Artificial Intelligence Into Ultrasound Diagnostics in Reproductive Medicine (AUDRIE)

September 3, 2026 updated by: Dr. Ács Nándor, Semmelweis University

Innovation for Women's Health: the Integration of Artificial Intelligence in the Diagnostic Ultrasound Assessment of Reproductive Medicine

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hungary
    • Budapest
      • Budapest, Budapest, Hungary, 1088
        • Recruiting
        • Department of Obstetrics and Gynecology, Semmelweis University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study population comprises patients aged 18-45 years who attend the Department of Obstetrics and Gynecology at Semmelweis University. A total of 1800 participants will be enrolled: 1200 for the endometriosis/adenomyosis cohort, 200 for the myometrial mass dignity-prediction cohort, and 200 for the cohort addressing other benign infertility-related conditions and AR/IVF outcome prediction.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of the AI algorithm for detection of endometriosis and adenomyosis on transvaginal ultrasound
Time Frame: 3 years
Sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) of the AI-based detection algorithm for endometriosis and adenomyosis, assessed against the reference standard of surgical findings and histopathological confirmation (for participants undergoing surgery) or, where surgery is not performed, expert consensus review of the standardized ultrasound examination.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2026

Primary Completion (Estimated)

May 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

September 3, 2026

First Submitted That Met QC Criteria

September 3, 2026

First Posted (Actual)

September 9, 2026

Study Record Updates

Last Update Posted (Actual)

September 9, 2026

Last Update Submitted That Met QC Criteria

September 3, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BM/13222-3/2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The dataset contains transvaginal ultrasound images and linked histopathological and clinical data, which carry a high re-identification risk even after anonymization, particularly given the imaging modality and the relatively narrow, well-defined patient population.

Data processing and storage are governed by a data-sharing agreement between Semmelweis University and GE HealthCare Hungary Ltd., under which anonymized data are accessible only to authorized GE HealthCare personnel on a secure, access-restricted, encrypted server, in compliance with the EU General Data Protection Regulation (GDPR). This arrangement does not extend to third-party researchers outside the collaboration.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe