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Gel may shield womb from post-surgery scars, boost baby chances

NCT ID NCT07280286

Disease control Sponsor: Federico II University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a gel placed inside the uterus after robotic fibroid removal can reduce scarring (adhesions) that may harm fertility. About 62 women having fibroid surgery will be randomly assigned to receive the gel or standard care. Researchers will check for adhesions with ultrasound and a camera scope, and track pregnancies for 24 months.

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 62 people

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

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Nov 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

18 to 45 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: * Age between 18 and 45 years; * BMI 18-35; * One or more fibroids diagnosed via ultrasound; * First myomectomy or uterine surgery; * Incomplete reproductive plans and/or infertility; * Adequate immune, respiratory, liver, cardiac, bone marrow, and kidney function; * Compliance and psychological ability to follow study procedures; * Acceptance and signing of informed consent. Exclusion Criteria: * Age under 18 years; * Age over 46 years; * Pregnancy or breastfeeding; * History of intrauterine adhesions; * Diagnosis or suspicion of malignant gynecological pathologies and/or autoimmune diseases; * Completed reproductive plans; * Severe respiratory, bone marrow, liver, or kidney dysfunction preventing safe surgical access.

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Conditions

The condition(s) this trial relates to.

gynatresia myofibroma Tissue Adhesions uterine corpus leiomyoma Asherman syndrome prevention target

As listed by the trial registrant

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

Adhesion; uterus, internal Myoma;uterus

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

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