Postbiotic Intervention on Vaginal Microbiota (NCT07278024) | Clinical Trial Compass
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 range
30 Years – 45 Years
Sex
FEMALE
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Vaginal microbiome composition (genus level)
Timeframe: Baseline (Week 0) and post-intervention (Week 8)