Characterization of Gut and Tongue Coating Microbiota in Patients With Diminished Ovarian Reserve

Plain-language summary

This study examines the gut and tongue coating microbiota (the microorganisms living in these areas) in women with diminished ovarian reserve. Female patients over the age of 20 who meet specific diagnostic criteria may take part. This is a study without a clinical phase and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Recruiting

Sponsor

Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University

Intervention

gut microbiota, tongue coating microbiota, tongue picture

Start date

1/28/2025

Estimated completion

12/31/2025

Countries

China

Related genes

Locations

• Hangzhou, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria Developed in accordance with:

The 13th Five-Year Plan textbook Obstetrics and Gynecology (9th Edition) by China National Health Commission The 14th Five-Year Plan National Key Publication Reproductive Endocrinology (2nd Edition) Expert Consensus on Clinical Diagnosis and Treatment of Diminished Ovarian Reserve (2022)

Inclusion Criteria:

* Female patients aged \>20 years.
* Diagnosis required meeting the essential criterion of AMH \<1.1 ng/mL plus at least one supportive criterion: FSH \>10 IU/L, FSH/LH ratio \>3.0, or AFC \<5-7 follicles (measured on menstrual days 2-3).
* Conscious with intact cognitive/linguistic functions to comply with study protocols.
* Approved by Ethics Committee of Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University, with written informed consent obtained.

Exclusion Criteria:

* Female participants aged \<20 years.
* Women in menopause, pregnancy, or lactation period.
* Participants with comorbidities that may interfere with drug efficacy (e.g., severe chronic diseases).
* Severe primary disorders involving cardiovascular, hepatic, renal, hematopoietic systems, or psychiatric illnesses.
* Non-compliance with medication protocols during the study, or cases with undeterminable efficacy outcomes/incomplete data.
* Use of sex hormone therapy within the past 3 months.
* Diagnosis of reproductive system malignancies.
* Gastrointestinal disorders or abnormal liver function.
* Poor adherence to study protocols or lost to follow-up.