Characterization of Gut and Tongue Coating Microbiota in Patients With Diminished Ovarian Reserve
NCT ID: NCT07124260
Last Updated: 2025-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2025-01-28
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Diminished Ovarian Reserve Group
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.
Healthy Control Group
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.
Interventions
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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.
Eligibility Criteria
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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
* 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.
20 Years
FEMALE
Yes
Sponsors
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Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University
OTHER
Responsible Party
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Wenjun Xiao
gynecologist
Locations
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Hangzhou TCM Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DOR CDJQ STJQ case control
Identifier Type: -
Identifier Source: org_study_id
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