Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-02-20 @ 4:43 PM
Study NCT ID:
NCT01791751
Status:
COMPLETED
Last Update Posted:
2013-02-15
First Post:
2012-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Clomiphene Citrate Administration During the Early Luteal Phase on Endocrine Profile in IVF Cycles
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002996', 'term': 'Clomiphene'}], 'ancestors': [{'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-12', 'studyFirstSubmitDate': '2012-11-12', 'studyFirstSubmitQcDate': '2013-02-12', 'lastUpdatePostDateStruct': {'date': '2013-02-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LH Levels (IU)', 'timeFrame': 'Luteal phase (up to 2 weeks)'}], 'secondaryOutcomes': [{'measure': 'Endometrial development (Noyes criteria)', 'timeFrame': 'Luteal phase (1 day)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Female Infertility']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect on LH levels of the 5-day CC administration during luteal phase in oocyte donors, to investigate whether the CC corrects the suppressed LH levels in the luteal phase and whether it prolongs the luteal phase in the agonist triggered antagonist cycles.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Oocyte donors\n* 18-35 years old\n* BMI 18-29 Kg/m2\n* Normal basal hormonal levels\n* No contraceptive pill\n\nExclusion Criteria:\n\n* Polycystic ovarian syndrome (PCOS)\n* Previous participation in the study'}, 'identificationModule': {'nctId': 'NCT01791751', 'acronym': 'CLOFA', 'briefTitle': 'Impact of Clomiphene Citrate Administration During the Early Luteal Phase on Endocrine Profile in IVF Cycles', 'organization': {'class': 'OTHER', 'fullName': 'Fundació Privada Eugin'}, 'officialTitle': 'Impact of Clomiphene Citrate Administration During the Early Luteal Phase on Endocrine Profile in Agonist Triggered GnRH Antagonist in Vitro Fertilization Cycles. Phase IV, Single-centre, Open-label, Controlled Clinical Trial.', 'orgStudyIdInfo': {'id': 'CLOFA'}, 'secondaryIdInfos': [{'id': '2011-002173-33', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clomifene Citrate', 'description': 'Clomifene Citrate 50 mg', 'interventionNames': ['Drug: Clomifene Citrate']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No intervention'}], 'interventions': [{'name': 'Clomifene Citrate', 'type': 'DRUG', 'description': 'Clomiphene citrate 100 mg daily for 5 days', 'armGroupLabels': ['Clomifene Citrate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08029', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Clínica EUGIN', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Marta Colodron, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinica EUGIN'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundació Privada Eugin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}