Assessing the severity of adenomyosis using ultrasound
Assessing Ultrasonographic Severity of Adenomyosis - a Feasibility and Interobserver Study
This study is testing a new way to use ultrasound to see how severe adenomyosis is in premenopausal women.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | Amsterdam UMC, location VUmc Academic / other |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT06117410 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to develop a quantifiable ultrasonographic method to grade the severity of adenomyosis in premenopausal women. Participants will undergo transvaginal ultrasound (TVUS) to identify direct features of adenomyosis, such as subendometrial lines or myometrial cysts. The study will evaluate various imaging techniques, including 2D and 3D ultrasound, elastography, and power Doppler, to assess the severity of adenomyosis and determine the interobserver variation in grading. The goal is to establish a reliable method for assessing adenomyosis severity that can be used in clinical practice.
Who should consider this trial
Good fit: Ideal candidates for this study are premenopausal women over 18 years old who have been diagnosed with adenomyosis based on ultrasound features.
Not a fit: Patients with hormonal medication or other significant gynecological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a standardized method for diagnosing and grading adenomyosis, leading to improved patient management.
How similar studies have performed: While there have been studies on ultrasound assessment of adenomyosis, this specific approach to grading severity is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * at least one direct MUSA feature (lines and buds, hyperechogenic islands, cysts) * premenopausal, older than18 years Exclusion Criteria: * hormonal medication * other reason for gynaecological symptoms, more evident than adenomyosis, e.g. deep infiltrating endometriosis, dominant uterine fibroids (\>5cm, \>5 myoma, intracavitary myoma), cervical or endometrial cancer.
Where this trial is running
Amsterdam
- Amsterdam UMC, location AMC — Amsterdam, Netherlands (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.