A Case-Control Study of Gut and Vaginal Microbiota Differences Between Premature Ovarian Insufficiency Patients and Healthy Controls

What this Trial Is About

Researchers are investigating the differences in gut and vaginal microbiota between women with premature ovarian insufficiency (POI) and healthy volunteers. POI is a condition where ovarian function declines before age 40, causing irregular or absent menstruation and lower estrogen levels, which impact reproductive and overall health. The study also explores the role of fungi in the human microbiome and how microorganisms may affect ovarian function through hormone balance. This case-control study will recruit 20 women diagnosed with POI and 20 age-matched healthy controls. Biological samples collected include blood, midstream urine, stool, and vaginal swabs. Blood samples are collected by nurses during specific menstrual days or anytime for non-menstruating women. Vaginal swabs are taken by gynecologists avoiding menstruation periods. Urine and stool samples are self-collected by participants and promptly processed for storage and analysis. Participants will provide demographic, lifestyle, reproductive, and medical information through questionnaires and medical records. Clinical assessments include hormone testing and metabolomics profiling from collected samples. The study team will oversee sample handling and data quality for future detailed microbiome and metabolite analyses. The primary outcomes are profiling of gut and vaginal microbiomes at enrollment, with secondary measures including blood, urine, fecal, and serum metabolomics. The study runs until January 2026.

Microbiome and Premature Ovarian Insufficiency