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Validation and Optimisation of Ultrasound Diagnosis of Adenomyosis

Validation and Optimisation of Ultrasound Diagnosis of Adenomyosis: a Prospective Observational Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06795711
Enrollment
465
Registered
2025-01-28
Start date
2022-04-04
Completion date
2025-03-31
Last updated
2025-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenomyosis

Keywords

adenomyosis, gynaecology, ultrasound

Brief summary

Defining ultrasound criteria for normal uterine biometry and assessing the prevalence of repeat abortions in patients with abnormalities of the uterine cavity

Detailed description

Adenomyosis is a gynaecological disorder with a high prevalence in women of childbearing age and is characterised by the presence of glands and endometrial stroma within the myometrium, associated or not with hypertrophy and hyperplasia of the surrounding myometrium. Adenomyosis may cause pelvic pain and/or abnormal uterine bleeding. Transvaginal ultrasound may be considered the main non-invasive diagnostic modality for the diagnosis of adenomyosis. The aim is to optimise the ultrasound diagnosis of uterine pathology and in particular of adenomyosis by defining uterine biometric parameters (longitudinal, transverse and anteroposterior diameters and their ratios; uterine volume) allowing patients to be divided into 3 groups: * Uterus affected by adenomyosis (group A): adenomyosis is a gynaecological condition with high prevalence in women of childbearing age and is characterised by the presence of endometrial tissue (innermost layer of the uterus) within the uterine muscle. Adenomyosis can cause abdominal pain and abnormal uterine bleeding. * Uterus affected by fibromatosis (group B): uterine fibromatosis is a gynaecological condition characterised by the appearance of numerous fibroids in the uterus. It is a very frequent condition in the general population and its frequency increases as the age of the patients increases. * Normal uterus (group C). Transvaginal ultrasound, although a reference diagnostic tool, still remains an operator-dependent examination to date: our secondary objective is to build models that can simplify diagnosis through the use of artificial intelligence. The aim is to create various artificial intelligence software that can 'learn to make a diagnosis'. This method has already been applied in radiology, proving capable of discriminating between benign and malignant tumours from images from different diagnostic methods with performance similar to that of experienced radiologists.

Interventions

None listed

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* age between 18 and 60; * obtaining informed consent

Exclusion criteria

* Hysterectomised patients; * Virgo patients (hymenal integrity); * Patients reporting intolerance to transvaginal ultrasound; * Gynaecological oncology; * Recent pregnancy or childbirth (within 6 months); * Menopausal patients

Design outcomes

Primary

MeasureTime frameDescription
Definition of uterine biometric parametersAfter enrollment on first visitDefinition of uterine biometric parameters for the diagnosis of adenomyotic uterus (group A), fibromatous uterus (group B) and normal uterus (group C) by means of transvaginal ultrasound, performed as per the care procedure. Evaluation of the diagnostic capacity of 'globular uterus' for the diagnosis of adenomyosis as an additional parameter to those already known in the literature with possible subsequent identification of a biometric cut-off
Diagnostic capacity of 'globular uterus' for the diagnosis of adenomyosisAfter enrollment on first visitEvaluation of the diagnostic capacity of 'globular uterus' for the diagnosis of adenomyosis as an additional parameter to those already known in the literature with possible subsequent identification of a biometric cut-off

Secondary

MeasureTime frameDescription
Construction of deep learning models on uterine ultrasound imagesAfter enrollment on first visitConstruction of deep learning models trained, validated and tested on uterine ultrasound images for the ultrasound diagnosis of adenomyosis and evaluation of their diagnostic accuracy
Evaluation of diagnostic accuracy of deep learning validatedAfter enrollment on first visitEvaluation of diagnostic accuracy of deep learning validated for ultrasound diagnosis of adenomyosis
Identification of the frequency of finding ultrasound signs of adenomyosis in the cervixAfter enrollment on first visitIn patients with a diagnosis of adenomyosis made on the basis of ultrasound features at the level of the uterine body and fundus
Evaluation of diagnostic accuracyAfter enrollment on first visitEvaluation of the diagnostic accuracy of trainees when experienced (identifying experienced operators as doctors in specialised training in Gynaecology and Obstetrics for at least four years, with an experience of at least 500 gynaecological ultrasound cases) and moderately experienced (identifying moderately experienced operators as doctors in specialised training in Gynaecology and Obstetrics for at least two years, with an experience of at least 200 gynaecological ultrasound cases

Countries

Italy

Contacts

Primary ContactDiego Raimondo, MD
die.raimondo@gmail.com+393290636618

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026