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NCT Number: NCT06331676

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

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.

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Femme Mère Enfant / GHE, Bron, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tissue collection

Procedure

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

Data Collection

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Axelle BRULPORT, PhD

CONTACT

[email protected]

Charles-André PHILIP, M.D., PhD

CONTACT

[email protected]

04 27 85 51 70 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study 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

Acronym: OTEndo

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Mar 26, 2024
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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