Characterization of Gut and Tongue Coating Microbiota in Patients 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
Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University
200 participants
Jan 28, 2025
OBSERVATIONAL
Conditions
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
Inclusion Criteria5
- 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)
- 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 Criteria9
- 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.
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Interventions
Fresh fecal samples were collected from patients during the non-menstrual period and subjected to 16S rDNA sequencing.
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 images were captured under fasting conditions between 6:00-9:00 AM on the same morning as fecal specimen collection.
Locations(1)
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NCT07124260