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NOT YET RECRUITING
NCT07865559
PHASE4

Vaginal Lactobacillus for Postoperative Microecology and Mucosal Repair in MRKH Syndrome

Sponsor: Obstetrics & Gynecology Hospital of Fudan University

View on ClinicalTrials.gov

Summary

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).

Official title: Effects of Vaginal Lactobacillus Capsule on Postoperative Vaginal Microecology and Mucosal Repair in Patients With Mayer-Rokitansky-Küster-Hauser (MRKH) Syndrome

Key Details

Gender

FEMALE

Age Range

18 Years - 35 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2026-11-01

Completion Date

2028-06-30

Last Updated

2026-10-08

Healthy Volunteers

No

Interventions

BIOLOGICAL

postoperative application of vaginal Lactobacillus capsule

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.

OTHER

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.