Artificial Intelligence Into Ultrasound Diagnostics in Reproductive Medicine (AUDRIE)
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.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Nandor Acs, PhD
- 電話番号：+3620825001
- メール：acs.nandor@semmelweis.hu
研究場所
-
-
Budapest
-
Budapest、Budapest、ハンガリー、1088
- 募集
- Department of Obstetrics and Gynecology, Semmelweis University
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
|---|
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Diagnostic accuracy of the AI algorithm for detection of endometriosis and adenomyosis on transvaginal ultrasound
時間枠：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
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- BM/13222-3/2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。