To Study the Predictive Value of Th1, Th2 and Th17 Cytokine Serum Levels Produced After Non-specific Stimulation on the Success of Embryo Implantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 255
- 试验地点
- 1
- 主要终点
- Ex vivo comparison of the immune profile between patients with Repeated Implantation Failure and patients with successful implantation.
研究概览
简要总结
Infertility affects approximately 10-15% of the population. The number of assisted reproduction procedures has increased by a factor of 3 to 5.3 worldwide over the last 20 years. Despite recent techniques, pregnancy rates seem to be limited to 35% by embryo transfer. Embryo implantation depends on two factors: the quality of the embryo and the endometrial receptivity. Although good quality embryos are transferred, implantation may not occur. Changes in the maternal cytokine profile at the time of implantation may result in poor implantation or early abortions. Consequently, a misdirection of the immunological profile could be responsible for repeated implantation failure (RIF). The definition of RIF is not consensual, but most commonly refers to 3 failures after good quality embryo transfer, and would affect between 5 and 10% of patients.
The possibility of defining a predictive immune profile for RIF from a peripheral blood sample is debated. However, after stimulation of immune cells in peripheral blood, patients with RIF show an excessive pro-inflammatory profile.
Our objective is to assess the activation of T cells and innate immune cells (via an anti-CD3 agonist and a TLR7-8 ligand, respectively) from a blood sample to predict implantation success after frozen embryo transfer. This functional test is easy to use and applicable in a clinical routine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adult women (aged 18 and above) treated in the Medically Assisted Procreation (MAP) center of the University Hospital of Nice, in the process of a frozen embryo transfer
- •Social security affiliation
- •Signed consent
排除标准
- •Contra-indication to frozen embryo transfer
- •Ongoing infection
- •Patients under guardianship
研究组 & 干预措施
Women treated in the Medically Assisted Procreation (MAP) center of Nice
干预措施: Unique blod sample (Biological)
结局指标
主要结局
Ex vivo comparison of the immune profile between patients with Repeated Implantation Failure and patients with successful implantation.
时间窗: 24 months
The immune profiles are defined as the concentrations (in IU/mL or pg/mL) and ratios of proinflammatory and anti-inflammatory cytokines measured after nonspecific stimulation of peripheral blood cells from each patient: IFNγ, IL6, IL1β, TNFα, IL4, IL10, TGFβ, IFNγ/IL4, IFNγ/IL10, IFNγ/TGFβ, IL6/IL4, IL6/IL10, IL6/TGFβ, IL1β/IL4, IL1β/IL10, IL1β/TGFβ, TNFα/IL4, TNFα/IL10, TNFα/TGFβ.
次要结局
- Ex vivo comparison of the immune profile between patients with one implantation failure and patients with successful implantation.(24 months)
- Ex vivo comparison of the immune profile between patients with one implantation failure in the context of inflammatory disorder (such as endometriosis) and patients with successful implantation.(24 months)
- Ex vivo comparison of the immune profile between patients with a pregnancy failure and patients with an active pregnancy at the end of the first trimester.(24 months)
