Clinical trial NCT01558882: Impact of Essure Tubal Sterilization Devices on the Endometrium
Official title: Impact of Essure Tubal Sterilization Devices on the Endometrium
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Sterilization, Tubal
Keywords: Essure
Change in uterine cytokines
Change in uterine natural killer cells
cytokine
natural killer cell
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2012-03-20
Enrollment: 2
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ten women desiring tubal sterilization via the ESSURE method.

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.


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

Primary outcomes:
measure: Change in number of uNK/CD56 cells per field
timeFrame: baseline (Day 0) - 3 months
Secondary outcomes:
measure: % change in IL-1 beta titration in uterine flushing sample
timeFrame: baseline (day 0) - 3 months
measure: % change in IL-12 titration in uterine flushing sample
timeFrame: baseline (day 0) - 3 months
measure: % change in IL-15 titration in uterine flushing sample
timeFrame: baseline (day 0) - 3 months
measure: % change in IL-18 titration in uterine flushing sample
timeFrame: baseline (day 0) - 3 months
measure: % change in TWEAK titration in uterine flushing sample
timeFrame: baseline (day 0) - 3 months
measure: % change in TNF-alpha titration in uterine flushing sample
timeFrame: baseline (day 0) - 3 months
measure: % change in G-CSF titration in uterine flushing sample
timeFrame: baseline (day 0) - 3 months
measure: % change in G-CSF receptor titration in uterine flushing sample
timeFrame: baseline (day 0) - 3 months
measure: % change in VEGF titration in uterine flushing sample
timeFrame: baseline (day 0) - 3 months
measure: Change in the number of macrophage cells per field on endometrial biopsy
timeFrame: baseline (day 0) to 3 months
measure: Change in the number of T cells per field on endometrial biopsy
timeFrame: baseline (day 0) to 3 months
measure: Change in expression of IL-1 beta in endometrial biopsy
timeFrame: baseline (day 0) to 3 months
measure: Change in expression of IL-12 in endometrial biopsy
timeFrame: baseline (day 0) to 3 months
measure: Change in expression of IL-15 in endometrial biopsy
timeFrame: baseline (day 0) to 3 months
measure: Change in expression of IL-18 in endometrial biopsy
timeFrame: baseline (day 0) to 3 months
measure: Change in expression of TWEAK in endometrial biopsy
timeFrame: baseline (day 0) to 3 months
measure: Change in expression of TNF-alpha in endometrial biopsy
timeFrame: baseline (day 0) to 3 months
measure: Change in expression of G-CSF in endometrial biopsy
timeFrame: baseline (day 0) to 3 months
measure: Change in expression of G-CSF receptor in endometrial biopsy
timeFrame: baseline (day 0) to 3 months
measure: Change in expression of VEGF in endometrial biopsy
timeFrame: baseline (day 0) to 3 months
measure: Change in expression of beta-2 microglobulin in endometrial biopsy
timeFrame: baseline (day 0) to 3 months
measure: Change in expression of RPL13A (reference gene) in endometrial biopsy
timeFrame: baseline (day 0) to 3 months
measure: Change in endometrial volume (cm^3)
timeFrame: baseline (day 0) to 3 months
measure: Change in subendometrial vascular flow index
timeFrame: baseline (day 0) to 3 months
measure: Time needed for Essure deployment (minutes)
timeFrame: baseline (day 0), immediatly after intervention
measure: Type of anesthesia used for Essure deployment
timeFrame: baseline (day 0), immediatly after intervention
measure: Number of spirals visible in the left uterine cavity after Essure deployment
timeFrame: baseline (day 0), immediatly after intervention
measure: Number of spirals visible in the right uterine cavity after Essure deployment
timeFrame: baseline (day 0), immediatly after intervention
measure: Presence/absence of bilateral tube obstruction
timeFrame: 3 months
measure: Change in number of uNK/CD56 cells per field
timeFrame: 2 months before intervention - Day 0
Other outcomes:
Locations:
city: Clamart Cedex
country: France
facility: APHP - Hôpital Antoine Beclere
city: Le Kremlin Bicêtre Cedex
country: France
facility: APHP - Centre Hospitalier Universitaire de Bicêtre
city: Montpellier
country: France
facility: CHRU de Montpellier - Hôpital Arnaud de Villeneuve
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Vincent Letouzey, MD
role: PRINCIPAL_INVESTIGATOR
References: