Developing a Complex ex Vivo Endometrial Tissue Model to Improve Endometriosis Care
Developing a Complex ex Vivo Endometrial Tissue Model Based on Patient Biopsies to Assess and Optimise the Response to Current and Potential Treatments for Endometriosis
Hospices Civils de Lyon
90 participants
Jun 21, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- Female
- People aged between 18 and 50
- Person who has or has had hormonal contraceptive treatment
- A person who has given written consent
- Person diagnosed with a benign gynaecological pathology not affecting the endometrium and requiring hysterectomy, hysteroscopy or laparoscopy or with a diagnosis of endometriosis and requiring laparoscopy or hysterectomy
- Person affiliated to the french social security
Exclusion Criteria10
- Pregnant at the time of sampling or within 3 months prior to sampling
- Breast-feeding women
- Women undergoing physiological menopause
- Anyone who has received hormonal treatment with hormones other than steroids in the three months prior to sampling
- Anyone with a non-hormonal contraceptive intrauterine device (copper coil)
- Anyone with a personal history of cancer of the breast, ovary, endometrium or cervix
- People with Lynch syndrome
- Persons under legal protection (guardianship, curatorship)
- Persons deprived of their liberty by judicial or administrative decision
- Persons with a body mass index (BMI) of less than 18.5 or more than 30
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Interventions
Eutopic and ectopic endometrium biopsies, additional blood and peritoneal fluid sampling
Questionnaire on menstrual health and history of hormone treatments for the research purpose
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06331676