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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kaohsiung Veterans General Hospital.

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 30, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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