Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2025-12-26 @ 1:57 PM
Study NCT ID:
NCT01121666
Status:
COMPLETED
Last Update Posted:
2016-04-15
First Post:
2010-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multi-centre Study to Compare Efficacy and Safety of AFOLIA and Gonal-f in Women for Assisted Reproductive Treatment
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': 'C571801', 'term': 'follitropin alfa'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clin@five.ch', 'phone': '+41 44 9324132', 'title': 'Dr. Melanie Ruf', 'organization': 'Five Office Ltd'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Study period + 30 days', 'eventGroups': [{'id': 'EG000', 'title': 'AFOLIA-150 (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days', 'otherNumAtRisk': 249, 'otherNumAffected': 182, 'seriousNumAtRisk': 249, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Gonal-f® (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days', 'otherNumAtRisk': 123, 'otherNumAffected': 83, 'seriousNumAtRisk': 123, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 44}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Injection site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 25}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Ovarian hyperstimulation syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 16}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Biliary colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Ovarian haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Ovarian hyperstimulation syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Body temparature increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Oocytes Retrieved (Per Protocol Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFOLIA-150 (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}, {'id': 'OG001', 'title': 'Gonal-f® (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}], 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'spread': '5.11', 'groupId': 'OG000'}, {'value': '10.6', 'spread': '6.06', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'This study was powered to test equivalence using a two one-sided test (TOST) with a power of 90%, an alpha error of 2.5% and a pre-determined clinical equivalence margin of +/-2.9 oocytes for the relevant population.', 'groupDescription': 'This study was powered to test equivalence using a two one-sided test (TOST) of the number of oocytes retrieved.', 'statisticalMethod': "Shuirmann's TOST", 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'This study was powered to test equivalence using a two one-sided test (TOST) of the number of oocytes retrieved with a power of 90%, an alpha error of 2.5% and a pre-determined clinical equivalence margin of +/-2.9 oocytes for the relevant population.'}], 'paramType': 'MEAN', 'timeFrame': '34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment', 'description': 'As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped.\n\nThe equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes', 'unitOfMeasure': 'Number of retrieved oocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population'}, {'type': 'SECONDARY', 'title': 'Number and Size of Follicles ≥ 12 mm at Day 8 of Stimulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFOLIA-150 (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}, {'id': 'OG001', 'title': 'Gonal-f® (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}], 'classes': [{'title': '≥ 12 mm', 'categories': [{'measurements': [{'value': '11.8', 'spread': '4.73', 'groupId': 'OG000'}, {'value': '11.1', 'spread': '4.23', 'groupId': 'OG001'}]}]}, {'title': '≥ 15 mm', 'categories': [{'measurements': [{'value': '8.3', 'spread': '3.81', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '3.60', 'groupId': 'OG001'}]}]}, {'title': '≥ 17 mm', 'categories': [{'measurements': [{'value': '4.9', 'spread': '3.29', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '2.71', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2357', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Follicles of 12 mm', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1395', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Follicles of 15 mm', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3992', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Follicles of 17 mm', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 8 of stimulation', 'description': 'The number and size of follicles 12 mm or over in diameter at day 8 of stimulation were evaluated as secondary end-point.', 'unitOfMeasure': 'Number of follicles', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants were analyzed.'}, {'type': 'SECONDARY', 'title': 'E2 Concentration at Day 8 and at Day of hCG Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFOLIA-150 (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}, {'id': 'OG001', 'title': 'Gonal-f® (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}], 'classes': [{'title': 'Day of hCG administration', 'categories': [{'measurements': [{'value': '8982.3', 'spread': '6535.3', 'groupId': 'OG000'}, {'value': '7704.2', 'spread': '5345.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '3958.9', 'spread': '3699.4', 'groupId': 'OG000'}, {'value': '3234.0', 'spread': '2428.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 8 of stimulation and at the day of hCG administration (after max. 16 days of r-FSH treatment)', 'description': 'The serum concentration of oestradiol was assessed at day 8 and the day of hCG administration.', 'unitOfMeasure': 'pmol/ L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants were analyzed.'}, {'type': 'SECONDARY', 'title': 'Total Dose of r-hFSH Administered', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFOLIA-150 (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}, {'id': 'OG001', 'title': 'Gonal-f® (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}], 'classes': [{'categories': [{'measurements': [{'value': '1555.7', 'spread': '293.00', 'groupId': 'OG000'}, {'value': '1569.2', 'spread': '259.20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9638', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day of hCG administration (after maximum 16 days of r-hFSH treatment)', 'description': 'Total dose of r-hFSH required was assessed.', 'unitOfMeasure': 'IU', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants were analyzed.'}, {'type': 'SECONDARY', 'title': 'Quality of Oocytes Retrieved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFOLIA-150 (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}, {'id': 'OG001', 'title': 'Gonal-f® (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}], 'classes': [{'title': 'day 2', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'day 3', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '34-36 hours after hCG administration', 'description': 'Number of patients with ovum pick-up', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population'}, {'type': 'SECONDARY', 'title': 'Fertilisation Rate of Oocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFOLIA-150 (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}, {'id': 'OG001', 'title': 'Gonal-f® (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}], 'classes': [{'categories': [{'measurements': [{'value': '66.1', 'spread': '24.84', 'groupId': 'OG000'}, {'value': '64.0', 'spread': '24.76', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day after ovum pick-up', 'description': 'Fertilisation rate was assessed', 'unitOfMeasure': 'percentage of oocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population'}, {'type': 'SECONDARY', 'title': 'Embryo Quality: Mean Number of Blastomeres', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFOLIA-150 (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}, {'id': 'OG001', 'title': 'Gonal-f® (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'spread': '2.41', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '2.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 2 of OPU/fertilisation', 'description': 'Main embryo quality parameter "mean number of blastomeres"', 'unitOfMeasure': 'Number of blastomeres at day 3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cryopreserved 2PNs, Embryos/Blastocysts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFOLIA-150 (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}, {'id': 'OG001', 'title': 'Gonal-f® (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}], 'classes': [{'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1, 2, 3 and 5 of OPU/fertilisation', 'unitOfMeasure': 'Patients with cryopreservation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population'}, {'type': 'SECONDARY', 'title': 'Number of Days of r-hFSH Stimulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFOLIA-150 (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}, {'id': 'OG001', 'title': 'Gonal-f® (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}], 'classes': [{'categories': [{'measurements': [{'value': '10.6', 'spread': '1.91', 'groupId': 'OG000'}, {'value': '10.7', 'spread': '1.72', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8926', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At the day of hCG administration, up to 16 days', 'description': 'Mean duration of stimulation was assessed.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Cycle Cancellation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFOLIA-150 (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}, {'id': 'OG001', 'title': 'Gonal-f® (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Until child birth/miscarriage, up to the end of the study', 'description': 'Number of patients with cycle cancellation was assessed.', 'unitOfMeasure': 'Number of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Good Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFOLIA-150 (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}, {'id': 'OG001', 'title': 'Gonal-f® (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}], 'classes': [{'categories': [{'measurements': [{'value': '217', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Until child birth/miscarriage, up to the end of the study', 'description': 'Good response was defined as "patients with an oocyte retrieval of four or more oocytes"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population.'}, {'type': 'SECONDARY', 'title': 'Implantation Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFOLIA-150 (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}, {'id': 'OG001', 'title': 'Gonal-f® (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}], 'classes': [{'categories': [{'measurements': [{'value': '31.8', 'groupId': 'OG000'}, {'value': '36.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Five to six weeks after oocyte retrieval', 'description': 'Defined as fetal sac per embryo transferred.', 'unitOfMeasure': 'Percentage of implantations', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population.'}, {'type': 'SECONDARY', 'title': 'Clinical Pregnancy Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFOLIA-150 (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}, {'id': 'OG001', 'title': 'Gonal-f® (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Five to six weeks after oocyte retrieval', 'description': 'Presence of at least one intrauterine gestational sac.', 'unitOfMeasure': 'Clinical pregnancies', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population'}, {'type': 'SECONDARY', 'title': 'Ongoing Pregnancy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFOLIA-150 (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}, {'id': 'OG001', 'title': 'Gonal-f® (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}], 'classes': [{'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Ten weeks after embryo transfer', 'description': 'Ongoing pregnancy per embryo transfer. Presence of at least one viable fetus 10 weeks after embryo transfer.', 'unitOfMeasure': 'Ongoing pregnancies', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population'}, {'type': 'SECONDARY', 'title': 'Live Birth Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFOLIA-150 (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}, {'id': 'OG001', 'title': 'Gonal-f® (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After childbirth with questionnaire', 'description': 'Patients with liveborn children', 'unitOfMeasure': 'Patients with liveborn children', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population'}, {'type': 'PRIMARY', 'title': 'Number of Oocytes Retrieved (Intention-to-treat Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFOLIA-150 (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}, {'id': 'OG001', 'title': 'Gonal-f® (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}], 'classes': [{'categories': [{'measurements': [{'value': '10.7', 'spread': '5.62', 'groupId': 'OG000'}, {'value': '10.4', 'spread': '6.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': "Shuirmann's TOST", 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'This study was powered to test equivalence using a two one-sided test (TOST) of the number of oocytes retrieved with a power of 90%, an alpha error of 2.5% and a pre-determined clinical equivalence margin of +/-2.9 oocytes for the relevant population.'}], 'paramType': 'MEAN', 'timeFrame': '34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment', 'description': 'As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped.\n\nThe equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes', 'unitOfMeasure': 'Number of retrieved oocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat population'}, {'type': 'SECONDARY', 'title': 'Embryo Quality: Absence of Multinucleation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFOLIA-150 (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}, {'id': 'OG001', 'title': 'Gonal-f® (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}], 'classes': [{'categories': [{'measurements': [{'value': '93.6', 'groupId': 'OG000'}, {'value': '93.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 3', 'description': 'Main embryo quality parameter "absence of multinucleation" observed.', 'unitOfMeasure': 'Percentage of absent multinucleation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population'}, {'type': 'SECONDARY', 'title': 'Quality of Oocytes Retrieved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFOLIA-150 (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}, {'id': 'OG001', 'title': 'Gonal-f® (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}], 'classes': [{'title': 'day 4', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'day 5', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At day 4 and 5', 'description': 'Number of patients with transferred blastocysts', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population'}, {'type': 'SECONDARY', 'title': 'Quality of Oocytes Retrieved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFOLIA-150 (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}, {'id': 'OG001', 'title': 'Gonal-f® (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.53', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day of embryo transfer, either 2, 3 or 5 days after oocyte retrieval', 'description': 'Number of embryos per blastocysts transferred', 'unitOfMeasure': 'embryos per blastocysts transferred', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population'}, {'type': 'SECONDARY', 'title': 'Clinical Pregnancy Rate (Second Treatment Cycle)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFOLIA-150 (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}, {'id': 'OG001', 'title': 'Gonal-f® (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Five to six weeks after oocyte retrieval', 'description': 'Presence of at least one intrauterine gestational sac.', 'unitOfMeasure': 'Clinical pregnancies', 'reportingStatus': 'POSTED', 'populationDescription': 'Population with a second treatment cycle'}, {'type': 'SECONDARY', 'title': 'Ongoing Pregnancy (Second Treatment Cycle)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFOLIA-150 (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}, {'id': 'OG001', 'title': 'Gonal-f® (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 weeks after embryo transfer', 'description': 'Ongoing pregnancy per embryo transfer. Presence of at least one viable fetus 10 weeks after embryo transfer.', 'unitOfMeasure': 'Ongoing pregnancies', 'reportingStatus': 'POSTED', 'populationDescription': 'Population with a second treatment cycle'}, {'type': 'SECONDARY', 'title': 'Quality of Oocytes Retrieved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFOLIA-150 (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}, {'id': 'OG001', 'title': 'Gonal-f® (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}], 'classes': [{'title': 'very mature', 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}, {'value': '9.4', 'groupId': 'OG001'}]}]}, {'title': 'mature', 'categories': [{'measurements': [{'value': '75.7', 'groupId': 'OG000'}, {'value': '75.3', 'groupId': 'OG001'}]}]}, {'title': 'immature', 'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000'}, {'value': '14.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After oocyte retrieval, 34 to 36 hours after hCG administration', 'description': 'The maturity of the cumulus oophorus was assessed.', 'unitOfMeasure': 'Percentage of cumulus oophori', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population'}, {'type': 'SECONDARY', 'title': 'Quality of Oocytes Retrieved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFOLIA-150 (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}, {'id': 'OG001', 'title': 'Gonal-f® (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}], 'classes': [{'title': 'Germinal vesicle', 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000'}, {'value': '9.1', 'groupId': 'OG001'}]}]}, {'title': 'Metaphase I', 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000'}, {'value': '7.7', 'groupId': 'OG001'}]}]}, {'title': 'Metaphase II', 'categories': [{'measurements': [{'value': '83.4', 'groupId': 'OG000'}, {'value': '83.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After oocyte retrieval, 34 to 36 hours after hCG administration', 'description': 'The nuclear maturity was assessed (Germinal vesicle, Metaphase I, Metaphase II).', 'unitOfMeasure': 'Percentage of cells', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AFOLIA-150 (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}, {'id': 'FG001', 'title': 'Gonal-f® (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '249'}, {'groupId': 'FG001', 'numSubjects': '123'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '220'}, {'groupId': 'FG001', 'numSubjects': '113'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '10'}]}]}], 'recruitmentDetails': 'Subjects were screened and enrolled at 15 centers in six European countries from July 2010 until April 2012.', 'preAssignmentDetails': 'Of 460 participants in this trial 88 were reported as screening failures prior the group assignment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '372', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AFOLIA-150 (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}, {'id': 'BG001', 'title': 'Gonal-f® (Follitropin Alfa)', 'description': 'Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.8', 'spread': '4.02', 'groupId': 'BG000'}, {'value': '32.1', 'spread': '3.76', 'groupId': 'BG001'}, {'value': '31.95', 'spread': '3.90', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '249', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '372', '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 (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '229', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '346', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Austria', 'categories': [{'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'Switzerland', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'FSH baseline concentration', 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'groupId': 'BG000', 'lowerLimit': '2.5', 'upperLimit': '17.1'}, {'value': '6.9', 'groupId': 'BG001', 'lowerLimit': '2.8', 'upperLimit': '10'}, {'value': '6.9', 'groupId': 'BG002', 'lowerLimit': '2.5', 'upperLimit': '17.1'}]}]}], 'paramType': 'MEAN', 'description': 'The FSH concentration was measured at baseline in IU/L.', 'unitOfMeasure': '(IU/L)', 'dispersionType': 'FULL_RANGE'}, {'title': 'Antral follicle count', 'classes': [{'categories': [{'measurements': [{'value': '15.1', 'groupId': 'BG000', 'lowerLimit': '10', 'upperLimit': '24'}, {'value': '15.3', 'groupId': 'BG001', 'lowerLimit': '10', 'upperLimit': '24'}, {'value': '15.2', 'groupId': 'BG002', 'lowerLimit': '10', 'upperLimit': '24'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Antral follicle count', 'dispersionType': 'FULL_RANGE'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '22.7', 'groupId': 'BG000', 'lowerLimit': '18.0', 'upperLimit': '30.3'}, {'value': '22.4', 'groupId': 'BG001', 'lowerLimit': '18.2', 'upperLimit': '28.7'}, {'value': '22.6', 'groupId': 'BG002', 'lowerLimit': '18.0', 'upperLimit': '30.3'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogramm/ square meter', 'dispersionType': 'FULL_RANGE'}, {'title': 'GnRH-agonist duration', 'classes': [{'categories': [{'measurements': [{'value': '23.5', 'groupId': 'BG000', 'lowerLimit': '11.0', 'upperLimit': '44.0'}, {'value': '22.7', 'groupId': 'BG001', 'lowerLimit': '12.0', 'upperLimit': '46.0'}, {'value': '23.1', 'groupId': 'BG002', 'lowerLimit': '11.0', 'upperLimit': '46.0'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'FULL_RANGE'}, {'title': 'AMH less than 24 pmol/L', 'classes': [{'categories': [{'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of patients of each group who had a lower AMH level than 24 pmol/L. The cut-off level was defined on the basis of the evaluated level published previously.', 'unitOfMeasure': 'Number of participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 460}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-16', 'studyFirstSubmitDate': '2010-05-10', 'resultsFirstSubmitDate': '2016-02-17', 'studyFirstSubmitQcDate': '2010-05-11', 'lastUpdatePostDateStruct': {'date': '2016-04-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-03-16', 'studyFirstPostDateStruct': {'date': '2010-05-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Oocytes Retrieved (Per Protocol Population)', 'timeFrame': '34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment', 'description': 'As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped.\n\nThe equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes'}, {'measure': 'Number of Oocytes Retrieved (Intention-to-treat Population)', 'timeFrame': '34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment', 'description': 'As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped.\n\nThe equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes'}], 'secondaryOutcomes': [{'measure': 'Number and Size of Follicles ≥ 12 mm at Day 8 of Stimulation', 'timeFrame': 'Day 8 of stimulation', 'description': 'The number and size of follicles 12 mm or over in diameter at day 8 of stimulation were evaluated as secondary end-point.'}, {'measure': 'E2 Concentration at Day 8 and at Day of hCG Administration', 'timeFrame': 'Day 8 of stimulation and at the day of hCG administration (after max. 16 days of r-FSH treatment)', 'description': 'The serum concentration of oestradiol was assessed at day 8 and the day of hCG administration.'}, {'measure': 'Total Dose of r-hFSH Administered', 'timeFrame': 'Day of hCG administration (after maximum 16 days of r-hFSH treatment)', 'description': 'Total dose of r-hFSH required was assessed.'}, {'measure': 'Quality of Oocytes Retrieved', 'timeFrame': '34-36 hours after hCG administration', 'description': 'Number of patients with ovum pick-up'}, {'measure': 'Fertilisation Rate of Oocytes', 'timeFrame': '1 day after ovum pick-up', 'description': 'Fertilisation rate was assessed'}, {'measure': 'Embryo Quality: Mean Number of Blastomeres', 'timeFrame': 'Day 2 of OPU/fertilisation', 'description': 'Main embryo quality parameter "mean number of blastomeres"'}, {'measure': 'Number of Participants With Cryopreserved 2PNs, Embryos/Blastocysts', 'timeFrame': 'Day 1, 2, 3 and 5 of OPU/fertilisation'}, {'measure': 'Number of Days of r-hFSH Stimulation', 'timeFrame': 'At the day of hCG administration, up to 16 days', 'description': 'Mean duration of stimulation was assessed.'}, {'measure': 'Number of Patients With Cycle Cancellation', 'timeFrame': 'Until child birth/miscarriage, up to the end of the study', 'description': 'Number of patients with cycle cancellation was assessed.'}, {'measure': 'Number of Patients With Good Response', 'timeFrame': 'Until child birth/miscarriage, up to the end of the study', 'description': 'Good response was defined as "patients with an oocyte retrieval of four or more oocytes"'}, {'measure': 'Implantation Rate', 'timeFrame': 'Five to six weeks after oocyte retrieval', 'description': 'Defined as fetal sac per embryo transferred.'}, {'measure': 'Clinical Pregnancy Rate', 'timeFrame': 'Five to six weeks after oocyte retrieval', 'description': 'Presence of at least one intrauterine gestational sac.'}, {'measure': 'Ongoing Pregnancy', 'timeFrame': 'Ten weeks after embryo transfer', 'description': 'Ongoing pregnancy per embryo transfer. Presence of at least one viable fetus 10 weeks after embryo transfer.'}, {'measure': 'Live Birth Rate', 'timeFrame': 'After childbirth with questionnaire', 'description': 'Patients with liveborn children'}, {'measure': 'Embryo Quality: Absence of Multinucleation', 'timeFrame': 'Day 3', 'description': 'Main embryo quality parameter "absence of multinucleation" observed.'}, {'measure': 'Quality of Oocytes Retrieved', 'timeFrame': 'At day 4 and 5', 'description': 'Number of patients with transferred blastocysts'}, {'measure': 'Quality of Oocytes Retrieved', 'timeFrame': 'Day of embryo transfer, either 2, 3 or 5 days after oocyte retrieval', 'description': 'Number of embryos per blastocysts transferred'}, {'measure': 'Clinical Pregnancy Rate (Second Treatment Cycle)', 'timeFrame': 'Five to six weeks after oocyte retrieval', 'description': 'Presence of at least one intrauterine gestational sac.'}, {'measure': 'Ongoing Pregnancy (Second Treatment Cycle)', 'timeFrame': '10 weeks after embryo transfer', 'description': 'Ongoing pregnancy per embryo transfer. Presence of at least one viable fetus 10 weeks after embryo transfer.'}, {'measure': 'Quality of Oocytes Retrieved', 'timeFrame': 'After oocyte retrieval, 34 to 36 hours after hCG administration', 'description': 'The maturity of the cumulus oophorus was assessed.'}, {'measure': 'Quality of Oocytes Retrieved', 'timeFrame': 'After oocyte retrieval, 34 to 36 hours after hCG administration', 'description': 'The nuclear maturity was assessed (Germinal vesicle, Metaphase I, Metaphase II).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Assisted reproductive treatment', 'Superovulation', 'Follitropin alfa', 'r-hFSH', 'AFOLIA'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'Ther purpose of this study is to show equivalence between AFOLIA and Gonal-f® with regard to the number of oocytes retrieved in women for assisted reproductive treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '38 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 20 and 38 years with regular menstrual cycles of 25-35 days\n* First or second cycle in the present series of ART\n* BMI ≥ 18 ≤ 30 kg/m2\n* Basal FSH \\< 10 IU/L (cycle day 2-5)\n* E2 levels \\< 50pg/mL (\\< 0.18 nmol/L) at the day of FSH administration\n* Antral follicle count (AFC) ≥ 10 to ≤ 25 follicles (sum of both ovaries)\n* Infertility due to any of the following factors: tubal factor, mild endometriosis (ASRM stage 1-2), male factor, unexplained infertility\n* Presence of both ovaries and normal uterine cavity (confirmed by transvaginal ultrasound within 6 months before randomisation)\n* Willingness to participate in the study and to comply with the study protocol\n* Informed consent\n\nExclusion Criteria:\n\n* Presence of pregnancy\n* History of ≥2 succeeding ART cycles (IVF and/or ICSI) before the study cycle without clinical pregnancy\n* Presence of clinically significant systemic disease\n* Presence of chronic cardiovascular, hepatic, renal or pulmonary disease\n* Presence of uncontrolled endocrine disorder\n* Previous history or presence of severe ovarian hyperstimulation syndrome\n* Presence of polycystic ovaries (PCO)\n* Presence of severe endometriosis (ASRM stage 3 or stage 4) and hydrosalpinx\n* Neoplasia, including tumors of the hypothalamus and pituitary gland\n* Abnormal bleeding of undetermined origin\n* History of poor response to gonadotropin treatment (defined as fewer than 5 oocytes retrieved in a previous attempt)\n* Male infertility without mobile spermatozoa in the ejaculate, that need testicular of epididymal sperm retrieval (MESA/TESE/TESA)\n* Endocrine abnormality such as TSH or prolactin level elevations outside the reference range if clinically relevant at screening\n* Any hormonal treatment within 1 month before the start of the FSH treatment (with the exception of levothyroxin)\n* History of drug, nicotine or alcohol abuse within the last 12 months (\\> 10 cigarettes/day)\n* Administration of other investigational products within the last month\n* Clinically abnormal findings at Visit 1\n* Planned PGS/PGD/PBB or assisted hatching\n* Concomitant participation in an other study protocol\n* History of extrauterine pregnancy in the previous 3 months\n* Known allergy or hypersensitivity to progesterone or to any of the excipients (including peanut oil) of the additional study medication (GnRH agonist, vitrelle®, and Utrogestan®)\n* Presence or history of thrombophlebitis or thromboembolic disorders\n* Presence or history of cerebral haemorrhage\n* Presence or history of porphyria'}, 'identificationModule': {'nctId': 'NCT01121666', 'briefTitle': 'Multi-centre Study to Compare Efficacy and Safety of AFOLIA and Gonal-f in Women for Assisted Reproductive Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Finox AG'}, 'officialTitle': 'A Phase III Assessor-blinded Randomized Parallel Group Multi-centre Study to Compare Efficacy and Safety of Two r-hFSH Formulations (AFOLIA Versus Gonal-f) in Women for Assisted Reproductive Treatment', 'orgStudyIdInfo': {'id': 'FIN3001'}, 'secondaryIdInfos': [{'id': '2010-019287-37', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Gonal-f® (Follitropin alfa)', 'interventionNames': ['Drug: Follitropin alfa']}, {'type': 'EXPERIMENTAL', 'label': 'AFOLIA-150 (Follitropin alfa)', 'interventionNames': ['Drug: Follitropin alfa']}], 'interventions': [{'name': 'Follitropin alfa', 'type': 'DRUG', 'description': '150IU per day subcutaneously for a maximum of 16 days', 'armGroupLabels': ['AFOLIA-150 (Follitropin alfa)', 'Gonal-f® (Follitropin alfa)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Graz', 'country': 'Austria', 'facility': 'Kinderwunsch Institut Schenk GmbH', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'city': 'Linz', 'country': 'Austria', 'facility': 'Landes-Frauenklinik und Kinderklinik Linz', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'AKH Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '11920', 'city': 'Vienna', 'country': 'Austria', 'facility': 'IVF Zentrum Döbling', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Vienna', 'country': 'Austria', 'facility': 'Privatspital Goldenes Kreuz', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Fertility Clinic', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '2400', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Copenhagen Fertility Center', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '2000', 'city': 'Frederiksberg', 'country': 'Denmark', 'facility': 'Dansk Fertilitetsklinik', 'geoPoint': {'lat': 55.67938, 'lon': 12.53463}}, {'zip': '53105', 'city': 'Bonn', 'country': 'Germany', 'facility': 'Universitätsklinikum Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Universitäts-Frauenklinik', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '08028', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Institut Universitari Dexeus', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28023', 'city': 'Madrid', 'country': 'Spain', 'facility': 'IVI Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University Hospital of Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': 'SE1 9RT', 'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's and St Thomas' NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Kings College Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "St Barthlomew's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Bruno Imthurn', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Finox AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}