Clinical trial NCT06331676: Developing a Complex ex Vivo Endometrial Tissue Model to Improve Endometriosis Care
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometriosis
Keywords: endometriosis
tissue bioengineering
hormonal therapies
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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..
Primary purpose: BASIC_SCIENCE

Brief 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 criteria: 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

Primary outcomes:
measure: Viability of all the cells forming the complex endometrial tissue generated ex vivo by tissue bioengineering.
timeFrame: through study completion, an average of 18 months
Secondary outcomes:
measure: Change in protein expression
timeFrame: through study completion, an average of 18 months
measure: Change in gene expression
timeFrame: through study completion, an average of 18 months
measure: Change in inflammation
timeFrame: through study completion, an average of 18 months
measure: Change in histological tissue structure
timeFrame: through study completion, an average of 18 months
measure: Change in histological tissue structure
timeFrame: through study completion, an average of 18 months
measure: Change in tissue elasticity
timeFrame: through study completion, an average of 18 months
measure: Change in steroid hormone physiology
timeFrame: At baseline
measure: Steroid hormones in peritoneal fluid
timeFrame: At baseline
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme Mère Enfant / GHE
city: Lyon
country: France
facility: Hôpital de la Croix-Rousse / GHN
Study officials:
References: