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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diminished Ovarian Reserve Group |
| ||
| Healthy Control Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gut microbiota | Diagnostic Test | Fresh fecal samples were collected from patients during the non-menstrual period and subjected to 16S rDNA sequencing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| anti-mullerian hormone | Anti-mullerian hormone in ng/mL | On the first day following participant enrollment. |
| 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. |
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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:
Exclusion Criteria:
Cisgender woman
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Women with diminished ovarian reserve
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenjun Xiao | Contact | 0086-19858195019 | Jenny_jun0829@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hangzhou TCM Hospital of Zhejiang Chinese Medical University | Recruiting | Hangzhou | Zhejiang | 310007 | China |
Anonymized data may be available upon reasonable request to the Ethics Committee, subject to a data transfer agreement.
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| ID | Term |
|---|---|
| D000069196 | Gastrointestinal Microbiome |
| ID | Term |
|---|---|
| D064307 | Microbiota |
| D008827 | Microbiological Phenomena |
| D058448 | Biota |
| D044822 | Biodiversity |
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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.
| 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. |
|
| On day 2 or 3 of the menstrual phase during the first menstrual cycle following participant enrollment. |
| 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. | 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 | 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. | 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 | 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. | 1-year follow-up period post-detection |
| D017753 |
| Ecosystem |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D004778 | Environment and Public Health |