Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:14 PM
Study NCT ID:
NCT07169435
Status:
COMPLETED
Last Update Posted:
2025-09-16
First Post:
2025-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Enhanced Reproductive Efficiency: Shorter Time to Pregnancy After Hysteroscopic-Assisted Novel Transvaginal Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-14', 'studyFirstSubmitDate': '2025-09-04', 'studyFirstSubmitQcDate': '2025-09-04', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the median time to pregnancy following surgery', 'timeFrame': '2 years', 'description': 'It is the time point at which half of the patients in the study who attempted to conceive after surgery had successfully become pregnant, and the other half had not'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Uterine Caesarean Scar Defect']}, 'descriptionModule': {'briefSummary': 'To investigate whether a novel hysteroscopic-assisted transvaginal repair technique results in a shorter time to pregnancy and superior fertility outcomes compared to traditional transvaginal repair.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '48 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This prospective cohort study was conducted between May 2019 and May 2023 at Department of Gynecology and Obstetrics, International Peace Maternity and Child Health Hospital (IPMCH), Jiao Tong University School of Medicine, Shanghai, China.', 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with a large niche (defined as niche with a depth of \\>50% of the myometrial thickness and a residual myometrial thickness (RMT) ≤3mm) Patients have fertility requirements Patients were aged between 18 and 48 years Patients who requested transvaginal surgery (the final decision about operation method was made by the patient (shared decision making))\n\nExclusion Criteria:\n\nPatients with a narrow vaginal canal or any evidence of severe pelvic adhesion around the uterus Patients with post-operative biopsy-proven atypical endometrial hyperplasia and endometrial cancer'}, 'identificationModule': {'nctId': 'NCT07169435', 'briefTitle': 'Enhanced Reproductive Efficiency: Shorter Time to Pregnancy After Hysteroscopic-Assisted Novel Transvaginal Repair', 'organization': {'class': 'OTHER', 'fullName': 'International Peace Maternity and Child Health Hospital'}, 'officialTitle': 'Enhanced Reproductive Efficiency: Shorter Time to Pregnancy After Hysteroscopic-Assisted Novel Transvaginal Repair', 'orgStudyIdInfo': {'id': '(GKLW)2018-23'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hysteroscopic-assisted novel transvaginal repair', 'description': 'Traditional transvaginal repair (TTR) procedure mainly involves two steps: the obvious scar-like defect excision and the full-thickness myometrial closure, which maybe form a new scar defect due to the uncertain scar healing process.'}, {'label': 'Traditional transvaginal repair', 'description': 'Hysteroscopic-assisted novel transvaginal repair (NTR) surgery does not need to remove the original scar defect. Instead, suture was used to interruptedly suture the myometrium at the upper and lower margins of the scar to close the niche or reduce its size, which retains the integrity of the myometrium.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'International Peace Maternity and Child Health Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Peace Maternity and Child Health Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}