RecruitingNot applicableFemale onlyEN original

Fecal Microbiota Transplantation for Obese Women With Polyendocrine Metabolic Ovarian Syndrome

⚠️

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About the trial

This single-center, 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 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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Kobieta w wieku 20-40 lat
  • Diagnoza zespołu policystycznych jajników (PCOS)
  • Wskaźnik masy ciała powyżej 24 kg/m² (nadwaga lub otyłość)
  • Planowany transfer zamrożonego zarodka w klinice
  • Dobrowolna zgoda na udział w badaniu

✗ Disqualifies

  • Wiek poniżej 20 lub powyżej 40 lat
  • Ciąża lub karmienie piersią
  • Inne zaburzenia hormonalne lub poważne problemy z narządami
  • Antybiotyki, probiotyki lub prebiotyki w ciągu ostatniego miesiąca
  • Leki zmieniające owulację w ciągu ostatnich 3 miesięcy
  • Poważne zaburzenia psychiczne
  • Udział w innym badaniu klinicznym

Simplified criteria — AI translation

Trial details

Minimum age
20 Years
Maximum age
40 Years
Last updated (source)
August 12, 2026
Sex
Female only

Therapies / drugs in trial

Locations (1)

Center for Reproductive Medicine,Shanghai Changzheng Hospital

Shanghai, China

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/6/2026.

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