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Mayer Rokitansky Kuster Hauser SyndromePhase 4NCT07865559

Vaginal Lactobacillus for Postoperative Microecology and Mucosal Repair in MRKH Syndrome

A Phase 4 study testing postoperative application of vaginal Lactobacillus capsule and routine care in people with Mayer Rokitansky Kuster Hauser Syndrome, run by Obstetrics & Gynecology Hospital of Fudan University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 35 years, women only
Conditions the study is for
Mayer Rokitansky Kuster Hauser Syndrome
What is being tested?
postoperative application of vaginal Lactobacillus capsule and routine care
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
No sites listed yet
Study dates
1 Nov 2026to 30 Jun 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients diagnosed with MRKH syndrome;
  • Undergoing initial surgical treatment;
  • Undergoing biological graft vaginoplasty;
  • Age: 18-35 years;
  • Voluntarily participating in this study, signing the informed consent form, with good compliance and cooperation with follow-up.

Who cannot join

  • History of previous vaginoplasty or other related treatments;
  • History of diabetes mellitus or systemic immune system diseases;
  • Concurrent severe medical or surgical diseases that make the patient unable to tolerate drug therapy;
  • Inability or unwillingness to sign the informed consent form;
  • Inability or unwillingness to comply with the study requiremen.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Xiaoyan Tang, Doctor contact

txyan9227@sina.com

About this study

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

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).

Read the detailed description

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.

Being tested
postoperative application of vaginal Lactobacillus capsule, routine care
Keywords
MRKH syndrome, Neovaginoplasty, vaginal Lactobacillus, Microecology, Vaginal repair
Medical subject headings
Mullerian aplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • postoperative application of vaginal Lactobacillus capsuleBiological

    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.

  • routine careOther

    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.

Study groups in NCT07865559
Study groupRoleWhat they receive
Arm1: intervention groupExperimentalpostoperative application of vaginal Lactobacillus capsule
Receives: Biological: postoperative application of vaginal Lactobacillus capsule
Arm 2: control groupOtherroutine care without application of vaginal Lactobacillus capsule
Receives: Other: routine care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 month postoperatively

  2. 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.

    Measured: 3 months postoperatively

  3. 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.

    Measured: 6 months postoperatively

  4. 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.

    Measured: 12 months postoperatively

Secondary outcomes (8)
  1. length of neovagina

    Length of neovagina was measured using a sterile disposable paper ruler, and the results were expressed in centimeter (cm).

    Measured: 1 month postoperatively

  2. length of neovagina

    Length of neovagina was measured using a sterile disposable paper ruler, and the results were expressed in centimeter (cm).

    Measured: 3 months postoperatively

  3. length of neovagina

    Length of neovagina was measured using a sterile disposable paper ruler, and the results were expressed in centimeter (cm).

    Measured: 6 months postoperatively

  4. length of neovagina

    Length of neovagina was measured using a sterile disposable paper ruler, and the results were expressed in centimeter (cm).

    Measured: 12 months postoperatively

  5. 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.

    Measured: 1 month postoperatively

  6. 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.

    Measured: 3 months postoperatively

  7. 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.

    Measured: 6 months postoperatively

  8. 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.

    Measured: 12 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion30 May 2028 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07865559
Sponsor's protocol ID
2026-57
Status last verified
Sep 2026
First submitted
27 Sep 2026
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Debray R, Herbert RA, Jaffe AL, Crits-Christoph A, Power ME, Koskella B. Priority effects in microbiome assembly. Nat Rev Microbiol. 2022 Feb;20(2):109-121. doi: 10.1038/s41579-021-00604-w. Epub 2021 Aug 27.

    PubMed 34453137
  • Chen N, Hao L, Zhang Z, Qin C, Jie Z, Pan H, Duan J, Huang X, Zhang Y, Gao H, Lu R, Sun T, Yang H, Shi J, Liang M, Guo J, Gao Q, Zhao X, Dou Z, Xiao L, Zhang S, Jin X, Xu X, Yang H, Wang J, Jia H, Zhang T, Kristiansen K, Chen C, Zhu L. Insights into the assembly of the neovaginal microbiota in Mayer-Rokitansky-Kuster-Hauser (MRKH) syndrome patients. Nat Commun. 2024 Sep 6;15(1):7808. doi: 10.1038/s41467-024-52102-1.

    PubMed 39242555
  • Huang X, Lin R, Mao B, Tang X, Zhao J, Zhang Q, Cui S. Lactobacillus crispatus CCFM1339 Inhibits Vaginal Epithelial Barrier Injury Induced by Gardnerella vaginalis in Mice. Biomolecules. 2024 Feb 18;14(2):240. doi: 10.3390/biom14020240.

    PubMed 38397477
  • Sharma M, Chopra C, Mehta M, Sharma V, Mallubhotla S, Sistla S, Sistla JC, Bhushan I. An Insight into Vaginal Microbiome Techniques. Life (Basel). 2021 Nov 13;11(11):1229. doi: 10.3390/life11111229.

    PubMed 34833105
  • Committee on Adolescent Health Care. ACOG Committee Opinion No. 728: Mullerian Agenesis: Diagnosis, Management, And Treatment. Obstet Gynecol. 2018 Jan;131(1):e35-e42. doi: 10.1097/AOG.0000000000002458.

    PubMed 29266078
  • Wagner A, Brucker SY, Ueding E, Grober-Gratz D, Simoes E, Rall K, Kronenthaler A, Schaffeler N, Rieger MA. Treatment management during the adolescent transition period of girls and young women with Mayer-Rokitansky-Kuster-Hauser syndrome (MRKHS): a systematic literature review. Orphanet J Rare Dis. 2016 Nov 16;11(1):152. doi: 10.1186/s13023-016-0536-6.

    PubMed 27852280

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing postoperative application of vaginal Lactobacillus capsule and routine care in people with Mayer Rokitansky Kuster Hauser Syndrome, run by Obstetrics & Gynecology Hospital of Fudan University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Keqin Hua, Doctor (+86-021-33189900, huakeqinjiaoshou@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lactobacillus count (time frame: 1 month postoperatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07865559, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.

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