A Therapeutic Protocol in Previous Failed ART Patients With High Total NK Cells: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- chemical pregnancy rate
研究概览
简要总结
patients with previous failed ART cycles with high peripheral NK cells will be divided into 2 groups: one group of patients with previous failed ART cyles will undergo standard treatment but the other group will have in addition lipid emulsion &prednisolone & LMWH
详细描述
patients with previous failed ART cycles with high peripheral NK cells will be divided into 2 groups: one group of patients with previous failed ART cyles will undergo standard treatment but the other group will have in addition lipid emulsion begin in the cycle before embryo transfer &prednisolone begin with the start of lipid emulsion & LMWH begin with the day of ET
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients with high peripheral NK cells > 10% unexplained infertility cases cases with endometriosis
排除标准
- •uterine factors poor responders< 3 MII oocytes severe male factor & Azospermia
研究组 & 干预措施
control
regular treatment with embryo transfer in the form of progesterone I.M. & Supp. in addition to low dose aspirin & folic acid
干预措施: combination therapy for high peripheral NK cells (Combination Product)
study
regular treatment with embryo transfer in the form of progesterone I.M. & Supp. in addition to low dose aspirin & folic acid but the investigators add in this arm lipid emulsion & prednisolone & LMWH
干预措施: combination therapy for high peripheral NK cells (Combination Product)
结局指标
主要结局
chemical pregnancy rate
时间窗: 14 days
quantitative serum test
次要结局
- clinical pregnancy rate(6 weeks of pregnancy)
研究者
Ahmed Saad
Assistant professor of Ob. & Gyn.
Benha University