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NCT Number: NCT07124260

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

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.

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Key information

Conditions

Diminished Ovarian Reserve

Age range

20 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hangzhou TCM Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310007, China

Location status: Recruiting

Location contact

Wenjun Xiao

CONTACT

[email protected]

0086-19858195019

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

gut microbiota

Diagnostic Test

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

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.

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.

Primary outcomes

  1. Follicle stimulating hormone

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

    Follicle stimulating hormone in IU/L

Secondary outcomes

  1. anti-mullerian hormone

    Time frame: On the first day following participant enrollment.

    Anti-mullerian hormone in ng/mL

  2. Antral Follicle Counting

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

    The antral follicle counting will be performed via transvaginal ultrasound with the patient in the lithotomy position after bladder voiding. The total number of antral follicles measuring 2-6 mm in diameter within both ovaries will be recorded and reported as individual counts.

  3. 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.

    Fecal midstream samples (≤10g) were collected using sterile sampling kits, immediately flash-frozen in liquid nitrogen, and stored at -80℃. Gut microbiota profiling was performed via 16S rRNA gene sequencing for both the Healthy Control Group and Diminished Ovarian Reserve Group. Differential gut microbiota at genus-level and higher taxonomic ranks between groups will be reported.

  4. 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

    Researchers collected tongue coating samples using sterile tongue swabs with 10 rotational scrapes at the mid-tongue region. Specimens were immediately flash-frozen in liquid nitrogen and stored at -80℃. Tongue microbiota profiling was performed via 16S rRNA gene sequencing for both the Healthy Control Group and Diminished Ovarian Reserve Group. Differential microbial communities at genus-level and higher taxonomic ranks between groups will be reported.

  5. pregnancy outcome

    Time frame: 1-year follow-up period post-detection

    In this context, pregnancy outcome specifically refers to term delivery status. All participants underwent systematic follow-up through telephone interviews or medical record retrieval to document the number of subjects achieving term delivery in both study cohorts.

Study contacts

Contact information is provided by the study sponsor or research team.

Wenjun Xiao

CONTACT

[email protected]

0086-19858195019

Sponsors and collaborators

Lead sponsor

Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University

Other

Registry information

Official study title

Dysbiosis of Gut-Tongue Coating Microbiota Crosstalk and Its Clinical Association With Diminished Ovarian Reserve: A Microbiome-Based Case-Control Study

Acronym: CGTCMPDOR

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 15, 2025
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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