Impact of Essure Tubal Sterilization Devices on the Endometrium

Centre Hospitalier Universitaire de Nīmes

Status: Terminated

Conditions: Sterilization, Tubal

Treatments: Device: Essure

Study type: Observational

Funder types: Other

Identifiers

NCT01558882

2012-A00253-40 (Other Identifier)

LOCAL/2011/VL-05

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: Female

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2 participants in 1 patient group

10 patients

Description:

The patients included desire tubal sterilization via the ESSURE technique.

Treatment:

Device: Essure