Tongue and gut bacteria patterns in women with diminished ovarian reserve

Dysbiosis of Gut-Tongue Coating Microbiota Crosstalk and Its Clinical Association With Diminished Ovarian Reserve: A Microbiome-Based Case-Control Study

This study will see if tongue-coating and gut bacteria differ between women with diminished ovarian reserve and healthy women and whether those bacteria relate to ovarian hormone levels.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 20 Years and up
• Sex: Female
• Sponsor: Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07124260 on ClinicalTrials.gov

What this trial studies

This observational study compares tongue-coating and intestinal microbiota between women diagnosed with diminished ovarian reserve (DOR) and healthy control women. Participants will provide tongue images, tongue coating samples, stool samples, and blood for ovarian reserve markers, and samples will be profiled by 16S rDNA sequencing with bioinformatics analysis. Researchers will correlate microbial features with serum AMH and FSH and compare shared taxa between tongue and gut to explore a tongue–gut microbial axis. The study aims to identify microbial markers or combinations that could serve as non-invasive indicators of DOR.

Who should consider this trial

Good fit: Women over 20 years old diagnosed with diminished ovarian reserve (AMH < 1.1 ng/mL plus at least one supportive criterion such as FSH > 10 IU/L, FSH/LH > 3, or low AFC) who can give informed consent and provide required samples.

Not a fit: Women who are pregnant, lactating, postmenopausal, younger than 20, or who do not have DOR are either excluded or unlikely to receive direct benefit from this study.

Why it matters

Potential benefit: If successful, the results could point to non-invasive microbiome-based indicators that help diagnose or better understand diminished ovarian reserve.

How similar studies have performed: Previous microbiome research has linked gut bacteria to estrogen metabolism and reproductive conditions, but applying combined tongue coating and gut profiling specifically to DOR is largely exploratory.

Eligibility criteria

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.

Where this trial is running

Hangzhou, Zhejiang

• Hangzhou TCM Hospital of Zhejiang Chinese Medical University — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Wenjun Xiao

Conditions Diminished Ovarian Reserve