Developing a Complex ex Vivo Endometrial Tissue Model to Improve Endometriosis Care (OTEndo)

Civil Hospices of Lyon

Status: Enrolling

Conditions: Endometriosis

Treatments: Procedure: Tissue collection; Other: Data collection

Study type: Interventional

Funder types: Other

Identifiers

NCT06331676

2023-A02339-36 (Other Identifier)

69HCL23_1120

Details and patient eligibility

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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Endometriosis

Experimental group

Description:

Women with endometriosis who have an indication for gynaecological surgery

Treatment:

Other: Data collection

Procedure: Tissue collection

Control

Active Comparator group

Description:

Women with no endometrial pathology who have an indication for gynaecological surgery

Treatment:

Other: Data collection

Procedure: Tissue collection