Assessment of the Efficacy of Intralipid 20% in Management of Women With Unexplained Recurrent Implantation Failure in IVF Cycles: A Double Blinded Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 主要终点
- Live birth rates
研究概览
简要总结
The study will include 100 women with unexplained recurrent implantation failure undergoing IVF/ICSI cycle.
Patients fulfilling the inclusion criteria will be randomised into two groups.
Study Group:
This group will include 50 women with unexplained recurrent implantation failure undergoing a trial of IVF/ICSI. This group will receive intravenous infusion of intralipid 20%, on the day of oocyte retrieval, a second dose on/ the following day of positive pregnancy test and a final dose 2-3 weeks later when attending for pregnancy scan.
Control Group:
This group will include 50 women with unexplained recurrent implantation failure undergoing a trial of IVF/ICSI. This group will receive intravenous infusion of placebo, on the day of oocyte retrieval, a second dose on/ the following day of positive pregnancy test and a final dose 2-3 weeks later when attending for pregnancy scan.
详细描述
The study will include 100 women with unexplained recurrent implantation failure undergoing IVF/ICSI cycle.
Randomisation:
Patients fulfilling the inclusion criteria will randomised to two groups.
Study Group:
This group will include 50 women with unexplained recurrent implantation failure undergoing a trial of IVF/ICSI. This group will receive intravenous infusion of intralipid 20%, on the day of oocyte retrieval, a second dose on/ the following day of positive pregnancy test and a final dose 2-3 weeks later when attending for pregnancy scan.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 20-38 years of age.
- •Repeated implantation failure with 3 or more failed IVF cycles with good quality embryos.
- •Normal trans-vaginal ultrasonography.
- •Normal hysteroscopy.
- •Normal male and female karyotyping.
- •Normal anti cardiolipin antibody IGG, IGM and Lupus anticoagulant.
- •Normal thrombophilia screen in the form of protein c, s, anti thrombin iii and factor v leiden.
- •Written and signed informed consent by the patient to participate in the study.
排除标准
- •Age more than 38 years.
- •Less than 3 failed IVF cycles.
- •Poor embryo quality.
- •Expected poor ovarian response.
- •Abnormal trans-vaginal ultrasound findings e.g. endometrial polyps or fibroids.
- •Abnormal male or female karyotyping.
- •Abnormal hysteroscopic finding e.g. endometrial polyps, endometrial hyperplasia, fibroid or congenital anomalies.
- •Positive Anticardiolipin antibodies or Lupus anticoagulant.
- •Positive thrombophilia screen.
- •Allergy to soy oil, eggs, peanut, peanut-based products or any active ingredient in the infusion.
- •Mental condition rendering the patients unable to understand the nature, scope and possible consequences of the study.
研究组 & 干预措施
Intralipid
Women with RIF received intralipid 20% (at a dose of 9mg/mL of the total blood volume, corresponding to 2 mL intralipid diluted at 20% in 250 mL normal saline) given over 1-2 hours on the day of oocyte retrieval. Dose is repeated on/the following day of a positive pregnancy test, followed by a final dose 2-3 weeks later when attending for pregnancy scan.
干预措施: Intralipid 20% (Drug)
Placebo
Women with RIF received intravenous infusion of 250 mL physiological saline solution over 1-2 hours on the day of oocyte retrieval. Dose is repeated on/the following day of a positive pregnancy test, followed by a final dose 2-3 weeks later when attending for pregnancy scan.
干预措施: Normal saline (Drug)
结局指标
主要结局
Live birth rates
时间窗: up to 40 weeks gestation
次要结局
- Clinical pregnancy rates(6 weeks gestation (2 weeks following embryo transfer))
- side effects and tolerability of Intralipid(up to 40 weeks gestation)
研究者
ISLAM GAMALELDIN
Specialist registrar Obstetrics and Gynaecology
Dar El Teb Institute