NCT01788540已完成4 期
The Role of Intralipid in Natural Killer Cell Positive Cases With Recurrent Miscarriages Undergoing IVF/ICSI Cycles: a Double Blind Randomized Controlled Trial
Woman's Health University Hospital, Egypt1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2013年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- chemical pregnancy rate
研究概览
简要总结
Intralipid infusion can improve the outcome in NK cells positive females with history of recurrent miscarriages undergoing IVF/ICSI cycles.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Couples with unexplained secondary infertility
- •Three or more prior consecutive clinical miscarriages after either spontaneous pregnancy or after IVF/ICSI.
- •Elevated natural killer (NK) cells CD16, CD56 and cells with both CD16/CD56 >12%.
排除标准
- •Age above forty years old.
- •Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies [IgG or IgM]); other recognised thrombophilic conditions (testing according to usual clinic practice).
- •Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy).
- •Abnormal parental karyotype.
- •Other identifiable causes of recurrent miscarriages (tests initiated only if clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus (SLE).
- •Disturbances of normal fat metabolism such as pathologic hyperlipemia
- •Allergic to it; or to eggs, soybean oil, or safflower oil.
- •Severe liver disease, kidney disease, lung disease, anemia, blood clotting disorder.
研究组 & 干预措施
Intralipid
Experimental
IV infusion of intralipid 20% is administrated on the day of vaginal egg collection in a dose of 9 mg/ml total blood volume corresponding to intralipid 2 ml 20% diluted in 250 ml saline over 30-60 minutes.
the intralipid infusion is then repeated within the one week of positive pregnancy test and every 2 weeks till end of first trimester
干预措施: Intralipid (Drug)
结局指标
主要结局
chemical pregnancy rate
时间窗: 10 months
Positive pregnancy test in blood as measured by quantitative B- hCG level
次要结局
- clinical pregnancy rate,(10 months)
研究者
Dina Mohamed Refaat Dakhly
M.D.
Woman's Health University Hospital, Egypt
研究点 (1)
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