AdenomyosisNCT06718088
Risk Factors Associated With the Progression of Adenomyosis
An observational study of Adenomyosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Adenomyosis
- How many people
- 258 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2022to 1 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
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
Who may be able to join
- Patients aged between 18 and 55 years;
- Presence of at least two direct and indirect signs according to the MUSA classification
- Obtaining informed consent
Who cannot join
- Patients undergoing hysterectomy;
- Virgo patients;
- Patients reporting intolerance to transvaginal ultrasound;
- Gynaecological oncology;
- Recent pregnancy or childbirth (within 6 months)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Paolo Casadio, MD, +390512144411, paolo.casadio@aosp.bo.it
Paolo Casadio, MD
About this study
Official title: Risk Factors Associated With The Progression Of Adenomyosis
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.
- Conditions
- Adenomyosis
- Keywords
- adenomyosis, risk factors, transvaginal ultrasound
- Medical subject headings
- Adenomyosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of adenomyosis
Risk of progression of adenomyosis and the risk factors associated with progression in patients with ultrasound diagnosis of adenomyosis
Measured: At 12, 24, 36 and 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start1 Jun 2022
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenomyosisStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paolo Casadio, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718088
- Sponsor's protocol ID
- PROADENO
- Status last verified
- Dec 2024
- First submitted
- 1 Dec 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors Associated With The Progression Of Adenomyosis
- ClinicalTrials.gov ID
- NCT06718088
- Acronym / sponsor ID
- PROADENO
- Conditions
- Adenomyosis
- Keywords
- adenomyosis, risk factors, transvaginal ultrasound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (3 listed)
- Patients aged between 18 and 55 years;
- Presence of at least two direct and indirect signs according to the MUSA classification
- Obtaining informed consent
Key exclusion criteria (5 listed)
- Patients undergoing hysterectomy;
- Virgo patients;
- Patients reporting intolerance to transvaginal ultrasound;
- Gynaecological oncology;
- Recent pregnancy or childbirth (within 6 months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression of adenomyosis
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paolo Casadio, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenomyosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paolo Casadio, MD (+390512144411, paolo.casadio@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of adenomyosis (time frame: At 12, 24, 36 and 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.