NCT05944822

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 13, 2023

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

November 13, 2023

Status Verified

July 1, 2023

Enrollment Period

9 months

First QC Date

June 27, 2023

Last Update Submit

November 9, 2023

Conditions

Inflammatory Disease

Keywords

contraceptive implantspro-inflammatory cytokines

Outcome Measures

Primary Outcomes (1)

  • cytokine IL10 in peritoneal fluid

    Level of cytokine IL10 in peritoneal fluid

    through study completion, an average of 4 months

Study Arms (3)

Essure

patient who underwent removal of the Essure® contraceptive implant

Other: pro-inflammatory cytokines

Control with no endometriosis/adenomyosis

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

Other: pro-inflammatory cytokines

Control with endometriosis/adenomyosis

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

Other: pro-inflammatory cytokines

Interventions

pro-inflammatory cytokinesOTHER

compare the levels of pro-inflammatory cytokines in patients with Essure® contraceptive implants and in control patients with endometriosis or adenomyosis.

Control with endometriosis/adenomyosisControl with no endometriosis/adenomyosisEssure

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • inability to understand the information given
  • person deprived of liberty
  • person under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gynaecology Department, Hôpital Femme Mère Enfant Hospices Civisl de Lyon

Bron, 69500, France

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2023

First Posted

July 13, 2023

Study Start

November 1, 2022

Primary Completion

July 31, 2023

Study Completion

December 30, 2023

Last Updated

November 13, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)