Fecal Microbiota Transplantation for Obese Women With Polyendocrine Metabolic Ovarian Syndrome (NCT07746635) | Clinical Trial Compass
RecruitingNot Applicable
Fecal Microbiota Transplantation for Obese Women With Polyendocrine Metabolic Ovarian Syndrome
China161 participantsStarted 2025-02-21
Plain-language summary
This prospective, two-stage clinical trial aims to evaluate the safety, preliminary efficacy, and reproductive outcomes of oral Fecal Microbiota Transplantation (FMT) freeze-dried capsules in overweight and obese patients with Polyendocrine Metabolic Ovarian Syndrome (PMOS) undergoing Frozen-Thawed Embryo Transfer (FET).The study is implemented in two sequential phases:
Phase Ⅰ (Pilot Exploration): A prospective, open-label, single-arm exploratory study in an initial evaluable cohort (n=11) to evaluate preliminary safety, dynamic gut microbiota colonization, endocrine/metabolic parameters, and pregnancy outcomes following FET.
Phase Ⅱ (Confirmatory RCT): A planned multicenter, prospective, randomized controlled trial (RCT) designed to validate the clinical efficacy and underlying mechanisms of oral FMT capsules compared with control interventions, based on findings established in Phase Ⅰ.
Who can participate
Age range
20 Years – 40 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\. Females aged 20 to 40 years old.
* 2\. Meeting the diagnostic criteria for Polyendocrine Metabolic Ovarian Syndrome (PMOS).
* 3\. Body Mass Index (BMI): \>24 kg/m²(covering overweight and obese patients according to Asian criteria, addressing the actual recruited cohort ranging from 24 kg/m² upwards).
* 4\. Scheduled to undergo Frozen-Thawed Embryo Transfer (FET) at the Reproductive Medicine Center.
* 5\. Voluntary participation with signed Informed Consent Form (ICF).
Exclusion Criteria:
* Age \< 20 or \> 40 years.
* Pregnancy or lactation.
* Other endocrine disorders (e.g., Cushing's syndrome, thyroid dysfunction); severe organ dysfunction or impaired intestinal mucosal barrier; use of antibiotics, probiotics, or prebiotics within 1 month.
* Use of ovulation-modifying or anti-androgen drugs within 3 months; severe psychiatric disorders.
* Concurrent participation in other clinical trials.
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
Clinical Pregnancy Rate
Timeframe: Assessed up to 8 weeks following the Frozen-Thawed Embryo Transfer (FET)(approximately within 6 months following the completion of the FMT intervention).
2
Biochemical Pregnancy Rate
Timeframe: Assessed at 14 days following the Frozen-Thawed Embryo Transfer (FET)
3
Incidence of Adverse Events (AEs)
Timeframe: Assessed from the first dose of FMT through the 12-week post-treatment follow-up