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Recruiting Not applicable

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

NCT06331676 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2024-06-21
Last updated
2026-01-30

Condition(s) studied

Endometriosis

Investigational drug(s) / intervention(s)

Tissue collectionData collection

Tissue collection: Eutopic and ectopic endometrium biopsies, additional blood and peritoneal fluid sampling

Data collection: Questionnaire on menstrual health and history of hormone treatments for the research purpose

Study 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

Sex
FEMALE
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
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 outcome measure(s)

  • Viability of all the cells forming the complex endometrial tissue generated ex vivo by tissue bioengineering. — through study completion, an average of 18 months
    The viability of all the cells forming the complex endometrial tissue generated ex vivo by tissue bioengineering will be assessed either by flow cytometry (labelling with propidium iodide or 7-AAD) or by immunofluorescence (with lipophilic carbocyanine dyes). The scientists involved in the project reserve the right to modify these labelling techniques and the markers mentioned, depending on the technical and logistical challenges encountered during the tissue bioengineering stages.

Trial sites (2)

FacilityCityRegionStatus
Hôpital Femme Mère Enfant / GHE Bron France Recruiting
Hôpital de la Croix-Rousse / GHN Lyon France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06331676 on ClinicalTrials.gov ↗ ← All trials in France