Impact of Essure Tubal Sterilization Devices on the Endometrium

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Essure Tubal Sterilization Devices on the Endometrium

Conditions
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Sterilization, Tubal

Intervention / Treatment
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* Device: Essure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 10 patients<br>The patients included desire tubal sterilization via the ESSURE technique. | Device: Essure<br>* Essure devices are deployed according to manufacturer's instructions for tubal sterilization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of uNK/CD56 cells per field | Number of cells per field from endometrial biopsy | baseline (Day 0) - 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % 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 | 
| % change in TNF-alpha titration in uterine flushing sample |  | baseline (day 0) - 3 months | 
| % change in G-CSF titration in uterine flushing sample |  | baseline (day 0) - 3 months | 
| % change in G-CSF receptor titration in uterine flushing sample |  | baseline (day 0) - 3 months | 
| % change in VEGF titration in uterine flushing sample |  | baseline (day 0) - 3 months | 
| Change in the number of macrophage cells per field on endometrial biopsy |  | baseline (day 0) to 3 months | 
| Change in the number of T cells per field on endometrial biopsy |  | baseline (day 0) to 3 months | 
| Change in expression of IL-1 beta in endometrial biopsy |  | baseline (day 0) to 3 months | 
| Change in expression of IL-12 in endometrial biopsy |  | baseline (day 0) to 3 months | 
| Change in expression of IL-15 in endometrial biopsy |  | baseline (day 0) to 3 months | 
| Change in expression of IL-18 in endometrial biopsy |  | baseline (day 0) to 3 months | 
| Change in expression of TWEAK in endometrial biopsy |  | baseline (day 0) to 3 months | 
| Change in expression of TNF-alpha in endometrial biopsy |  | baseline (day 0) to 3 months | 
| Change in expression of G-CSF in endometrial biopsy |  | baseline (day 0) to 3 months | 
| Change in expression of G-CSF receptor in endometrial biopsy |  | baseline (day 0) to 3 months | 
| Change in expression of VEGF in endometrial biopsy |  | baseline (day 0) to 3 months | 
| Change in expression of beta-2 microglobulin in endometrial biopsy |  | baseline (day 0) to 3 months | 
| Change in expression of RPL13A (reference gene) in endometrial biopsy |  | baseline (day 0) to 3 months | 
| Change in endometrial volume (cm^3) |  | baseline (day 0) to 3 months | 
| Change in subendometrial vascular flow index |  | baseline (day 0) to 3 months | 
| Time needed for Essure deployment (minutes) |  | baseline (day 0), immediatly after intervention | 
| Type of anesthesia used for Essure deployment |  | baseline (day 0), immediatly after intervention | 
| Number of spirals visible in the left uterine cavity after Essure deployment |  | baseline (day 0), immediatly after intervention | 
| Number of spirals visible in the right uterine cavity after Essure deployment |  | baseline (day 0), immediatly after intervention | 
| Presence/absence of bilateral tube obstruction |  | 3 months | 
| Change in number of uNK/CD56 cells per field |  | 2 months before intervention - Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Essure, Change in uterine cytokines, Change in uterine natural killer cells, cytokine, natural killer cell