Premature Ovarian InsufficiencyNCT07275671
Microbiome and Premature Ovarian Insufficiency
An observational study of Premature Ovarian Insufficiency and Reproductive Health, run by Westlake University at 2 sites in China.
Trial summary
This study investigates the differences in gut and vaginal microbiota between women with premature ovarian insufficiency (POI) and healthy volunteers. POI refers to the reduction in ovarian function before the age of 40, leading to irregular or absent menstruation and decreased estrogen levels, which can significantly… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Ovarian Insufficiency, Reproductive Health
- How many people
- 39 participants
- Where
- 2 sitesChina
- Study dates
- 13 May 2025to 18 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: All the participants should be residents living in East China.
Who may be able to join
- (For POI patients)
- Women aged 20 to 40 years at screening visit.
- Clinical diagnosis of premature ovarian insufficiency (based on diagnostic criteria: 25 < FSH ≤ 40 IU/L, reduced follicle count and abnormal follicle development by ultrasound).
- Able to provide informed consent.
- (For healthy volunteers)
- Age (±2 years) and sex-matched healthy control individuals for each POI patient.
- Able to provide informed consent.
Who cannot join
- (For POI patients)
- Family history of premature ovarian insufficiency.
- Use of hormone therapy (such as HRT) within the past 6 months.
- Serious illness (e.g., heart failure or malignancy).
- Smoking more than 15 cigarettes per day or history of alcohol or drug addiction.
- Inflammatory gastrointestinal diseases.
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- Chronic diseases that may affect the gut microbiota (e.g., diabetes, cirrhosis, or cardiovascular disease).
- Blood or autoimmune diseases, or use of immunosuppressants in the past 3 months.
- Use of antibiotics in the past 3 months before sample collection.
- Chronic constipation.
- (For healthy volunteers)
- Have a history of infertility or recurrent miscarriage.
- Pregnant or breastfeeding.
- Use of hormone therapy (e.g., loratadine, oral contraceptives, etc.) within the past 6 months.
- Inflammatory gastrointestinal diseases.
- Smoking more than 15 cigarettes per day or history of alcohol or drug addiction.
- Chronic diseases that may affect the gut microbiota (e.g., diabetes, cirrhosis, or cardiovascular disease).
- Blood or autoimmune diseases, or use of immunosuppressants in the past 3 months.
- Use of antibiotics in the past 3 months before sample collection.
- Chronic constipation.
- Participating in other clinical trials.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Shanghai Changzheng Hospital
Shanghai
The Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai
About this study
Official title: A Case-Control Study of Gut and Vaginal Microbiota Differences Between Premature Ovarian Insufficiency Patients and Healthy Controls
This study investigates the differences in gut and vaginal microbiota between women with premature ovarian insufficiency (POI) and healthy volunteers. POI refers to the reduction in ovarian function before the age of 40, leading to irregular or absent menstruation and decreased estrogen levels, which can significantly affect women's reproductive and overall health. Recent research has suggested that gut microorganisms may influence the balance of steroid hormones through various metabolic pathways. Additionally, certain vaginal bacteria appear enriched in patients with POI, but whether these microorganisms directly impact ovarian function, and how, remains unclear. This study also seeks to address the underexplored role of fungi within the human microbiome. To comprehensively compare differences in gut and vaginal microbiota, the study will recruit 20 women with POI and 20 healthy controls. Both demographic and clinical information will be collected, along with biological samples including blood, urine, stool, and vaginal swabs.
Read the detailed description
This project utilizes a case-control study design to systematically compare the microbiome profiles of women diagnosed with premature ovarian insufficiency (POI) and healthy controls. A total of 20 participants with POI and 20 age-matched healthy volunteers will be recruited. Biological samples collected will include blood, midstream urine, stool, and vaginal swab per participant. Blood samples will be obtained by licensed nurses; for menstruating women, samples are drawn during days 2-5 of the most recent cycle, while for those with amenorrhea or menopause, samples are taken at any time for serum hormone testing. Vaginal swab samples are collected by experienced gynecologists, avoiding collection during menstruation. Urine samples are self-collected by volunteers and immediately handed over to research staff for freezing, while stool samples are self-collected and sent to the laboratory staff by low-temperature shipping for prompt processing and storage. Both samples are collected outside of the menstrual period. Comprehensive baseline data will be obtained through questionnaires and electronic medical records by trained interviewers. This includes demographic details, lifestyle factors, reproductive and menstrual history, use of antibiotics and supplements, Kupperman Index (KMI), Hospital Anxiety and Depression Scale (HAD), and sleep quality assessments. All biosamples will be handled according to strict aseptic procedures, aliquoted and stored at -80°C for subsequent omics analyses. Data collection and quality control procedures will be overseen and maintained by the research team for long-term storage and analysis.
- Keywords
- Premature Ovarian Insufficiency, Gut microbiome, Vaginal microbiome
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| POI | Premature ovarian insufficiency | |
| CTL | Healthy control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiome profiling
The microbiome profile is analyzed based on stool samples in cases and controls.
Measured: At enrollment
Vaginal microbiome profiling
The microbiome profile is analyzed based on vaginal swab samples.
Measured: At enrollment
Secondary outcomes (1)
Fecal and serum metabolomics profiling
Metabolomics profiles are analyzed based on blood samples and stool samples in cases and controls.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start13 May 2025
- Primary completion18 Dec 2025
- Study completion18 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ovarian InsufficiencyStudies 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
- Cross-sectional
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Westlake University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275671
- Sponsor's protocol ID
- 20250416ZJS004
- Status last verified
- Jun 2026
- First submitted
- 27 Nov 2025
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case-Control Study of Gut and Vaginal Microbiota Differences Between Premature Ovarian Insufficiency Patients and Healthy Controls
- ClinicalTrials.gov ID
- NCT07275671
- Acronym / sponsor ID
- 20250416ZJS004
- Keywords
- Premature Ovarian Insufficiency, Gut microbiome, Vaginal microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Westlake UniversityUniversity, hospital or other
- Study start
- 13 May 2025 (actual)
- Primary completion
- 18 Dec 2025 (actual)
- Study completion
- 18 Dec 2025 (actual)
- First posted
- 10 Dec 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.
This study investigates the differences in gut and vaginal microbiota between women with premature ovarian insufficiency (POI) and healthy volunteers. POI refers to the reduction in ovarian function before the age of 40, leading to irregular or absent menstruation and decreased estrogen levels, which can significantly affect women's reproductive and overall health. Recent research has suggested that gut microorganisms may influence the balance of steroid hormones through various metabolic pathways. Additionally, certain vaginal bacteria appear enriched in patients with POI, but whether these microorganisms directly impact ovarian function, and how, remains unclear. This study also seeks to address the underexplored role of fungi within the human microbiome. To comprehensively compare differences in gut and vaginal microbiota, the study will recruit 20 women with POI and 20 healthy controls. Both demographic and clinical information will be collected, along with biological samples including blood, urine, stool, and vaginal swabs.
Detailed description
This project utilizes a case-control study design to systematically compare the microbiome profiles of women diagnosed with premature ovarian insufficiency (POI) and healthy controls. A total of 20 participants with POI and 20 age-matched healthy volunteers will be recruited. Biological samples collected will include blood, midstream urine, stool, and vaginal swab per participant. Blood samples will be obtained by licensed nurses; for menstruating women, samples are drawn during days 2-5 of the most recent cycle, while for those with amenorrhea or menopause, samples are taken at any time for serum hormone testing. Vaginal swab samples are collected by experienced gynecologists, avoiding collection during menstruation. Urine samples are self-collected by volunteers and immediately handed over to research staff for freezing, while stool samples are self-collected and sent to the laboratory staff by low-temperature shipping for prompt processing and storage. Both samples are collected outside of the menstrual period. Comprehensive baseline data will be obtained through questionnaires and electronic medical records by trained interviewers. This includes demographic details, lifestyle factors, reproductive and menstrual history, use of antibiotics and supplements, Kupperman Index (KMI), Hospital Anxiety and Depression Scale (HAD), and sleep quality assessments. All biosamples will be handled according to strict aseptic procedures, aliquoted and stored at -80°C for subsequent omics analyses. Data collection and quality control procedures will be overseen and maintained by the research team for long-term storage and analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POI | – | –Premature ovarian insufficiency |
| CTL | – | –Healthy control |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All the participants should be residents living in East China.
Key inclusion criteria (7 listed)
- (For POI patients)
- Women aged 20 to 40 years at screening visit.
- Clinical diagnosis of premature ovarian insufficiency (based on diagnostic criteria: 25 < FSH ≤ 40 IU/L, reduced follicle count and abnormal follicle development by ultrasound).
- Able to provide informed consent.
- (For healthy volunteers)
Key exclusion criteria (21 listed)
- (For POI patients)
- Family history of premature ovarian insufficiency.
- Use of hormone therapy (such as HRT) within the past 6 months.
- Serious illness (e.g., heart failure or malignancy).
- Smoking more than 15 cigarettes per day or history of alcohol or drug addiction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gut microbiome profiling
Time frame: At enrollment
The microbiome profile is analyzed based on stool samples in cases and controls.
Vaginal microbiome profiling
Time frame: At enrollment
The microbiome profile is analyzed based on vaginal swab samples.
1 secondary outcome
Fecal and serum metabolomics profiling
Time frame: At enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Ovarian Insufficiency and Reproductive Health, run by Westlake University at 2 sites 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 7 inclusion and 21 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: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiome profiling (time frame: At enrollment). The study lists 2 primary outcomes in all. 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 Jun 2026.