Endometriosis Transcriptomic Cell Atlas

NCT06502548 | Recruiting

• 1 other identifier: RC31/23/0430
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Endometriosis; Infertility

Keywords

Stem cells; Organoid; Estrogen Receptor ERα; immune cells; single cell transcriptomic

Outcome Measures

Primary Outcomes (4)

• Analyze of the number of the different cell types (immune cells and endometrial stem cells) present in the endometrium of healthy control patients

  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

  During surgery

• Analyze of the number of the different cell types (immune cells and endometrial stem cells) present in endometriosis lesions for endometriosis patients.

  During surgery

• Analyze of the number of the different cell types (immune cells and endometrial stem cells) present in endometrium of endometriosis patients.

  During surgery

Study Arms (2)

Patient with endometriosis

OTHER

Endometriosis patients will be operated on as part of their pathology.

Procedure: Endometriosis

Healthy control patient

OTHER

Healthy patients will be operated for tubal ligation or hysterectomies.

Procedure: Tubal ligation or Hysterectomy

Interventions

Endometriosis PROCEDURE

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.

Patient with endometriosis

Tubal ligation or Hysterectomy PROCEDURE

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.

Healthy control patient

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

University Hospital Toulouse

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Endometriosis; Infertility

Interventions

Sterilization, Tubal; Hysterectomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative; Sterilization, Reproductive

Study Officials

• Elodie CHANTALAT, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elodie CHANTALAT, MD

CONTACT

0561323953; chantalat.e@chu-toulouse.fr

Françoise LENFANT, PhD

CONTACT

francoise.lenfant@inserm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 16, 2024
• Study Start: September 27, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)