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RecruitingNCT06718088Updated Dec 5, 2024

Risk Factors Associated With the Progression of Adenomyosis

An observational study in Adenomyosis, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Recruiting at 1 site in Italy. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-12-05.

Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Jun 2022; still recruiting 4 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
258
Ages
18 Years to 55 Years
Sex
Female
01

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.

Read the detailed description

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 is considered the main non-invasive diagnostic modality for the diagnosis of adenomyosis.

The goal of formulating a recognised and unified terminology for the description of ultrasound criteria for the diagnosis of adenomyosis was achieved by the Morphological Uterus Sonographic Assessment (MUSA) consensus.

The MUSA consensus consists of a list of ultrasound features associated with adenomyosis, namely:

  • globular uterus: uterus with a more spherical conformation and more slender bottom than normal. The definition of a 'globular uterus' is currently subjective and there are no quantitative uterine biometric parameters available to differentiate a uterus with adenomyosis from a uterus not affected by the disease (normal or fibromatous uterus).
  • asymmetric thickening of the uterine walls;
  • inhomogeneous eco-structure due to the presence of multiple hyperechogenic striae intermixed with hypoechogenic striae (thin shadow cones) giving the typical ultrasound appearance described as 'rain in the forest' or 'fan-shaped shadowing';
  • cystic spaces or non-vascularised intra-myometrial anecogenic lacunae, often surrounded by a hyper-echogenic halo, caused by glandular ectasia;
  • hyperechogenic islands deepening in the myometrium, expression of the presence of islands of ectopic endometrial tissue;
  • subendometrial lines and spicules;
  • intralesional and irregular vascularisation of the myometrium (vessels penetrate in a rectilinear within adenomyomas or foci of adenomyosis);
  • poor definition of the endometrium/myometrium junction (JZ);
  • thickening, irregularities and interruptions of the JZ.

To these ultrasound features summarised by the MUSA consensus, the literature adds two that are considered equally typical of the pathology:

  • uterine pain on pressure of the ultrasound probe;
  • the 'question mark sign', i.e. a pathological angle at the uterine fundus, an expression of uterine anatomical distortion.

Previous studies on the occurrence of adenomyosis have been limited to women undergoing hysterectomy, probably overestimating its prevalence compared to the general population. Recent studies, on the other hand, have begun to investigate the morphological features of adenomyosis using TVUS, an inexpensive and widely available method, to determine its prevalence and the factors that may influence its onset. They defined a prevalence of the condition as 20.9% among women attending a gynaecological outpatient setting.

Although adenomyosis is a very common condition among patients of childbearing age, its natural evolution 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 regarding 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.

The study is prospective and retrospective observational.

02

Conditions studied

  • Adenomyosis

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Keywords

  • adenomyosis
  • risk factors
  • transvaginal ultrasound
03

In context

Adenomyosis

135 studies on the registry are indexed under Adenomyosis; 50 are open to participants now.

This study's planned enrollment of 258 is above the median of 150 across 56 observational studies indexed under Adenomyosis.

Browse Adenomyosis studies →

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 493 studies on the registry; 273 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
No
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

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

Exclusion Criteria:

  • Patients undergoing hysterectomy;
  • Virgo patients;
  • Patients reporting intolerance to transvaginal ultrasound;
  • Gynaecological oncology;
  • Recent pregnancy or childbirth (within 6 months)
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
258 participants (estimated)
Patient registry
No
06

What researchers measure

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 months

07

Study locations

1 of 1 sites recruiting
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna
    Bologna, 40138, Italy
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06718088
Lead sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Responsible party
Sponsor
First posted
Dec 5, 2024
Start date
Jun 1, 2022
Primary completion
Jun 1, 2026 (estimated)
Completion
Jun 1, 2026 (estimated)
Last update
Dec 5, 2024

Study contacts

Paolo Casadio, MD
Contact
paolo.casadio@aosp.bo.it
+390512144411
Paolo Casadio, MD
principal investigator · IRCCS Azienda Ospedaliero-Universitaria di Bologna

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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