Ignite Creation Date:
2025-12-25 @ 3:43 AM
Ignite Modification Date:
2026-04-12 @ 1:12 PM
Study NCT ID:
NCT00575302
Status:
WITHDRAWN
Last Update Posted:
2010-04-13
First Post:
2007-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Optimal Posology of Gonadotrophins in Patients With Insufficient Ovarian Response Due to Age
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'whyStopped': '36 cases were included and the 4 centers and they are unable to increase their recruitment to obtain the 400 cases necessary to reach statistical significance.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-04-12', 'studyFirstSubmitDate': '2007-12-17', 'studyFirstSubmitQcDate': '2007-12-17', 'lastUpdatePostDateStruct': {'date': '2010-04-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of mature oocytes', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'follicular development', 'timeFrame': '1 month'}, {'measure': 'fertilization rate', 'timeFrame': '1 month'}, {'measure': 'implantation rate', 'timeFrame': '1 month'}, {'measure': 'embryo quality', 'timeFrame': '1 month'}, {'measure': 'pregnancy rate', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['IVF', 'poor responder', 'recFSH', 'Fertilization in Vitro', 'Poor responders'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'In In vitro fertilization (IVF) treatment, poor responder patients of more than 38 years old are randomized prospectively into two dosages of gonadotrophins. The outcome of treatment will be analyzed.', 'detailedDescription': 'Women \\> 38 years, who had an insufficient response to stimulation with regular (for age) posology of 225 IU of gonadotrophins (urinary or recombinant), in an agonist protocol will be randomized prospectively into 2 groups:\n\n300 IU versus 450 IU of Gonal-f® administered in a short agonist protocol. Insufficient response is defined as: development of ≤ 4 mature follicles (of ≥ 16 mm) at time of hCG administration.\n\nPatient can be eligible for several cycles in same protocol.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '38 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women \\> 38 years with insufficient response to stimulation with 225 IU of gonadotrophins (urinary or recombinant), in an agonist protocol.\n* Insufficient response is defined as: development of ≤ 4 mature follicles (of ≥ 16 mm) at time of hCG administration.\n* Patient can be eligible for several cycles in same protocol.\n\nExclusion Criteria:\n\n* Patients who already received doses \\> 225 IU\n* Patients older than 42 years\n* Patients with basal FSH concentrations ≥ 15 mU/ml at day 3'}, 'identificationModule': {'nctId': 'NCT00575302', 'briefTitle': 'Study of Optimal Posology of Gonadotrophins in Patients With Insufficient Ovarian Response Due to Age', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Chretien'}, 'officialTitle': 'Study of Optimal Posology of Gonadotrophins in Patients With Insufficient Ovarian Response Due to Age', 'orgStudyIdInfo': {'id': 'Study 300 versus 450'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '300', 'description': 'administration of 300 IU Gonal-f® in a short agonist protocol.', 'interventionNames': ['Drug: Gonal-f®: follitropin alpha']}, {'type': 'EXPERIMENTAL', 'label': '450', 'description': 'administration of 450 IU Gonal-f® in a short agonist protocol.', 'interventionNames': ['Drug: Gonal-f®: follitropin alpha']}], 'interventions': [{'name': 'Gonal-f®: follitropin alpha', 'type': 'DRUG', 'description': 'Gonal-f®: follitropin alpha, administration of 300 U', 'armGroupLabels': ['300']}, {'name': 'Gonal-f®: follitropin alpha', 'type': 'DRUG', 'description': 'Gonal-f®: follitropin alpha, administration of 450 U', 'armGroupLabels': ['450']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Rocourt', 'state': 'Liège', 'country': 'Belgium', 'facility': 'CHC Saint-Vincent', 'geoPoint': {'lat': 50.67579, 'lon': 5.54621}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHU Saint-Pierre', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1180', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'IMEC', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'UZ Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Annick Delvigne, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHC Saint-Vincent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Chretien', 'class': 'OTHER'}, 'collaborators': [{'name': 'EMD Serono', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Annick Delvigne', 'oldOrganization': 'CHC Saint-Vincent'}}}}