Risk Factors Associated With the Progression of Adenomyosis
ConditionAdenomyosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-55
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Patients aged between 18 and 55 years;
Presence of at least two direct and indirect signs according to the MUSA classification
Obtaining informed consent
Disqualifiers
Patients undergoing hysterectomy;
Virgo patients;
Patients reporting intolerance to transvaginal ultrasound;
Gynaecological oncology;
Trial 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
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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
Time frame
At 12, 24, 36 and 48 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov