protocolSection identificationModule nctId: NCT06331676, orgStudyIdInfo id: 69HCL23_1120, secondaryIdInfos id: 2023-A02339-36, type: OTHER, domain: ID RCB, briefTitle: Developing a Complex ex Vivo Endometrial Tissue Model to Improve Endometriosis Care, acronym: OTEndo, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-10, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Hospices Civils de Lyon, class: OTHER, descriptionModule briefSummary: Endometriosis is a chronic gynaecological disease characterised by the growth of endometrium outside the uterus. It affects 10% of childbearing age women.There is no cure for endometriosis. Hormonal treatments should be the first line therapy. The benefit-risk ratio of symptomatic treatment with hormone therapy varies greatly from one woman to another. The pathophysiology of endometriosis and the mechanisms of action of these treatments are still poorly understood. This may be due to the lack of an optimal experimental model for studying the disease.The aim of this project is to develop a complex ex vivo endometrial model recapitulating the organisation and properties of the human endometrium using innovative tissue bioengineering methods. This model will make it possible to develop a pre-clinical approach that predicts individual response to different types of hormonal treatment in order to optimise therapeutic choices and provide a better understanding of the effects of these treatments., conditionsModule conditions: Endometriosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants enrolled in this study will be given an eutopic and ectopic endometrium biopsies, blood and peritoneal fluid sampling and should answer to a questionnaire on menstrual health and history of hormone treatments for the research purpose.., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Tissue collection, interventions name: Data collection, outcomesModule primaryOutcomes measure: Viability of all the cells forming the complex endometrial tissue generated ex vivo by tissue bioengineering., secondaryOutcomes measure: Change in protein expression, secondaryOutcomes measure: Change in gene expression, secondaryOutcomes measure: Change in inflammation, secondaryOutcomes measure: Change in histological tissue structure, secondaryOutcomes measure: Change in histological tissue structure, secondaryOutcomes measure: Change in tissue elasticity, secondaryOutcomes measure: Change in steroid hormone physiology, secondaryOutcomes measure: Steroid hormones in peritoneal fluid, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hôpital Femme Mère Enfant / GHE, city: Bron, zip: 69500, country: France, contacts name: Charles-André PHILIP, MD, PhD, role: CONTACT, phone: 04 27 85 51 70, phoneExt: +33, email: charles-andre.philip01@chu-lyon.fr, geoPoint lat: 45.73333, lon: 4.91667, locations facility: Hôpital de la Croix-Rousse / GHN, city: Lyon, zip: 69004, country: France, contacts name: Gil DUBERNARD, MD, PhD, role: CONTACT, phone: 04 72 07 16 42, phoneExt: +33, email: gil.dubernard@chu-lyon.fr, geoPoint lat: 45.74848, lon: 4.84669, hasResults: False