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Fecal Microbiota Transplantation for Obese Women With Polyendocrine Metabolic Ovarian Syndrome

RecruitingNAAges 20 Years - 40 YearsFemaleShanghai Changzheng Hospital
NCT07746635 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • oral Fecal Microbiota Transplantation
  • Placebo
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Where

1 site
Center for Reproductive Medicine,Shanghai Changzheng Hospital
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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