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Recruiting Observational

Risk Factors Associated With the Progression of Adenomyosis

NCT06718088 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2022-06-01
Last updated
2024-12-05

Condition(s) studied

Adenomyosis

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
Inclusion Criteria: * Patients aged between 18 and 55 years; * Presence of at least two direct and indirect signs according to the MUSA classification * Obtaining informed consent Exclusion Criteria: * Patients undergoing hysterectomy; * Virgo patients; * Patients reporting intolerance to transvaginal ultrasound; * Gynaecological oncology; * Recent pregnancy or childbirth (within 6 months)

Primary outcome measure(s)

  • Progression of adenomyosis — At 12, 24, 36 and 48 months
    Risk of progression of adenomyosis and the risk factors associated with progression in patients with ultrasound diagnosis of adenomyosis

Trial sites (1)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliero-Universitaria di Bologna Bologna Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06718088 on ClinicalTrials.gov ↗ ← All trials in Italy