Tongue and gut bacteria patterns in women with diminished ovarian reserve
Official title: Dysbiosis of Gut-Tongue Coating Microbiota Crosstalk and Its Clinical Association With Diminished Ovarian Reserve: A Microbiome-Based Case-Control Study
Run by Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University · NCT07124260 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 20 Years and up |
| Sex | Women only |
| Enrollment | 200 (estimated) |
| Sponsor | Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | January 28, 2025 |
| Main results expected | December 1, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | August 26, 2025 |
| Trial ID | NCT07124260 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Hangzhou TCM Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Wenjun Xiao
- Email: Jenny_jun0829@163.com
- Phone: 0086-19858195019
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.