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

NCT06331676 | Recruiting

• 2 other identifiers: 69HCL23_11202023-A02339-36
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Endometriosis

Keywords

endometriosis; tissue bioengineering; hormonal therapies

Outcome Measures

Primary Outcomes (1)

• Viability of all the cells forming the complex endometrial tissue generated ex vivo by tissue bioengineering.

  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.

  through study completion, an average of 18 months

Secondary Outcomes (8)

• Change in protein expression

  through study completion, an average of 18 months

• Change in gene expression

  through study completion, an average of 18 months

• Change in inflammation

  through study completion, an average of 18 months

• Change in histological tissue structure

  through study completion, an average of 18 months

• Change in histological tissue structure

  through study completion, an average of 18 months

Study Arms (2)

Endometriosis

EXPERIMENTAL

Women with endometriosis who have an indication for gynaecological surgery

Procedure: Tissue collection; Other: Data collection

Control

ACTIVE COMPARATOR

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

Procedure: Tissue collection; Other: Data collection

Interventions

Data collection OTHER

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

Control; Endometriosis

Tissue collection PROCEDURE

Eutopic and ectopic endometrium biopsies, additional blood and peritoneal fluid sampling

Control; Endometriosis

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

Hôpital Femme Mère Enfant / GHE

Bron, 69500, France

RECRUITING

Hôpital de la Croix-Rousse / GHN

Lyon, 69004, France

RECRUITING

MeSH Terms

Conditions

Endometriosis

Interventions

Tissue Banks; Data Collection

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Biological Specimen Banks; Health Facilities; Health Care Facilities Workforce and Services; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Charles-André PHILIP, M.D., PhD

CONTACT

04 27 85 51 70; charles-andre.philip01@chu-lyon.fr

Axelle BRULPORT, PhD

CONTACT

axelle.brulport@inserm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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..

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: March 26, 2024
• Study Start: June 21, 2024
• Primary Completion (Estimated): March 21, 2028
• Study Completion (Estimated): March 21, 2028
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

FR (2)