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RECRUITING Not applicable ClinicalTrials.gov

Fecal Microbiota Transplantation for Obese Women With Polyendocrine Metabolic Ovarian Syndrome

Sponsor: Shanghai Changzheng Hospital • ClinicalTrials.gov ID: NCT07746635

Registry updated: 2026-09-22
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Description

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.

Interventions

  • oral Fecal Microbiota Transplantation (Biological)
    Participants will receive standardized oral FMT freeze-dried powder capsules without antibiotic pretreatment. The capsules are derived from strictly screened, traceable healthy donors from a standardized Microbiota Biobank. Dosage and Regimen: Oral administration of 5 capsules twice daily on an empty stomach for 6 consecutive days, which constitutes one course. The complete regimen consists of 3 identical courses administered at Week 0, Week 4, and Week 8. Background: Standardized lifestyle and dietary guidance will be provided throughout the study.
  • Placebo (Other)
    Participants will receive visually and olfactory-matched placebo capsules without antibiotic pretreatment. Dosage and Regimen:Oral administration of 5 capsules twice daily on an empty stomach for 6 consecutive days per course. The complete regimen consists of 3 identical courses administered at Week 0, Week 4, and Week 8, exactly mirroring the experimental arm. Background: Standardized lifestyle and dietary guidance will be provided throughout the study.

Eligibility criteria

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.

Conditions

PCOS (Polycystic Ovary Syndrome)

Locations

  • Center for Reproductive Medicine,Shanghai Changzheng Hospital — Shanghai, Shanghai Municipality, China
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record