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临床试验/NCT01718210
NCT01718210已完成4 期

GM-CSF Supplemented Medium for IVF Embryo Growth in Patients With Recurrent Implantation Failure

Centre for Endocrinology and Reproductive Medicine, Italy1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年12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
100
试验地点
1
主要终点
Pregnancy rate

研究概览

简要总结

The purpose of this study is to determine whether in Assisted Reproductive Technologies the use of culture medium supplemented with GM-CSF, a growth factor working on stem cells, may improve the embryo implantation in patients experiencing recurrent implantation failure in IVF cycles.

详细描述

In Assisted Reproductive Technologies the rate of pregnancy for cycle and the implantation rate remain low nevertheless the improvement in the last years. In particular there are a group of patients, in young reproductive age, experiencing recurrent implantation failure, nevertheless the good embryos produced and transferred. Recently, it has been showed that culture medium supplemented with GM-CSF, may improve the embryo outcomes in IVF. In this trial the investigators will test the potential benefits of this culture medium on embryos of patients experiencing recurrent implantation failure. 100 women with recurrent implantation failure, at least three failed previous IVF attempts with at least 8 good embryos transferred no more than 40 years old will be selected. These patients will be assigned to two arms, one experimental and one other of control by a computer generated sequence. After the oocyte retrieval and fertilization by ICSI procedure, the fertilised oocyte (2PN)will cultured with the GM-CSF supplemented culture medium (EmbryoGen, Origio, Denmark), or in normal culture in micro drop of 30microliters under oil until the day of transfer (day three or 8 cells sage embryos). A maximum of three embryos will be transferred. The pregnancy rate the implantation rate will be the outcomes considered

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
Single (Participant)

入排标准

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

入选标准

  • woman age 40 years old or less,
  • 3 or more consecutive previous failed IVF cycles with a total of at least 8 good embryos replaced in uterus

排除标准

  • chromosomal defects in the couple,
  • metabolic diseases (diabetes, etc),
  • other genetic diseases (thalassemia, cystic fibrosis, etc.)

研究组 & 干预措施

GM-CSF medium

Experimental

patient's embryos are incubated after fertilization with mediun supplemented with GM-CSF

干预措施: GM-CSF medium (Drug)

CONTROL

Placebo Comparator

50 women with recurrent implantation failure (at leat three previous IVF attempts failed with at least 8 good embryos transferred in uterus)that the obtained with IVF are incubated with a standard medium for IVF, and utilized as control group.

干预措施: CONTROL (Drug)

结局指标

主要结局

Pregnancy rate

时间窗: 9 months

The number of patients become pregnant after IVF where GM-CSF medium is used, compared with the number of patients become pregnant in the control group

次要结局

  • Implantation rate(9 months)

研究者

发起方
Centre for Endocrinology and Reproductive Medicine, Italy
申办方类型
Network
责任方
Sponsor

研究点 (1)

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