data recorded in this timeframe but were later recorded as having live births so are included here as "YES" for ongoing pregnancy.'}, {'type': 'SECONDARY', 'title': 'Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Menotrophin', 'description': 'Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)'}, {'id': 'OG001', 'title': 'Follitropin Alfa', 'description': 'A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).'}], 'classes': [{'title': 'Did not meet criterion', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '3 follicles ≥ 17 mm in diameter', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': '4 follicles ≥ 17 mm in diameter', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': '5 follicles ≥ 17 mm in diameter', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': '6 follicles ≥ 17 mm in diameter', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '7 follicles ≥ 17 mm in diameter', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '8 follicles ≥ 17 mm in diameter', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '9 follicles ≥ 17 mm in diameter', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '10 follicles ≥ 17 mm in diameter', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '11-14 follicles ≥ 17 mm in diameter', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '15 follicles ≥ 17 mm in diameter', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '16 follicles ≥ 17 mm in diameter', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13)', 'description': 'The criterion for ovulation induction was three follicles ≥ 17 mm diameter as shown by pelvic ultrasound examination. Patients were assessed by pelvic ultrasound on the morning (prior to menotrophin or follitropin alfa administration) of Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13) until the criterion was met.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated patients population'}, {'type': 'SECONDARY', 'title': 'Participants With Varying Numbers of Oocytes Retrieved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Menotrophin', 'description': 'Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)'}, {'id': 'OG001', 'title': 'Follitropin Alfa', 'description': 'A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).'}], 'classes': [{'title': '0 oocytes retrieved', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '1 oocyte retrieved', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '2 oocytes retrieved', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '3 oocytes retrieved', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '4 oocytes retrieved', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '5 oocytes retrieved', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': '6 oocytes retrieved', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '7 oocytes retrieved', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '8 oocytes retrieved', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '9 oocytes retrieved', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '10 oocytes retrieved', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '11 oocytes retrieved', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '12 oocytes retrieved', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '13 oocytes retrieved', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '14 oocytes retrieved', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '15 oocytes retrieved', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '16 oocytes retrieved', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '17-18 oocytes retrieved', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '19 oocytes retrieved', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '20 oocytes retrieved', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '21 oocytes retrieved', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '22 oocytes retrieved', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '23 oocytes retrieved', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately study day 15', 'description': 'Number of participants with grouped by the number of oocytes retrieved. Oocytes were retrieved following ovulation induction by subcutaneous administration of human chorionic gonadotrophin (hCG) in the form of choriogonadotropin alfa at a dose of 250 micrograms once participants reached the criteria of at least three follicles with \\>= 17mm in diameter.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated patients population.'}, {'type': 'SECONDARY', 'title': 'Participants With Varying Numbers of Pronuclear Stage Oocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Menotrophin', 'description': 'Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)'}, {'id': 'OG001', 'title': 'Follitropin Alfa', 'description': 'A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).'}], 'classes': [{'title': '1 pronuclear stage oocyte', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '2 pronuclear stage oocytes', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': '3 pronuclear stage oocytes', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '4 pronuclear stage oocytes', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': '5 pronuclear stage oocytes', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': '6 pronuclear stage oocytes', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '7 pronuclear stage oocytes', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '8 pronuclear stage oocytes', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '9 pronuclear stage oocytes', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '10 pronuclear stage oocytes', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '11 pronuclear stage oocytes', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '12 pronuclear stage oocytes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '13 pronuclear stage oocytes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '14-16 pronuclear stage oocytes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '17 pronuclear stage oocytes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately study day 15', 'description': 'Number of participants with various groupings of pronuclear oocytes retrieved 16-20 hours after insemination.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients treated population'}, {'type': 'SECONDARY', 'title': 'Participants With Varying Numbers of Embryos Transferred', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Menotrophin', 'description': 'Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)'}, {'id': 'OG001', 'title': 'Follitropin Alfa', 'description': 'A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).'}], 'classes': [{'title': '0 embryos transferred', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '1 embryo transferred', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '2 embryos transferred', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': '3 embryos transferred', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately study day 17', 'description': 'Number of participants with various categories of numbers of embryos transferred.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients treated population'}, {'type': 'SECONDARY', 'title': 'Participants With Varying Numbers of Embryos Frozen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Menotrophin', 'description': 'Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)'}, {'id': 'OG001', 'title': 'Follitropin Alfa', 'description': 'A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).'}], 'classes': [{'title': '0 embryos frozen', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': '1 embryo frozen', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '2 embryos frozen', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '3 embryos frozen', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '4 embryos frozen', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '5 embryos frozen', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '6-8 embryos frozen', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '9 embryos frozen', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '10 embryos frozen', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately study day 17', 'description': 'Number of participants with different categories of number of embryos frozen.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients treated population'}, {'type': 'SECONDARY', 'title': 'Mean Number of Days Stimulated With Gonadotrophins', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Menotrophin', 'description': 'Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)'}, {'id': 'OG001', 'title': 'Follitropin Alfa', 'description': 'A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).'}], 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'spread': '1.71', 'groupId': 'OG000'}, {'value': '8.9', 'spread': '1.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'study days 1 - 13', 'description': 'Number of days stimulated with study drug until participant met the criteria for ovulation induction. Ovulation induction criteria is three follicles greater than or equal to 17 mm diameter as shown by pelvic ultrasound examination.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients treated population'}, {'type': 'SECONDARY', 'title': 'Pregnancy Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Menotrophin', 'description': 'Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)'}, {'id': 'OG001', 'title': 'Follitropin Alfa', 'description': 'A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).'}], 'classes': [{'title': 'Miscarriage', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Pre-term: 1 live birth', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Pre-term: 2 live births', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Pre-term stillbirth', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Full term: 1 live birth', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Full term: 2 live births', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately 10 months', 'description': 'Long term follow-up to determine the outcome of the pregnancy.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients treated population'}, {'type': 'SECONDARY', 'title': 'Mean Endometrial Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Menotrophin', 'description': 'Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)'}, {'id': 'OG001', 'title': 'Follitropin Alfa', 'description': 'A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).'}], 'classes': [{'categories': [{'measurements': [{'value': '11.7', 'spread': '2.73', 'groupId': 'OG000'}, {'value': '11.0', 'spread': '2.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 7 or 9 or 11 or 13', 'description': 'Measurement performed on day of human chorionic gonadotrophin (hCG) administration/ovulation induction.', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients treated population'}, {'type': 'SECONDARY', 'title': 'Mean Estradiol Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Menotrophin', 'description': 'Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)'}, {'id': 'OG001', 'title': 'Follitropin Alfa', 'description': 'A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).'}], 'classes': [{'categories': [{'measurements': [{'value': '6706.6', 'spread': '4109.26', 'groupId': 'OG000'}, {'value': '6268.3', 'spread': '4132.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 7 or 9 or 11 or 13', 'description': 'Measurement on day of human chorionic gonadotrophin (hCG) administration / ovulation induction.', 'unitOfMeasure': 'picomoles / liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patient treated population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Menotrophin', 'description': 'Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)'}, {'id': 'FG001', 'title': 'Follitropin Alfa', 'description': 'A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'All Patients Treated Population', 'achievements': [{'comment': 'Also the safety population. One randomized patient did not receive study medication.', 'groupId': 'FG000', 'numSubjects': '37'}, {'comment': 'Also the safety population. Three randomized patients did not receive study medication.', 'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Did not meet hCG criterion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'other reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'preAssignmentDetails': 'Ninety (90) participants were screened and 80 participants randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Menotrophin', 'description': 'Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)'}, {'id': 'BG001', 'title': 'Follitropin Alfa', 'description': 'A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.7', 'spread': '3.45', 'groupId': 'BG000'}, {'value': '30.9', 'spread': '2.67', 'groupId': 'BG001'}, {'value': '30.8', 'spread': '3.06', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Tobacco Use', 'classes': [{'title': 'Smoker', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Ex-smoker', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Never Smoked', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '24.02', 'spread': '3.689', 'groupId': 'BG000'}, {'value': '23.81', 'spread': '3.731', 'groupId': 'BG001'}, {'value': '23.91', 'spread': '3.687', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Body mass index (BMI) is measure of body fat based on height and weight that applies to both adult men and women', 'unitOfMeasure': 'Kilograms/Meters squared', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '74.1', 'spread': '8.83', 'groupId': 'BG000'}, {'value': '73.8', 'spread': '9.96', 'groupId': 'BG001'}, {'value': '74.0', 'spread': '9.37', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pulse', 'classes': [{'categories': [{'measurements': [{'value': '75.7', 'spread': '9.63', 'groupId': 'BG000'}, {'value': '74.5', 'spread': '9.16', 'groupId': 'BG001'}, {'value': '75.1', 'spread': '9.35', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Systolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '115.3', 'spread': '12.50', 'groupId': 'BG000'}, {'value': '116.1', 'spread': '14.55', 'groupId': 'BG001'}, {'value': '115.7', 'spread': '13.51', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-12', 'studyFirstSubmitDate': '2005-11-22', 'resultsFirstSubmitDate': '2010-01-08', 'studyFirstSubmitQcDate': '2005-11-22', 'lastUpdatePostDateStruct': {'date': '2010-02-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-02-12', 'studyFirstPostDateStruct': {'date': '2005-11-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With an Ongoing Pregnancy', 'timeFrame': 'Approx week 13; 9 weeks or more after the 1st positive pregnancy test', 'description': 'Number of participants who met human chorionic gonadotrophin (hCG) criterion, received an embryo transfer, tested positive with a serum pregnancy test 11-14 days after embryo transfer and had an ongoing pregnancy (defined as positive fetal heart action) at ≥ 9 weeks after the first positive pregnancy test.'}, {'measure': 'Percentage of Participants With an Ongoing Pregnancy', 'timeFrame': 'Approx week 13; 9 weeks or more after the first positive pregnancy test', 'description': 'Percentage of participants who had an ongoing pregnancy ≥ 9 weeks after the first positive pregnancy test, as indicated by positive fetal heart action.'}], 'secondaryOutcomes': [{'measure': 'Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters', 'timeFrame': 'Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13)', 'description': 'The criterion for ovulation induction was three follicles ≥ 17 mm diameter as shown by pelvic ultrasound examination. Patients were assessed by pelvic ultrasound on the morning (prior to menotrophin or follitropin alfa administration) of Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13) until the criterion was met.'}, {'measure': 'Participants With Varying Numbers of Oocytes Retrieved', 'timeFrame': 'Approximately study day 15', 'description': 'Number of participants with grouped by the number of oocytes retrieved. Oocytes were retrieved following ovulation induction by subcutaneous administration of human chorionic gonadotrophin (hCG) in the form of choriogonadotropin alfa at a dose of 250 micrograms once participants reached the criteria of at least three follicles with \\>= 17mm in diameter.'}, {'measure': 'Participants With Varying Numbers of Pronuclear Stage Oocytes', 'timeFrame': 'Approximately study day 15', 'description': 'Number of participants with various groupings of pronuclear oocytes retrieved 16-20 hours after insemination.'}, {'measure': 'Participants With Varying Numbers of Embryos Transferred', 'timeFrame': 'Approximately study day 17', 'description': 'Number of participants with various categories of numbers of embryos transferred.'}, {'measure': 'Participants With Varying Numbers of Embryos Frozen', 'timeFrame': 'Approximately study day 17', 'description': 'Number of participants with different categories of number of embryos frozen.'}, {'measure': 'Mean Number of Days Stimulated With Gonadotrophins', 'timeFrame': 'study days 1 - 13', 'description': 'Number of days stimulated with study drug until participant met the criteria for ovulation induction. Ovulation induction criteria is three follicles greater than or equal to 17 mm diameter as shown by pelvic ultrasound examination.'}, {'measure': 'Pregnancy Outcomes', 'timeFrame': 'Approximately 10 months', 'description': 'Long term follow-up to determine the outcome of the pregnancy.'}, {'measure': 'Mean Endometrial Thickness', 'timeFrame': 'Day 7 or 9 or 11 or 13', 'description': 'Measurement performed on day of human chorionic gonadotrophin (hCG) administration/ovulation induction.'}, {'measure': 'Mean Estradiol Level', 'timeFrame': 'Day 7 or 9 or 11 or 13', 'description': 'Measurement on day of human chorionic gonadotrophin (hCG) administration / ovulation induction.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'Prospective open label, randomised, parallel group, comparative pilot.', 'detailedDescription': 'Ongoing pregnancy rate, defined as positive fetal heart action 9 weeks after the first positive pregnancy test. Number/diameter of follicles, number of oocytes retrieved, number of pronuclear oocytes (referred to as zygotes or pre-embryos in the UK), quality of pronuclear stage oocytes, number of embryos transferred, quality of embryos, number of frozen embryos, endometrial thickness and morphology on day of HCG administration, estradiol levels at day of HCG administration, implantation rate, number of days stimulated with gonadotrophins and number of ampoules used, clinical pregnancy rate at 6 weeks after the first positive pregnancy test, pregnancy outcome.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Female patients aged \\> or = 20 and \\< or = 35 years with a BMI of \\>18 and \\<32 kg/m2 who have received no more than two previous cycles of in vitro fertilisation (IVF) or other assisted reproductive technique (ART) and whose partners have normal sperm (according to WHO 1999 criteria).\n\nInclusion criteria:\n\n* Signed informed consent;\n* Subfertile premenopausal female patients eligible for IVF treatment;\n* Aged \\>=20 and \\<=35 years;\n* Body mass index of \\>18 and \\<32 kg/m2\n* Normal endocrine assessment within the last 6 months;\n* Normal pelvic ultrasound (showing two ovaries, no ovarian abnormalities and normal uterus) within the last 6 months;\n* Receipt of no more than two previous cycles of IVF (or other ART);\n* At least 3 consecutive ovulatory menstrual cycles of 24-35 days, and documented evidence of ovulatory cycles within the previous 12 months;\n* No fertility-modifying treatment within the 3 months prior to this treatment cycle;\n* Infertility attributable to or in association with either tubal factor, or unexplained causes;\n* Sperm of partner classed as normal according to WHO 1999 criteria within the year prior to beginning therapy;\n* Negative serum beta-HCG pregnancy test prior to beginning therapy;\n* Clinically normal baseline haematology, clinical chemistry, and urinalysis parameter values, negative serum HBsAg and HIV antibody tests;\n* Screening endocrine test results (estradiol, LH, FSH, progesterone, prolactin, TSH) in early follicular phase within the normal limits for the clinical laboratory.\n\nExclusion criteria\n\n* Presence of any clinically relevant systemic disease(e.g. insulin- dependent diabetes mellitus);\n* A history of or current endocrine disease, including polycystic ovary- like syndrome and hyperprolactinaemia;\n* A history of coagulation disorders;\n* Persistent ovarian cysts;\n* Contraindications for the use of gonadotrophins or GnRH antagonists;\n* A history of hypersensitivity to any of the constituents of the study medication or related compounds;\n* Three or more previous cycles of IVF (or other ART);\n* A history of alcohol abuse (more than 30 units per week on a regular basis);\n* History of chemo- or radiotherapy;\n* Currently breast-feeding, pregnant or with a contraindication to pregnancy;\n* Diagnosed poor responders in prior IVF treatment;\n* History of severe ovarian hyperstimulation syndrome (OHSS) (4 or 5) in former IVF treatment;\n* Investigational drug within the 30 days prior to treatment;\n* Any other condition or history that the investigator considers might increase the risk to the individual.'}, 'identificationModule': {'nctId': 'NCT00257556', 'briefTitle': 'A Study of the Efficacy and Safety of Highly Purified Menotrophin Versus Recombinant Follitropin Alfa', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'A Prospective, Open Label, Randomised, Parallel Group, Comparative Pilot Study to Study the Efficacy and Safety of Highly Purified Menotrophin Versus Recombinant FSH (Follitropin Alfa) Administered Subcutaneously to Subfertile Female Patients Undergoing IVF Using Antagonist Downregulation', 'orgStudyIdInfo': {'id': 'FE999906 CS004 (PROSPECT)'}, 'secondaryIdInfos': [{'id': '2004-001307-35', 'type': 'REGISTRY', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Menotrophin', 'interventionNames': ['Drug: Menotrophin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Follitropin alfa', 'interventionNames': ['Drug: Follitropin alfa']}], 'interventions': [{'name': 'Menotrophin', 'type': 'DRUG', 'otherNames': ['Menopur', 'hMG', 'highly purified menotrophin'], 'description': '150 IU Menotrophin daily subcutaneous injection for a maximum of 13 days. In the event of hyperstimulation, the dose was reduced to 75 IU daily.', 'armGroupLabels': ['Menotrophin']}, {'name': 'Follitropin alfa', 'type': 'DRUG', 'otherNames': ['rFSH', 'recombinant FSH'], 'description': '150 IU follitropin alfa daily by subcutaneous injection for a maximum of 13 days. In the event of hyperstimulation, the dose was reduced to 75 IU daily.', 'armGroupLabels': ['Follitropin alfa']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44135', 'city': 'Dortmund', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis und Tagesklinik, Olpe 19', 'geoPoint': {'lat': 51.51494, 'lon': 7.466}}, {'zip': '69115', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Universitats-Frauenklinik Heidelberg Abt. Gynakologische Endokrinologie und Fertilitatsstorungen, Voßstr. 9', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '1134', 'city': 'Hildesheim', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis und Tagesklinik, Zingel 29', 'geoPoint': {'lat': 52.15077, 'lon': 9.95112}}, {'zip': 'EH16 4SA', 'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'Royal Infirmary of Edinburgh, 51 Little France', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'LS1 3EX', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Leeds General Infirmary, Great George Street', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'S10 2SF', 'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'The Royal Hallamshire Hospital, University of Sheffield, Jessop Wing, Tree Root Walk', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}], 'overallOfficials': [{'name': 'Clinical Development Support', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ferring Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ferring Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Clinical Development Support', 'oldOrganization': 'Ferring Pharmaceuticals'}}}}