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โ† Trials
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Artificial Intelligence Into Ultrasound Diagnostics in Reproductive Medicine

Recruitingn/aAges 18 Years - 45 YearsFemaleSemmelweis University
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In plain words

What the trial is, and whether it could suit you

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 suspecte

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๐Ÿ“‹ Eligibility rules (as published)
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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What it tests

  • Not listed
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Where

1 site
Department of Obstetrics and Gynecology, Semmelweis University
Budapest, Hungary
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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