Oral fecal microbiota capsules for obese women with polycystic ovary syndrome having embryo transfer
Tests oral fecal microbiota capsules in overweight women with PCOS undergoing frozen embryo transfer.
Plain-language title generated from the registry record
Registry title: Fecal Microbiota Transplantation for Obese Women With Polyendocrine Metabolic Ovarian Syndrome
Key facts
- Where
- Shanghai, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 20 to 40 with polyendocrine metabolic ovarian syndrome (PMOS) who are overweight or obese and are scheduled for a frozen-thawed embryo transfer (FET).
- Age
- 20 to 40 years
- Sex
- Women only
- Disease stage
- Polyendocrine metabolic ovarian syndrome (PMOS), with a body mass index (BMI) above 24.0 kg/m².
- Earlier treatment
- Scheduled for a frozen-thawed embryo transfer (FET). Cannot have used antibiotics, probiotics or prebiotics within 1 month, or ovulation-modifying or anti-androgen drugs within 3 months.
Main reasons for not taking part
- Pregnant or breastfeeding
- Other hormone disorders, such as Cushing's syndrome or thyroid problems
- Severe organ problems or a damaged gut lining
- Severe psychiatric disorders
- Taking part in another clinical trial
Read by machine on 13 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 20 and 40 years old?
Source: NCT07746635, who can take part
Where in China
- Center for Reproductive Medicine,Shanghai Changzheng HospitalShanghai, ChinaContact: Jiping XuTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Shanghai Changzheng Hospital
- Trial code
- NCT07746635
- Record updated
- 10 November 2026
- Original description
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:Read full original descriptionShow less
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
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.
Inclusion: 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: Concurrent participation in other clinical trials; 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 < 20 or > 40 years; Pregnancy or lactation.