Actively Recruiting
Microbiome and Premature Ovarian Insufficiency
Led by Westlake University · Updated on 2025-12-10
40
Participants Needed
2
Research Sites
37 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Microbiome and Premature Ovarian Insufficiency
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 20 to 40 years at screening visit
- Clinical diagnosis of premature ovarian insufficiency with specified hormone levels and ultrasound findings (for POI patients)
- Able to provide informed consent
- Age- and sex-matched healthy controls within ±2 years for each POI patient
- Able to provide informed consent (for healthy volunteers)
You will not qualify if you...
- Family history of premature ovarian insufficiency (for POI patients)
- Use of hormone therapy within past 6 months
- Serious illness such as heart failure or malignancy
- Smoking more than 15 cigarettes per day or history of alcohol or drug addiction
- Inflammatory gastrointestinal diseases
- Chronic diseases affecting gut microbiota (e.g., diabetes, cirrhosis, cardiovascular disease)
- Blood or autoimmune diseases or use of immunosuppressants in past 3 months
- Use of antibiotics in past 3 months before sample collection
- Chronic constipation
- History of infertility or recurrent miscarriage (for healthy volunteers)
- Pregnant or breastfeeding (for healthy volunteers)
- Participation in other clinical trials (for healthy volunteers)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Shanghai Changzheng Hospital
Shanghai, China
Actively Recruiting
2
The Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
Actively Recruiting
Research Team
J
Jusheng Zheng, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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