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

NCT ID: NCT06331676

Last Updated: 2026-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-21

Study Completion Date

2028-03-21

Brief Summary

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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.

Detailed Description

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Conditions

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Endometriosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Endometriosis

Women with endometriosis who have an indication for gynaecological surgery

Group Type EXPERIMENTAL

Tissue collection

Intervention Type PROCEDURE

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

Data collection

Intervention Type OTHER

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

Control

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

Group Type ACTIVE_COMPARATOR

Tissue collection

Intervention Type PROCEDURE

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

Data collection

Intervention Type OTHER

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

Interventions

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Tissue collection

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

Intervention Type PROCEDURE

Data collection

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Femme Mère Enfant / GHE

Bron, , France

Site Status RECRUITING

Hôpital de la Croix-Rousse / GHN

Lyon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Charles-André PHILIP, M.D., PhD

Role: CONTACT

04 27 85 51 70 ext. +33

Axelle BRULPORT, PhD

Role: CONTACT

Facility Contacts

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Charles-André PHILIP, MD, PhD

Role: primary

04 27 85 51 70 ext. +33

Gil DUBERNARD, MD, PhD

Role: primary

04 72 07 16 42 ext. +33

Other Identifiers

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2023-A02339-36

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL23_1120

Identifier Type: -

Identifier Source: org_study_id

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