Fecal Microbiota Transplantation for Obese Women With Polyendocrine Metabolic Ovarian Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: oral Fecal Microbiota Transplantation.
- Who it may be relevant to
- Registry conditions: PCOS (Polycystic Ovary Syndrome). Basic parameters: 20 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Fecal Microbiota Transplantation for the Treatment of Polyendocrine Metabolic Ovarian Syndrome in Obese Women:A Phase Ⅰ/ⅡSingle-Arm Pilot Study and Planned Randomized Controlled Trial
Overview
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.
Detailed description
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.
Interventions
- Biological oral Fecal Microbiota Transplantation
Participants will receive standardized oral FMT freeze-dried powder capsules 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. A second identical course will be administered 4 weeks after the completion of the first course (totaling 2 courses). Background: Standardized lifestyle and dietary guidance will be pr
Primary outcome measures
- Clinical Pregnancy Rate [Time frame: Assessed up to 8 weeks following the Frozen-Thawed Embryo Transfer (FET)(approximately within 6 months following the completion of the FMT intervention).]
- Biochemical Pregnancy Rate [Time frame: Assessed at 14 days following the Frozen-Thawed Embryo Transfer (FET)]
- Incidence of Adverse Events (AEs) [Time frame: Assessed from the first dose of FMT through the 12-week post-treatment follow-up]
Secondary outcome measures (7)
- Change in Body Mass Index (BMI) [Time frame: Baseline and 4 weeks post-FMT.]
- Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) [Time frame: Baseline, 4 weeks post-FMT, and 12 weeks post-FMT.]
- Change in Serum Total Testosterone (T) Level [Time frame: Baseline, 4 weeks post-FMT, and 12 weeks post-FMT.]
- Change in Serum Luteinizing Hormone (LH) Level [Time frame: Baseline, 4 weeks post-FMT, and 12 weeks post-FMT.]
- Change in Serum Interleukin-6 (IL-6) Level [Time frame: Baseline, 4 weeks post-FMT, and 12 weeks post-FMT.]
- Change in Gut Microbiota Alpha Diversity (Shannon Index) [Time frame: Baseline and 4 weeks post-FMT.]
- Live Birth Rate (LBR) [Time frame: Assesssed up to 42 weeks following the Frozen-Thawed Embryo Transfer (FET)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Center for Reproductive Medicine,Shanghai Changzheng Hospital — Shanghai
Identifiers
NCT: NCT07746635 · 2025SL038