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Can a gut microbiome transplant boost fertility in PCOS?

NCT ID NCT07746635

Disease control Sponsor: Shanghai Changzheng Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 05, 2026 · Last updated Sep 10, 2026 · Updated 5 times

Summary

This trial investigates whether taking capsules containing freeze-dried fecal matter from healthy donors—known as fecal microbiota transplantation (FMT)—can improve pregnancy outcomes and metabolic health in overweight or obese women with polycystic ovary syndrome (PCOS) who are undergoing frozen embryo transfer. The study will first test safety and early signs of effectiveness in a small group, then compare FMT against a control in a larger randomized phase. Participants will take the capsules for two 6-day courses, alongside standard lifestyle and dietary guidance.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
oral fecal microbiota transplantation (FMT) freeze-dried capsules from healthy donors
What this could lead to
If successful, this could offer a new way to improve fertility and metabolic health in obese women with PCOS, potentially increasing the chances of a successful pregnancy after IVF.
What could go wrong
This is an early-stage pilot study with a small number of participants, so results may not be conclusive. FMT can cause digestive side effects like diarrhea or bloating, and the long-term effects are not fully known.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 161 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

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.

Ages

20 to 40 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * 1\. Females aged 20 to 40 years old. * 2\. Meeting the diagnostic criteria for Polyendocrine Metabolic Ovarian Syndrome (PMOS). * 3\. Body Mass Index (BMI): \>24 kg/m²(covering overweight and obese patients according to Asian criteria, addressing the actual recruited cohort ranging from 24 kg/m² upwards). * 4\. Scheduled to undergo Frozen-Thawed Embryo Transfer (FET) at the Reproductive Medicine Center. * 5\. Voluntary participation with signed Informed Consent Form (ICF). Exclusion Criteria: * Age \< 20 or \> 40 years. * Pregnancy or lactation. * Other endocrine disorders (e.g., Cushing's syndrome, thyroid dysfunction); severe organ dysfunction or impaired intestinal mucosal barrier; use of antibiotics, probiotics, or prebiotics within 1 month. * Use of ovulation-modifying or anti-androgen drugs within 3 months; severe psychiatric disorders. * Concurrent participation in other clinical trials.

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Conditions

The condition(s) this trial relates to.

polycystic ovary syndrome

As listed by the trial registrant

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

PCOS (polycystic ovary syndrome)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Center for Reproductive Medicine,Shanghai Changzheng Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200003, China

More trials for these conditions

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