Fecal microbiota transplantation for overweight women with PMOS undergoing embryo transfer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial tests oral fecal microbiota transplantation (FMT) capsules in overweight or obese women with Polyendocrine Metabolic Ovarian Syndrome (PMOS) who are having a frozen-thawed embryo transfer. It consists of two stages: a small, open-label pilot to assess safety and preliminary effects on gut microbiota and pregnancy outcomes, followed by a larger randomized controlled trial to confirm efficacy against standard care or placebo. The study measures safety, metabolic and endocrine changes, and reproductive outcomes, with Phase 2 designed to validate mechanisms identified in Phase 1. The intervention uses freeze-dried oral FMT capsules and compares them to a control in a multicenter setting after initial single-center exploration.

Why it matters

Who can join: the full rules

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): \>24.0 kg/m²(covering overweight and obese patients according to Asian criteria, addressing the actual recruited cohort ranging from 24.0 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.

Where it's running

• Center for Reproductive Medicine,Shanghai Changzheng Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Ningxia Sun, MD-PhD — Shanghai Changzheng Hospital
• Study coordinator: Ningxia Sun, Chief
• Email: suesunchzh@126.com
• Phone: 13817975897

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.