Microbiome and Premature Ovarian Insufficiency

NCT07275671 | Recruiting DMC

• 1 other identifier: 20250416ZJS004
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Premature Ovarian Insufficiency; Reproductive Health

Keywords

Premature Ovarian Insufficiency; Gut microbiome; Vaginal microbiome

Outcome Measures

Primary Outcomes (2)

• Gut microbiome profiling

  The microbiome profile is analyzed based on stool samples in cases and controls.

  At enrollment

• Vaginal microbiome profiling

  The microbiome profile is analyzed based on vaginal swab samples.

  At enrollment

Secondary Outcomes (2)

• Blood and urine metabolomics profiling

  At enrollment

• Fecal and serum metabolomics profiling

  At enrollment

Study Arms (2)

POI

Premature ovarian insufficiency

CTL

Healthy control

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All the participants should be residents living in East China.

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Westlake University: lead

Study Sites (2)

Shanghai Changzheng Hospital

Shanghai, China

RECRUITING

The Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Stool, Urine, Vaginal swab

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Central Study Contacts

Jusheng Zheng, PhD

CONTACT

86-0571-86915303; zhengjusheng@westlake.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 10, 2025
• Study Start: May 13, 2025
• Primary Completion: December 1, 2025
• Study Completion: January 30, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-11

Locations

CN (2)