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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20+
SponsorHangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Women with diminished ovarian reserve

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Diminished Ovarian Reserve Group3 interventions
Group B: Healthy Control Group3 interventions

Trial outcomes

Primary outcomes

1

Follicle stimulating hormone

Follicle stimulating hormone in IU/L

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

Secondary outcomes

1

anti-mullerian hormone

Anti-mullerian hormone in ng/mL

Time frame
On the first day following participant enrollment.
2

Antral Follicle Counting

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.

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

gut microbiota

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.

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.
4

tongue coating microbiota

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.

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

Other outcomes

Sponsors and contacts

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