[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659457":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":45,"studyPopulation":35,"armGroups":46,"interventions":58,"overallOfficials":67,"centralContacts":71,"locations":35,"responsibleParty":79,"collaborators":35,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":35,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":35,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":107,"whyStopped":35,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":35},{"fullName":5,"class":6},"Obstetrics & Gynecology Hospital of Fudan University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":35},[9,13,15,17],{"measure":10,"description":11,"timeFrame":12},"Lactobacillus count","Vaginal secretions were collected for Lactobacillus counting. Lactobacilli were counted according to the Nugent criteria. The number of lactobacilli per high-power field (HPF): \\\u003C1 = (+), 1-4 = (++), 5-30 = (+++), and \\>30 = (++++). Among these, (+++) and (++++) represent the normal lactobacillus count in healthy individuals. (+++) and (++++) are considered effective\u002Fvalid; (+) and (++) are ineffective\u002Finvalid.","1 month postoperatively",{"measure":10,"description":11,"timeFrame":14},"3 months postoperatively",{"measure":10,"description":11,"timeFrame":16},"6 months postoperatively",{"measure":10,"description":18,"timeFrame":19},"Vaginal secretions were collected for Lactobacillus counting: Lactobacilli were counted according to the Nugent criteria. The number of lactobacilli per high-power field (HPF): \\\u003C1 = (+), 1-4 = (++), 5-30 = (+++), and \\>30 = (++++). Among these, (+++) and (++++) represent the normal Lactobacillus count in healthy individuals. (+++) and (++++) are considered effective; (+) and (++) are ineffective.","12 months postoperatively",[21,24,25,26,27,30,31,32],{"measure":22,"description":23,"timeFrame":12},"length of neovagina","Length of neovagina was measured using a sterile disposable paper ruler, and the results were expressed in centimeter (cm).",{"measure":22,"description":23,"timeFrame":14},{"measure":22,"description":23,"timeFrame":16},{"measure":22,"description":23,"timeFrame":19},{"measure":28,"description":29,"timeFrame":12},"percentage of squamous epithelialization of neovagina","During gynecological examination, after the neovagina was opened with a vaginal speculum, the total neovaginal length and the length of the squamous metaplastic portion were measured separately using a disposable sterile paper ruler. Percentage of squamous epithelialization of neovagina was calculated as the length of the squamous metaplastic portion divided by the total neovaginal length. A higher percentage of squamous epithelialization indicates a better outcome of vaginoplasty.",{"measure":28,"description":29,"timeFrame":14},{"measure":28,"description":29,"timeFrame":16},{"measure":33,"description":34,"timeFrame":19},"Sexual life quality","Sexual life quality was assessed by Female Sexual Function Index (FSFI). The FSFI is a standardized self-report scale used to evaluate female sexual function over the past 4 weeks. It was developed by Rosen et al. in 2000 and consists of 19 items across 6 domains, covering sexual desire, sexual arousal, vaginal lubrication, orgasm, sexual satisfaction, and dyspareunia. Each domain has a maximum score of 6 points (after adjustment), and the total score ranges from 2.0 to 36. Lower scores indicate more obvious sexual function problems.",null,{"allocation":37,"interventionModel":38,"interventionModelDescription":35,"primaryPurpose":39,"observationalModel":35,"timePerspective":35,"maskingInfo":40},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":41,"maskingDescription":35,"whoMasked":42},"DOUBLE",[43,44],"PARTICIPANT","OUTCOMES_ASSESSOR","This study is planned to use a randomized controlled trial design and enroll 32 patients with MRKH syndrome who have undergone biological graft vaginoplasty. The patients will be randomly assigned 1:1 to an intervention group (postoperative application of vaginal Lactobacillus capsule) and a control group (routine care). In both groups, vaginal secretions will be collected before treatment and at 1, 3, 6, and 12 months postoperatively; gynecological examinations will be performed; symptom and sign record forms will be completed; and adverse reactions will be documented. The following outcome measures will be evaluated: (1) Primary efficacy outcome measures: microecology-related indicators, including routine vaginal secretion testing, Lactobacillus counts, and microbial diversity analysis. (2) Secondary efficacy outcome measures: neovaginal length and width, the degree of mucosal squamous epithelial metaplasia, the incidence of adverse events, and sexual function scale scores.",[47,53],{"label":48,"type":49,"description":50,"interventionNames":51},"Arm1: intervention group","EXPERIMENTAL","postoperative application of vaginal Lactobacillus capsule",[52],"Biological: postoperative application of vaginal Lactobacillus capsule",{"label":54,"type":6,"description":55,"interventionNames":56},"Arm 2: control group","routine care without application of vaginal Lactobacillus capsule",[57],"Other: routine care",[59,63],{"type":60,"name":50,"description":61,"armGroupLabels":62,"otherNames":35},"BIOLOGICAL","The patients in intervention group (n=16) will wash the vulva with clean water every night and then insert one Dingjunsheng capsule (0.25 g\u002Fcapsule, containing Lactobacillus delbrueckii ≥0.25 × 10⁶ CFU\u002FmL; for vaginal use; Lot No.: 20120804; Inner Mongolia Shuangqi Pharmaceutical Co., Ltd.) deep into the vagina once nightly for 10 consecutive days. The methods of disinfecting and wearing the vaginal mold will be the same in both groups.",[48],{"type":6,"name":64,"description":65,"armGroupLabels":66,"otherNames":35},"routine care","The patients in control group (n=16) will wash the vulva with clean water every night without using any medication and wear the vaginal mold. The methods of disinfecting and wearing the vaginal mold will be the same in both groups.",[54],[68],{"name":69,"affiliation":5,"role":70},"Keqin Hua, Doctor","PRINCIPAL_INVESTIGATOR",[72,76],{"name":69,"role":73,"phone":74,"phoneExt":35,"email":75},"CONTACT","+86-021-33189900","huakeqinjiaoshou@163.com",{"name":77,"role":73,"phone":35,"phoneExt":35,"email":78},"Xiaoyan Tang, Doctor","txyan9227@sina.com",{"type":70,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"Keqin Hua","Doctor, Principal Investigator, Clinical Professor","100659457","phase-4-vaginal-lactobacillus-for-postoperative-microecology-and-mucosal-repair-in-mrkh-syndrome-100659457",false,"NCT07865559","Vaginal Lactobacillus for Postoperative Microecology and Mucosal Repair in MRKH Syndrome","Effects of Vaginal Lactobacillus Capsule on Postoperative Vaginal Microecology and Mucosal Repair in Patients With Mayer-Rokitansky-Küster-Hauser (MRKH) Syndrome","Inclusion Criteria:\n\n* Patients diagnosed with MRKH syndrome;\n* Undergoing initial surgical treatment;\n* Undergoing biological graft vaginoplasty;\n* Age: 18-35 years;\n* Voluntarily participating in this study, signing the informed consent form, with good compliance and cooperation with follow-up.\n\nExclusion Criteria:\n\n* History of previous vaginoplasty or other related treatments;\n* History of diabetes mellitus or systemic immune system diseases;\n* Concurrent severe medical or surgical diseases that make the patient unable to tolerate drug therapy;\n* Inability or unwillingness to sign the informed consent form;\n* Inability or unwillingness to comply with the study requiremen.","FEMALE","18 Years","35 Years",{"count":93,"type":94},32,"ESTIMATED","INTERVENTIONAL",[97],"PHASE4","This study is aimed to evaluate the promoting effects of vaginal Lactobacillus capsule on microecological reconstruction and mucosal repair of the neovagina after biological graft vaginoplasty in patients with MRKH syndrome, , through a randomized controlled trial (RCT).",[100],"Mayer Rokitansky Kuster Hauser Syndrome",[102,103,104,105,106],"MRKH syndrome","Neovaginoplasty","vaginal Lactobacillus","Microecology","Vaginal repair","NOT_YET_RECRUITING","2026-10-04",{"date":110,"type":111},"2026-10-08","ACTUAL",{"date":113,"type":94},"2026-11-01",{"date":115,"type":94},"2028-06-30",{"name":5,"class":6}]