Visualising uterine microcirculation using contrast-enhanced ultrasound for differentiating between healthy controls and participants with adenomyosis: rationale and design of the UteroVue Adenomyosis study

Background Adenomyosis is a benign uterine condition characterised by ectopic growth of endometrial tissue within the myometrium. It is associated with dysmenorrhea, heavy menstrual bleeding and subfertility. Diagnosing adenomyosis remains challenging, due to its typically diffuse distribution. A potential distinguishing feature is abnormal uterine microcirculation, which can be visualised using contrast-enhanced ultrasound (CEUS). In our recent pilot study on the feasibility of uterine CEUS in ten participants, CEUS showed promise for diagnosing adenomyosis. The current clinical trial aims to explore if qualitative CEUS characteristics and quantitative CEUS perfusion parameters describing the uterine microcirculation can be used to differentiate between healthy controls and participants with (moderate to severe) adenomyosis. Methods In this explorative prospective cross-sectional study, healthy controls and participants with adenomyosis are recruited. They undergo conventional ultrasound and two-dimensional and three-dimensional CEUS. The primary outcomes are quantitative CEUS perfusion parameters. Secondary outcomes are qualitative CEUS characteristics and the relationship between CEUS findings and findings on conventional ultrasound, magnetic resonance imaging, and histopathology. Discussion This is the first large study to apply extensive CEUS analysis in participants with adenomyosis and compare the results with those of a healthy control group. This study will provide insights into the microcirculation of adenomyosis, which may lay the groundwork for improving diagnostics of adenomyosis.