Impact of Essure Tubal Sterilization Devices on the Endometrium

NCT01558882 | Terminated

• 2 other identifiers: LOCAL/2011/VL-052012-A00253-40
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 4

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.

Conditions

Sterilization, Tubal

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in number of uNK/CD56 cells per field

  Number of cells per field from endometrial biopsy

  baseline (Day 0) - 3 months

Secondary Outcomes (30)

• % 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

Study Arms (1)

10 patients

The patients included desire tubal sterilization via the ESSURE technique.

Device: Essure

Interventions

Essure DEVICE

Essure devices are deployed according to manufacturer's instructions for tubal sterilization.

10 patients

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ten women desiring tubal sterilization via the ESSURE method.

You may qualify if:

• 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

You may not qualify if:

• The patient is participating in another 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (4)

APHP - Hôpital Antoine Beclere

Clamart, 92141, France

Location

APHP - Centre Hospitalier Universitaire de Bicêtre

Le Kremlin-Bicêtre, 94275, France

Location

CHRU de Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, 34295, France

Location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

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.

Study Officials

• Vincent Letouzey, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2012
• First Posted: March 20, 2012
• Study Start: January 21, 2014
• Primary Completion: November 28, 2014
• Study Completion: November 28, 2014
• Last Updated: June 19, 2017

Record last verified: 2017-06

Locations

FR (4)