A Phase 4 interventional study of postoperative application of vaginal Lactobacillus capsule and routine care in Mayer Rokitansky Kuster Hauser Syndrome, sponsored by Obstetrics & Gynecology Hospital of Fudan University. Not yet recruiting. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Obstetrics & Gynecology Hospital of Fudan University · Phase 4, Interventional, and Treatment
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).
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.
Obstetrics & Gynecology Hospital of Fudan University is the lead sponsor of 24 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
postoperative application of vaginal Lactobacillus capsule
Biological: postoperative application of vaginal Lactobacillus capsule
routine care without application of vaginal Lactobacillus capsule
Other: routine care
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/capsule, containing Lactobacillus delbrueckii ≥0.25 × 10⁶ CFU/mL; 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.
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.
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): \<1 = (+), 1-4 = (++), 5-30 = (+++), and \>30 = (++++). Among these, (+++) and (++++) represent the normal lactobacillus count in healthy individuals. (+++) and (++++) are considered effective/valid; (+) and (++) are ineffective/invalid.
Time frame: 1 month postoperatively
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): \<1 = (+), 1-4 = (++), 5-30 = (+++), and \>30 = (++++). Among these, (+++) and (++++) represent the normal lactobacillus count in healthy individuals. (+++) and (++++) are considered effective/valid; (+) and (++) are ineffective/invalid.
Time frame: 3 months postoperatively
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): \<1 = (+), 1-4 = (++), 5-30 = (+++), and \>30 = (++++). Among these, (+++) and (++++) represent the normal lactobacillus count in healthy individuals. (+++) and (++++) are considered effective/valid; (+) and (++) are ineffective/invalid.
Time frame: 6 months postoperatively
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): \<1 = (+), 1-4 = (++), 5-30 = (+++), and \>30 = (++++). Among these, (+++) and (++++) represent the normal Lactobacillus count in healthy individuals. (+++) and (++++) are considered effective; (+) and (++) are ineffective.
Time frame: 12 months postoperatively
length of neovagina
Length of neovagina was measured using a sterile disposable paper ruler, and the results were expressed in centimeter (cm).
Time frame: 1 month postoperatively
length of neovagina
Length of neovagina was measured using a sterile disposable paper ruler, and the results were expressed in centimeter (cm).
Time frame: 3 months postoperatively
length of neovagina
Length of neovagina was measured using a sterile disposable paper ruler, and the results were expressed in centimeter (cm).
Time frame: 6 months postoperatively
length of neovagina
Length of neovagina was measured using a sterile disposable paper ruler, and the results were expressed in centimeter (cm).
Time frame: 12 months postoperatively
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.
Time frame: 1 month postoperatively
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.
Time frame: 3 months postoperatively
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.
Time frame: 6 months postoperatively
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.
Time frame: 12 months postoperatively
No study locations are listed for this record.
Plan to share: No
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Mullerian aplasia
Obstetrics & Gynecology Hospital of Fudan University