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

Civil Hospices of Lyon

Status: Active, not recruiting

Conditions: Inflammatory Disease

Treatments: Other: pro-inflammatory cytokines

Study type: Observational

Funder types: Other

Identifiers

NCT05944822

69HCL23_0557

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 3 patient groups

Essure

Description:

patient who underwent removal of the Essure® contraceptive implant

Treatment:

Other: pro-inflammatory cytokines

Control with no endometriosis/adenomyosis

Description:

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

Treatment:

Other: pro-inflammatory cytokines

Control with endometriosis/adenomyosis

Description:

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

Treatment:

Other: pro-inflammatory cytokines