Impact of Essure Tubal Sterilization Devices on the Endometrium

This study is currently recruiting participants.
Verified March 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01558882
First received: March 18, 2012
Last updated: March 4, 2014
Last verified: March 2014
  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:


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 (Day 0) - 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 (day 0) - 3 months ] [ Designated as safety issue: No ]
  • % change in IL-12 titration in uterine flushing sample [ Time Frame: baseline (day 0) - 3 months ] [ Designated as safety issue: No ]
  • % change in IL-15 titration in uterine flushing sample [ Time Frame: baseline (day 0) - 3 months ] [ Designated as safety issue: No ]
  • % change in IL-18 titration in uterine flushing sample [ Time Frame: baseline (day 0) - 3 months ] [ Designated as safety issue: No ]
  • % change in TWEAK titration in uterine flushing sample [ Time Frame: baseline (day 0) - 3 months ] [ Designated as safety issue: No ]
  • % change in TNF-alpha titration in uterine flushing sample [ Time Frame: baseline (day 0) - 3 months ] [ Designated as safety issue: No ]
  • % change in G-CSF titration in uterine flushing sample [ Time Frame: baseline (day 0) - 3 months ] [ Designated as safety issue: No ]
  • % change in G-CSF receptor titration in uterine flushing sample [ Time Frame: baseline (day 0) - 3 months ] [ Designated as safety issue: No ]
  • % change in VEGF titration in uterine flushing sample [ Time Frame: baseline (day 0) - 3 months ] [ Designated as safety issue: No ]
  • Change in the number of macrophage cells per field on endometrial biopsy [ Time Frame: baseline (day 0) to 3 months ] [ Designated as safety issue: No ]
  • Change in the number of T cells per field on endometrial biopsy [ Time Frame: baseline (day 0) to 3 months ] [ Designated as safety issue: No ]
  • Change in expression of IL-1 beta in endometrial biopsy [ Time Frame: baseline (day 0) to 3 months ] [ Designated as safety issue: No ]
  • Change in expression of IL-12 in endometrial biopsy [ Time Frame: baseline (day 0) to 3 months ] [ Designated as safety issue: No ]
  • Change in expression of IL-15 in endometrial biopsy [ Time Frame: baseline (day 0) to 3 months ] [ Designated as safety issue: No ]
  • Change in expression of IL-18 in endometrial biopsy [ Time Frame: baseline (day 0) to 3 months ] [ Designated as safety issue: No ]
  • Change in expression of TWEAK in endometrial biopsy [ Time Frame: baseline (day 0) to 3 months ] [ Designated as safety issue: No ]
  • Change in expression of TNF-alpha in endometrial biopsy [ Time Frame: baseline (day 0) to 3 months ] [ Designated as safety issue: No ]
  • Change in expression of G-CSF in endometrial biopsy [ Time Frame: baseline (day 0) to 3 months ] [ Designated as safety issue: No ]
  • Change in expression of G-CSF receptor in endometrial biopsy [ Time Frame: baseline (day 0) to 3 months ] [ Designated as safety issue: No ]
  • Change in expression of VEGF in endometrial biopsy [ Time Frame: baseline (day 0) to 3 months ] [ Designated as safety issue: No ]
  • Change in expression of beta-2 microglobulin in endometrial biopsy [ Time Frame: baseline (day 0) to 3 months ] [ Designated as safety issue: No ]
  • Change in expression of RPL13A (reference gene) in endometrial biopsy [ Time Frame: baseline (day 0) to 3 months ] [ Designated as safety issue: No ]
  • Change in endometrial volume (cm^3) [ Time Frame: baseline (day 0) to 3 months ] [ Designated as safety issue: No ]
  • Change in subendometrial vascular flow index [ Time Frame: baseline (day 0) to 3 months ] [ Designated as safety issue: No ]
  • Time needed for Essure deployment (minutes) [ Time Frame: baseline (day 0), immediatly after intervention ] [ Designated as safety issue: No ]
  • Type of anesthesia used for Essure deployment [ Time Frame: baseline (day 0), immediatly after intervention ] [ Designated as safety issue: No ]
  • Number of spirals visible in the left uterine cavity after Essure deployment [ Time Frame: baseline (day 0), immediatly after intervention ] [ Designated as safety issue: No ]
  • Number of spirals visible in the right uterine cavity after Essure deployment [ Time Frame: baseline (day 0), immediatly after intervention ] [ Designated as safety issue: No ]
  • Presence/absence of bilateral tube obstruction [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Change in number of uNK/CD56 cells per field [ Time Frame: 2 months before intervention - Day 0 ] [ 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.

Endometrial flushing samples will also be included in the Nîmes University Hospital biobank.


Estimated Enrollment: 10
Study Start Date: January 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (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 sterilization 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 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
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
APHP - Hôpital Antoine Beclere Not yet recruiting
Clamart Cedex, France, 92141
Sub-Investigator: Nathalie Lédée, MD         
APHP - Centre Hospitalier Universitaire de Bicêtre Recruiting
Le Kremlin Bicêtre Cedex, France, 94275
Sub-Investigator: Hervé Fernandez, MD, PhD         
Sub-Investigator: Guillaume Legendre, MD         
CHU de Nîmes - Hôpital Universitaire Carémeau 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         
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: March 4, 2014
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 April 16, 2014