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NCT05944822 Clinical Trial

Pro-inflammatory Cytokines in Case of Essure®

Inflammatory Disease Clinical Trial

— ESCYTO  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05944822
Other study ID # 69HCL23_0557
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 1, 2022
Est. completion date December 30, 2023

Study information
Verified date July 2023
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 150
Est. completion date December 30, 2023
Est. primary completion date July 31, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
France Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civisl de Lyon Bron

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary cytokine IL10 in peritoneal fluid Level of cytokine IL10 in peritoneal fluid through study completion, an average of 4 months
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