NCT07275671 Microbiome and Premature Ovarian Insufficiency
| NCT ID | NCT07275671 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Westlake University |
| Condition | Premature Ovarian Insufficiency |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-05-13 |
| Primary Completion | 2025-12-01 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This study investigates the differences in gut and vaginal microbiota between women with premature ovarian insufficiency (POI) and healthy volunteers. POI refers to the reduction in ovarian function before the age of 40, leading to irregular or absent menstruation and decreased estrogen levels, which can significantly affect women's reproductive and overall health. Recent research has suggested that gut microorganisms may influence the balance of steroid hormones through various metabolic pathways. Additionally, certain vaginal bacteria appear enriched in patients with POI, but whether these microorganisms directly impact ovarian function, and how, remains unclear. This study also seeks to address the underexplored role of fungi within the human microbiome. To comprehensively compare differences in gut and vaginal microbiota, the study will recruit 20 women with POI and 20 healthy controls. Both demographic and clinical information will be collected, along with biological samples including blood, urine, stool, and vaginal swabs.
Eligibility Criteria
Inclusion Criteria: (For POI patients) 1. Women aged 20 to 40 years at screening visit. 2. Clinical diagnosis of premature ovarian insufficiency (based on diagnostic criteria: 25 \< FSH ≤ 40 IU/L, reduced follicle count and abnormal follicle development by ultrasound). 3. Able to provide informed consent. (For healthy volunteers) 1. Age (±2 years) and sex-matched healthy control individuals for each POI patient. 2. Able to provide informed consent. Exclusion Criteria: (For POI patients) 1. Family history of premature ovarian insufficiency. 2. Use of hormone therapy (such as HRT) within the past 6 months. 3. Serious illness (e.g., heart failure or malignancy). 4. Smoking more than 15 cigarettes per day or history of alcohol or drug addiction. 5. Inflammatory gastrointestinal diseases. 6. Chronic diseases that may affect the gut microbiota (e.g., diabetes, cirrhosis, or cardiovascular disease). 7. Blood or autoimmune diseases, or use of immunosuppressants in the past 3 months. 8. Use of