Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2026-01-04 @ 7:08 AM
Study NCT ID:
NCT00702195
Status:
COMPLETED
Last Update Posted:
2024-08-15
First Post:
2008-06-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Phase II Clinical Trials of Org 36286 (Study 38817)(P06054)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'C571802', 'term': 'follitropin beta'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2003-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-13', 'studyFirstSubmitDate': '2008-06-18', 'studyFirstSubmitQcDate': '2008-06-19', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pregnancy status at 20 weeks of gestation; Take-home baby rate', 'timeFrame': 'one pregnancy period'}], 'secondaryOutcomes': [{'measure': 'Pregnancy follow-up; Delivery follow-up; Neonatal outcome; Infant follow-up; Congenital Malformations and Chromosomal Abnormalities', 'timeFrame': 'one pregnancy period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Neonatal outcome', 'Congenital malformations', 'In-Vitro Fertilization', 'Controlled ovarian stimulation', 'Follow-up', 'Ovulation Induction', 'Neonates'], 'conditions': ['Pregnancy']}, '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 was to evaluate whether Org 36286 treatment in any Phase IIa clinical development trial of Org 36286 for OI or COH in assisted reproductive treatment programs was safe for pregnant subjects and their offspring. Data from subjects who participated in Trials 38805 and 38807 and became pregnant were evaluated.', 'detailedDescription': 'This was an open prospective follow-up trial to monitor pregnancy, delivery, and neonatal outcome of women who became pregnant during any Phase IIa clinical trial of Org 36286 for OI or COH for IVF. For this trial, no study specific assessments were required, but information obtained in standard practice was used.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All women who became pregnant during Trials 38805 or 38807 were enrolled in Trial 38817', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects taking part in any clinical development trial of Org 36286 for OI or COH for IVF in Phase IIa;\n* Ongoing pregnancy confirmed by ultrasonography (USS) at or beyond 12 weeks of gestation;\n* Able and willing to give written informed consent.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT00702195', 'briefTitle': 'Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Phase II Clinical Trials of Org 36286 (Study 38817)(P06054)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established During Phase II Clinical Trials for the Development of Org 36286 (Corifollitropin Alfa).', 'orgStudyIdInfo': {'id': 'P06054'}, 'secondaryIdInfos': [{'id': '38817'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental Group 1', 'description': 'all doses of Org 36286 (corifollitropin alfa) from trial 38805 (7.5 μg, 15 μg, 30 μg and 60 μg)', 'interventionNames': ['Drug: Org 36286 (corifollitropin alfa)']}, {'label': 'Experimental Group 2', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'label': 'Experimental Group 3', 'description': 'all doses of Org 36286 (corifollitropin alfa) from trial 38807 (120 μg, 180 μg and 240 μg)', 'interventionNames': ['Drug: Org 36286 (corifollitropin alfa)']}, {'label': 'Experimental Group 4', 'description': '150 IU Puregon®', 'interventionNames': ['Drug: recFSH']}], 'interventions': [{'name': 'Org 36286 (corifollitropin alfa)', 'type': 'DRUG', 'otherNames': ['corifollitropin alfa'], 'description': 'single dose of Org 36286 (corifollitropin alfa) administered under protocol 38805/38807', 'armGroupLabels': ['Experimental Group 1', 'Experimental Group 3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'single dose of placebo (administered under protocol 38805)', 'armGroupLabels': ['Experimental Group 2']}, {'name': 'recFSH', 'type': 'DRUG', 'otherNames': ['follitropin beta', 'Puregon®', 'Follistim®'], 'description': '150 IU recFSH daily (reference group administered under protocol 38807)', 'armGroupLabels': ['Experimental Group 4']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}