Actively Recruiting
Dysbiosis of Gut-Tongue Coating Microbiota Crosstalk and Its Clinical Association With Diminished Ovarian Reserve: A Microbiome-Based Case-Control Study
Led by Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University · Updated on 2025-08-26
200
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying women with diminished ovarian reserve (DOR) to understand differences in tongue appearance and the types of bacteria found on the tongue and in the gut compared to healthy women. The study aims to clarify how these microbial differences relate to hormone levels and whether changes in oral and gut bacteria might influence estrogen metabolism in DOR patients. This observational study uses advanced genetic sequencing and bioinformatics to explore these connections. Participants include women diagnosed with DOR and healthy controls. Samples of feces and tongue coating are collected during fasting in the morning within one week after menstruation. Tongue images are also taken at the same time. The study uses 16S rDNA sequencing technology to analyze bacterial composition and identify markers linked to hormone levels. Researchers compare bacterial abundance in the tongue and gut to investigate interactions along the tongue-gut axis. Women in the study provide blood samples on specific days of their menstrual cycle to measure follicle stimulating hormone, anti-mullerian hormone, and count antral follicles. Fecal and tongue coating samples are collected for microbiota analysis. Pregnancy outcomes are followed for one year after sample collection. The study assesses microbiota differences, hormone levels, and clinical outcomes, with all procedures conducted under ethical approval and informed consent.
CONDITIONS
Brief Title
Characterization of Gut and Tongue Coating Microbiota in Patients With Diminished Ovarian Reserve
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged over 20 years
- Diagnosis of diminished ovarian reserve with AMH less than 1.1 ng/mL plus at least one supportive criterion: FSH over 10 IU/L, FSH/LH ratio over 3.0, or antral follicle count less than 5-7 follicles measured on menstrual days 2-3
- Conscious with intact cognitive and language functions to comply with study protocols
- Approved by Ethics Committee with written informed consent obtained
You will not qualify if you...
- Female participants younger than 20 years
- Women in menopause, pregnancy, or lactation
- Participants with severe chronic diseases or comorbidities that may interfere with drug efficacy
- Severe primary disorders of cardiovascular, liver, kidney, blood, or psychiatric systems
- Non-compliance with medication protocols, incomplete data, or undeterminable efficacy outcomes
- Use of sex hormone therapy within the past 3 months
- Diagnosis of reproductive system cancers
- Gastrointestinal disorders or abnormal liver function
- Poor adherence to study protocols or lost to follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within one week after menstruation completion during the first menstrual cycle following enrollment
Participants provide fresh fecal samples and tongue coating samples under fasting conditions for 16S rDNA sequencing, and tongue images are captured to analyze microbiota differences related to diminished ovarian reserve.
1 visit (in-person) in the morning under fasting conditions
Duration - During the first menstrual cycle following enrollment
Participants undergo blood tests for follicle stimulating hormone, anti-mullerian hormone, and antral follicle counting during the first menstrual cycle following enrollment to assess ovarian reserve.
1 to 2 visits (in-person) on day 1 and day 2 or 3 of the menstrual phase
Duration - 1 year post-detection
Participants are followed for pregnancy outcomes to observe clinical associations over time.
Follow-up visits as needed over 1 year
Trial Site Locations
Total: 1 location
1
Hangzhou TCM Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, China, 310007
Actively Recruiting
Research Team
W
Wenjun Xiao
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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