Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-01-10 @ 3:15 PM
Study NCT ID:
NCT03345251
Status:
COMPLETED
Last Update Posted:
2021-09-02
First Post:
2017-10-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Endometrial Manipulation and Its Effect on ICSI
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '640 were enrolled but 608 were analyzed'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 640}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2017-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-28', 'studyFirstSubmitDate': '2017-10-25', 'studyFirstSubmitQcDate': '2017-11-15', 'lastUpdatePostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of participants who achieved clinical pregnancy', 'timeFrame': '6 weeks after embryo transfer', 'description': 'Describes how many participant will continue pregnancy after positive pregnancy test'}], 'secondaryOutcomes': [{'measure': 'The number of participants who achieved ongoing pregnancy and live birth', 'timeFrame': '9 months after embryo transfer', 'description': 'Describes who many participant will continue pregnancy till he had birth and a live birth'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ICSI - physical - Manipulation - scratching'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'Unexplained infertility is clinically diagnosed when there are no apparent or clear factors causing infertility on regular infertility assessment tools . Failure of implantation is a possible factor causing unexplained infertility . Implantation is the main rate limiting step in IVF outcome. Implantation is described at cellular and molecular level by adhesion or fixation of good quality embryo to receptive endometrium within a critical period of time which is called the window of implantation .', 'detailedDescription': 'Testing the effect of Physical manipulation of the endometrium on the quality of the endometrium prior to ICSI cycle and if it increases the success rate'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infertile female age 20-35 years\n* Previous Failed one ICSI trial\n* normal basal hormonal profile \\[FSH, LH\\] 3-10 mIU/ml and 1.8-8.5 mIU/ml respectively, --normal endometrial cavity\n* patent tubes\n* normal Husband semen analysis\n\nExclusion Criteria:\n\n* Ovarian factor of infertility\n* Tubal factor of infertility\n* Endometrial factor of infertility\n* Male factor of infertility'}, 'identificationModule': {'nctId': 'NCT03345251', 'briefTitle': 'Physical Endometrial Manipulation and Its Effect on ICSI', 'organization': {'class': 'OTHER', 'fullName': 'Aljazeera Hospital'}, 'officialTitle': 'Physical Endometrial Manipulation and Its Effect on Success Rate in Patients With Previous ICSI Failure', 'orgStudyIdInfo': {'id': 'Algazeerah'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'manipulation of endometrium', 'description': 'The arm is physical manipulation to the endometrium prior to ICSI By one of these interventions )Hydrotubation , Sonohysterography or endometrial scratching', 'interventionNames': ['Device: Hydrotubation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'no manipulation to endometrium in ICSI', 'description': 'This is the control group , with no manipulation to endometrium prior to ICSI No intervention to this group', 'interventionNames': ['Device: Hydrotubation']}], 'interventions': [{'name': 'Hydrotubation', 'type': 'DEVICE', 'otherNames': ['Sonohysterography', 'Endometrial scratching'], 'armGroupLabels': ['manipulation of endometrium', 'no manipulation to endometrium in ICSI']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'country': 'Egypt', 'facility': 'Algazeerah', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Mahmoud Alalfy, master', 'role': 'STUDY_CHAIR', 'affiliation': 'Algazeerah hospital -Location (Giza -Egypt )'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aljazeera Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mahmoud Alalfy', 'investigatorFullName': 'Mahmoud Alalfy', 'investigatorAffiliation': 'Aljazeera Hospital'}}}}