Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University
Phase
Observational
Started
2025-01-28
Last updated
2025-08-26
Condition(s) studied
Diminished Ovarian Reserve
Investigational drug(s) / intervention(s)
gut microbiotatongue coating microbiotatongue picture
gut microbiota: Fresh fecal samples were collected from patients during the non-menstrual period and subjected to 16S rDNA sequencing.
tongue coating microbiota: Tongue coating samples were collected under fasting conditions between 6:00-9:00 AM on the same day as fecal specimen collection and subjected to 16S rDNA sequencing.
tongue picture: Tongue images were captured under fasting conditions between 6:00-9:00 AM on the same morning as fecal specimen collection.
Study summary
The goal of this observational study is to investigate the distinct tongue manifestation characteristics in patients with diminished ovarian reserve (DOR) compared to healthy individuals, and to clarify the features of tongue coating microbiota, gut microbiota, and their interrelationships in DOR patients. The main question it aims to answer is:
Whether there are significant differences in tongue manifestations, tongue coating microbiota, and gut microbiota characteristics between DOR patients and healthy populations; Whether associations exist between tongue coating microbiota and gut microbiota in DOR patients; Whether the pathogenesis of DOR may influence estrogen metabolism through alterations in oral and gut microbiota.
Eligibility
Sex
FEMALE
Min age
20 Years
Max age
—
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Follicle stimulating hormone — On day 2 or 3 of the menstrual phase during the first menstrual cycle following participant enrollment. Follicle stimulating hormone in IU/L
Trial sites (1)
Facility
City
Region
Status
Hangzhou TCM Hospital of Zhejiang Chinese Medical University
Hangzhou
Zhejiang
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.