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

July 12, 2023 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bron, France, 69500
        • Recruiting
        • Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civisl de Lyon
        • Sub-Investigator:
          • Philippe CHABERT, MD
        • Contact:
        • Principal Investigator:
          • Gautier CHENE, MD
        • Sub-Investigator:
          • Géry LAMBLIN, MD
        • Sub-Investigator:
          • Karine LEBAIL-CARVAL, MD
        • Sub-Investigator:
          • Erdogan Nohuz, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study focuses on patients who underwent surgery to remove the Essure® contraceptive implant and on control patients who underwent benign gynecological laparoscopic surgery.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cytokine IL10 in peritoneal fluid
Time Frame: through study completion, an average of 4 months
Level of cytokine IL10 in peritoneal fluid
through study completion, an average of 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Estimated)

July 31, 2023

Study Completion (Estimated)

August 30, 2023

Study Registration Dates

First Submitted

June 27, 2023

First Submitted That Met QC Criteria

July 12, 2023

First Posted (Actual)

July 13, 2023

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 69HCL23_0557

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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