Effect Of Intravenous IntralipidTherapyon Pregnancy Outcome in Women With History of Recurrent Implantation Failure Undergoing Intracytoplasmic Sperm Injection-Embryo Transfer Cycle: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 142
- 主要终点
- pregnancy rate
研究概览
简要总结
To evaluate the effect ofempiricintralipidinfusion therapy on pregnancy outcomes in patient withunexplained recurrentimplantation failure (RIF) undergoIntracytoplasmic sperm injection (ICSI).
详细描述
the aim to evaluate the effect ofempiricintralipidinfusion therapy on pregnancy outcomes in patient withunexplained recurrentimplantation failure (RIF) undergoIntracytoplasmic sperm injection (ICSI).
A total of 142 patients with history of unexplained RIF3 or more cycles were included in the study. Patient were randomized into two groups, study group (n=71) and control group (n=71). The study groupreceivedintralipid 20%infusionon the day of embryo transfer (ET) and a second dose on the day of pregnancy test. The control group underwent ET without intralipidinfusion.Allpatientswereclosely monitored for any side effectsincluding allergic reactions.
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
- 21 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age < 42 years
- •BMI < 30 kg/m2
- •history of 3 or more recurrent implantation failure undergoing Intracytoplasmic Sperm Injection (ICSI ) cycle.
- •exclusion criteria
- •women with medical contraindications of intralipidinfusion.
- •uterine fibroid.
- •endometrial polyp.
- •endometriosis,hydrosalpinx.
- •intrauterine adhesion and uterine anomalies.
- •Women with positive thrombophilia screen.
- •diminished ovarian reserve.
- •severe male factor infertility .
- •chronic medical illnesses which may contribute in impaired chance of pregnancy .
排除标准
- 未提供
研究组 & 干预措施
treatment group who recived intralipid
71 patients who recived intralipid on day of embryo transfer day, pregnancy day.
干预措施: intralipid 20% (Drug)
结局指标
主要结局
pregnancy rate
时间窗: 14 day post embryo transfer day
number of patient with positive b-hcg level 14 day post embryo transfer day.over the study population number in study period.
次要结局
- miscarrage rate(miscarrage before 20 week gestation)
- live birth rate(delivery after 28 week gestation)
研究者
jawharah ali alzebidi
fellow
King Fahad Medical City