Microbiome and Premature Ovarian Insufficiency
A Case-Control Study of Gut and Vaginal Microbiota Differences Between Premature Ovarian Insufficiency Patients and Healthy Controls
Westlake University
40 participants
May 13, 2025
OBSERVATIONAL
Conditions
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
Inclusion Criteria7
- (For POI patients)
- Women aged 20 to 40 years at screening visit.
- Clinical diagnosis of premature ovarian insufficiency (based on diagnostic criteria: 25 \< FSH ≤ 40 IU/L, reduced follicle count and abnormal follicle development by ultrasound).
- Able to provide informed consent.
- (For healthy volunteers)
- Age (±2 years) and sex-matched healthy control individuals for each POI patient.
- Able to provide informed consent.
Exclusion Criteria21
- (For POI patients)
- Family history of premature ovarian insufficiency.
- Use of hormone therapy (such as HRT) within the past 6 months.
- Serious illness (e.g., heart failure or malignancy).
- Smoking more than 15 cigarettes per day or history of alcohol or drug addiction.
- Inflammatory gastrointestinal diseases.
- Chronic diseases that may affect the gut microbiota (e.g., diabetes, cirrhosis, or cardiovascular disease).
- Blood or autoimmune diseases, or use of immunosuppressants in the past 3 months.
- Use of antibiotics in the past 3 months before sample collection.
- Chronic constipation.
- (For healthy volunteers)
- Have a history of infertility or recurrent miscarriage.
- Pregnant or breastfeeding.
- Use of hormone therapy (e.g., loratadine, oral contraceptives, etc.) within the past 6 months.
- Inflammatory gastrointestinal diseases.
- Smoking more than 15 cigarettes per day or history of alcohol or drug addiction.
- Chronic diseases that may affect the gut microbiota (e.g., diabetes, cirrhosis, or cardiovascular disease).
- Blood or autoimmune diseases, or use of immunosuppressants in the past 3 months.
- Use of antibiotics in the past 3 months before sample collection.
- Chronic constipation.
- Participating in other clinical trials.
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Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07275671