Impact of Essure Tubal Sterilization Devices on the Endometrium

The mobilization of natural killer cells (uNK) triggers and coordinates all stages of embryo implantation. They are at the origin of the local secretion of cytokines, growth factors, chemokines affecting vascular development and the local immunotrophisme for the conceptus. The main objective of this study is to evaluate the expression of endometrial uNK cells before and after tubal obstruction by Essure devices. Endoluminal and endometrial levels of various cytokines and growth factors will also be studied.

Study Overview

• Status: Terminated
• Conditions: Sterilization, Tubal
• Intervention / Treatment: Device: Essure

• Study Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

Study Locations

• France
  • Clamart Cedex, France, 92141
    • APHP - Hôpital Antoine Béclère
  • Le Kremlin Bicêtre Cedex, France, 94275
    • APHP - Centre Hospitalier Universitaire de Bicêtre
  • Montpellier, France, 34295
    • CHRU de Montpellier - Hôpital Arnaud de Villeneuve
  • Nîmes Cedex 09, France, 30029
    • CHU de Nîmes - Hopital Universitaire Caremeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 31 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Ten women desiring tubal sterilization via the ESSURE method.

Description

Inclusion Criteria:

• The patient must have given his/her informed and signed consent
• The patient must be insured or beneficiary of a health insurance plan
• The patient is available for 3 months of follow up
• The patient has had at least one child
• The patient desires definitive tubal sterilization via the ESSURE technique
• The legal delay of 4 months between request for sterilization and surgery has been respected
• Local contraception (condom or spermicide) must be used for three months before and after tubal sterilization

Exclusion Criteria:

• The patient is participating in another study
• The patient is in an exclusion period determined by a previous study
• The patient is under judicial protection, under tutorship or curatorship
• The patient refuses to sign the consent
• It is impossible to correctly inform the patient
• The patient is pregnant, parturient, or breastfeeding
• The patient had a diagnosed pregnancy (this includes pregnancies lost or interruptions in the 2nd or 3rd trimester) within the 4 months before ESSURE implants
• The patient has a contraindication for a treatment used in this study
• The patient uses one of the following types of contraception: intrauterine device; oestroprogestatif (pill).
• Endometriosis
• Gynecological infection
• adenomyosis
• uterine polyp
• uterine surgery

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
10 patients; The patients included desire tubal sterilization via the ESSURE technique.	Device: Essure; Essure devices are deployed according to manufacturer's instructions for tubal sterilization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in number of uNK/CD56 cells per field	Number of cells per field from endometrial biopsy	baseline (Day 0) - 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
% change in IL-1 beta titration in uterine flushing sample	baseline (day 0) - 3 months
% change in IL-12 titration in uterine flushing sample	baseline (day 0) - 3 months
% change in IL-15 titration in uterine flushing sample	baseline (day 0) - 3 months
% change in IL-18 titration in uterine flushing sample	baseline (day 0) - 3 months
% change in TWEAK titration in uterine flushing sample	baseline (day 0) - 3 months
% change in TNF-alpha titration in uterine flushing sample	baseline (day 0) - 3 months
% change in G-CSF titration in uterine flushing sample	baseline (day 0) - 3 months
% change in G-CSF receptor titration in uterine flushing sample	baseline (day 0) - 3 months
% change in VEGF titration in uterine flushing sample	baseline (day 0) - 3 months
Change in the number of macrophage cells per field on endometrial biopsy	baseline (day 0) to 3 months
Change in the number of T cells per field on endometrial biopsy	baseline (day 0) to 3 months
Change in expression of IL-1 beta in endometrial biopsy	baseline (day 0) to 3 months
Change in expression of IL-12 in endometrial biopsy	baseline (day 0) to 3 months
Change in expression of IL-15 in endometrial biopsy	baseline (day 0) to 3 months
Change in expression of IL-18 in endometrial biopsy	baseline (day 0) to 3 months
Change in expression of TWEAK in endometrial biopsy	baseline (day 0) to 3 months
Change in expression of TNF-alpha in endometrial biopsy	baseline (day 0) to 3 months
Change in expression of G-CSF in endometrial biopsy	baseline (day 0) to 3 months
Change in expression of G-CSF receptor in endometrial biopsy	baseline (day 0) to 3 months
Change in expression of VEGF in endometrial biopsy	baseline (day 0) to 3 months
Change in expression of beta-2 microglobulin in endometrial biopsy	baseline (day 0) to 3 months
Change in expression of RPL13A (reference gene) in endometrial biopsy	baseline (day 0) to 3 months
Change in endometrial volume (cm^3)	baseline (day 0) to 3 months
Change in subendometrial vascular flow index	baseline (day 0) to 3 months
Time needed for Essure deployment (minutes)	baseline (day 0), immediatly after intervention
Type of anesthesia used for Essure deployment	baseline (day 0), immediatly after intervention
Number of spirals visible in the left uterine cavity after Essure deployment	baseline (day 0), immediatly after intervention
Number of spirals visible in the right uterine cavity after Essure deployment	baseline (day 0), immediatly after intervention
Presence/absence of bilateral tube obstruction	3 months
Change in number of uNK/CD56 cells per field	2 months before intervention - Day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2014
• Primary Completion (Actual): November 28, 2014
• Study Completion (Actual): November 28, 2014

Study Registration Dates

• First Submitted: March 18, 2012
• First Submitted That Met QC Criteria: March 18, 2012
• First Posted (Estimate): March 20, 2012

Study Record Updates

• Last Update Posted (Actual): June 19, 2017
• Last Update Submitted That Met QC Criteria: June 16, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: cytokine; Essure; Change in uterine cytokines; Change in uterine natural killer cells; natural killer cell
• Other Study ID Numbers: LOCAL/2011/VL-05; 2012-A00253-40 (Other Identifier: RCB number)