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.
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.
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.
Parallel
oral Fecal Microbiota Transplantation
Biological/VaccineParticipants 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 interventionParticipants 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.
Clinical Pregnancy Rate
The percentage of participants who achieve a confirmed clinical pregnancy, defined as the presence of at least one intrauterine gestational sac with a viable fetal heartbeat confirmed by transvaginal ultrasound.
Biochemical Pregnancy Rate
The percentage of participants who achieve a biochemical pregnancy, confirmed by a serum beta-hCG level \> 10 mIU/mL.
Incidence of Adverse Events (AEs)
The number of participants experiencing any treatment-related adverse events or serious adverse events, graded according to the Common Terminology Criteria for Adverse Events (CTCAE v5.0),including diarrhea,bloating,abdominal pain,constipation,etc.
Change in Body Mass Index (BMI)
Evaluation of the mean change in Body Mass Index (calculated as weight in kilograms divided by height in meters squared) from baseline to post-treatment.
Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Evaluation of the mean change in insulin resistance assessed by the HOMA-IR index (calculated from fasting blood glucose and fasting insulin levels).
Change in Serum Total Testosterone (T) Level
Evaluation of the mean change in fasting serum total testosterone levels from baseline.
Change in Serum Luteinizing Hormone (LH) Level
Evaluation of the mean change in fasting serum luteinizing hormone levels from baseline.
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