Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-03 @ 7:59 PM
Study NCT ID:
NCT06508151
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-18
First Post:
2024-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neovaginoplasty Using Photoinduced-imine-crosslink Hydrogel in MRKH Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C537371', 'term': 'Mullerian aplasia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-12', 'studyFirstSubmitDate': '2024-06-27', 'studyFirstSubmitQcDate': '2024-07-12', 'lastUpdatePostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Degree of vaginal squamous epithelialization', 'timeFrame': '1 month', 'description': 'Percentage of squamous epithelialization of neovagina'}, {'measure': 'Degree of vaginal squamous epithelialization', 'timeFrame': '3 months', 'description': 'Percentage of squamous epithelialization of neovagina'}, {'measure': 'Degree of vaginal squamous epithelialization', 'timeFrame': '6 months', 'description': 'Percentage of squamous epithelialization of neovagina'}], 'secondaryOutcomes': [{'measure': 'length of neovagina', 'timeFrame': '1 month', 'description': 'length in centimetre, measured by a ruler'}, {'measure': 'length of neovagina', 'timeFrame': '3 months', 'description': 'length in centimetre, measured by a ruler'}, {'measure': 'length of neovagina', 'timeFrame': '6 months', 'description': 'length in centimetre, measured by a ruler'}, {'measure': 'width of neovagina', 'timeFrame': '1 month', 'description': 'width in centimetre, measured by ruler'}, {'measure': 'width of neovagina', 'timeFrame': '3 months', 'description': 'width in centimetre, measured by ruler'}, {'measure': 'width of neovagina', 'timeFrame': '6 months', 'description': 'width in centimetre, measured by ruler'}, {'measure': 'Sexual life quality', 'timeFrame': '6 months', 'description': 'Female Sexual Function Index, a self-reported questionnaire to measure sexual life quality'}, {'measure': 'Sexual life quality', 'timeFrame': '1 year', 'description': 'Female Sexual Function Index, a self-reported questionnaire to measure sexual life quality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Photoinduced-imine-crosslink hydrogel', 'MRKH syndrome', 'Neovaginoplasty'], 'conditions': ['Mayer Rokitansky Kuster Hauser Syndrome']}, 'referencesModule': {'references': [{'pmid': '31667605', 'type': 'RESULT', 'citation': 'Zhang X, Qiu J, Ding J, Hua K. Comparison of neovaginoplasty using acellular porcine small intestinal submucosa graft or Interceed in patients with Mayer-Rokitansky-Kuster-Hauser syndrome. Arch Gynecol Obstet. 2019 Dec;300(6):1633-1636. doi: 10.1007/s00404-019-05352-0. Epub 2019 Oct 30.'}, {'pmid': '37604908', 'type': 'RESULT', 'citation': 'Bao B, Zeng Q, Li K, Wen J, Zhang Y, Zheng Y, Zhou R, Shi C, Chen T, Xiao C, Chen B, Wang T, Yu K, Sun Y, Lin Q, He Y, Tu S, Zhu L. Rapid fabrication of physically robust hydrogels. Nat Mater. 2023 Oct;22(10):1253-1260. doi: 10.1038/s41563-023-01648-4. Epub 2023 Aug 21.'}, {'pmid': '34605063', 'type': 'RESULT', 'citation': 'Zhang W, Bao B, Jiang F, Zhang Y, Zhou R, Lu Y, Lin S, Lin Q, Jiang X, Zhu L. Promoting Oral Mucosal Wound Healing with a Hydrogel Adhesive Based on a Phototriggered S-Nitrosylation Coupling Reaction. Adv Mater. 2021 Dec;33(48):e2105667. doi: 10.1002/adma.202105667. Epub 2021 Oct 4.'}, {'pmid': '31089131', 'type': 'RESULT', 'citation': 'Hong Y, Zhou F, Hua Y, Zhang X, Ni C, Pan D, Zhang Y, Jiang D, Yang L, Lin Q, Zou Y, Yu D, Arnot DE, Zou X, Zhu L, Zhang S, Ouyang H. A strongly adhesive hemostatic hydrogel for the repair of arterial and heart bleeds. Nat Commun. 2019 May 14;10(1):2060. doi: 10.1038/s41467-019-10004-7.'}]}, 'descriptionModule': {'briefSummary': 'Evaluating the effectiveness and safety of neovaginoplasty using photoinduced-imine-crosslink hydrogel in patients with MRKH syndrome by comparing the differences in the degree of squamous epithelialization, vaginal length and width, and sexual life quality.', 'detailedDescription': "This is a randomized controlled trial. Patients meeting the inclusion criteria will be enrolled in this study: 1)Diagnosed with MRKH syndrome; 2)Without previous treatments; 3)Age: 18-35 years old; 4)Voluntary agreement to participate in the study, sign the informed consent form, and demonstrate good compliance with follow-up.\n\nA centralized block randomization will be used to randomly assign patients to ensure that there will be an equal number of patients (1:1) in the hydrogel group and control group. The sample size is 20.\n\nUnder general anesthesia and catheterized bladder, the patient was in the lithotomy position. In the connective tissue plane between the bladder and rectum, the vestiges of the müllerian ducts were identified. With the index finger in the rectum as a direction and protection, Hegar's dilators of increasing size (4.5-10) were pushed through the dimples gently. After that, a double-barreled canal appeared. Then, the raphe between the canals was incised. The neovagina was created. According to the randomization, a vaginal mold spreaded with hydrogel or not was placed. The patients were suggested to wear the vaginal mold continuously over the following 6 months. After that, they were allowed to have the first sexual intercourse. Otherwise, the mold wearing time was 1 h daily, until they had sexual activity at least twice a week.\n\nThe primary endpoint is the degree of vaginal squamous epithelialization 1 month, 3 months, 6 months after surgery. The secondary endpoints include neovaginal length and width, sexual life quality, and surgical complications."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed with MRKH syndrome;\n2. Without previous related treatments; 3)18-35 years old;\n\n4)Voluntary agreement to participate in the study, sign the informed consent form, and demonstrate good compliance with follow-up.\n\nExclusion Criteria:\n\n1. With any previous artificial colpoplasty or other related treatment;\n2. With history of diabetes or systemic immune system disease.'}, 'identificationModule': {'nctId': 'NCT06508151', 'briefTitle': 'Neovaginoplasty Using Photoinduced-imine-crosslink Hydrogel in MRKH Patients', 'organization': {'class': 'OTHER', 'fullName': 'Obstetrics & Gynecology Hospital of Fudan University'}, 'officialTitle': 'Study on the Effectiveness and Safety of Neovaginoplasty Using Photoinduced-imine-crosslink Hydrogel in Patients With Mayer-Rokitansky-Kuster-Hauser Syndrome', 'orgStudyIdInfo': {'id': '2024-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'After neovaginoplasty, a vaginal mold spreaded with photoinduced-imine-crosslink hydrogel was placed in the neovagina.', 'interventionNames': ['Procedure: neovaginoplasty and vaginal mold spreaded with photoinduced-imine-crosslink hydrogel']}, {'type': 'OTHER', 'label': 'Arm 2', 'description': 'After neovaginoplasty, a vaginal mold was placed in the neovagina directly without anything spreaded.', 'interventionNames': ['Procedure: neovaginoplasty and vaginal mold']}], 'interventions': [{'name': 'neovaginoplasty and vaginal mold spreaded with photoinduced-imine-crosslink hydrogel', 'type': 'PROCEDURE', 'description': "Under general anesthesia and catheterized bladder, the patient was in the lithotomy position. In the connective tissue plane between the bladder and rectum, the vestiges of the müllerian ducts were identified. With the index finger in the rectum as a direction and protection, Hegar's dilators of increasing size (4.5-10) were pushed through the dimples gently. After that, a double-barreled canal appeared. Then, the raphe between the canals was incised. The neovagina was created. According to the randomization, a vaginal mold spreaded with hydrogel or not was placed in the neovagina for 6 months. The patients were suggested to wear the vaginal mold continuously over the following 6 months. After that, they were allowed to have the first sexual intercourse. Otherwise, the mold wearing time was 1 h daily, until they had sexual activity at least twice a week.", 'armGroupLabels': ['Arm 1']}, {'name': 'neovaginoplasty and vaginal mold', 'type': 'PROCEDURE', 'description': "Under general anesthesia and catheterized bladder, the patient was in the lithotomy position. In the connective tissue plane between the bladder and rectum, the vestiges of the müllerian ducts were identified. With the index finger in the rectum as a direction and protection, Hegar's dilators of increasing size (4.5-10) were pushed through the dimples gently. After that, a double-barreled canal appeared. Then, the raphe between the canals was incised. The neovagina was created. According to the randomization, a vaginal mold spreaded with hydrogel or not was placed in the neovagina for 6 months. The patients were suggested to wear the vaginal mold continuously over the following 6 months. After that, they were allowed to have the first sexual intercourse. Otherwise, the mold wearing time was 1 h daily, until they had sexual activity at least twice a week.", 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Keqin Hua, Doctor', 'role': 'CONTACT', 'email': 'huakeqinjiaoshou@163.com', 'phone': '+86-021-33189900'}], 'overallOfficials': [{'name': 'Keqin Hua, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Obstetrics & Gynecology Hospital of Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Obstetrics & Gynecology Hospital of Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor, Principal Investigator, Clinical Professor', 'investigatorFullName': 'Keqin Hua', 'investigatorAffiliation': 'Obstetrics & Gynecology Hospital of Fudan University'}}}}