EndometriosisOTEndoNCT06331676
Developing a Complex ex Vivo Endometrial Tissue Model to Improve Endometriosis Care
A study testing Tissue collection and Data collection in people with Endometriosis, run by Hospices Civils de Lyon at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Tissue collection and Data collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesFrance
- Study dates
- 21 Jun 2024to 21 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Axelle BRULPORT, PhD contact
France2 sites, 2 recruiting
- Recruiting
Hôpital Femme Mère Enfant / GHE
Bron, 69500
Charles-André PHILIP, MD, PhD, 04 27 85 51 70 ext. +33, charles-andre.philip01@chu-lyon.fr
- Recruiting
Hôpital de la Croix-Rousse / GHN
Lyon, 69004
Gil DUBERNARD, MD, PhD, 04 72 07 16 42 ext. +33, gil.dubernard@chu-lyon.fr
About this study
Official 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
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
- Being tested
- Tissue collection, Data collection
- Keywords
- endometriosis, tissue bioengineering, hormonal therapies
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue collectionProcedure or surgery
Eutopic and ectopic endometrium biopsies, additional blood and peritoneal fluid sampling
Data collectionOther
Questionnaire on menstrual health and history of hormone treatments for the research purpose
| Study group | Role | What they receive |
|---|---|---|
| Endometriosis | Experimental | Women with endometriosis who have an indication for gynaecological surgery Receives: Procedure: Tissue collection; Other: Data collection |
| Control | Active comparator | Women with no endometrial pathology who have an indication for gynaecological surgery Receives: Procedure: Tissue collection; Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 18 months
Secondary outcomes (8)
Change in protein expression
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.
Measured: through study completion, an average of 18 months
Change in gene expression
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.
Measured: through study completion, an average of 18 months
Change in inflammation
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.
Measured: through study completion, an average of 18 months
Change in histological tissue structure
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.
Measured: through study completion, an average of 18 months
Change in histological tissue structure
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.
Measured: through study completion, an average of 18 months
Change in tissue elasticity
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.
Measured: through study completion, an average of 18 months
Change in steroid hormone physiology
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.
Measured: At baseline
Steroid hormones in peritoneal fluid
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.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start21 Jun 2024
- Primary completion21 Mar 2028 (estimated)
- Study completion21 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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..
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331676
- Sponsor's protocol ID
- 69HCL23_1120
- Other IDs
- 2023-A02339-36
- Acronym
- OTEndo
- Status last verified
- Jan 2026
- First submitted
- 9 Feb 2024
- Last updated
- 30 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06331676
- Acronym / sponsor ID
- OTEndo / 69HCL23_1120
- Conditions
- Endometriosis
- Keywords
- endometriosis, tissue bioengineering, hormonal therapies
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 21 Jun 2024 (actual)
- Primary completion
- 21 Mar 2028 (estimated)
- Study completion
- 21 Mar 2028 (estimated)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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..
| Arm | Type | Receives |
|---|---|---|
| Endometriosis | Experimental | Procedure: Tissue collection, Other: Data collectionWomen with endometriosis who have an indication for gynaecological surgery |
| Control | Active comparator | Procedure: Tissue collection, Other: Data collectionWomen with no endometrial pathology who have an indication for gynaecological surgery |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tissue collectionEutopic and ectopic endometrium biopsies, additional blood and peritoneal fluid sampling | Procedure or surgery | Control, Endometriosis |
| Data collectionQuestionnaire on menstrual health and history of hormone treatments for the research purpose | Other | Control, Endometriosis |
Primary outcome
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.
8 secondary outcomes
Change in protein expression
Time frame: through study completion, an average of 18 months
Change in gene expression
Time frame: through study completion, an average of 18 months
Change in inflammation
Time frame: through study completion, an average of 18 months
Change in histological tissue structure
Time frame: through study completion, an average of 18 months
Change in histological tissue structure
Time frame: through study completion, an average of 18 months
Change in tissue elasticity
Time frame: through study completion, an average of 18 months
Change in steroid hormone physiology
Time frame: At baseline
Steroid hormones in peritoneal fluid
Time frame: At baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Axelle BRULPORT, PhD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tissue collection and Data collection in people with Endometriosis, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charles-André PHILIP, M.D., PhD (04 27 85 51 70 ext. +33, charles-andre.philip01@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.