Risk Factors Associated With the Progression of Adenomyosis

NCT06718088 | Recruiting

• 1 other identifier: PROADENO
• Study Type: observational
• Target: 258
• Locations: 1 country
• Sites: 1

Brief Summary

Adenomyosis is a gynaecological disorder with a high prevalence in women of childbearing age and is characterised by the presence of endometrial glands and 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 (TVUS) is considered the main non-invasive diagnostic modality for the diagnosis of adenomyosis. Although adenomyosis is a very common condition among patients of childbearing age, its natural course is still debated. Some studies have evaluated the role of hormonal treatments (systemic or local oestrogen or progestin-based) on adenomyosis, which have been effective in controlling symptoms such as pelvic pain and abnormal uterine bleeding. Despite all this, no evidence is available on the progression of adenomyosis and the factors that may influence its progression over time. The aim of this study is therefore to assess the progression of adenomyosis and associated risk factors using transvaginal ultrasound.

Conditions

Adenomyosis

Keywords

adenomyosis; risk factors; transvaginal ultrasound

Outcome Measures

Primary Outcomes (1)

• Progression of adenomyosis

  Risk of progression of adenomyosis and the risk factors associated with progression in patients with ultrasound diagnosis of adenomyosis

  At 12, 24, 36 and 48 months

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ultrasound diagnosis of adenomyosis who were referred to the ultrasound outpatient clinics for routine check-ups or pre-operative visits, as per their regular care routine. The retrospective arm of the study will enrol patients who have been admitted to our outpatient clinics since 1 January 2018. The ultrasound diagnosis of adenomyosis will be made if at least 2 ultrasound signs compatible with adenomyosis are present according to the modified MUSA consensus. Women included in the study will be offered ultrasound follow-up at 6, 12, 24, 36, 48 months after the first outpatient visit with a diagnosis of adenomyosis. Subsequently, patients will be divided into three groups according to evidence of progression, stability and regression of the adenomyotic picture at follow-up

You may qualify if:

• Patients aged between 18 and 55 years;
• Presence of at least two direct and indirect signs according to the MUSA classification
• Obtaining informed consent

You may not qualify if:

• Patients undergoing hysterectomy;
• Virgo patients;
• Patients reporting intolerance to transvaginal ultrasound;
• Gynaecological oncology;
• Recent pregnancy or childbirth (within 6 months)

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di 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

• Paolo Casadio, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo Casadio, MD

CONTACT

+390512144411; paolo.casadio@aosp.bo.it

Study Design

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

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 5, 2024
• Study Start: June 1, 2022
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

IT (1)