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Microbiome clues in early ovarian failure: study compares bacteria in women with POI and healthy controls

NCT ID NCT07275671

Knowledge-focused Sponsor: Westlake University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at gut and vaginal bacteria in 20 women with premature ovarian insufficiency (POI) and 20 healthy women of similar age. POI causes ovaries to stop working normally before age 40, affecting hormones and fertility. Researchers collected stool, vaginal swabs, blood, and urine to compare the microbiome and chemical profiles. The goal was to find differences that might help understand how bacteria influence ovarian health.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

39 people

The number who actually took part.

Started

May 2025

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

All the participants should be residents living in East China.

Ages

20 to 40 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

primary ovarian failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Premature ovarian insufficiency Reproductive health

Contacts and locations

Locations

  • Shanghai Changzheng Hospital

    Shanghai, China

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

    Shanghai, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.