Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingNot a traditional drug phaseinterventionalRules rewrite
Not a traditional drug phase: testing oral Fecal Microbiota Transplantation for PCOS (Polycystic Ovary Syndrome)
This prospective, two-stage clinical trial aims to measure the safety, preliminary how well it works, 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, randomly assigned controlled trial (RCT) designed to validate the clinical how well it works and underlying mechanisms of oral FMT capsules compared with control interventions, based on findings established in Phase Ⅰ.
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are oral Fecal Microbiota Transplantation, or Placebo. The registry lists allocation as randomized. This prospective, two-stage clinical trial aims to measure the safety, preliminary how well it works, 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.
They plan to enroll about 411 people at Shanghai. Taking part typically means an infusion or injection of a biologic plus check-ins.
Official title (unrewritten)
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
2\. Meeting the diagnostic criteria for Polyendocrine Metabolic Ovarian Syndrome (PMOS)
3\. Body Mass Index (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
Who the registry excludes
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
This study is a double blind, dummy treatment (placebo) controlled, randomly assigned trial of study subjects with PCOS and low vitamin D to 2 groups- dummy treatment (placebo) and vitamin D replacement. Participants and investigators will be blinded to treatment modality until the end of the trial period
Girls and women 12-35 years old with obesity and polycystic ovarian syndrome who are on or off metformin, will receive a glucagon like peptide-1 receptor agonist intervention for 10 months to induce metabolic changes, weight loss and improve reproductive abnormalities.
The study aims to investigate the relationship between fasting insulin and Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) across various demographic factors, including age, sex, race/ethnicity, body-mass index (BMI), and polycystic ovary syndrome (PCOS) diagnosis. By analyzing these variables, the study seeks to identify potential variations in insulin levels, which could provide valuable insights into the impact of different factors on metabolic health and the development of insulin-related conditions.
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07746635?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07746635?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.