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

January 28, 2026 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bron, France, 69500
      • Lyon, France, 69004
        • Recruiting
        • Hôpital de la Croix-Rousse / GHN
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endometriosis
Women with endometriosis who have an indication for gynaecological surgery
Procedure: Tissue collection
Eutopic and ectopic endometrium biopsies, additional blood and peritoneal fluid sampling
Other: Data collection
Questionnaire on menstrual health and history of hormone treatments for the research purpose
Active Comparator: Control
Women with no endometrial pathology who have an indication for gynaecological surgery
Procedure: Tissue collection
Eutopic and ectopic endometrium biopsies, additional blood and peritoneal fluid sampling
Other: Data collection
Questionnaire on menstrual health and history of hormone treatments for the research purpose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viability of all the cells forming the complex endometrial tissue generated ex vivo by tissue bioengineering.
Time Frame: 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.
through study completion, an average of 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in protein expression
Time Frame: through study completion, an average of 18 months
Comparing changes in protein expression in the model of complex endometrial tissue generated ex vivo by tissue bioengineering (eutopic endometrium) in each donor, between control and endometriosis groups and between eutopic and ectopic endometrium in endometriosis group.
through study completion, an average of 18 months
Change in gene expression
Time Frame: through study completion, an average of 18 months
Comparing changes in gene expression in the model of complex endometrial tissue generated ex vivo by tissue bioengineering (eutopic endometrium) in each donor, between control and endometriosis groups and between eutopic and ectopic endometrium in endometriosis group.
through study completion, an average of 18 months
Change in inflammation
Time Frame: through study completion, an average of 18 months

The concentration (expressed in pg/gl) of the following cytokines will be measured using Luminex technology (Bio-Plex 200 analyser): Interleukin (IL) 1β, IL-1RA, IL-2, IL-2R, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12p40/p70, IL-13, IL-15, IL-17, Tumor Necrosis Factor TNFα, interferons (IFN) IFN-α, IFN-γ, Granulocyte-Macrophage Colony Stimulating Factor GM-CSF, Macrophage Inflammatory Protein MIP-1α, MIP-1β, Interferon gamma-induced protein 10 IP-10, Eotaxin, RANTES, and Monocyte Chemoattractant Protein-1 MCP-1.

Changes in these inflammation markers concentration in the model of complex endometrial tissue generated ex vivo by tissue bioengineering (eutopic endometrium) in each donor, between control and endometriosis groups and between eutopic and ectopic endometrium in endometriosis group will be assessed.
through study completion, an average of 18 months
Change in histological tissue structure
Time Frame: through study completion, an average of 18 months
Comparing changes in histological tissue structure (density of glands open to the lumen and glands located in the basal layer of the endometrium expressed in number of glands/cm3 of tissue, measured with an haematoxiline-eosin stainings and using Image J software) in the model of complex endometrial tissue generated ex vivo by tissue bioengineering (eutopic endometrium) in each donor, between control and endometriosis groups and between eutopic and ectopic endometrium in endometriosis group.
through study completion, an average of 18 months
Change in histological tissue structure
Time Frame: through study completion, an average of 18 months
Comparing changes in histological tissue structure (thickness of the endometrium expressed in micrometer) in the model of complex endometrial tissue generated ex vivo by tissue bioengineering (eutopic endometrium) in each donor, between control and endometriosis groups and between eutopic and ectopic endometrium in endometriosis group.
through study completion, an average of 18 months
Change in tissue elasticity
Time Frame: through study completion, an average of 18 months
Comparing changes in tissue elasticity by assessing the speed of shear waves in the model of complex endometrial tissue generated ex vivo by tissue bioengineering (eutopic endometrium) in each donor, between control and endometriosis groups and between eutopic and ectopic endometrium in endometriosis group.
through study completion, an average of 18 months
Change in steroid hormone physiology
Time Frame: At baseline

Measurement of steroid hormones concentration levels in blood and comparison between control and endometriosis groups.

Steroid hormones assays will be carried out using ELISA® technologies. The following hormones will be measured: prolactin, Luteinizing Hormone (LH), estradiol (E2), estrone, progesterone and Sex hormone-binding globulin SHBG. The unit of measurement is pg/ml for all hormones.
At baseline
Steroid hormones in peritoneal fluid
Time Frame: At baseline

Measurement of steroid hormones concentration levels in peritoneal fluid and comparison between control and endometriosis groups.

Steroid hormones assays will be carried out using ELISA® technologies. The following hormones will be measured: prolactin, Luteinizing Hormone (LH), estradiol (E2), estrone, progesterone and Sex hormone-binding globulin SHBG. The unit of measurement is pg/ml for all hormones.
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2024

Primary Completion (Estimated)

March 21, 2028

Study Completion (Estimated)

March 21, 2028

Study Registration Dates

First Submitted

February 9, 2024

First Submitted That Met QC Criteria

March 19, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL23_1120
  • 2023-A02339-36 (Other Identifier: ID RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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