AI into Ultrasound Diagnostics in Reproductive Medicine

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to develop and validate artificial intelligence–based algorithms that can aid ultrasound diagnosis of endometriosis, adenomyosis, myometrial masses, uterine malformations, and endometrial receptivity. Algorithms will be trained and tested on standardized transvaginal ultrasound images obtained during routine exams. The study will also explore whether AI features can predict histological characteristics of myometrial masses and the likelihood of successful outcomes in assisted reproduction. Participants are women with suspected endometriosis or adenomyosis, uterine abnormalities, leiomyomas planned for surgery, or those undergoing IVF, recruited at Semmelweis University in Budapest. No interventions are described beyond ultrasound imaging with AI analysis as part of the observational framework.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Obstetrics and Gynecology, Semmelweis University
  Budapest, Budapest, Hungary Recruiting

Study contacts

• Study coordinator: Nandor Acs, PhD
• Email: acs.nandor@semmelweis.hu
• Phone: +3620825001

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.