Fecal Microbiota Transplantation for Obese Women With Polyendocrine Metabolic Ovarian Syndrome

Background:Polyendocrine Metabolic Ovarian Syndrome (PMOS), formerly recognized as Polycystic Ovary Syndrome (PCOS), is a systemic disorder characterized by hyperandrogenism, insulin resistance, chronic low-grade inflammation, and gut microbiota dysbiosis. These abnormalities frequently impair endometrial receptivity, oocyte quality, and clinical pregnancy outcomes in assisted reproductive technology (ART) cycles. Fecal Microbiota Transplantation (FMT) offers a targeted approach to restore gut microecology and alleviate metabolic-endocrine dysfunction.

Study Design:This study adopts a prospective, two-stage sequential implementation framework.

Phase 1 (Single-Arm Exploratory Pilot Stage):

Objective: To establish preliminary safety, tolerability, gut microbiota remodeling, and reproductive feasibility of oral FMT in PMOS patients undergoing FET.

Cohort: An initial exploratory cohort of 11 evaluable overweight or obese patients with PMOS (BMI24.0kg/m2) scheduled for Frozen-Thawed Embryo Transfer (FET).

Design: Prospective, open-label, single-arm pilot study without a concurrent control group.

Phase 2 (Randomized Controlled Trial Stage):

Objective: To rigorously confirm therapeutic efficacy, metabolic amelioration, and pregnancy rate enhancement in a larger sample size based on Phase 1 safety and biomarker findings.

Design: Prospective, randomized controlled trial comparing oral FMT capsule intervention with standard care/placebo control.

Intervention Protocol:Participants in the FMT intervention receive oral FMT freeze-dried powder capsules derived from strictly screened, traceable healthy donors provided by a standardized Microbiota Biobank.

Dosage: 5 capsules twice daily, taken orally on an empty stomach for 6 consecutive days per course.

Schedule: Two or three identical courses separated by a 4-week interval. Background Care: Standardized lifestyle and dietary guidance are maintained throughout both phases.

Study Endpoints:

Primary Endpoints:Reproductive and pregnancy outcomes following FET (biochemical pregnancy rate, clinical pregnancy rate, embryo implantation rate).Safety and tolerability (incidence, severity, and causality of Adverse Events).

Secondary Endpoints:

Endocrine profiles (LH, FSH, Total Testosterone, Free Testosterone, PRL, Progesterone, Estradiol).

Metabolic and glycemic parameters (BMI, fasting blood glucose, HbA1c, fasting insulin, HOMA-IR, lipid profiles).

Systemic inflammatory and gut barrier markers (CRP, TNF-α, IL-6, IL-22, LPS). Gut microbiota structure and diversity via metagenomic sequencing and bile acid metabolomics.

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.