Predictive Inmunological Study to Assess the Rate of Gestation, Abortion and Live Newborn in Patients With Recurrent Abortions and Recurrent Implantation Failure.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 主要终点
- Maternal genetic compatibility profile fetal KIR-HLA-C
研究概览
简要总结
The involvement of the immune system in the process of implantation and its modulation as a therapeutic line in these alterations, failure of implantation and repetition abortion are controversial and make it necessary to conduct clinical studies properly led and with a study population chosen by strict criteria in order to better understand the involvement of the different innate and adaptive immune mechanisms in the field of reproductive medicine and especially in clinically expressed failures recurrent implantation failure and recurrent abortions.
详细描述
A prospective pilot study is proposed in patients with recurrent implantation failure and recurrent abortions undergoing assisted reproductive techniques.
The main objective of this study is to determine the involvement of key effectors of innate immune response in the endometrium that induces a pro-inflammatory response, and to be able to know in particular what is the distribution of KIR receptors in the uNK and the HLA-C typing in patient-mother, egg/semen donors, male-father, abortive remains, live newborns.
To this end, the distribution of KIR and HLA-C receptors will be studied two arms/patient groups, divided from a population chosen according to inclusion/exclusion criteria:
- Group I: group recurrent abortions.
- Group II: group recurrent implementation failure. The study population will include subjects of older age (aged between 18 and 37 years) who will be divided into 2 total Study Arms N x 200 (n x 100 for each arm).
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
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Pregnant or lactating women.
- •They cannot offer cooperation.
- •Participation in a study or clinical trial during the 3 months prior to inclusion.
- •Patients with fibromes.
- •Patients with PCOS.
- •Patients with some genetic alteration (altered karitype, cystic fibrosis, multiple sclerosis, rheumatoid arthritis...)
- •Patients chronic infectious disease.
- •Patients in maintenance treatment with immunosuppressants.
- •Patients who have received systemic corticosteroids in the last 4 weeks.
- •Patients diagnosed with chronic lymphoproliferative disease.
结局指标
主要结局
Maternal genetic compatibility profile fetal KIR-HLA-C
时间窗: 2 years
KIR AA, KIR AB, KIR BB
次要结局
未报告次要终点