Developing a Complex ex Vivo Endometrial Tissue Model to Improve Endometriosis Care
Recruiting · NCT06331676 · Interventional (participants receive a specific treatment) · Lead sponsor: Hospices Civils de Lyon
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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
Where it is running
2 locations listed.
- Hôpital Femme Mère Enfant / GHE - Bron, France
- Hôpital de la Croix-Rousse / GHN - Lyon, France