Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2026-03-22 @ 1:54 AM
Study NCT ID:
NCT04736459
Status:
UNKNOWN
Last Update Posted:
2021-02-03
First Post:
2021-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-washing the Catheter With a Culture Medium Before Intrauterine Insemination
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-01-29', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-29', 'studyFirstSubmitDate': '2021-01-29', 'studyFirstSubmitQcDate': '2021-01-29', 'lastUpdatePostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': '8 weeks after intrauterine insemination', 'description': 'Clinical pregnancy will be defined as the presence of a heartbeat at 6th gestational weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intrauterine insemination, pre-washing catheter'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'The aim of the study to evaluate the possible effect of washing the insemination catheters before intrauterine insemination on the pregnancy outcomes.\n\nWe know that washing the catheters are already washed in the case of embryo transfer for assisted reproductive techniques. Based on this knowledge, we also constituted the hypothesis which is about the impact of washing the catheter on the gametes and embryos. The pre-washing the catheter before intrauterine insemination may provide higher pregnancy results.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 1-year infertility\n* at least one patent fallopian tube confirmed by hysterosalpingography (HSG) or laparoscopy\n* ovulatory menstrual cycles\n* suitable semen analysis according to the World Health Organization (WHO) criteria for intrauterine insemination\n\nExclusion Criteria:\n\n* bilateral tubal occlusion\n* mild or severe endometriosis\n* day 3 serum FSH (follicle-stimulating hormone) \\> 13 IU/L\n* abnormal thyroid function tests, hyperprolactinemia\n* total motile sperm count (TMSC) \\< 5 millions or severe teratospermia (\\<4% normal forms) following semen preparation\n* more than 3 follicles above the size of 17mm on the day of ovulation triggering'}, 'identificationModule': {'nctId': 'NCT04736459', 'briefTitle': 'Pre-washing the Catheter With a Culture Medium Before Intrauterine Insemination', 'organization': {'class': 'OTHER', 'fullName': 'Eskisehir Osmangazi University'}, 'officialTitle': 'Does Pre-washing the Catheter With a Culture Medium Before Intrauterine Insemination Have an Effect on Pregnancy Rates?', 'orgStudyIdInfo': {'id': '2222392979'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Washed Catheter', 'description': 'Washed catheter arm: will be washed with culture medium before insemination', 'interventionNames': ['Procedure: Pre-washed catheter vs. Unwashed catheter in the intrauterine insemination']}, {'type': 'SHAM_COMPARATOR', 'label': 'Unwashed Catheter', 'description': 'Unwashed catheter arm: will not be washed with culture medium.', 'interventionNames': ['Procedure: Pre-washed catheter vs. Unwashed catheter in the intrauterine insemination']}], 'interventions': [{'name': 'Pre-washed catheter vs. Unwashed catheter in the intrauterine insemination', 'type': 'PROCEDURE', 'description': 'The pre-washed catheter will be washed with culture medium before intrauterine insemination The unwashed catheter will not be washed with culture medium as a standard intrauterine insemination procedure', 'armGroupLabels': ['Unwashed Catheter', 'Washed Catheter']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Vehbi Yavuz Tokgöz', 'role': 'CONTACT', 'email': 'mdtokgoz@hotmail.com', 'phone': '+902222392979'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eskisehir Osmangazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assocciate Professor', 'investigatorFullName': 'Vehbi Yavuz Tokgoz', 'investigatorAffiliation': 'Eskisehir Osmangazi University'}}}}