Fecal Microbiota Transplantation for Obese Women With Polyendocrine Metabolic Ovarian Syndrome
Recruiting · NCT07746635 · Interventional (participants receive a specific treatment) · Lead sponsor: Shanghai Changzheng Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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.
Where it is running
1 location listed.
- Center for Reproductive Medicine,Shanghai Changzheng Hospital - Shanghai, Shanghai Municipality, China