EndometriosisEDISONNCT06502548
Endometriosis Transcriptomic Cell Atlas
A study testing Endometriosis and Tubal ligation or Hysterectomy in people with Endometriosis and Infertility, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Endometriosis is an estrogen-dependent, chronic inflammatory gynecologic disease affecting women of reproductive age, with a therapeutic wandering of 6 to 10 years. A better understanding of the initiation phase is a major challenge to improve diagnosis and treatment. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis, Infertility
- What is being tested?
- Endometriosis and Tubal ligation or Hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteFrance
- Study dates
- 27 Sep 2024to Sep 2027
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients over 18 and under 45 years of age
- Patients with multiple endometriosis sites (superficial, deep and endometriomas) with an indication for surgery to treat disabling painful symptoms and stage III or IV endometriosis in the context of infertility.
- Healthy patients including those operated on between the ages of 18 and 45 for tubal ligation
- Healthy patients operated on between the ages of 18 and 45 for hysterectomies for benign causes other than endometriosis or adenomyosis
- Patients operated on strictly at the time of menstruation
- Participants who have not been on hormonal treatment for 2 months
- Participant having signed the free and informed consent form
- Membership of a Social Security scheme or equivalent
Who cannot join
- Patients with endometriosis non-surgically treated
- Patients with endometriosis receiving hormonal treatment at the time of surgery or having received hormonal treatment in the 2 months prior to surgery
- Patients with adenomyosis only
- Healthy non-endometriotic patients undergoing hysterectomy for infectious or malignant causes
- Patients benefiting from a legal protection measure (guardianship, curatorship, safeguard of justice)
- Patients with positive serology for human immunodeficiency virus (HIV), human T-lymphotropic virus (HTLV), hepatitis B (HBV) and hepatitis C (HCV)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Françoise LENFANT, PhD contact
France1 site, 1 recruiting
- Recruiting
University Hospital Toulouse
Toulouse
Elodie CHANTALAT, MD, chantalat.e@chu-toulouse.fr
Elodie CHANTALAT, MD
About this study
Official title: Establishing an Endometriosis Transcriptomic Cell Atlas to Decipher the Pathophysiological Role of Stem Cells and Estrogens in the Disease
Endometriosis is an estrogen-dependent, chronic inflammatory gynecologic disease affecting women of reproductive age, with a therapeutic wandering of 6 to 10 years. A better understanding of the initiation phase is a major challenge to improve diagnosis and treatment. The most widely accepted hypothesis to explain the formation of endometriotic lesions is the tubal retrograde reflux during menstruation. However, only 10% of the reproductive age women will develop endometriosis while 90% of women experience retrograde menstruation. This raises the question of the stem cells present in the endometrium and menstrual reflux of these patients, but also of both the peritoneal microenvironment and the estrogenic local signaling which allow the implantation of these lesions.
Read the detailed description
Using tissues collected at different phases of menstrual cycle in healthy women and patients operated for endometriotic lesions, 3 main objectives :
- To characterize cellular heterogeneity between eutopic endometrium and ectopic lesions in parallel with peritoneal fluid to identify potential stem cells and the immune microenvironment in order to find new biomarkers (using a combination of unbiased transcriptomic, spectral flow cytometry and multiplex imaging analysis)
- To develop organoid models that integrate peritoneal fluid elements (supernatant and/or cells) to clarify stem cell properties/characteristics and their supportive environment
- To leverage the use of these endometrial derived-organoids to functionally study the differential influence of estrogen signaling in women with or without endometriosis
- Conditions
- Endometriosis, Infertility
- Being tested
- Endometriosis, Tubal ligation or Hysterectomy
- Keywords
- Stem cells, Organoid, Estrogen Receptor ERα, immune cells, single cell transcriptomic
- Medical subject headings
- Endometriosis, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndometriosisProcedure or surgery
Anatomopathology waste will be recovered, i.e. the remainder of the endometriosis lesions and the remainder of the endometrial biopsy.
A blood sample will be taken the day before surgery, as part of the treatment, for a hormonal check-up.
Tubal ligation or HysterectomyProcedure or surgery
During surgery, an endometrial biopsy will be taken for research purposes. A blood sample will be taken the day before surgery, as part of the treatment, for a hormonal check-up.
| Study group | Role | What they receive |
|---|---|---|
| Patient with endometriosis | Other | Endometriosis patients will be operated on as part of their pathology. Receives: Procedure: Endometriosis |
| Healthy control patient | Other | Healthy patients will be operated for tubal ligation or hysterectomies. Receives: Procedure: Tubal ligation or Hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyze of the number of the different cell types (immune cells and endometrial stem cells) present in the endometrium of healthy control patients
Measured: During surgery
Analyze of the number of the different cell types (immune cells and endometrial stem cells) present in the peritoneal fluid of healthy control patients
Measured: During surgery
Analyze of the number of the different cell types (immune cells and endometrial stem cells) present in endometriosis lesions for endometriosis patients.
Measured: During surgery
Analyze of the number of the different cell types (immune cells and endometrial stem cells) present in endometrium of endometriosis patients.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start27 Sep 2024
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (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 University Hospital, ToulouseThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elodie CHANTALAT, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502548
- Sponsor's protocol ID
- RC31/23/0430
- Acronym
- EDISON
- Status last verified
- Nov 2026
- First submitted
- 28 Jun 2024
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing an Endometriosis Transcriptomic Cell Atlas to Decipher the Pathophysiological Role of Stem Cells and Estrogens in the Disease
- ClinicalTrials.gov ID
- NCT06502548
- Acronym / sponsor ID
- EDISON / RC31/23/0430
- Conditions
- Endometriosis, Infertility
- Keywords
- Stem cells, Organoid, Estrogen Receptor ERα, immune cells, single cell transcriptomic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 16 Jul 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 an estrogen-dependent, chronic inflammatory gynecologic disease affecting women of reproductive age, with a therapeutic wandering of 6 to 10 years. A better understanding of the initiation phase is a major challenge to improve diagnosis and treatment. The most widely accepted hypothesis to explain the formation of endometriotic lesions is the tubal retrograde reflux during menstruation. However, only 10% of the reproductive age women will develop endometriosis while 90% of women experience retrograde menstruation. This raises the question of the stem cells present in the endometrium and menstrual reflux of these patients, but also of both the peritoneal microenvironment and the estrogenic local signaling which allow the implantation of these lesions.
Detailed description
Using tissues collected at different phases of menstrual cycle in healthy women and patients operated for endometriotic lesions, 3 main objectives :
- To characterize cellular heterogeneity between eutopic endometrium and ectopic lesions in parallel with peritoneal fluid to identify potential stem cells and the immune microenvironment in order to find new biomarkers (using a combination of unbiased transcriptomic, spectral flow cytometry and multiplex imaging analysis)
- To develop organoid models that integrate peritoneal fluid elements (supernatant and/or cells) to clarify stem cell properties/characteristics and their supportive environment
- To leverage the use of these endometrial derived-organoids to functionally study the differential influence of estrogen signaling in women with or without endometriosis
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with endometriosis | Other | Procedure: EndometriosisEndometriosis patients will be operated on as part of their pathology. |
| Healthy control patient | Other | Procedure: Tubal ligation or HysterectomyHealthy patients will be operated for tubal ligation or hysterectomies. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients over 18 and under 45 years of age
- Patients with multiple endometriosis sites (superficial, deep and endometriomas) with an indication for surgery to treat disabling painful symptoms and stage III or IV endometriosis in the context of infertility.
- Healthy patients including those operated on between the ages of 18 and 45 for tubal ligation
- Healthy patients operated on between the ages of 18 and 45 for hysterectomies for benign causes other than endometriosis or adenomyosis
- Patients operated on strictly at the time of menstruation
Key exclusion criteria (6 listed)
- Patients with endometriosis non-surgically treated
- Patients with endometriosis receiving hormonal treatment at the time of surgery or having received hormonal treatment in the 2 months prior to surgery
- Patients with adenomyosis only
- Healthy non-endometriotic patients undergoing hysterectomy for infectious or malignant causes
- Patients benefiting from a legal protection measure (guardianship, curatorship, safeguard of justice)
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 |
|---|---|---|
| EndometriosisAnatomopathology waste will be recovered, i.e. the remainder of the endometriosis lesions and the remainder of the endometrial biopsy. A blood sample will be taken the day before surgery, as part of the treatment, for a hormonal check-up. | Procedure or surgery | Patient with endometriosis |
| Tubal ligation or HysterectomyDuring surgery, an endometrial biopsy will be taken for research purposes. A blood sample will be taken the day before surgery, as part of the treatment, for a hormonal check-up. | Procedure or surgery | Healthy control patient |
Primary outcome
Analyze of the number of the different cell types (immune cells and endometrial stem cells) present in the endometrium of healthy control patients
Time frame: During surgery
Analyze of the number of the different cell types (immune cells and endometrial stem cells) present in the peritoneal fluid of healthy control patients
Time frame: During surgery
Analyze of the number of the different cell types (immune cells and endometrial stem cells) present in endometriosis lesions for endometriosis patients.
Time frame: During surgery
Analyze of the number of the different cell types (immune cells and endometrial stem cells) present in endometrium of endometriosis patients.
Time frame: During surgery
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 5 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Françoise LENFANT, PhD contact
Elodie CHANTALAT, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endometriosis and Tubal ligation or Hysterectomy in people with Endometriosis and Infertility, run by University Hospital, Toulouse at 1 site 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 8 inclusion and 6 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 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Elodie CHANTALAT, MD (0561323953 ext. +33, chantalat.e@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyze of the number of the different cell types (immune cells and endometrial stem cells) present in the endometrium of healthy control patients (time frame: During surgery). The study lists 4 primary outcomes in all. 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 5 Nov 2026.