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Postbiotic Intervention on Vaginal Microbiota

NCT07278024 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-12-11

No results posted yet for this study

Summary

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.

Conditions

  • Infertile Women Undergoing IVF or ICSI

Interventions

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.

Sponsors & Collaborators

  • Kaohsiung Veterans General Hospital.

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2025-07-31
Completion
2025-11-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07278024 on ClinicalTrials.gov