Ignite Creation Date:
2025-12-24 @ 4:22 PM
Ignite Modification Date:
2025-12-29 @ 3:56 AM
Study NCT ID:
NCT01312766
Status:
COMPLETED
Last Update Posted:
2016-07-22
First Post:
2011-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study in in Vitro Fertilisation (IVF) Patients
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'}], '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': 'barbara.cometti@ibsa.ch', 'phone': '+41 58 360 10 00', 'title': 'Dr. Barbara Cometti, Senior Clinical Research Manager, IBSA', 'organization': 'IBSA Institut Biochimique SA'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'hMG-IBSA', 'description': 'New hMG preparation.\n\nMenotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.', 'otherNumAtRisk': 135, 'otherNumAffected': 46, 'seriousNumAtRisk': 135, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Menopur', 'description': 'Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.', 'otherNumAtRisk': 135, 'otherNumAffected': 42, 'seriousNumAtRisk': 135, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 23, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 18, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 33, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 32, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hot flushes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vestibular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'peritoneal heamorrage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headacje', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abortion Incomplete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abortion Missed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abortion threatened', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ectopic pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperemesis gravidarum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Imminent abortion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'OHSS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ovarina torsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal haemorrage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Number of Oocytes Retrieved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'hMG-IBSA', 'description': 'New hMG preparation.\n\nMenotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.'}, {'id': 'OG001', 'title': 'Menopur', 'description': 'Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.6', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '9.7', 'spread': '5.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '0.43', 'ciUpperLimit': '3.43', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The one-way Analysis of Variance with Least-Squares means was performed to calculate the 95% Confidence Interval of the difference between the two treatments. If the lower bound of the 95% Confidence Interval of the difference between means (hMG-IBSA minus Menopur®) was greater than -2.1, then hMG-IBSA would be considered to be not-inferior to the comparator.'}], 'paramType': 'MEAN', 'timeFrame': 'up to 24 days after treatment start', 'unitOfMeasure': 'number of oocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean hMG Dose (Total);', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'hMG-IBSA', 'description': 'New hMG preparation.\n\nMenotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.'}, {'id': 'OG001', 'title': 'Menopur', 'description': 'Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.'}], 'classes': [{'categories': [{'measurements': [{'value': '2171.4', 'spread': '980', 'groupId': 'OG000'}, {'value': '2303.6', 'spread': '906', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.25', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'up to 22 days after treatment start', 'unitOfMeasure': 'Internationa Units (IU)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Embryo Quality (Percentage of Patients With at Least One Top Quality Embryo)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'hMG-IBSA', 'description': 'New hMG preparation.\n\nMenotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.'}, {'id': 'OG001', 'title': 'Menopur', 'description': 'Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.3', 'spread': '1.74', 'groupId': 'OG000'}, {'value': '63.3', 'spread': '1.65', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 28 days after treatment start', 'description': 'Assessed by counting the total number of embryos obtained, the number of embryos transferred, frozen and discarded.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analysed corresponds to the patients who had at least one embryo to be analysed (i.e 120 participants in the hMG-IBSA group and 123 in the Menopur group). Of this, 119 in the hMG-IBSA group and 121 in the Menopur group underwent embryo transfer.'}, {'type': 'SECONDARY', 'title': 'Positive b-hCG Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'hMG-IBSA', 'description': 'New hMG preparation.\n\nMenotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.'}, {'id': 'OG001', 'title': 'Menopur', 'description': 'Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.7', 'groupId': 'OG000'}, {'value': '45.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.90', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'up to 5 weeks after treatment start', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Controlled Ovarian Stimulation Duration (Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'hMG-IBSA', 'description': 'New hMG preparation.\n\nMenotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.'}, {'id': 'OG001', 'title': 'Menopur', 'description': 'Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.2', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '10.6', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'up to 23 days after treatment start', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '17-β Estradiol (E2) Serum Concentration on the Monitoring Day Before hCG Injection;', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'hMG-IBSA', 'description': 'New hMG preparation.\n\nMenotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.'}, {'id': 'OG001', 'title': 'Menopur', 'description': 'Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.'}], 'classes': [{'categories': [{'measurements': [{'value': '2613.8', 'spread': '1531.6', 'groupId': 'OG000'}, {'value': '2364.0', 'spread': '1441.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 23 days after treatment start', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Implantation Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'hMG-IBSA', 'description': 'New hMG preparation.\n\nMenotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.'}, {'id': 'OG001', 'title': 'Menopur', 'description': 'Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.1', 'spread': '41.0', 'groupId': 'OG000'}, {'value': '28.2', 'spread': '36.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10-11 weeks after embryo transfer', 'description': 'defined as the mean of the total number of implanted embryos (presence of gestational sac assessed by ultrasound) divided by the total number of transferred embryos x 100;', 'unitOfMeasure': 'percentage of embryos transferred', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Pregnancy Rate,', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'hMG-IBSA', 'description': 'New hMG preparation.\n\nMenotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.'}, {'id': 'OG001', 'title': 'Menopur', 'description': 'Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '37.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.61', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '10 - 11 weeks after embryo transfer', 'description': 'defined as a pregnancy showing ultrasound embryonic heart activity at 10 - 11 weeks after embryo transfer;', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Mature (Grade III Metaphase II) Oocytes Retrieved.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'hMG-IBSA', 'description': 'New hMG preparation.\n\nMenotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.'}, {'id': 'OG001', 'title': 'Menopur', 'description': 'Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '5.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'at the end of the stimulation.', 'unitOfMeasure': 'oocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ratio Mature/Total Number of Oocytes Retrieved.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'hMG-IBSA', 'description': 'New hMG preparation.\n\nMenotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.'}, {'id': 'OG001', 'title': 'Menopur', 'description': 'Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.'}], 'classes': [{'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'at the end of the stimulation.', 'description': 'Percentage of retrieved oocytes considered to be mature.', 'unitOfMeasure': 'percentage of total oocytes retrieved', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Number of Inseminated Oocytes (IVF and ICSI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'hMG-IBSA', 'description': 'New hMG preparation.\n\nMenotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.'}, {'id': 'OG001', 'title': 'Menopur', 'description': 'Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '5.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'on the day of oocyte retrieval', 'description': 'number of oocytes that were inseminated via IVF or injected via ICSI technique.', 'unitOfMeasure': 'oocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Cleaved Embryos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'hMG-IBSA', 'description': 'New hMG preparation.\n\nMenotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.'}, {'id': 'OG001', 'title': 'Menopur', 'description': 'Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '3.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'two days after insemination', 'unitOfMeasure': 'embryos', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Live Birth Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'hMG-IBSA', 'description': 'New hMG preparation.\n\nMenotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.'}, {'id': 'OG001', 'title': 'Menopur', 'description': 'Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.6', 'groupId': 'OG000'}, {'value': '36.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.61', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '9 months after treatment', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'hMG-IBSA', 'description': 'New hMG preparation.\n\nMenotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.'}, {'id': 'FG001', 'title': 'Menopur', 'description': 'Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '135'}, {'groupId': 'FG001', 'numSubjects': '135'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}, {'groupId': 'FG001', 'numSubjects': '130'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'hMG-IBSA', 'description': 'New hMG preparation.\n\nMenotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.'}, {'id': 'BG001', 'title': 'Menopur', 'description': 'Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'spread': '4.0', 'groupId': 'BG000'}, {'value': '33.0', 'spread': '4.1', 'groupId': 'BG001'}, {'value': '33.1', 'spread': '4.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 270}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-10', 'studyFirstSubmitDate': '2011-03-07', 'resultsFirstSubmitDate': '2014-02-28', 'studyFirstSubmitQcDate': '2011-03-09', 'lastUpdatePostDateStruct': {'date': '2016-07-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-28', 'studyFirstPostDateStruct': {'date': '2011-03-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Number of Oocytes Retrieved', 'timeFrame': 'up to 24 days after treatment start'}], 'secondaryOutcomes': [{'measure': 'Mean hMG Dose (Total);', 'timeFrame': 'up to 22 days after treatment start'}, {'measure': 'Embryo Quality (Percentage of Patients With at Least One Top Quality Embryo)', 'timeFrame': 'up to 28 days after treatment start', 'description': 'Assessed by counting the total number of embryos obtained, the number of embryos transferred, frozen and discarded.'}, {'measure': 'Positive b-hCG Test', 'timeFrame': 'up to 5 weeks after treatment start'}, {'measure': 'Controlled Ovarian Stimulation Duration (Days)', 'timeFrame': 'up to 23 days after treatment start'}, {'measure': '17-β Estradiol (E2) Serum Concentration on the Monitoring Day Before hCG Injection;', 'timeFrame': 'up to 23 days after treatment start'}, {'measure': 'Implantation Rate', 'timeFrame': '10-11 weeks after embryo transfer', 'description': 'defined as the mean of the total number of implanted embryos (presence of gestational sac assessed by ultrasound) divided by the total number of transferred embryos x 100;'}, {'measure': 'Clinical Pregnancy Rate,', 'timeFrame': '10 - 11 weeks after embryo transfer', 'description': 'defined as a pregnancy showing ultrasound embryonic heart activity at 10 - 11 weeks after embryo transfer;'}, {'measure': 'Number of Mature (Grade III Metaphase II) Oocytes Retrieved.', 'timeFrame': 'at the end of the stimulation.'}, {'measure': 'Ratio Mature/Total Number of Oocytes Retrieved.', 'timeFrame': 'at the end of the stimulation.', 'description': 'Percentage of retrieved oocytes considered to be mature.'}, {'measure': 'Total Number of Inseminated Oocytes (IVF and ICSI)', 'timeFrame': 'on the day of oocyte retrieval', 'description': 'number of oocytes that were inseminated via IVF or injected via ICSI technique.'}, {'measure': 'Number of Cleaved Embryos', 'timeFrame': 'two days after insemination'}, {'measure': 'Live Birth Rate', 'timeFrame': '9 months after treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous hMG preparations when administered to patients undergoing controlled ovarian stimulation for IVF.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women undergoing ovarian stimulation for IVF with the following characteristics:\n\n * Able and willing to sign the Patient Consent Form and adhere to the study visitation schedule\n * \\>18 and \\<40 years old\n * BMI between 18 and 30 kg/m2\n * less than 3 previously completed IVF cycles (i.e. completed cycle = egg recovery)\n * basal FSH \\<10 IU/L and E2 \\<80 pg/ml (\\~290 pmol/l)\n * Within 12 months of the beginning of the study, uterine cavity consistent with expected normal function as assessed through transvaginal ultrasound, hysterosalpingogram, sonohysterogram or hysteroscopic examination\n * Successful down-regulation performed with a standard GnRH-Agonist long protocol (Criteria for successful down-regulation: endometrial thickness \\< 7mm or serum E2 level \\<50 pg/ml (\\~185 pmol/l).\n\nExclusion Criteria:\n\n* age \\<18 and \\>40 years\n* primary ovarian failure or women known as poor responders (i.e. requiring more than 225 IU of hMG as a starting dose in previous treatment cycles or having less than 3 oocytes retrieved, or with a pre-ovulatory E2 serum concentration \\<500pg/ml (\\~1800 pmol/l))\n* PCOS\n* one or both ovaries inaccessible for oocyte retrieval\n* ovarian cysts \\>10 mm\n* hydrosalpinx that have not been surgically removed or ligated;\n* stage 3 or 4 endometriosis\n* oocyte donation\n* implantation of previously frozen embryos\n* patients affected by pathologies associated with any contraindication of being pregnant\n* hypersensitivity to the study medication\n* abnormal bleeding of undetermined origin\n* uncontrolled thyroid or adrenal dysfunction\n* neoplasias\n* severe impairment of renal and/or hepatic function\n* use of concomitant medications that might interfere with study evaluations (e.g. non-study hormonal medications, prostaglandin inhibitors, psychotropic agents)'}, 'identificationModule': {'nctId': 'NCT01312766', 'briefTitle': 'Safety and Efficacy Study in in Vitro Fertilisation (IVF) Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'IBSA Institut Biochimique SA'}, 'officialTitle': 'Safety and Efficacy Study Comparing a New hMG Formulation (hMG-IBSA) to a Reference Product (Menopur®) in Patients Undergoing Ovarian Stimulation for in Vitro Fertilisation (IVF)', 'orgStudyIdInfo': {'id': '10EU/hMG02'}, 'secondaryIdInfos': [{'id': '2010-021021-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hMG-IBSA', 'description': 'New hMG preparation.', 'interventionNames': ['Drug: Menotropins']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Menopur', 'interventionNames': ['Drug: Menotropins']}], 'interventions': [{'name': 'Menotropins', 'type': 'DRUG', 'description': 'Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.', 'armGroupLabels': ['hMG-IBSA']}, {'name': 'Menotropins', 'type': 'DRUG', 'description': 'Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.', 'armGroupLabels': ['Menopur']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'state': 'Copenhagen', 'country': 'Denmark', 'facility': 'Fertility clinic at Hvidovre Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}, {'zip': '5000', 'city': 'Odense', 'state': 'Odensee C', 'country': 'Denmark', 'facility': 'Odense Universitetshospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Groupe Hospitalier Cochin - Saint Vincent de Paul', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '1088', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'First Dept. Obstetric and Gynaecology, Semmelweiss University', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '4031', 'city': 'Basel', 'state': 'Canton of Basel-City', 'country': 'Switzerland', 'facility': 'Universitätsspital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': 'WS9 8LT', 'city': 'Aldridge', 'state': 'West Midlands', 'country': 'United Kingdom', 'facility': 'Midland Fertility Services', 'geoPoint': {'lat': 52.60549, 'lon': -1.91715}}], 'overallOfficials': [{'name': 'Dominique De Ziegler, MD, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital Cochin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IBSA Institut Biochimique SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}