EndometriosisAUDRIENCT07810920
Artificial Intelligence Into Ultrasound Diagnostics in Reproductive Medicine
An observational study of Endometriosis and Adenomyosis of Uterus, run by Semmelweis University at 1 site in Hungary.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis, Adenomyosis of Uterus, Leiomyoma (Uterine Fibroids)
- How many people
- 1,600 participants
- Where
- 1 siteHungary
- Study dates
- 1 Sep 2026to 31 Dec 2030
- How long will I take part?
- 3 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
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 1600 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.
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, Semmelweis University
Budapest, Budapest, 1088
About this study
Official title: 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.
- Conditions
- Endometriosis, Adenomyosis of Uterus, Leiomyoma (Uterine Fibroids), Uterine Neoplasms, Congenital Abnormalities, Infertility, Female
- Keywords
- reproductive medicine, artificial intelligence, deep learning, endometriosis, endometrial receptivity, adenomyosis, uterine leiomyoma
- Medical subject headings
- Endometriosis, Adenomyosis, Leiomyoma, Uterine Neoplasms, Congenital Abnormalities, Infertility, Female, Myofibroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of the AI algorithm for detection of endometriosis and adenomyosis on transvaginal ultrasound
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start1 Sep 2026
- Primary completion31 May 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,600 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ács Nándor, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810920
- Sponsor's protocol ID
- BM/13222-3/2026
- Acronym
- AUDRIE
- Status last verified
- May 2026
- First submitted
- 3 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.