跳至主要内容
临床试验/NCT02420886
NCT02420886已完成不适用

The Effects of GM-CSF, HB-EGF and LIF Cytokines Supplementation Need Verification for Human Embryo Development in Vitro

Ibn Sina Hospital2 个研究点 分布在 1 个国家目标入组 443 人开始时间: 2015年5月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
443
试验地点
2
主要终点
ongoing pregnancy rate ( % )

研究概览

简要总结

Assessment of the embryological benefit of in vitro adding of Cytokines (LIF 5ng/ml, HB-EGF 5ng/ml and GM-CSF 2n/ml) to the culture media and closely monitor its effect on embryogenesis and implantation outcomes.

详细描述

The IVF culture media design and upgrade underwent many ideas during the last 3 decades, we suppose that adding the Cytokines (LIF 5ng/ml, HB-EGF 5ng/ml and GM-CSF 2ng/ml) as a growth factor that have multi-ways to might improve embryo development in vitro so we decide to design a trial to compare the embryogenesis by sibling Oocytes of the same patient between two arm of the same culture media and the same culture condition. One arm with Cytokines and the other is traditional one and closely monitor the outcome within the 2 arms and record the results.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • all patients

排除标准

  • over 40 years

研究组 & 干预措施

Cytokines supplemented In Vitro single culture media

Active Comparator

We will add Cytokines (LIF, HB-EGF and GM-CSF) to LIFEGLOBAL culture media and assess the embryogenesis and pregnancy.

干预措施: Adding LIF, HB-EGF and GM-CSF to Lifeglobal human IVF culture media (Other)

Traditional Single step culture media

No Intervention

结局指标

主要结局

ongoing pregnancy rate ( % )

时间窗: 6 months

次要结局

  • top-quality embryo rate(6 days of culture)
  • rates for blastocyst formation and quality(6 days of culture)
  • clinical pregnancy rate ( % )(6 months)
  • implantation rate(6 months)
  • embryo utilization rate(6 days of culture)
  • fertilization rate(6 days of culture)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Muhammad Fawzy

IVF Laboratory Director

Ibn Sina Hospital

研究点 (2)

Loading locations...

相似试验

Adding Cytokines to In Vitro Human Culture Media to... | 临床试验