Microbiome and Premature Ovarian Insufficiency

June 23, 2026 updated by: Westlake University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Shanghai, China
        • Shanghai Changzheng Hospital
      • Shanghai, China
        • The Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All the participants should be residents living in East China.

Description

Inclusion Criteria:

(For POI patients)

  1. Women aged 20 to 40 years at screening visit.
  2. Clinical diagnosis of premature ovarian insufficiency (based on diagnostic criteria: 25 < FSH ≤ 40 IU/L, reduced follicle count and abnormal follicle development by ultrasound).
  3. Able to provide informed consent.

(For healthy volunteers)

  1. Age (±2 years) and sex-matched healthy control individuals for each POI patient.
  2. Able to provide informed consent.

Exclusion Criteria:

(For POI patients)

  1. Family history of premature ovarian insufficiency.
  2. Use of hormone therapy (such as HRT) within the past 6 months.
  3. Serious illness (e.g., heart failure or malignancy).
  4. Smoking more than 15 cigarettes per day or history of alcohol or drug addiction.
  5. Inflammatory gastrointestinal diseases.
  6. Chronic diseases that may affect the gut microbiota (e.g., diabetes, cirrhosis, or cardiovascular disease).
  7. Blood or autoimmune diseases, or use of immunosuppressants in the past 3 months.
  8. Use of antibiotics in the past 3 months before sample collection.
  9. Chronic constipation.

(For healthy volunteers)

  1. Have a history of infertility or recurrent miscarriage.
  2. Pregnant or breastfeeding.
  3. Use of hormone therapy (e.g., loratadine, oral contraceptives, etc.) within the past 6 months.
  4. Inflammatory gastrointestinal diseases.
  5. Smoking more than 15 cigarettes per day or history of alcohol or drug addiction.
  6. Chronic diseases that may affect the gut microbiota (e.g., diabetes, cirrhosis, or cardiovascular disease).
  7. Blood or autoimmune diseases, or use of immunosuppressants in the past 3 months.
  8. Use of antibiotics in the past 3 months before sample collection.
  9. Chronic constipation.
  10. Participating in other clinical trials.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
POI
Premature ovarian insufficiency
CTL
Healthy control

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Gut microbiome profiling
Time Frame: At enrollment
The microbiome profile is analyzed based on stool samples in cases and controls.
At enrollment
Vaginal microbiome profiling
Time Frame: At enrollment
The microbiome profile is analyzed based on vaginal swab samples.
At enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fecal and serum metabolomics profiling
Time Frame: At enrollment
Metabolomics profiles are analyzed based on blood samples and stool samples in cases and controls.
At enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Westlake University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 13, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 18, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 18, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20250416ZJS004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings