Medical students
Camilla Maj Villebro and Helene Marina Lauritzen
Department of Obstetrics and Gynecology, OUH
| Projekt styring | ||
| Projekt status | Open | |
| Data indsamlingsdatoer | ||
| Start | 07.02.2024 | |
| Slut | 31.12.2025 | |
The ENDORE study
Short summary
Up to 10% of women in the reproductive age suffer from endometriosis which can lead to severe pain and affect women's fertility. This mini-MTV evaluates the diagnostic method 'Endosure' to determine the presence of endometriosis in women. The method consists of three electrodes that measure tissue contractions (CPM) in the abdomen, and an AI-derived software calculates the severity and probability of endometriosis.
Rationale
Endometriosis is a disorder defined as the presence of the endometrium-like tissue in extrauterine locations and includes chronic inflammation, angiogenesis and invasion. The prevalence of endometriosis within the general female population has been estimated to be around 2-10% and up to 50% when it comes to infertile women. The disease is associated with symptoms like dysmenorrhea, menorrhagia, dyspareunia, abdominopelvic pain and infertility. The symptomatology of endometriosis has a significant negative impact on women's quality of life. So far, there has been suggested various theories to explain the patho-mechanisms of the formation of endometriosis. Among these theories the most dominant hypothesis describes the cause as "retrograde menstruation" and is also referred to as "The theory of Samson" but new studies suggest a more complex patho-mechanism probably related to abnormal gene signaling and environmental influence causing abnormal progesteron receptor responsiveness. The retrograde bleeding might add to inflammation and invasion thereby aggravating the malfunctioning of the progesterone receptor. Part of the reason for the extended time it takes to reach an endometriosis diagnosis is the incomplete understanding of endometriosis' pathophysiology and thereby the lack of standardized clinical outcome measurements. Laparoscopy has been considered the most reliable method for diagnosing endometriosis for a significant period of time. The laparoscopy is an invasive method and not without risk and therefore several medical technologies have been studied as a non-invasive diagnostic tool for endometriosis. Imaging technologies like TVUS and MRI have been studied in comparison to the laparoscopy. This has been implemented in the new ESHRE guidelines. Taking into consideration that the imaging tools have challenges regarding negative findings and that laparoscopy is an invasive method with risks, there is a need for a reliable non-invasive diagnostic tool that is ideally low cost and with high sensitivity and specificity. The aim of this study is to evaluate if the non-invasive Endosure test can differentiate between women with endometriosis diagnosed by MRI or laparoscopy and controls without known endometriosis or presumed endometriosis. The accuracy of the diagnostic method will be assessed by examining statistical measures including sensitivity and specificity.
Description of the cohort
The study includes 3 different groups: 1) cases, who are women diagnosed with endometriosis. 2) a control group without endometriosis or symptoms of the disease. 3) a control group which include women without endometriosis, who has been clinically examined at the department because of signs of endometriosis.
Data and biological material
The study will include 3 types of data 1) questionnaire data 2) diagnostic data from the patients journals. 3) an abdominal Ultrasound in order to exclude controls with unknown endometriosis. 4) the clinical test with electrodes and AI derived software.