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Impact of Essure Tubal Sterilization Devices on the Endometrium

This study has been terminated.
(Trouble with recruting)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01558882
First Posted: March 20, 2012
Last Update Posted: June 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
  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 ]
    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 ]
  • % change in IL-12 titration in uterine flushing sample [ Time Frame: baseline (day 0) - 3 months ]
  • % change in IL-15 titration in uterine flushing sample [ Time Frame: baseline (day 0) - 3 months ]
  • % change in IL-18 titration in uterine flushing sample [ Time Frame: baseline (day 0) - 3 months ]
  • % change in TWEAK titration in uterine flushing sample [ Time Frame: baseline (day 0) - 3 months ]
  • % change in TNF-alpha titration in uterine flushing sample [ Time Frame: baseline (day 0) - 3 months ]
  • % change in G-CSF titration in uterine flushing sample [ Time Frame: baseline (day 0) - 3 months ]
  • % change in G-CSF receptor titration in uterine flushing sample [ Time Frame: baseline (day 0) - 3 months ]
  • % change in VEGF titration in uterine flushing sample [ Time Frame: baseline (day 0) - 3 months ]
  • Change in the number of macrophage cells per field on endometrial biopsy [ Time Frame: baseline (day 0) to 3 months ]
  • Change in the number of T cells per field on endometrial biopsy [ Time Frame: baseline (day 0) to 3 months ]
  • Change in expression of IL-1 beta in endometrial biopsy [ Time Frame: baseline (day 0) to 3 months ]
  • Change in expression of IL-12 in endometrial biopsy [ Time Frame: baseline (day 0) to 3 months ]
  • Change in expression of IL-15 in endometrial biopsy [ Time Frame: baseline (day 0) to 3 months ]
  • Change in expression of IL-18 in endometrial biopsy [ Time Frame: baseline (day 0) to 3 months ]
  • Change in expression of TWEAK in endometrial biopsy [ Time Frame: baseline (day 0) to 3 months ]
  • Change in expression of TNF-alpha in endometrial biopsy [ Time Frame: baseline (day 0) to 3 months ]
  • Change in expression of G-CSF in endometrial biopsy [ Time Frame: baseline (day 0) to 3 months ]
  • Change in expression of G-CSF receptor in endometrial biopsy [ Time Frame: baseline (day 0) to 3 months ]
  • Change in expression of VEGF in endometrial biopsy [ Time Frame: baseline (day 0) to 3 months ]
  • Change in expression of beta-2 microglobulin in endometrial biopsy [ Time Frame: baseline (day 0) to 3 months ]
  • Change in expression of RPL13A (reference gene) in endometrial biopsy [ Time Frame: baseline (day 0) to 3 months ]
  • Change in endometrial volume (cm^3) [ Time Frame: baseline (day 0) to 3 months ]
  • Change in subendometrial vascular flow index [ Time Frame: baseline (day 0) to 3 months ]
  • Time needed for Essure deployment (minutes) [ Time Frame: baseline (day 0), immediatly after intervention ]
  • Type of anesthesia used for Essure deployment [ Time Frame: baseline (day 0), immediatly after intervention ]
  • Number of spirals visible in the left uterine cavity after Essure deployment [ Time Frame: baseline (day 0), immediatly after intervention ]
  • Number of spirals visible in the right uterine cavity after Essure deployment [ Time Frame: baseline (day 0), immediatly after intervention ]
  • Presence/absence of bilateral tube obstruction [ Time Frame: 3 months ]
  • Change in number of uNK/CD56 cells per field [ Time Frame: 2 months before intervention - Day 0 ]

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.


Enrollment: 2
Actual Study Start Date: January 21, 2014
Study Completion Date: November 28, 2014
Primary Completion Date: November 28, 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01558882


Locations
France
APHP - Hôpital Antoine Beclere
Clamart Cedex, France, 92141
APHP - Centre Hospitalier Universitaire de Bicêtre
Le Kremlin Bicêtre Cedex, France, 94275
CHRU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, France, 34295
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Vincent Letouzey, MD Centre Hospitalier Universitaire de Nîmes
  More Information

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 ( Other Identifier: RCB number )
First Submitted: March 18, 2012
First Posted: March 20, 2012
Last Update Posted: June 19, 2017
Last Verified: June 2017

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