NCT07746635Recruiting
Fecal Microbiota Transplantation for Obese Women With Polyendocrine Metabolic Ovarian Syndrome
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
Source: ClinicalTrials.gov · Last updated 22 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 201 (estimated)
- First submitted
- 25 Jul 2026
- Start date
- 15 Apr 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Shanghai Changzheng Hospital
- Diseases
- Obesity
- NCT number
- NCT07746635
What you commit to
- Study type: Interventional
- Planned participants: 201
- From 15 Apr 2025 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent participation in other clinical trials.
Other illness
- 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.
Age
- Age \< 20 or \> 40 years.
Other
- Pregnancy or lactation.
Who the study is looking for
- 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.
- 5\. Voluntary participation with signed Informed Consent Form (ICF).
Age in the registry: 20 years to 40 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Center for Reproductive Medicine,Shanghai Changzheng Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.