Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-01-15 @ 3:20 AM
Study NCT ID:
NCT00993902
Status:
COMPLETED
Last Update Posted:
2009-10-14
First Post:
2009-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Double and Single Intrauterine Insemination In Controlled Ovarian Stimulation (COH) Cycles With Multifollicular Development
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012847', 'term': 'Single Person'}], 'ancestors': [{'id': 'D017533', 'term': 'Marital Status'}, {'id': 'D005191', 'term': 'Family Characteristics'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 228}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-13', 'studyFirstSubmitDate': '2009-07-22', 'studyFirstSubmitQcDate': '2009-10-13', 'lastUpdatePostDateStruct': {'date': '2009-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ongoing pregnancy rates', 'timeFrame': 'pregnancy >12 weeks of gestation'}], 'secondaryOutcomes': [{'measure': 'The effects of different coh regimens on outcomes', 'timeFrame': '14 days after IUI procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Double IUI', 'Intrauterine insemination', 'Unexplained infertility'], 'conditions': ['Infertility']}, 'referencesModule': {'references': [{'pmid': '20457669', 'type': 'DERIVED', 'citation': 'Bagis T, Haydardedeoglu B, Kilicdag EB, Cok T, Simsek E, Parlakgumus AH. Single versus double intrauterine insemination in multi-follicular ovarian hyperstimulation cycles: a randomized trial. Hum Reprod. 2010 Jul;25(7):1684-90. doi: 10.1093/humrep/deq112. Epub 2010 May 10.'}]}, 'descriptionModule': {'briefSummary': 'Our hypothesis is double insemination will improve pregnancy rates in coh cycles with more than one dominant follicles (\\>16mm).', 'detailedDescription': 'Metaanalysis for the effects of double IUI demonstrates that effects of this procedure is not different from single IUI. It is known that nearly 25% of coh cycles is evident by monofollicular development.For this reason it is possible that this monofollicular cycles in the studies could decrease the effects of double IUI.\n\nInclusion criteria:\n\n1. Patients with unexplained infertility or mild male factor infertility whom admitted to the COH+IUI programme in our infertility unit.\n2. Female age \\<37 years old.\n3. Baseline FSH \\<12 mIU/L\n4. Total antral follicle count\\>6\n5. During the first three cycles of COH+IUI\n6. Minimum 2 follicles \\>16 mm at the day of HCG.\n\nPrimary outcome:\n\nOngoing pregnancy rates\n\nSecondary outcomes:\n\nThe effects of different coh regimens (CC,FSH,CC+FSH)on the outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '37 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unexplained and mild male factor infertile patients\n* Minimum 2 follicles \\>16 mm at the day of HCG\n* First 3 cycles\n\nExclusion Criteria:\n\n* Basal FSH \\>12 mIU/L\n* Total antral follicle count\\<6\n* Severe male factor infertility'}, 'identificationModule': {'nctId': 'NCT00993902', 'briefTitle': 'Double and Single Intrauterine Insemination In Controlled Ovarian Stimulation (COH) Cycles With Multifollicular Development', 'organization': {'class': 'OTHER', 'fullName': 'Baskent University'}, 'orgStudyIdInfo': {'id': 'BU1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Single IUI', 'description': 'Single IUI will be carried on after 36-38 hours of HCG administration', 'interventionNames': ['Procedure: Intrauterine insemination (single)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Double IUI', 'interventionNames': ['Procedure: Double intrauterine insemination']}], 'interventions': [{'name': 'Intrauterine insemination (single)', 'type': 'PROCEDURE', 'otherNames': ['Group I'], 'description': 'Single IUI after 36-38 hours of HCG', 'armGroupLabels': ['Single IUI']}, {'name': 'Double intrauterine insemination', 'type': 'PROCEDURE', 'otherNames': ['Grup II'], 'description': 'Double insemination after 18 and 40 hours of HCG administration.', 'armGroupLabels': ['Double IUI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01120', 'city': 'Adana', 'country': 'Turkey (Türkiye)', 'facility': 'Baskent University Medical Faculty Obstetric and Gynecelogy Department, Infertility and IVF unit', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baskent University', 'class': 'OTHER'}, 'responsibleParty': {'oldOrganization': 'Associated Prof.Tayfun Bagis, MD'}}}}