Impact of Essure Tubal Sterilization Devices on the Endometrium

June 16, 2017 updated by: Centre Hospitalier Universitaire de Nīmes
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clamart Cedex, France, 92141
        • APHP - Hôpital Antoine Béclère
      • Le Kremlin Bicêtre Cedex, France, 94275
        • APHP - Centre Hospitalier Universitaire de Bicêtre
      • Montpellier, France, 34295
        • CHRU de Montpellier - Hôpital Arnaud de Villeneuve
      • Nîmes Cedex 09, France, 30029
        • CHU de Nîmes - Hopital Universitaire Caremeau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

31 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Ten women desiring tubal sterilization via the ESSURE method.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in number of uNK/CD56 cells per field
Time Frame: baseline (Day 0) - 3 months
Number of cells per field from endometrial biopsy
baseline (Day 0) - 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
% change in IL-1 beta titration in uterine flushing sample
Time Frame: baseline (day 0) - 3 months
baseline (day 0) - 3 months
% change in IL-12 titration in uterine flushing sample
Time Frame: baseline (day 0) - 3 months
baseline (day 0) - 3 months
% change in IL-15 titration in uterine flushing sample
Time Frame: baseline (day 0) - 3 months
baseline (day 0) - 3 months
% change in IL-18 titration in uterine flushing sample
Time Frame: baseline (day 0) - 3 months
baseline (day 0) - 3 months
% change in TWEAK titration in uterine flushing sample
Time Frame: baseline (day 0) - 3 months
baseline (day 0) - 3 months
% change in TNF-alpha titration in uterine flushing sample
Time Frame: baseline (day 0) - 3 months
baseline (day 0) - 3 months
% change in G-CSF titration in uterine flushing sample
Time Frame: baseline (day 0) - 3 months
baseline (day 0) - 3 months
% change in G-CSF receptor titration in uterine flushing sample
Time Frame: baseline (day 0) - 3 months
baseline (day 0) - 3 months
% change in VEGF titration in uterine flushing sample
Time Frame: baseline (day 0) - 3 months
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
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
baseline (day 0) to 3 months
Change in expression of IL-1 beta in endometrial biopsy
Time Frame: baseline (day 0) to 3 months
baseline (day 0) to 3 months
Change in expression of IL-12 in endometrial biopsy
Time Frame: baseline (day 0) to 3 months
baseline (day 0) to 3 months
Change in expression of IL-15 in endometrial biopsy
Time Frame: baseline (day 0) to 3 months
baseline (day 0) to 3 months
Change in expression of IL-18 in endometrial biopsy
Time Frame: baseline (day 0) to 3 months
baseline (day 0) to 3 months
Change in expression of TWEAK in endometrial biopsy
Time Frame: baseline (day 0) to 3 months
baseline (day 0) to 3 months
Change in expression of TNF-alpha in endometrial biopsy
Time Frame: baseline (day 0) to 3 months
baseline (day 0) to 3 months
Change in expression of G-CSF in endometrial biopsy
Time Frame: baseline (day 0) to 3 months
baseline (day 0) to 3 months
Change in expression of G-CSF receptor in endometrial biopsy
Time Frame: baseline (day 0) to 3 months
baseline (day 0) to 3 months
Change in expression of VEGF in endometrial biopsy
Time Frame: baseline (day 0) to 3 months
baseline (day 0) to 3 months
Change in expression of beta-2 microglobulin in endometrial biopsy
Time Frame: baseline (day 0) to 3 months
baseline (day 0) to 3 months
Change in expression of RPL13A (reference gene) in endometrial biopsy
Time Frame: baseline (day 0) to 3 months
baseline (day 0) to 3 months
Change in endometrial volume (cm^3)
Time Frame: baseline (day 0) to 3 months
baseline (day 0) to 3 months
Change in subendometrial vascular flow index
Time Frame: baseline (day 0) to 3 months
baseline (day 0) to 3 months
Time needed for Essure deployment (minutes)
Time Frame: baseline (day 0), immediatly after intervention
baseline (day 0), immediatly after intervention
Type of anesthesia used for Essure deployment
Time Frame: baseline (day 0), immediatly after intervention
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
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
baseline (day 0), immediatly after intervention
Presence/absence of bilateral tube obstruction
Time Frame: 3 months
3 months
Change in number of uNK/CD56 cells per field
Time Frame: 2 months before intervention - Day 0
2 months before intervention - Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 21, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 28, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 28, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LOCAL/2011/VL-05
  • 2012-A00253-40 (Other Identifier: RCB number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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