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

NCT07124260 | Recruiting

• 1 other identifier: DOR CDJQ STJQ case control
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diminished Ovarian Reserve

Outcome Measures

Primary Outcomes (1)

• Follicle stimulating hormone

  Follicle stimulating hormone in IU/L

  On day 2 or 3 of the menstrual phase during the first menstrual cycle following participant enrollment.

Secondary Outcomes (5)

• anti-mullerian hormone

  On the first day following participant enrollment.

• Antral Follicle Counting

  On day 2 or 3 of the menstrual phase during the first menstrual cycle following participant enrollment.

• gut microbiota

  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

  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

  1-year follow-up period post-detection

Study Arms (2)

Diminished Ovarian Reserve Group

Diagnostic Test: gut microbiota; Diagnostic Test: tongue coating microbiota; Diagnostic Test: tongue picture

Healthy Control Group

Diagnostic Test: gut microbiota; Diagnostic Test: tongue coating microbiota; Diagnostic Test: tongue picture

Interventions

gut microbiota DIAGNOSTIC_TEST

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

Diminished Ovarian Reserve Group; Healthy Control Group

tongue coating microbiota 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.

Diminished Ovarian Reserve Group; Healthy Control Group

tongue picture DIAGNOSTIC_TEST

Tongue images were captured under fasting conditions between 6:00-9:00 AM on the same morning as fecal specimen collection.

Diminished Ovarian Reserve Group; Healthy Control Group

Eligibility Criteria

• Age: 20 Years+
• Gender Eligibility Details: Cisgender woman
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with diminished ovarian reserve

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University: lead

Study Sites (1)

Hangzhou TCM Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310007, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The preserved biological samples comprised fresh human fecal specimens and human tongue coating samples. Microbial DNA will be extracted from fecal and tongue coating samples using the QIAamp DNA Microbiome Kit (Qiagen, Hilden, Germany). Whole-genome DNA was isolated via the centrifugal adsorption column method, and DNA quality was evaluated by agarose gel electrophoresis (1.0% agarose concentration, 150V voltage, 20-minute electrophoresis time). Samples meeting the following criteria-distinct genomic bands, total DNA quantity \>200 ng, DNA concentration \>10 ng/μL, OD260/280 \>1, and OD260/230 \>2-were selected for sequencing library construction and subsequent sequencing.

MeSH Terms

Interventions

Gastrointestinal Microbiome

Intervention Hierarchy (Ancestors)

Microbiota; Microbiological Phenomena; Biota; Biodiversity; Ecosystem; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health

Central Study Contacts

Wenjun Xiao

CONTACT

0086-19858195019; Jenny_jun0829@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: gynecologist

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 15, 2025
• Study Start: January 28, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 31, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Locations

CN (1)