ESCYTO: Pro-inflammatory Cytokines in Case of Essure®
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- cytokine IL10 in peritoneal fluid [through study completion, an average of 4 months]
Level of cytokine IL10 in peritoneal fluid
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civisl de Lyon | Bron | France | 69500 |
Sponsors and Collaborators
- Hospices Civils de Lyon
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 69HCL23_0557