An interventional study of oral Fecal Microbiota Transplantation and Placebo in PCOS (Polycystic Ovary Syndrome), sponsored by Shanghai Changzheng Hospital. Recruiting at 1 site in China. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Shanghai Changzheng Hospital · Not applicable, Interventional, and Treatment
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.
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 (BMI≥24.0kg/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: 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.
956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.
This study's planned enrollment of 411 is above the median of 70 across 697 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Shanghai Changzheng Hospital is the lead sponsor of 128 studies on the registry; 60 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this experimental arm are overweight and obese patients with Polyendocrine Metabolic Ovarian Syndrome (PMOS) scheduled for Frozen-Thawed Embryo Transfer (FET). They will receive standardized oral fecal microbiota transplantation (FMT) capsules without antibiotic pretreatment. Standardized lifestyle and dietary guidance will be provided throughout the study.
Biological: oral Fecal Microbiota Transplantation
Participants in this comparing arm are overweight and obese patients with Polyendocrine Metabolic Ovarian Syndrome (PMOS) scheduled for Frozen-Thawed Embryo Transfer (FET). They will receive visually and olfactory-matched placebo capsules without antibiotic pretreatment. Standardized lifestyle and dietary guidance will be provided throughout the study.
Other: Placebo
Participants 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.
Participants 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.
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
The percentage of participants who achieve a biochemical pregnancy, confirmed by a serum beta-hCG level \> 10 mIU/mL.
Time frame: Assessed at 14 days following the Frozen-Thawed Embryo Transfer (FET)
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.
Time frame: Assessed from the first dose of FMT through the 12-week post-treatment follow-up
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.
Time frame: Baseline and 4 weeks post-FMT.
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).
Time frame: Baseline, 4 weeks post-FMT, and 12 weeks post-FMT.
Change in Serum Total Testosterone (T) Level
Evaluation of the mean change in fasting serum total testosterone levels from baseline.
Time frame: Baseline, 4 weeks post-FMT, and 12 weeks post-FMT.
Change in Serum Luteinizing Hormone (LH) Level
Evaluation of the mean change in fasting serum luteinizing hormone levels from baseline.
Time frame: Baseline, 4 weeks post-FMT, and 12 weeks post-FMT.
Change in Serum Interleukin-6 (IL-6) Level
Evaluation of the mean change in systemic inflammatory marker Interleukin-6 (IL-6) from baseline.
Time frame: Baseline, 4 weeks post-FMT, and 12 weeks post-FMT.
Change in Gut Microbiota Alpha Diversity (Shannon Index)
Evaluation of the change in gut microbial alpha diversity from baseline, primarily assessed using the Shannon Diversity Index derived from metagenomic or 16S rRNA sequencing of fecal samples.
Time frame: Baseline and 4 weeks post-FMT.
Live Birth Rate (LBR)
The percentage of participants who deliver at least one live-born infant after 24 weeks of gestation.
Time frame: Assesssed up to 42 weeks following the Frozen-Thawed Embryo Transfer (FET)
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Dec 2028, 44 months after the start.
Of 202 non-industry interventional studies with no phase under Polycystic Ovary Syndrome, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 39. This study's planned 44 months is above that.
Counting every sponsor, half of 217 studies reached it within 18 months; a quarter within 7 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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