Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2026-02-22 @ 7:22 PM
Study NCT ID:
NCT02349750
Status:
COMPLETED
Last Update Posted:
2015-01-29
First Post:
2015-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endometrial Scratch Injury in Women With Unexplained Infertility Undergoing IUI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 154}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-28', 'studyFirstSubmitDate': '2015-01-24', 'studyFirstSubmitQcDate': '2015-01-28', 'lastUpdatePostDateStruct': {'date': '2015-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical pregnancy', 'timeFrame': '14 days after IUI'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Endometrial Scratch Injury', 'Unexplained infertility', 'intrauterine insemenation', 'ovulation induction'], 'conditions': ['Unexplained Infertility']}, 'descriptionModule': {'briefSummary': 'The study included 154 infertile women Patients received 100 mg of oral clomiphene citrate for five days starting on day 3 of the menstrual cycle, followed by daily injection of 150 IU of hMG and when more than two dominant follicles reached a diameter of 17 mm 5,000 IU of hCG was injected intramuscularly. Patients were randomly allocated into two equal groups: Group C received IUI without ESI and Group S had ESI using No.8 neonatal feeding tube and after 24 to 36 hours, IUI was performed. Successful pregnancy was con-firmed by ultrasound and patients had failed trial underwent another trial of IUI for a maximum of three trials.', 'detailedDescription': 'The study included 154 infertile women with mean duration of infertility of 3.9±0.4 years. Patients received 100 mg of oral clomiphene citrate for five days starting on day 3 of the menstrual cycle, followed by daily injection of 150 IU of hMG and when more than two dominant follicles reached a diameter of 17 mm 5,000 IU of hCG was injected intramuscularly. Patients were randomly allocated into two equal groups: Group C received IUI without ESI and Group S had ESI using No.8 neonatal feeding tube and after 24 to 36 hours, IUI was performed. Successful pregnancy was con-firmed by ultrasound and patients had failed trial underwent another trial of IUI for a maximum of three trials.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1\\. Couple with unexplained infertility and assigned for IUI\n\nExclusion Criteria:\n\n1. Woman's age of more than 40 years\n2. Ovarian cyst detected in the ultrasound examination\n3. Uterine lesions such as submucosal leiomyoma\n4. A previous diagnosis of moderate to severe pelvic endometriosis\n5. Women with body mass index ≥35 kg/m2 o\n6. Women with signs of hyperandrogenemia dy"}, 'identificationModule': {'nctId': 'NCT02349750', 'briefTitle': 'Endometrial Scratch Injury in Women With Unexplained Infertility Undergoing IUI', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Endometrial Scratch Injury Induced Higher Pregnancy Rate for Women With Unexplained Infertility Undergoing IUI With Ovarian Stimulation', 'orgStudyIdInfo': {'id': '123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'endometrial scratch injury', 'description': 'Patients received 100 mg of oral clomiphene citrate for five days starting on day 3 of the menstrual cycle, followed by daily injection of 150 IU of hMG and when more than two dominant follicles reached a diameter of 17 mm 5,000 IU of hCG was injected intramuscularly. Group S had ESI using No.8 neonatal feeding tube and after 24 to 36 hours, IUI was performed.', 'interventionNames': ['Procedure: endometrial scratch injury']}, {'type': 'NO_INTERVENTION', 'label': 'Non endometrial scratch injury', 'description': 'Patients received 100 mg of oral clomiphene citrate for five days starting on day 3 of the menstrual cycle, followed by daily injection of 150 IU of hMG and when more than two dominant follicles reached a diameter of 17 mm 5,000 IU of hCG was injected intramuscularly. Group C received IUI without ESI and after 24 to 36 hours, IUI was performed.'}], 'interventions': [{'name': 'endometrial scratch injury', 'type': 'PROCEDURE', 'description': 'ESI using No.8 neonatal feeding tube', 'armGroupLabels': ['endometrial scratch injury']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ahmed M Maged, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kasr Alainy medical school'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Ahmed Maged', 'investigatorAffiliation': 'Cairo University'}}}}