Melk

Endometriosis is a condition affecting at least 1 in 10 women worldwide, with diagnosis often delayed by 5 to 10 years. Currently, a definitive diagnosis requires invasive laparoscopy, which can be costly and burdensome for patients. This multicenter diagnostic validation study evaluates a new non-invasive laboratory test that analyzes biomarkers from menstrual blood samples to diagnose endometriosis. The study involves self-collection of menstrual blood samples by participants. It is a prospective multicenter study conducted at gynecological centers in Austria and Germany, with plans to expand to other sites. The test's diagnostic accuracy will be assessed by comparing women with confirmed endometriosis to control groups without the condition, using measures such as sensitivity, specificity, and predictive values. Participants will be menstruating women aged 14 to 49 years, divided into groups including those with histologically or imaging-confirmed endometriosis, those with no evidence of endometriosis via laparoscopy, and healthy women without symptoms and negative imaging. The primary outcome is the diagnostic accuracy of the menstrual blood-based biomarker test, assessed from a single self-collected sample within seven months after enrollment. The study is expected to last three years.