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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A00253-40 | Other Identifier | RCB number |
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Trouble with recruting
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10 patients | The patients included desire tubal sterilization via the ESSURE technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Essure | Device | Essure devices are deployed according to manufacturer's instructions for tubal sterilization. |
|
| 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 |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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Ten women desiring tubal sterilization via the ESSURE method.
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| Name | Affiliation | Role |
|---|---|---|
| Vincent Letouzey, MD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| APHP - Hôpital Antoine Beclere | Clamart | 92141 | France | |||
| APHP - Centre Hospitalier Universitaire de Bicêtre |
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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.
| % 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 |
| Le Kremlin-Bicêtre |
| 94275 |
| France |
| CHRU de Montpellier - Hôpital Arnaud de Villeneuve | Montpellier | 34295 | France |
| CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |