NCT07810920Recruiting
Artificial Intelligence Into Ultrasound Diagnostics in Reproductive Medicine
Innovation for Women's Health: the Integration of Artificial Intelligence in the Diagnostic Ultrasound Assessment of Reproductive Medicine
Source: ClinicalTrials.gov · Last updated 18 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1600 (estimated)
- First submitted
- 3 Sept 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 31 May 2030
- Lead sponsor
- Semmelweis University
- Diseases
- Endometriosis
- NCT number
- NCT07810920
What you commit to
- Study type: Observational
- Planned participants: 1600
- From 1 Sept 2026 to the primary completion date, 31 May 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- TVUS is not technically feasible.
- Postmenopausal status.
- Pregnancy.
- Puerperium (up to 3 months postpartum).
- For the endometrial receptivity sub-study, confirmed uterine or endometrial pathology other than adenomyosis.
Who the study is looking for
- 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.
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Obstetrics and Gynecology, Semmelweis University Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.