Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-30 @ 5:40 AM
Study NCT ID:
NCT01412606
Status:
COMPLETED
Last Update Posted:
2012-08-30
First Post:
2011-08-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endometrial Scratching in Couples With Unexplained Subfertility
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', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-28', 'studyFirstSubmitDate': '2011-08-08', 'studyFirstSubmitQcDate': '2011-08-08', 'lastUpdatePostDateStruct': {'date': '2012-08-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'miscarriage rate', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Unexplained infertility-endometrial scratching', 'effect of endometrial biopsy (scratching) on clinical pregnancy rates in women with unexplained infertility'], 'conditions': ['Subfertility']}, 'referencesModule': {'references': [{'pmid': '23106834', 'type': 'DERIVED', 'citation': 'Gibreel A, Badawy A, El-Refai W, El-Adawi N. Endometrial scratching to improve pregnancy rate in couples with unexplained subfertility: a randomized controlled trial. J Obstet Gynaecol Res. 2013 Mar;39(3):680-4. doi: 10.1111/j.1447-0756.2012.02016.x. Epub 2012 Oct 29.'}]}, 'descriptionModule': {'briefSummary': 'Endometrial scratching in luteal phase of a spontaneous menstrual cycle may increase pregnancy rate in women with unexplained infertility.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women aged between 20 and 39 years with at least one year of infertility\n* regular menstruation with the length of the cycle between 22-34 days and ovulation confirmed by appropriately timed mid-luteal progesterone\n* fertile semen variables\n* bilateral tubal patency (demonstrated by laparoscopy or hysterosalpingography).'}, 'identificationModule': {'nctId': 'NCT01412606', 'acronym': 'ESUS', 'briefTitle': 'Endometrial Scratching in Couples With Unexplained Subfertility', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Endometrial Scratching in Couples With Unexplained Subfertility', 'orgStudyIdInfo': {'id': 'AG2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Scrathcing', 'description': 'scratching of endometrium on day 21-26 of a spontaneous menstrual cycle', 'interventionNames': ['Procedure: scratching']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Uterine sounding on day 21-26 of a spontaneous menstrual cycle', 'interventionNames': ['Procedure: scratching']}], 'interventions': [{'name': 'scratching', 'type': 'PROCEDURE', 'description': 'scratching endometrium on day 21-26 of a spontaneous menstrual cycle', 'armGroupLabels': ['Control', 'Scrathcing']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Mansoura University Teaching Hospital Gynecology outpatient clinic', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Ahmed Gibreel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mansoura University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Ahmed Gibreel', 'investigatorAffiliation': 'Mansoura University'}}}}