Validation and Optimisation of Ultrasound Diagnosis of Adenomyosis

NCT06795711 | Recruiting

• 1 other identifier: ADENAS
• Study Type: observational
• Target: 465
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Adenomyosis

Keywords

adenomyosis; gynaecology; ultrasound

Outcome Measures

Primary Outcomes (2)

• Definition of uterine biometric parameters

  Definition 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

  After enrollment on first visit

• Diagnostic capacity of 'globular uterus' for the diagnosis of adenomyosis

  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

  After enrollment on first visit

Secondary Outcomes (4)

• Construction of deep learning models on uterine ultrasound images

  After enrollment on first visit

• Evaluation of diagnostic accuracy of deep learning validated

  After enrollment on first visit

• Identification of the frequency of finding ultrasound signs of adenomyosis in the cervix

  After enrollment on first visit

• Evaluation of diagnostic accuracy

  After enrollment on first visit

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients consecutively attending our ultrasound clinics for routine check-ups or pre-operative examinations will be included, as per regular practice. For the purposes of the analysis, patients will be divided into three groups according to the ultrasound and/or surgical diagnosis of A adenomyosis (presence of at least 2 ultrasound signs compatible with adenomyosis (MUSA) or presence of glands and endometrial stroma in myometrial location), B fibromatosis (uterus with inhomogeneous echostructure lacking 2 or more signs compatible with uterine adenomyosis or histological finding of several benign tumours consisting of smooth muscle tissue and fibrous tissue in varying proportions), C normal uterus (normal echostructure on transvaginal ultrasound)

You may qualify if:

• age between 18 and 60;
• obtaining informed consent

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Adenomyosis

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Diego Raimondo, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diego Raimondo, MD

CONTACT

+393290636618; die.raimondo@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: January 28, 2025
• Study Start: April 4, 2022
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: January 28, 2025

Record last verified: 2024-11

Locations

IT (1)