Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2026-01-18 @ 5:57 PM
Study NCT ID:
NCT01999959
Status:
COMPLETED
Last Update Posted:
2013-12-03
First Post:
2013-11-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Pertubation on Pregnancy Rates Before Intrauterine Insemination Treatment
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-26', 'studyFirstSubmitDate': '2013-11-26', 'studyFirstSubmitQcDate': '2013-11-26', 'lastUpdatePostDateStruct': {'date': '2013-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pregnancy rate', 'timeFrame': '6 months', 'description': 'Pregnancy rate at 6 month-follow-up'}]}, 'conditionsModule': {'keywords': ['Unexplained Infertility, Pertubation, Gonadotrophin, Ovulation Induction, Intrauterine Insemination'], 'conditions': ['Infertility', 'Pertubation', 'Insemination']}, 'referencesModule': {'references': [{'pmid': '24695882', 'type': 'DERIVED', 'citation': 'Yildiz F, Bozkurt N, Erdem A, Erdem M, Oktem M, Onur Karabacak R. Effect of Pertubation on Pregnancy Rates before Intrauterine Insemination Treatment in Patients with Unexplained Infertility. Int J Fertil Steril. 2014 Apr;8(1):77-84. Epub 2014 Mar 9.'}]}, 'descriptionModule': {'briefSummary': 'To demonstrate a possible beneficial impact of pertubation we designed a randomized prospective study, in which uterine washing was administered prior to insemination in patients diagnosed with unexplained infertility.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age of 18-44 years; presence of regular menstrual cycles and ovulation; absence of tubal occlusion on HSG; sperm concentration \\>15 million spermatozoa/ml and total sperm number \\>39 million/ml according to WHO criteria\n\nExclusion Criteria:\n\n* the presence of endocrinologic disease; use of nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids; clinical findings suggestive of pelvic inflammatory disease; and the presence of undiagnosed uterine bleeding'}, 'identificationModule': {'nctId': 'NCT01999959', 'briefTitle': 'Effect of Pertubation on Pregnancy Rates Before Intrauterine Insemination Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'orgStudyIdInfo': {'id': '3061750'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pertubation performed', 'description': 'Study group had pertubation and insemination', 'interventionNames': ['Procedure: Pertubation']}, {'type': 'NO_INTERVENTION', 'label': 'Pertubation not performed', 'description': 'Study group had insemination only'}], 'interventions': [{'name': 'Pertubation', 'type': 'PROCEDURE', 'description': 'a lavage procedure of the intrauterine cavity and bilateral fallopian tubes', 'armGroupLabels': ['Pertubation performed']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'state': 'Cankaya', 'country': 'Turkey (Türkiye)', 'facility': 'Gazi University Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Funda Korkmaz', 'investigatorAffiliation': 'Gazi University'}}}}