Oral Fecal Microbiota Transplantation for Overweight and Obese Women With Polyendocrine Metabolic Ovarian Syndrome Undergoing Frozen-Thawed Embryo Transfer

What this Trial Is About

Researchers are studying overweight and obese women with Polyendocrine Metabolic Ovarian Syndrome PMOS who are undergoing Frozen-Thawed Embryo Transfer FET. The trial evaluates the safety, early effects, and reproductive outcomes of oral Fecal Microbiota Transplantation FMT capsules. This research is divided into two phases an initial pilot study to explore safety and gut microbiota changes, followed by a larger randomized controlled trial to confirm the treatments effects on metabolism and pregnancy outcomes. Participants receive oral freeze-dried FMT capsules made from healthy donors, taken as five capsules twice daily on an empty stomach for six consecutive days per course. They complete three courses with four-week breaks between each. A placebo group receives matching capsules without active FMT. Throughout both phases, participants receive lifestyle and dietary guidance to support their treatment. During the study, participants undergo evaluations of pregnancy rates, including biochemical and clinical pregnancy assessments after FET, and monitoring of adverse events for 12 weeks post-treatment. Researchers also measure changes in hormone levels, metabolic markers like insulin resistance and body mass index, inflammatory markers, and gut microbiota diversity. Outcomes such as live birth rate are tracked up to 42 weeks following embryo transfer, with assessments scheduled at baseline and various points after FMT completion.

Fecal Microbiota Transplantation for Obese Women With Polyendocrine Metabolic Ovarian Syndrome