[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555135":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":25,"responsibleParty":38,"collaborators":25,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":25,"eligibilityCriteria":47,"healthyVolunteers":43,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":25,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":64,"whyStopped":25,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":25},{"fullName":5,"class":6},"Obstetrics & Gynecology Hospital of Fudan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1","EXPERIMENTAL","After neovaginoplasty, a vaginal mold spreaded with photoinduced-imine-crosslink hydrogel was placed in the neovagina.",[13],"Procedure: neovaginoplasty and vaginal mold spreaded with photoinduced-imine-crosslink hydrogel",{"label":15,"type":6,"description":16,"interventionNames":17},"Arm 2","After neovaginoplasty, a vaginal mold was placed in the neovagina directly without anything spreaded.",[18],"Procedure: neovaginoplasty and vaginal mold",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","neovaginoplasty and vaginal mold spreaded with photoinduced-imine-crosslink hydrogel","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.",[9],null,{"type":21,"name":27,"description":23,"armGroupLabels":28,"otherNames":25},"neovaginoplasty and vaginal mold",[15],[30],{"name":31,"affiliation":5,"role":32},"Keqin Hua, Doctor","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":25,"email":37},"CONTACT","+86-021-33189900","huakeqinjiaoshou@163.com",{"type":32,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Keqin Hua","Doctor, Principal Investigator, Clinical Professor","100555135","neovaginoplasty-using-photoinduced-imine-crosslink-hydrogel-in-mrkh-patients-100555135",false,"NCT06508151","Neovaginoplasty Using Photoinduced-imine-crosslink Hydrogel in MRKH Patients","Study on the Effectiveness and Safety of Neovaginoplasty Using Photoinduced-imine-crosslink Hydrogel in Patients With Mayer-Rokitansky-Kuster-Hauser Syndrome","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.","FEMALE","18 Years","35 Years",{"count":52,"type":53},20,"ESTIMATED","INTERVENTIONAL",[56],"NA","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.",[59],"Mayer Rokitansky Kuster Hauser Syndrome",[61,62,63],"Photoinduced-imine-crosslink hydrogel","MRKH syndrome","Neovaginoplasty","NOT_YET_RECRUITING","2024-07-12",{"date":67,"type":68},"2024-07-18","ACTUAL",{"date":70,"type":53},"2024-08-01",{"date":72,"type":53},"2026-06-30",{"name":5,"class":6}]