CompletedNot Applicable

Postbiotic Intervention on Vaginal Microbiota

Taiwan15 participantsStarted 2025-04-01

Plain-language 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.

Who can participate

Age range30 Years – 45 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Vaginal microbiome composition (genus level)

Timeframe: Baseline (Week 0) and post-intervention (Week 8)

Trial details

NCT IDNCT07278024

SponsorKaohsiung Veterans General Hospital.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-31