Fecal Microbiota Transplantation for Obese Women With Polyendocrine Metabolic Ovarian Syndrome

NCT07746635 | Recruiting

• 1 other identifier: 2025SL038
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PCOS (Polycystic Ovary Syndrome)

Keywords

FMT; PCOS; PMOS

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Assessed from the first dose of FMT through the 12-week post-treatment follow-up

Secondary Outcomes (7)

• Change in Body Mass Index (BMI)

  Baseline and 4 weeks post-FMT.

• Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

  Baseline, 4 weeks post-FMT, and 12 weeks post-FMT.

• Change in Serum Total Testosterone (T) Level

  Baseline, 4 weeks post-FMT, and 12 weeks post-FMT.

• Change in Serum Luteinizing Hormone (LH) Level

  Baseline, 4 weeks post-FMT, and 12 weeks post-FMT.

• Change in Serum Interleukin-6 (IL-6) Level

  Baseline, 4 weeks post-FMT, and 12 weeks post-FMT.

Study Arms (2)

Oral FMT Capsules Group

EXPERIMENTAL

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

Placebo Capsules Group

PLACEBO COMPARATOR

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

Interventions

oral Fecal Microbiota Transplantation BIOLOGICAL

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.

Oral FMT Capsules Group

Placebo OTHER

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.

Placebo Capsules Group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Females aged 20 to 40 years old.
• \. Meeting the diagnostic criteria for Polyendocrine Metabolic Ovarian Syndrome (PMOS).
• \. 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).
• \. Scheduled to undergo Frozen-Thawed Embryo Transfer (FET) at the Reproductive Medicine Center.
• \. Voluntary participation with signed Informed Consent Form (ICF).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead

Study Sites (1)

Center for Reproductive Medicine,Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Ningxia Sun, MD-PhD

  Shanghai Changzheng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ningxia Sun, Chief

CONTACT

13817975897; suesunchzh@126.com

Yichi Zhang, MD

CONTACT

19121277344; zorzhang@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Phase 1: Single Group Assignment Phase 2: Parallel Assignment

Study Record Dates

• First Submitted: July 25, 2026
• First Posted: August 5, 2026
• Study Start: April 15, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)