Clinical trial · Interventional
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
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| PCOS (Polycystic Ovary Syndrome) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oral Fecal Microbiota Transplantation | Biological | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Oral FMT Capsules Group
- description
- 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.
- interventionNames
- Biological: oral Fecal Microbiota Transplantation
- type
- PLACEBO_COMPARATOR
- label
- Placebo Capsules Group
- description
- 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.
- interventionNames
- Other: Placebo
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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): \>24.0 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). 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.
References
Publications (0)
Data not yet available