Image

Validation and Optimisation of Ultrasound Diagnosis of Adenomyosis

Validation and Optimisation of Ultrasound Diagnosis of Adenomyosis

Recruiting
18-60 years
Female
Phase N/A

Powered by AI

Overview

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

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.

Eligibility

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

Study details
    Adenomyosis

NCT06795711

IRCCS Azienda Ospedaliero-Universitaria di Bologna

21 October 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.