Taking people in HungaryNo phase

AI Support for Ultrasound Diagnosis of Women's Reproductive Conditions

Develops AI tools to help read ultrasound scans for endometriosis and related uterine conditions.

Key facts

Who runs it: Semmelweis University
Where: Budapest, HungarySee the site
Trial code: NCT07810920
Registry title: Artificial Intelligence Into Ultrasound Diagnostics in Reproductive Medicine
Status: Recruiting
People taking part: 1,600 people, planned
Started: 1 Sept 2026
Expected to end: 31 Dec 2030
Type of study: Observational, 5 groups
Record updated: 18 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women aged 18-45 who come for an ultrasound because of suspected endometriosis or adenomyosis, a uterine fibroid planned for surgery, a suspected uterus anomaly, or planned IVF treatment.

Age: 18 to 45 years
Sex: Women only
Disease stage: Suspected endometriosis or adenomyosis, a confirmed fibroid (leiomyoma) scheduled for surgery, a suspected congenital uterine anomaly or other pathology inside the uterus, or IVF treatment or embryo transfer planned.

Main reasons for not taking part

Ultrasound through the vagina (TVUS) is not technically possible
After menopause
Pregnancy, or up to 3 months after giving birth
Suspected precancer, or current or past cancer
Long-term illness such as uncontrolled diabetes, severe heart or lung disease, autoimmune disease or uncontrolled thyroid disease

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

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

Who cannot take part

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
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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 45 years old?

Where in Hungary

Department of Obstetrics and Gynecology, Semmelweis UniversityBudapest, HungaryContact: Nandor Acs, PhDTaking people

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

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.

The 5 groups in the trial

Endometriosis cohort
Women aged 18-45 years with clinical suspicion of endometriosis, in whom the diagnosis is subsequently confirmed by laparoscopy or laparotomy with histological analysis of the resected specimen (peritoneal, ovarian, or deep infiltrating endometriosis). No intervention is administered; participants undergo a standardized transvaginal ultrasound examination (IDEA protocol) and complete clinical and quality-of-life questionnaires (NRS, EHP-30) as part of routine care.
Ademyosis cohort
Women aged 18-45 years with clinical suspicion of adenomyosis, assessed by standardized transvaginal ultrasound (MUSA protocol) for direct and indirect sonographic features, morphological subtype, and severity. No intervention is administered; assessment occurs as part of routine gynecological care.
Myometrial mass cohort
Women aged 18-45 years with a previously confirmed uterine leiomyoma scheduled for surgical treatment. Participants undergo standardized ultrasound assessment of leiomyoma location, size, and sonographic features prior to surgery, with post-surgical histopathological correlation. No intervention is administered beyond standard-of-care surgical treatment already planned.
Uterine malformation cohort
Women aged 18-45 years undergoing ultrasound examination for suspected congenital (Müllerian) uterine anomaly or other intracavitary uterine pathology. Participants undergo standardized ultrasound assessment; no intervention is administered.
Endometrial receptivity cohort
Women aged 18-45 years scheduled for IVF treatment or embryo transfer, without confirmed uterine or endometrial pathology other than adenomyosis. Participants undergo standardized ultrasound assessment of endometrial thickness, morphology, and vascularity (IETA protocol) around the window of implantation, linked to subsequent assisted reproduction treatment and pregnancy outcome. No intervention is administered.