NCT01558882终止不适用
Impact of Essure Tubal Sterilization Devices on the Endometrium
Centre Hospitalier Universitaire de Nīmes4 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2014年1月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 4
- 主要终点
- Change in number of uNK/CD56 cells per field
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in number of uNK/CD56 cells per field
时间窗: baseline (Day 0) - 3 months
Number of cells per field from endometrial biopsy
次要结局
- % 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 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-12 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 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 expression of IL-1 beta 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 IL-15 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)
- Presence/absence of bilateral tube obstruction(3 months)
- Change in number of uNK/CD56 cells per field(2 months before intervention - Day 0)
- 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)
研究者
研究点 (4)
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