Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-26 @ 1:14 AM
Study NCT ID:
NCT00702234
Status:
COMPLETED
Last Update Posted:
2024-09-05
First Post:
2008-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05714 (Care Program)(P05715)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000013', 'term': 'Congenital Abnormalities'}], 'ancestors': [{'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C437186', 'term': 'follicle stimulating hormone, human, with HCG C-terminal peptide'}, {'id': 'C092464', 'term': 'LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-'}, {'id': 'D011374', 'term': 'Progesterone'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003339', 'term': 'Corpus Luteum Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045167', 'term': 'Progesterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'Publications must be based on data validated and released by the Sponsor. Any scientific paper, presentation, or other communication concerning the study must first be submitted to the Sponsor, at least 6 weeks prior to estimated publication or presentation, for written consent. Sponsor has the right to make its consent conditional upon proper representation of the interpretation of both the Sponsor and the Investigator in the discussion of the data in such communications.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From approximately 10 weeks after fresh ET in base study P05714 (NCT00696878) up to 12 weeks after birth in current follow-up study (Up to approximately 9 months).', 'eventGroups': [{'id': 'EG000', 'title': 'Expectant Mothers - Corifollitropin Alfa 150 µg', 'description': 'In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.', 'otherNumAtRisk': 268, 'otherNumAffected': 0, 'seriousNumAtRisk': 268, 'seriousNumAffected': 145}, {'id': 'EG001', 'title': 'Fetuses Present at 10 Weeks After Fresh ET in Base Study', 'description': 'This group includes fetuses associated with expectant mothers who were administered corifollitropin alfa in base study P05714 (NCT00696878) who were enrolled in this follow-up study P05715. The fetuses were present at 10 weeks after fresh ET in base study P05714 and/or at enrollment of the expectant mother in this follow-up study P05715.', 'otherNumAtRisk': 315, 'otherNumAffected': 0, 'seriousNumAtRisk': 315, 'seriousNumAffected': 84}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Anaemia neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Disseminated intravascular coagulation in newborn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Bradycardia foetal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Bradycardia neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cardio-respiratory arrest neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Foetal heart rate disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Ventricular hypokinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Anal atresia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Ankyloglossia congenital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Anomaly of external ear congenital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Atrial septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cleft palate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Congenital cytomegalovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Congenital diaphragmatic hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Congenital hand malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Congenital hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Congenital infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Congenital naevus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Congenital nose malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Congenital pulmonary artery anomaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Congenital pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Congenital tongue anomaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Congenital torticollis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cryptorchism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cystic lymphangioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Duodenal atresia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dysmorphism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Factor IX deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Factor VIII deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': "Fallot's tetralogy", 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Haemangioma congenital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Laryngomalacia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Oculoauriculovertebral dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Patent ductus arteriosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pulmonary artery stenosis congenital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pulmonary malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pulmonary sequestration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pyloric stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Renal dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Skull malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Solitary kidney', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Strabismus congenital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Syndactyly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Talipes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Trisomy 18', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Trisomy 21', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'VACTERL syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Ventricular septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypoacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dacryostenosis acquired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Retinopathy of prematurity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Acute hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cholecystitis', 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'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Prolonged labour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Retained placenta or membranes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Small for dates baby', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Threatened labour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Transverse presentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Twin pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Umbilical cord abnormality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Umbilical cord prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Uterine contractions abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Mental disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Perineal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vaginal laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Asthmatic crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Bronchial obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Immature respiratory system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Infantile apnoeic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Neonatal asphyxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Neonatal aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Neonatal respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cafe au lait spots', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Seborrhoeic dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Abortion induced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Caesarean section', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Selective abortion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 315, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Women With Ongoing Pregnancy After a Corifollitropin Alfa COS Cycle in Base Study and ≥1 Live Born Infant During Follow-up (Live Birth Rate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '682', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Women - Corifollitropin Alfa 150 µg', 'description': 'In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 32 months after first dose of corifollitropin alfa in base study P05714 (NCT00696878)', 'description': 'The live birth rate was defined as the number of participants who had an ongoing pregnancy after a corifollitropin alfa COS cycle in base study P05714 (NCT00696878) and who had at least one live born infant during follow-up, divided by the number of participants treated in the base study. For this analysis, it was assumed that any participants with ongoing pregnancy after a COS cycle in base study who did not enroll in follow-up study P05715 had no live born infants.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants administered corifollitropin alfa in base study P05714 (NCT00696878)'}, {'type': 'PRIMARY', 'title': 'Number of Expectant Mothers Experiencing Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Mothers - Corifollitropin Alfa 150 µg', 'description': 'In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.'}], 'classes': [{'categories': [{'measurements': [{'value': '203', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months)', 'description': 'An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa in base study P05714 (NCT00696878) and who enrolled in the follow-up study.'}, {'type': 'PRIMARY', 'title': 'Number of Expectant Mothers Experiencing Serious AEs (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Expectant Mothers - Corifollitropin Alfa 150 µg', 'description': 'In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.'}], 'classes': [{'categories': [{'measurements': [{'value': '145', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months)', 'description': 'An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa in base study P05714 (NCT00696878) and who enrolled in the follow-up study.'}, {'type': 'PRIMARY', 'title': 'Number of Live Born Infants Experiencing AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Live Born Infants', 'description': 'This group includes infants born to mothers who were administered corifollitropin alfa in base study P05714 (NCT00696878) and who were enrolled in this follow-up study P05715. These infants, whose gestation outcome was live birth, are a subgroup of the total number of fetuses that were present at 10 weeks after fresh ET in base study P05714 and/or at enrollment of the expectant mother in this follow-up study P05715. Fetuses not born alive or with unknown outcome are not included in this reporting group.'}], 'classes': [{'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 weeks after birth', 'description': 'An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa in base study P05714 (NCT00696878) and who enrolled in the follow-up study.'}, {'type': 'PRIMARY', 'title': 'Number of Live Born Infants Experiencing SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Live Born Infants', 'description': 'This group includes infants born to mothers who were administered corifollitropin alfa in base study P05714 (NCT00696878) and who were enrolled in this follow-up study P05715. These infants, whose gestation outcome was live birth, are a subgroup of the total number of fetuses that were present at 10 weeks after fresh ET in base study P05714 and/or at enrollment of the expectant mother in this follow-up study P05715. Fetuses not born alive or with unknown outcome are not included in this reporting group.'}], 'classes': [{'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 weeks after birth', 'description': 'An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa in base study P05714 (NCT00696878) and who enrolled in the follow-up study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Women/Expectant Mothers - Corifollitropin Alfa 150 µg', 'description': 'In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of Gonadotropin Releasing Hormone (GnRH) antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of recombinant Human Chorion Gonadotropin (\\[rec\\]hCG) (5,000-10,000 IU/250 µg). Daily dosing with Follicle Stimulating Hormone (FSH) (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.'}, {'id': 'FG001', 'title': 'Fetuses Present at 10 Weeks After Fresh ET in Base Study', 'description': 'This group includes fetuses associated with expectant mothers who were administered corifollitropin alfa in base study P05714 (NCT00696878) who were enrolled in this follow-up study P05715. The fetuses were present at 10 weeks after fresh ET in base study P05714 and/or at enrollment of the expectant mother in this follow-up study P05715.'}], 'periods': [{'title': 'Base Study (NCT00696878)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '682'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '178'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '504'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Follow-up Study: Expectant Mothers', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'A participant could enter follow-up study without meeting definition for "Completion" of base study', 'groupId': 'FG000', 'numSubjects': '268'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '246'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Follow-up Study: Fetuses/Infants', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Fetuses present 10 weeks after fresh ET and/or at enrollment of expectant mother in follow-up study', 'groupId': 'FG001', 'numSubjects': '315'}]}, {'type': 'Live Born Infants', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Of the 11 that were not live born infants, outcome is known for 8 (fetus was lost) and unknown for 3', 'groupId': 'FG001', 'numSubjects': '304'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'All 288 who completed were live born infants', 'groupId': 'FG001', 'numSubjects': '288'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '27'}]}]}], 'recruitmentDetails': 'Of 272 participants with ongoing pregnancy at 10 weeks after fresh embryo transfer (ET) in base study P05714 (NCT00696878), 268 enrolled in this follow-up study P05715. A participant could enter follow-up study without meeting formal definition for "Completion" of base study.', 'preAssignmentDetails': 'To complete base study P05714 (NCT00696878), a participant must have embryo transfer in the 3rd Controlled Ovarian Stimulation (COS) cycle (Treatment Cycle 3). For this follow-up trial P05715, study completion for participant (expectant mother) or live born infant was defined as completion of infant follow-up visit at 4-12 weeks after delivery.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Expectant Mothers - Corifollitropin Alfa 150 µg', 'description': 'In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.8', 'spread': '3.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '268', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Individuals who participated in base study P05714 (NCT00696878) and received at least one dose of corifollitropin alfa, who had an ongoing pregnancy confirmed by ultrasound at least 10 weeks after fresh ET in base study P05714 and were able and willing to give written informed consent to be enrolled in the follow-up study.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 268}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2010-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-13', 'studyFirstSubmitDate': '2008-06-18', 'resultsFirstSubmitDate': '2015-04-09', 'studyFirstSubmitQcDate': '2008-06-18', 'lastUpdatePostDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-04-09', 'studyFirstPostDateStruct': {'date': '2008-06-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Women With Ongoing Pregnancy After a Corifollitropin Alfa COS Cycle in Base Study and ≥1 Live Born Infant During Follow-up (Live Birth Rate)', 'timeFrame': 'Up to approximately 32 months after first dose of corifollitropin alfa in base study P05714 (NCT00696878)', 'description': 'The live birth rate was defined as the number of participants who had an ongoing pregnancy after a corifollitropin alfa COS cycle in base study P05714 (NCT00696878) and who had at least one live born infant during follow-up, divided by the number of participants treated in the base study. For this analysis, it was assumed that any participants with ongoing pregnancy after a COS cycle in base study who did not enroll in follow-up study P05715 had no live born infants.'}, {'measure': 'Number of Expectant Mothers Experiencing Adverse Events (AEs)', 'timeFrame': 'From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months)', 'description': 'An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.'}, {'measure': 'Number of Expectant Mothers Experiencing Serious AEs (SAEs)', 'timeFrame': 'From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months)', 'description': 'An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.'}, {'measure': 'Number of Live Born Infants Experiencing AEs', 'timeFrame': 'Up to 12 weeks after birth', 'description': 'An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.'}, {'measure': 'Number of Live Born Infants Experiencing SAEs', 'timeFrame': 'Up to 12 weeks after birth', 'description': 'An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Neonatal outcome', 'Congenital malformations', 'In-Vitro fertilization', 'Controlled ovarian stimulation', 'Follow-up'], 'conditions': ['Pregnancy', 'Neonates']}, 'referencesModule': {'references': [{'pmid': '22587997', 'type': 'DERIVED', 'citation': 'Bonduelle M, Mannaerts B, Leader A, Bergh C, Passier D, Devroey P. Prospective follow-up of 838 fetuses conceived after ovarian stimulation with corifollitropin alfa: comparative and overall neonatal outcome. Hum Reprod. 2012 Jul;27(7):2177-85. doi: 10.1093/humrep/des156. Epub 2012 May 15.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this trial is to evaluate whether corifollitropin alfa (Org 36286) treatment for the induction of multifollicular growth in women undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) is safe for pregnant participants and their offspring. In addition, a primary efficacy variable, live birth rate, was evaluated.', 'detailedDescription': 'This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcomes of women who were treated with corifollitropin alfa and became pregnant after fresh embryo transfer during the base study P05714 (NCT00696878). For this trial, no study specific assessments are required, but information as obtained in standard practice will be used.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women with an ongoing pregnancy at least 10 weeks after fresh embryo transfer in base study P05714 (NCT00696878) were enrolled in this trial.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants who participated in base study P05714 (NCT00696878) and received at least one dose of corifollitropin alfa in base study P05714;\n* Ongoing pregnancy confirmed by ultrasound at least 10 weeks after a fresh embryo transfer in base study P05714;\n* Able and willing to give written informed consent.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT00702234', 'acronym': 'Care', 'briefTitle': 'Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05714 (Care Program)(P05715)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Controlled Ovarian Stimulation in Clinical Trial 38825 for Org 36286 (Corifollitropin Alfa)', 'orgStudyIdInfo': {'id': 'P05715'}, 'secondaryIdInfos': [{'id': '2004-004967-30', 'type': 'EUDRACT_NUMBER'}, {'id': '38829', 'type': 'OTHER', 'domain': 'Organon'}, {'id': 'MK-8962-008', 'type': 'OTHER', 'domain': 'Merck'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women/Expectant Mothers - Corifollitropin Alfa 150 µg', 'description': 'In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of Gonadotropin Releasing Hormone (GnRH) antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of recombinant Human Chorion Gonadotropin (\\[rec\\]hCG) (5,000-10,000 IU/250 µg). Daily dosing with Follicle Stimulating Hormone (FSH) (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh embryo transfer in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.', 'interventionNames': ['Biological: Corifollitropin alfa', 'Biological: GnRH antagonist', 'Biological: (rec)hCG', 'Biological: FSH', 'Drug: Progesterone']}], 'interventions': [{'name': 'Corifollitropin alfa', 'type': 'BIOLOGICAL', 'otherNames': ['Org 36286', 'SCH 900962', 'MK-8962'], 'description': 'Subcutaneous (SC) administration of corifollitropin alfa at a dose of 150 μg in base study P05714 (NCT00696878). In this follow-up study P05715, no study medications were administered.', 'armGroupLabels': ['Women/Expectant Mothers - Corifollitropin Alfa 150 µg']}, {'name': 'GnRH antagonist', 'type': 'BIOLOGICAL', 'description': 'SC administration of a GnRH antagonist at a dose of 0.25 mg/day in base study P05714 (NCT00696878). In this follow-up study P05715, no study medications were administered.', 'armGroupLabels': ['Women/Expectant Mothers - Corifollitropin Alfa 150 µg']}, {'name': '(rec)hCG', 'type': 'BIOLOGICAL', 'description': 'SC administration of (rec)hCG at a dose of 5,000-10,000 IU/250 µg in base study P05714 (NCT00696878). In this follow-up study P05715, no study medications were administered.', 'armGroupLabels': ['Women/Expectant Mothers - Corifollitropin Alfa 150 µg']}, {'name': 'FSH', 'type': 'BIOLOGICAL', 'description': 'SC administration of FSH at a dose not to exceed 225 IU/day in base study P05714 (NCT00696878). In this follow-up study P05715, no study medications were administered.', 'armGroupLabels': ['Women/Expectant Mothers - Corifollitropin Alfa 150 µg']}, {'name': 'Progesterone', 'type': 'DRUG', 'description': 'Vaginal administration of progesterone at a dose of at least 600 mg/day in base study P05714 (NCT00696878). In this follow-up study P05715, no study medications were administered.', 'armGroupLabels': ['Women/Expectant Mothers - Corifollitropin Alfa 150 µg']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}