Characterization of Gut and Tongue Coating Microbiota in Patients With Diminished Ovarian Reserve

NCT ID: NCT07124260

Last Updated: 2025-08-26

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-28

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Diminished Ovarian Reserve

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Diminished Ovarian Reserve Group

gut microbiota

Intervention Type DIAGNOSTIC_TEST

Fresh fecal samples were collected from patients during the non-menstrual period and subjected to 16S rDNA sequencing.

tongue coating microbiota

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Fresh fecal samples were collected from patients during the non-menstrual period and subjected to 16S rDNA sequencing.

tongue coating microbiota

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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 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.
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University

OTHER

Sponsor Role lead

Responsible Party

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Wenjun Xiao

gynecologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hangzhou TCM Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wenjun Xiao

Role: CONTACT

0086-19858195019

Facility Contacts

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Wenjun Xiao

Role: primary

0086-19858195019

Other Identifiers

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DOR CDJQ STJQ case control

Identifier Type: -

Identifier Source: org_study_id

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