Diminished Ovarian ReserveCGTCMPDORNCT07124260
Characterization of Gut and Tongue Coating Microbiota in Patients With Diminished Ovarian Reserve
An observational study of Diminished Ovarian Reserve, run by Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diminished Ovarian Reserve
- What is being tested?
- gut microbiota, tongue coating microbiota and tongue picture
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 28 Jan 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women with diminished ovarian reserve
Who may be able to join
- 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.
Who cannot join
- 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.
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- Diagnosis of reproductive system malignancies.
- Gastrointestinal disorders or abnormal liver function.
- Poor adherence to study protocols or lost to follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hangzhou TCM Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310007
Wenjun Xiao, 0086-19858195019, Jenny_jun0829@163.com
About this study
Official title: Dysbiosis of Gut-Tongue Coating Microbiota Crosstalk and Its Clinical Association With Diminished Ovarian Reserve: A Microbiome-Based Case-Control Study
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.
Read the detailed description
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
- Diminished Ovarian Reserve
- Being tested
- gut microbiota, tongue coating microbiota, tongue picture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gut microbiotaDiagnostic test
Fresh fecal samples were collected from patients during the non-menstrual period and subjected to 16S rDNA sequencing.
tongue coating microbiotaDiagnostic 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 pictureDiagnostic test
Tongue images were captured under fasting conditions between 6:00-9:00 AM on the same morning as fecal specimen collection.
| Study group | Role | What they receive |
|---|---|---|
| Diminished Ovarian Reserve Group | Not described Receives: Diagnostic Test: gut microbiota; Diagnostic Test: tongue coating microbiota; Diagnostic Test: tongue picture | |
| Healthy Control Group | Not described Receives: Diagnostic Test: gut microbiota; Diagnostic Test: tongue coating microbiota; Diagnostic Test: tongue picture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follicle stimulating hormone
Follicle stimulating hormone in IU/L
Measured: On day 2 or 3 of the menstrual phase during the first menstrual cycle following participant enrollment.
Secondary outcomes (5)
anti-mullerian hormone
Anti-mullerian hormone in ng/mL
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1-year follow-up period post-detection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start28 Jan 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diminished Ovarian ReserveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenjun Xiao, Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124260
- Sponsor's protocol ID
- DOR CDJQ STJQ case control
- Acronym
- CGTCMPDOR
- Status last verified
- Aug 2025
- First submitted
- 1 Aug 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymized data may be available upon reasonable request to the Ethics Committee, subject to a data transfer agreement.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysbiosis of Gut-Tongue Coating Microbiota Crosstalk and Its Clinical Association With Diminished Ovarian Reserve: A Microbiome-Based Case-Control Study
- ClinicalTrials.gov ID
- NCT07124260
- Acronym / sponsor ID
- CGTCMPDOR / DOR CDJQ STJQ case control
- Conditions
- Diminished Ovarian Reserve
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women with diminished ovarian reserve
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gut microbiotaFresh fecal samples were collected from patients during the non-menstrual period and subjected to 16S rDNA sequencing. | Diagnostic test | Diminished Ovarian Reserve Group, Healthy Control Group |
| tongue coating microbiotaTongue 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. | Diagnostic test | Diminished Ovarian Reserve Group, Healthy Control Group |
| tongue pictureTongue images were captured under fasting conditions between 6:00-9:00 AM on the same morning as fecal specimen collection. | Diagnostic test | Diminished Ovarian Reserve Group, Healthy Control Group |
Primary outcome
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
5 secondary outcomes
anti-mullerian hormone
Time frame: On the first day following participant enrollment.
Antral Follicle Counting
Time frame: On day 2 or 3 of the menstrual phase during the first menstrual cycle following participant enrollment.
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.
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
pregnancy outcome
Time frame: 1-year follow-up period post-detection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: Undecided. Anonymized data may be available upon reasonable request to the Ethics Committee, subject to a data transfer agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diminished Ovarian Reserve, run by Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenjun Xiao (0086-19858195019, Jenny_jun0829@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Follicle stimulating hormone (time frame: On day 2 or 3 of the menstrual phase during the first menstrual cycle following participant enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.