Impact of Essure Tubal Sterilization Devices on the Endometrium

NCT ID: NCT01558882

Last Updated: 2017-06-19

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 2 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-21
• Study Completion Date: 2014-11-28

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

10 patients

The patients included desire tubal sterilization via the ESSURE technique.

Essure

Intervention Type: DEVICE

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

Interventions

Essure

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent Letouzey, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

APHP - Hôpital Antoine Beclere

Clamart, , France

APHP - Centre Hospitalier Universitaire de Bicêtre

Le Kremlin-Bicêtre, , France

CHRU de Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, , France

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Countries

France

Other Identifiers

2012-A00253-40

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2011/VL-05

Identifier Type: -

Identifier Source: org_study_id