Pro-inflammatory Cytokines in Case of Essure®

Study Overview
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Brief Summary
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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.

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

Conditions
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Inflammatory Disease

Intervention / Treatment
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* Other: pro-inflammatory cytokines


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contraceptive implants, pro-inflammatory cytokines