Gut and vaginal microbiome differences in premature ovarian insufficiency

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

This project will compare gut and vaginal microbiomes of women aged 20–40 with premature ovarian insufficiency and matched healthy volunteers to see if microbial differences are linked to POI.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 20 Years to 40 Years
• Sex: Female
• Sponsor: Westlake University (Academic / other)
• Locations: 2 sites (Shanghai and 1 other locations)
• Trial ID: NCT07275671 on ClinicalTrials.gov

What this trial studies

This is a case-control observational comparison enrolling 20 women with premature ovarian insufficiency (POI) and 20 age-matched healthy volunteers. Participants provide blood, midstream urine, stool, and vaginal swab samples and complete questionnaires on demographics, reproductive history, medications, and symptom scales. Sample collection follows standardized timing (blood in early cycle when possible; swabs and stool collected outside menstruation) and biosamples are stored at -80°C for downstream multi-omics analyses. The study will compare bacterial and fungal community profiles between groups and correlate microbiome features with clinical and hormonal data.

Who should consider this trial

Good fit: Ideal participants are women aged 20–40 who either have a clinical diagnosis of POI (meeting the study's hormonal and ultrasound criteria) or are age- and sex-matched healthy volunteers who can give informed consent.

Not a fit: People unlikely to benefit include those with a family history of POI, recent hormone therapy, serious comorbid conditions, inflammatory gastrointestinal disease, chronic illnesses affecting the gut, recent immunosuppressant use, or substance dependence, because they are excluded from participation or their conditions confound microbiome signals.

Why it matters

Potential benefit: If successful, this work could identify microbial signatures linked to POI that might help guide future diagnostic tests or microbiome-directed therapies.

How similar studies have performed: Previous research has reported associations between gut or vaginal bacteria and ovarian function, but causal links remain unproven and the role of fungi is largely untested, so this is exploratory rather than confirmatory.

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 antibiotics in the past 3 months before sample collection.
9. Chronic constipation.

(For healthy volunteers)

1. Have a history of infertility or recurrent miscarriage.
2. Pregnant or breastfeeding.
3. Use of hormone therapy (e.g., loratadine, oral contraceptives, etc.) within the past 6 months.
4. Inflammatory gastrointestinal diseases.
5. Smoking more than 15 cigarettes per day or history of alcohol or drug addiction.
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 antibiotics in the past 3 months before sample collection.
9. Chronic constipation.
10. Participating in other clinical trials.

Where this trial is running

Shanghai and 1 other locations

• Shanghai Changzheng Hospital — Shanghai, China (Recruiting)
• The Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Jusheng Zheng, PhD

Conditions Premature Ovarian Insufficiency; Reproductive Health; Gut microbiome; Vaginal microbiome