Intravenous Intralipid Therapy Among Women Aged 35-40 Years With Positive Peripheral Blood Natural Killer Cells Undergoing in Vitro Fertilization-Embryo Transfer: A Randomized Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
Intralipid can suppress natural killer cells that are known to be involve in repeated implantation failure and recurrent miscarriages.Intralipid is made of purified soybean oil, egg phospholipids, glycerol and water. It provides essential fatty acids, linoleic acid, omega- 3 and 6 fatty acids and alpha-linolenic acid. The effects of Intralipid in suppressing natural killer cell activity (NKa) were found to be comparable to intravenous immunoglobulin (IVIG) by laboratory experiments.We will study the effect of intralipid infusion on the pregnancy outcome of women aged 35-40 years with history of repeated implantation failure of miscarriage and who have positive peripheral blood natural killer cells
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
- None
入排标准
- 年龄范围
- 35 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subfertile women aged 35-40 years with repeated implantation failure or recurrent miscarriage with positive natural killer cells undergoing Intracytoplasmic sperm injection (ICSI ) cycle.
排除标准
- •women above 40years or less than 35 years
- •Disturbances of normal fat metabolism such as pathologic hyperlipidemia,Lipoid nephrosis or acute pancreatitis with hyperlipidemia.
- •Allergic to eggs, soybean oil, or safflower oil.
- •Severe liver disease, kidney disease, lung disease, anemia, blood coagulation disorder.
- •Uterine fibroid, endometrial polyp, endometriosis and hydrosalpinx.
- •Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies (Immunoglobulin G or M)[IgG or IgM]); other recognised thrombophilic conditions (testing according to usual clinic practice).
- •Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy).
- •Fibroids distorting uterine cavity.
- •Abnormal parental karyotype.
研究组 & 干预措施
Intralipid infusion
100 Subfertile women aged 35-40 years with repeated implantation failure or recurrent miscarriage with positive natural killer cells undergoing ICSI cycle.
干预措施: Intralipid infusion (Drug)
结局指标
主要结局
Clinical pregnancy rate
时间窗: 10 months
Intrauterine gestational sac with fatal pole and positive pulsation
次要结局
- Miscarriage rate(12 months)
- Chemical pregnancy(10 months)
- ongoing pregnancy rate(10 months)
- Ectopic rate(12 months)
- implantation rate(10 months)