Pro-inflammatory Cytokines in Case of Essure® (ESCYTO)

Study of Pro-inflammatory Cytokines in Case of Essure® Contraceptive Implants

It is estimated that 750,000 women (including 200,000 French) have benefited from permanent sterilization by ESSURE® contraceptive implant. The observation in some of these patients of gynecological and extra-gynecological symptoms leads to the surgical removal of these implants.

The pathophysiological mechanism(s) is (are) not yet determined. Several pathophysiological hypotheses have been proposed, in particular the inflammatory hypothesis. The investigators propose to study markers of inflammation (pro-inflammatory cytokines) in peritoneal fluid and blood. Cytokines are involved in the physiopathology of autoimmune diseases, infectious pathologies, or even cancer; they are used in everyday practice and can constitute a therapeutic target.

Based on the literature which finds a high concentration of cytokines in cases of endometriosis, and a low concentration in healthy control patients, the investigators want to assess inflammation in patients with Essure® implants.

The demonstration of one or more specifically increased cytokines in the Essure® group could validate the inflammatory hypothesis and lead to the implementation of specific treatments and relevant markers.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Disease
• Intervention / Treatment: Other: pro-inflammatory cytokines

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Gautier CHENE, Pr; Phone Number: +33 (4) 72 35 58 70; Email: gautier.chene@chu-lyon.fr

Study Locations

• France
  • Bron, France, 69500
    • Recruiting
    • Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civisl de Lyon
    • Sub-Investigator: Philippe CHABERT, MD
    • Contact: Gautier CHENE, MD; Phone Number: +33 (4) 72 35 58 70; Email: gautier.chene@chu-lyon.fr
    • Principal Investigator: Gautier CHENE, MD
    • Sub-Investigator: Géry LAMBLIN, MD
    • Sub-Investigator: Karine Lebail-Carval, MD
    • Sub-Investigator: Erdogan Nohuz, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study focuses on patients who underwent surgery to remove the Essure® contraceptive implant and on control patients who underwent benign gynecological laparoscopic surgery.

Description

Inclusion Criteria:

• women over 18
• intervention between January 2021 and November 2022
• person having expressed his non-opposition

Essure group : patient who underwent removal of the Essure® contraceptive implant

Control with no endometriosis/adenomyosis : patient who underwent benign laparoscopic gynecological surgery and with no diagnosis of endometriosis or adenomyosis

Control with endometriosis/adenomyosis : patient who underwent benign laparoscopic gynecological surgery and with diagnosis of endometriosis or adenomyosis

Exclusion Criteria:

• inability to understand the information given
• person deprived of liberty
• person under guardianship

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Essure; patient who underwent removal of the Essure® contraceptive implant	Other: pro-inflammatory cytokines; compare the levels of pro-inflammatory cytokines in patients with Essure® contraceptive implants and in control patients with endometriosis or adenomyosis.
Control with no endometriosis/adenomyosis; patient who underwent benign laparoscopic gynecological surgery and with no diagnosis of endometriosis or adenomyosis	Other: pro-inflammatory cytokines; compare the levels of pro-inflammatory cytokines in patients with Essure® contraceptive implants and in control patients with endometriosis or adenomyosis.
Control with endometriosis/adenomyosis; patient who underwent benign laparoscopic gynecological surgery and with diagnosis of endometriosis or adenomyosis	Other: pro-inflammatory cytokines; compare the levels of pro-inflammatory cytokines in patients with Essure® contraceptive implants and in control patients with endometriosis or adenomyosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cytokine IL10 in peritoneal fluid	Level of cytokine IL10 in peritoneal fluid	through study completion, an average of 4 months

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Estimated): July 31, 2023
• Study Completion (Estimated): August 30, 2023

Study Registration Dates

• First Submitted: June 27, 2023
• First Submitted That Met QC Criteria: July 12, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: pro-inflammatory cytokines; contraceptive implants
• Other Study ID Numbers: 69HCL23_0557

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No