Characterization of Gut and Tongue Coating Microbiota in Patients With Diminished Ovarian Reserve
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: gut microbiota, tongue coating microbiota, tongue picture.
- Who it may be relevant to
- Registry conditions: Diminished Ovarian Reserve. Basic parameters: from 20 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Dysbiosis of Gut-Tongue Coating Microbiota Crosstalk and Its Clinical Association With Diminished Ovarian Reserve: A Microbiome-Based Case-Control Study
Overview
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.
Detailed description
This study enrolled DOR patients and healthy women as controls to systematically analyze compositional differences in intestinal and tongue coating microbiota between the two groups. Using 16S rDNA sequencing technology combined with bioinformatics methods, we screened characteristic microbiota associated with DOR and identified microbial markers significantly correlated with serum estrogen levels (AMH, FSH) through Spearman correlation analysis. We further compared abundance differences of homologous bacteria between tongue coating and gut microbiota to determine whether DOR alters the abundance or prevalence of specific bacterial species by affecting tongue-gut axis microbial interactions. The potential of tongue-gut differential microbiota combinations as non-invasive diagnostic biomarkers for DOR was explored.
Interventions
- Diagnostic test gut microbiota
Fresh fecal samples were collected from patients during the non-menstrual period and subjected to 16S rDNA sequencing. - Diagnostic test 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. - Diagnostic test tongue picture
Tongue images were captured under fasting conditions between 6:00-9:00 AM on the same morning as fecal specimen collection.
Primary outcome measures
- Follicle stimulating hormone [Time frame: On day 2 or 3 of the menstrual phase during the first menstrual cycle following participant enrollment.]
Secondary outcome measures (5)
- anti-mullerian hormone [Time frame: On the first day following participant enrollment.]
- Antral Follicle Counting [Time frame: On day 2 or 3 of the menstrual phase during the first menstrual cycle following participant enrollment.]
- gut microbiota [Time frame: Fresh fecal samples were collected in the morning under fasting conditions within one week after menstruation completion during the first menstrual cycle following enrollment.]
- tongue coating microbiota [Time frame: Tongue coating samples were collected in the morning under fasting conditions within one week after menstruation completion during the first menstrual cycle following enrollment, with priority given to coordinating collection on the same day as fecal spe]
- pregnancy outcome [Time frame: 1-year follow-up period post-detection]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
China · 1 center
- Hangzhou TCM Hospital of Zhejiang Chinese Medical University — Hangzhou
Identifiers
NCT: NCT07124260 · DOR CDJQ STJQ case control