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Can AI learn to spot endometriosis and fibroids on ultrasound?

NCT ID NCT07810920

Diagnosis Sponsor: Semmelweis University Source: ClinicalTrials.gov ↗

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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 Results may not be published yet.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
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

Researchers at Semmelweis University are building and testing artificial intelligence algorithms that read standardized transvaginal ultrasound images. The study includes women aged 18 to 45 who have suspected endometriosis or adenomyosis, a confirmed uterine mass scheduled for surgery, a suspected uterine anomaly, or who are scheduled for IVF. Participants undergo ultrasound exams following established protocols, and researchers collect clinical, questionnaire, and surgical tissue data to build a database for developing the AI tools. The goal is to see whether AI can accurately detect and classify these conditions in real time and predict IVF outcomes from endometrial features.

What this could mean

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

Active substance
AI-based ultrasound diagnostic algorithms
What this could lead to
If it works, AI could help doctors spot endometriosis, adenomyosis, fibroids, and uterine anomalies faster and more consistently during routine ultrasound, and give better guidance on IVF chances.
What could go wrong
The algorithms are still being developed and tested, so they may not match expert human reading or may not work well across different clinics and ultrasound machines. This is an observational study, not a treatment trial, so it will not cure or treat any condition.

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

About 1,600 people

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

Started

Sep 2026

Expected to finish

Dec 2030

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.

Who is studied

The study population comprises patients aged 18-45 years who attend the Department of Obstetrics and Gynecology at Semmelweis University. A total of 1600 participants will be enrolled: 1200 for the endometriosis/adenomyosis cohort, 200 for the myometrial mass dignity-prediction cohort, and 200 for the cohort addressing other benign infertility-related conditions and AR/IVF outcome prediction.

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: * Women aged 18-45 years with clinical suspicion of endometriosis or adenomyosis, in whom the diagnosis of endometriosis is subsequently confirmed, including peritoneal, ovarian, and deep infiltrating endometriosis. The diagnosis is established by imaging, laparoscopy, or laparotomy, based on characteristic intraoperative findings and histological analysis (#Enzian classification). * Women undergoing ultrasound examination for suspected congenital uterine anomaly or other intracavitary uterine pathology. * Women with previously confirmed leiomyoma scheduled for surgical treatment. * Women scheduled for IVF treatment or embryo transfer. * Willingness and capacity to provide written informed consent prior to enrolment. Exclusion Criteria: * TVUS is not technically feasible. * Postmenopausal status. * Pregnancy. * Puerperium (up to 3 months postpartum). * Suspected premalignancy, or presence or history of malignancy. * Chronic comorbidities, including uncontrolled diabetes mellitus, severe cardiovascular or respiratory disease, systemic autoimmune disease, or uncontrolled thyroid dysfunction. * Other conditions, including psychiatric illness or substance use, and any circumstance in which study participation could pose a risk to the patient, or in which enrolment could bias the study results. * For the endometrial receptivity sub-study, confirmed uterine or endometrial pathology other than adenomyosis.

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Conditions

The condition(s) this trial relates to.

adenomyosis Congenital Abnormalities endometriosis female infertility leiomyoma myofibroma tumor of uterus uterine anomalies uterine cancer uterine corpus leiomyoma

As listed by the trial registrant

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

Adenomyosis of uterus Congenital abnormalities Endometriosis Infertility, female Leiomyoma (uterine fibroids) Uterine neoplasms

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

  • Department of Obstetrics and Gynecology, Semmelweis University

    RECRUITING

    Budapest, Budapest, 1088, Hungary

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