Artificial Intelligence Into Ultrasound Diagnostics in Reproductive Medicine
Recruiting · NCT07810920 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- Department of Obstetrics and Gynecology, Semmelweis University - Budapest, Budapest, Hungary