Impact of Essure Tubal Sterilization Devices on the Endometrium

Sponsor

Centre Hospitalier Universitaire de Nīmes (Other)

Overall Status

Terminated

CT.gov ID

NCT01558882

Collaborator

(none)

Enrollment

Locations

10.2

Actual Duration (Months)

0.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sterilization, Tubal	Device: Essure

Study Design

Study Type:

Observational

Actual Enrollment :

2 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Impact of Essure Tubal Sterilization Devices on the Endometrium

Actual Study Start Date :

Jan 21, 2014

Actual Primary Completion Date :

Nov 28, 2014

Actual Study Completion Date :

Nov 28, 2014

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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

% 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	APHP - Hôpital Antoine Beclere	Clamart Cedex	France	92141
2	APHP - Centre Hospitalier Universitaire de Bicêtre	Le Kremlin Bicêtre Cedex	France	94275
3	CHRU de Montpellier - Hôpital Arnaud de Villeneuve	Montpellier	France	34295
4	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09	France	30029