Impact of Essure Tubal Sterilization Devices on the Endometrium - Full Text View

Purpose

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	Intervention
Sterilization, Tubal	Device: Essure

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Impact of Essure Tubal Sterilization Devices on the Endometrium

Resource links provided by NLM:

MedlinePlus related topics: Tubal Ligation

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:

Change in number of uNK/CD56 cells per field [ Time Frame: baseline - 3 months ] [ Designated as safety issue: No ]
Number of cells per field from endometrial biopsy

Secondary Outcome Measures:

% change in IL-1 beta titration in uterine flushing sample [ Time Frame: baseline - 3 months ] [ Designated as safety issue: No ]
% change in IL-12 titration in uterine flushing sample [ Time Frame: baseline - 3 months ] [ Designated as safety issue: No ]
% change in IL-15 titration in uterine flushing sample [ Time Frame: baseline - 3 months ] [ Designated as safety issue: No ]
% change in IL-18 titration in uterine flushing sample [ Time Frame: baseline - 3 months ] [ Designated as safety issue: No ]
% change in TWEAK titration in uterine flushing sample [ Time Frame: baseline - 3 months ] [ Designated as safety issue: No ]
% change in TNF-alpha titration in uterine flushing sample [ Time Frame: baseline - 3 months ] [ Designated as safety issue: No ]
% change in G-CSF titration in uterine flushing sample [ Time Frame: baseline - 3 months ] [ Designated as safety issue: No ]
% change in G-CSF receptor titration in uterine flushing sample [ Time Frame: baseline - 3 months ] [ Designated as safety issue: No ]
% change in VEGF titration in uterine flushing sample [ Time Frame: baseline - 3 months ] [ Designated as safety issue: No ]
Change in the number of macrophage cells per field on endometrial biopsy [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
Change in the number of T cells per field on endometrial biopsy [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
Change in expression of IL-1 beta in endometrial biopsy [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
Change in expression of IL-12 in endometrial biopsy [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
Change in expression of IL-15 in endometrial biopsy [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
Change in expression of IL-18 in endometrial biopsy [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
Change in expression of TWEAK in endometrial biopsy [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
Change in expression of TNF-alpha in endometrial biopsy [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
Change in expression of G-CSF in endometrial biopsy [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
Change in expression of G-CSF receptor in endometrial biopsy [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
Change in expression of VEGF in endometrial biopsy [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
Change in expression of beta-2 microglobulin in endometrial biopsy [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
Change in expression of RPL13A (reference gene) in endometrial biopsy [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
Change in endometrial volume (cm^3) [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
Change in subendometrial vascular flow index [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
Time needed for Essure deployment (minutes) [ Time Frame: baseline ] [ Designated as safety issue: No ]
Type of anesthesia used for Essure deployment [ Time Frame: baseline ] [ Designated as safety issue: No ]
Number of spirals visible in the left uterine cavity after Essure deployment [ Time Frame: baseline ] [ Designated as safety issue: No ]
Number of spirals visible in the right uterine cavity after Essure deployment [ Time Frame: baseline ] [ Designated as safety issue: No ]
Presence/absence of bilateral tube obstruction [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

All left over samples will be included in the hematology biological collection at the Nîmes University Hospital.

Estimated Enrollment:	10
Study Start Date:	June 2013
Estimated Study Completion Date:	October 2014
Estimated Primary Completion Date:	October 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	35 Years to 41 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Ten women desiring tubal sterilzation via the ESSURE method.

Criteria

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 sterilisation

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 has a contra-indication for a treatment used in this study
The patient uses one of the following types of contreception: intrauterine device; oestroprogestatif (pill).
Endometriosis
Gynecological infection
adenomyosis
uterin polype
uterine surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01558882

Contacts

Contact: Vincent Letouzey, MD	+33.(0)4.66.68.32.16	vincent.letouzey@chu-nimes.fr
Contact: Carey M Suehs, Ph D	+33.(0)4.66.68.67.88	carey.suehs@chu-nimes.fr

Locations

France
CHU de Nîmes - Hôpital Universitaire Carémeau	Not yet recruiting
Nîmes Cedex 09, France, 30029
Principal Investigator: Vincent Letouzey, MD
Sub-Investigator: Renaud de Tayrac, MD PhD
Sub-Investigator: Pierre Marès, MD PhD
Sub-Investigator: Stéphanie Huberlant
Sub-Investigator: Nathalie Lédée, MD

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nīmes

Investigators

Principal Investigator:

Vincent Letouzey, MD

Centre Hospitalier Universitaire de Nîmes

More Information

No publications provided

Responsible Party:	Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:	NCT01558882 History of Changes
Other Study ID Numbers:	LOCAL/2011/VL-05, 2012-A00253-40
Study First Received:	March 18, 2012
Last Updated:	May 14, 2013
Health Authority:	France: Committee for the Protection of Personnes France: ANSM - French Health Products Safety Agency

Keywords provided by Centre Hospitalier Universitaire de Nīmes:

Essure
Change in uterine cytokines
Change in uterine natural killer cells
cytokine
natural killer cell

Additional relevant MeSH terms:

Disinfectants
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013