Impact of Essure Tubal Sterilization Devices on the Endometrium

Terminated

• Conditions: Sterilization, Tubal
• Interventions: Device: Essure

• Registration Number: NCT01558882
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-18
• Study First Submitted QC: 2012-03-18
• Study First Posted: 2012-03-20
• Study Start: 2014-01-21
• Primary Completion: 2014-11-28
• Study Completion: 2014-11-28
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-16
• Last Update Posted: 2017-06-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
10 patients	Essure	The patients included desire tubal sterilization via the ESSURE technique.

Primary Outcome Measures

Name	Time	Method
Change in number of uNK/CD56 cells per field	baseline (Day 0) - 3 months	Number of cells per field from endometrial biopsy

Secondary Outcome Measures

Name	Time	Method
Change in expression of IL-12 in endometrial biopsy	baseline (day 0) to 3 months
% 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 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 G-CSF in endometrial biopsy	baseline (day 0) to 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 expression of IL-1 beta 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 IL-15 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 RPL13A (reference gene) 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 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
Presence/absence of bilateral tube obstruction	3 months
Change in number of uNK/CD56 cells per field	2 months before intervention - Day 0
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

Trial Locations

Locations (4)

APHP - Hôpital Antoine Beclere; 🇫🇷 Clamart Cedex, France

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France

APHP - Centre Hospitalier Universitaire de Bicêtre; 🇫🇷 Le Kremlin Bicêtre Cedex, France

CHRU de Montpellier - Hôpital Arnaud de Villeneuve; 🇫🇷 Montpellier, France