Interaction Between Decidual Cells and NK Cells in Endometriosis

NCT07652593 | Not Yet Recruiting

• 1 other identifier: 2024_0074
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Endometriosis is a chronic gynecological disease characterized by the presence of endometrial-like tissue outside the uterus and is frequently associated with pelvic pain and infertility. Increasing evidence suggests that immune dysfunction may contribute to the development and persistence of the disease. The purpose of this prospective case-control study is to compare immune cell characteristics in women with deep endometriosis and women without endometriosis during the secretory phase of the menstrual cycle. Participants will undergo collection of clinical data, blood samples, endometrial samples, and vaginal microbiota samples. For participants undergoing clinically indicated pelvic surgery, additional biological samples may be collected during the procedure. The study aims to improve understanding of the immune mechanisms involved in endometriosis and to identify potential biomarkers associated with the disease.

Conditions

Endometriosis

Keywords

Endometriosis; Deep Endometriosis; Natural Killer Cells; NK Cells; Endometrial Immune Microenvironment; CD39; Immunology; Vaginal Microbiota; Pelvic Pain; Cytokines; Women's Health; Biomarkers

Outcome Measures

Primary Outcomes (1)

• CD39 Expression on Natural Killer Cells in Endometrial and Peritoneal Samples

  Comparison of CD39 expression on natural killer (NK) cells in endometrial and peritoneal samples collected from women with deep endometriosis and women without endometriosis.

  At sample collection during the secretory phase of the menstrual cycle (Days 16-24)

Secondary Outcomes (6)

• NK Cell Cytotoxic Function

  At sample collection during the secretory phase of the menstrual cycle (Days 16-24)

• Endometrial and NK Cell Interactions

  At sample collection during the secretory phase of the menstrual cycle (Days 16-24)

• Ex Vivo Modulation of NK Cell Function

  Following sample collection, up to study completion (16 months)

• Association Between Hormonal Levels and NK Cell Profile

  At sample collection during the secretory phase of the menstrual cycle (Days 16-24)

• Association Between Clinical Characteristics and Immune Markers

  At sample collection during the secretory phase of the menstrual cycle (Days 16-24)

Study Arms (2)

Endometriosis Group

EXPERIMENTAL

Adult women with confirmed deep endometriosis undergoing collection of clinical data and biological samples, including blood, endometrial tissue, vaginal microbiota samples, and, when clinically indicated, additional samples collected during pelvic surgery.

Procedure: Biological Sample Collection

Control Group

ACTIVE COMPARATOR

Adult women without endometriosis undergoing collection of clinical data and biological samples, including blood, endometrial tissue, vaginal microbiota samples, and, when clinically indicated, additional samples collected during pelvic surgery.

Procedure: Biological Sample Collection

Interventions

Biological Sample Collection PROCEDURE

Collection of blood samples, endometrial samples, vaginal microbiota samples, and surgical specimens when clinically indicated for immunological and biomarker analyses.

Control Group; Endometriosis Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants must be individuals who identify as female and meet all study eligibility criteria.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Endometriosis Group
• Female participant aged 18 years or older.
• Confirmed diagnosis of deep endometriosis by imaging or surgery.
• Pelvic pain and/or severe dysmenorrhea (Visual Analog Scale \> 4).
• Premenopausal.
• No contraceptive or hormonal treatment during the study menstrual cycle.
• Affiliated with a health insurance system.
• Able and willing to provide written informed consent.
• Control Group
• Female participant aged 18 years or older.
• No diagnosis of endometriosis.
• Premenopausal.
• No contraceptive or hormonal treatment during the study menstrual cycle.
• No chronic pelvic pain or severe dysmenorrhea (Visual Analog Scale \< 4).
• Affiliated with a health insurance system.

You may not qualify if:

• Current infection.
• Active cancer.
• Active autoimmune disease.
• Concomitant hormonal treatment.
• Pregnancy.
• Participant under guardianship or legal protection.
• Participant deprived of liberty.

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Hôpital Foch

Suresnes, 92150, France

Location

MeSH Terms

Conditions

Endometriosis; Pelvic Pain

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marie CARBONNEL, MD

  Foch hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florence Couppey, clinical project manager

CONTACT

+33 (0)1 46 25 31 30; f.couppey@hopital-foch.com

Study Design

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

Model Details: Participants are assigned to one of two parallel groups according to disease status: women with confirmed deep endometriosis and women without endometriosis. Clinical data and biological samples are collected during the secretory phase of the menstrual cycle and compared between groups.

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 17, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

FR (1)