Pro-inflammatory Cytokines in Case of Essure®

Last updated: November 9, 2023
Sponsor: Hospices Civils de Lyon
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Inflammation

Ulcerative Colitis (Pediatric)

Treatment

pro-inflammatory cytokines

Clinical Study ID

NCT05944822
69HCL23_0557
  • Ages > 18
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: pro-inflammatory cytokines
Phase:
Study Start date:
November 01, 2022
Estimated Completion Date:
December 30, 2023

Connect with a study center

  • Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civisl de Lyon

    Bron, 69500
    France

    Site Not Available

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