N80.0
Conditions
Interventions
Group 1: Reference collective:
MRI in test persons without menstrual cycle associated symptoms
Group 2: Study collective:
MRI in patients with a high suspicion of Adenomyosis
Sponsors
Charité – Universitätsmedizin Berlin
Eligibility
Sex/Gender
Female
Age
12 Years to 30 Years
Inclusion criteria
Inclusion criteria: -Postmenarchal participants -Regular menstrual cycle (21-35 days)
Exclusion criteria
Exclusion criteria: - Male or diverse gender - Premenarchal children - Postmenopausal women - Irregular cycle - Deep pelvic endometriosis - Known pregnancy - Hormonal contraceptives or other hormone therapies - Intrauterine devices - Malformations of the urogenital tract, surgical interventions, or minimally invasive treatments of the uterus in the past - MRI-specific contraindications (pacemakers, foreign bodies or implants in the pelvis and hip, claustrophobia)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the distinction between physiological and pathological changes in the uterus for the assessment of early-stage adenomyosis, particularly regarding the thickness of the junctional zone of the uterus. | — |
Secondary
| Measure | Time frame |
|---|---|
| - One of the two examination time points (menstrual phase or ovulatory phase) is superior to the other for differentiating adenomyosis features. - There is an imaging biomarker that correlates better with clinical symptoms than the thickness of the junctional zone. - A combination of imaging biomarkers may surpass the correlation with clinical symptoms compared to measurements of junctional zone thickness. - The assessment of changes in the uterus can be automated and standardized nationwide using artificial intelligence. | — |
Countries
Germany
Contacts
Public ContactMatthias May
Universitätsklinik Erlangen
Outcome results
None listed