Postbiotic Intervention on Vaginal Microbiota

November 30, 2025 updated by: Li-Te Lin, Kaohsiung Veterans General Hospital.

To Investigate the Effect of Postbiotic Intervention on Vaginal Microbiota in Infertile Women

This study investigates the effects of postbiotic intervention on vaginal microbiota in infertile patients. Using a pre-post test design, we will enroll 15 women aged 30-45 years with at least two IVF failures. Participants will receive postbiotic intervention for 8 weeks. Vaginal secretion samples will be collected before and after treatment for 16S rRNA sequencing analysis to assess microbial composition, dominant species distribution, α-diversity index, and Lactobacillus content. Primary outcomes include changes in vaginal microbiota composition and diversity, alterations in Lactobacillus abundance, and pregnancy rates in subsequent IVF-FET cycles.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background The demand for infertility treatment is increasing, with approximately 10-15% of couples of reproductive age experiencing varying degrees of fertility issues. Vaginal microbiota dysbiosis may be a significant factor contributing to infertility, and a healthy vaginal microbiota environment plays a crucial role in embryo implantation. This study aims to investigate the effects of postbiotic intervention on the vaginal microbiota of infertile patients by analyzing the vaginal microbiota before and after bacteriocin treatment to evaluate its effectiveness in improving the vaginal microbial environment.

Objective This study aims to investigate changes in vaginal microbiota before and after the use of postbiotic intervention.

Methods This study employs a pre-post test design, planning to enroll 15 women aged 30-45 years diagnosed with infertility with at least two IVF treatment failure. All subjects must be free from severe gynecological diseases, not using antibiotics or probiotics, and without acute vaginal infection symptoms. The study period is 8 weeks. Before intervention, baseline data collection will include complete medical history and infertility treatment records. During the first visit, vaginal secretion samples will be collected for vaginal microbiota assessment through 16S rRNA sequencing analysis, simultaneously measuring Lactobacillus content and microbial diversity. Subjects will then use postbiotic intervention continuously for 8 weeks. After treatment, a second sampling will be conducted to re-analyze the vaginal microbiota. The primary outcome measures include changes in microbial composition before and after use, including dominant species distribution, α-diversity index, and changes in Lactobacillus content. All specimens will be collected, transported, and preserved following standard operating procedures to ensure testing quality. Research data will be analyzed using paired sample statistical methods to assess pre-post treatment differences, with significance level set at p<0.05.

Outcome

  1. Compare differences in vaginal microbiota before and after using postbiotic intervention.
  2. Compare differences in taxonomic abundance before and after using postbiotic intervention.
  3. Check pregnancy rate of IVF-FET cycle after postbiotic intervention use

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung City, Taiwan
        • Department of Obstetrics and Gynecology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • (1) age 30-45 years;
  • (2) body mass index 18-30 kg/m²;
  • (3) history of ≥2 prior IVF treatment failures despite transfer of good-quality embryos;
  • (4) planned FET cycle;
  • (5) willingness to comply with the eight-week postbiotic intervention protocol

Exclusion Criteria:

  • (1) active acute vaginal infection with symptomatic presentation;
  • (2) antibiotic or probiotic use within the preceding three months;
  • (3) congenital uterine anomalies including septate, bicornuate, or unicornuate uterus;
  • (4) severe intrauterine adhesions (Asherman syndrome grade III-IV);
  • (5) history of gynecologic malignancy;
  • (6) known allergy or hypersensitivity to Lactobacillus-derived products;
  • (7) current ongoing pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: postbiotics
Other: postbiotics
Participants will self-administer postbiotic intervention via intravaginal suppositories containing purified bacteriocin peptides . The intervention consists of one suppository administered intravaginally at bedtime, once daily for 8 consecutive weeks (56 days total). Each suppository contains a standardized concentration of bacteriocins extracted from Lactobacillus strains.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaginal microbiome composition (genus level)
Time Frame: Baseline (Week 0) and post-intervention (Week 8)
Changes in vaginal bacterial community structure assessed through 16S rRNA gene sequencing of vaginal secretion samples collected at baseline (Week 0) and post-intervention (Week 8)
Baseline (Week 0) and post-intervention (Week 8)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Taxonomic abundance (%)
Time Frame: Baseline (Week 0) and post-intervention (Week 8)
Quantitative measurement of the relative proportions of bacterial taxa at different taxonomic levels (phylum, genus, and species) in vaginal samples before and after bacteriocin treatment. Results will report the percentage abundance of major bacterial groups.
Baseline (Week 0) and post-intervention (Week 8)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy rate (%)
Time Frame: through study completion, an average of 8 months
Visualization of fetal cardiac activity on transvaginal ultrasound at 6-7 weeks' gestation
through study completion, an average of 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Veterans General Hospital.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Actual)

July 31, 2025

Study Completion (Actual)

November 30, 2025

Study Registration Dates

First Submitted

November 30, 2025

First Submitted That Met QC Criteria

November 30, 2025

First Posted (Actual)

December 11, 2025

Study Record Updates

Last Update Posted (Actual)

December 11, 2025

Last Update Submitted That Met QC Criteria

November 30, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSVGH25-CT1-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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