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Innovation for Women's health: the integration of artificial intelligence in the diagnostic ultrasound assessment of reproductive medicine

NCT ID NCT07810920

NEW Sponsor: Semmelweis University Source: ClinicalTrials.gov ↗

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Recruiting now This study
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By invitation only
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Completed
The trial has finished. Results may not be published yet.
Stopped early
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Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Approved
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When the status isn't known

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First seen Sep 09, 2026 · Last updated Sep 09, 2026

Summary

The goal of this observational study is to develop and validate artificial intelligence (AI)-based algorithms that support ultrasound diagnosis of endometriosis, adenomyosis, myometrial masses, uterine malformations, and impaired endometrial receptivity in women aged 18-45 years. The main questions it aims to answer are: Can AI algorithms, applied to standardized transvaginal ultrasound images, accurately detect and classify endometriosis and adenomyosis in real time during routine examination? Can AI-based ultrasound assessment predict the histological dignity of myometrial masses, and the likelihood of successful assisted reproduction (AR/IVF) outcome from endometrial features? Participants attending the Department of Obstetrics and Gynecology, Semmelweis University, with clinical suspicion of endometriosis or adenomyosis, a confirmed myometrial mass scheduled for surgery, a suspected uterine anomaly, or scheduled IVF treatment, will undergo standardized transvaginal ultrasound examination (following the IDEA, MUSA, and IETA protocols) alongside collection of clinical, questionnaire, and, where surgery is performed, histopathological data. Imaging and clinical data will be used to build a database supporting the development and validation of the AI algorithms.

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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 1800 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) (19). * 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 cancer

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

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  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

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Contacts and locations

Locations

  • Department of Obstetrics and Gynecology, Semmelweis University

    RECRUITING

    Budapest, Budapest, 1088, Hungary

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