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临床试验/NCT02651285
NCT02651285Unknown4 期

G-CSF Supplemented Medium for IVF Embryo Culture in Patients Undergoing IVF

Centre for Endocrinology and Reproductive Medicine, Italy2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
4 期
发起方
入组人数
180
试验地点
2
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 G-CSF, a growth factor working on stem cells, may improve the embryo implantation and pregnancy rate in infertile patients undergoing 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 also in relatively young reproductive age women nevertheless the good embryos produced and transferred pregnancy rate and implantation rate remain low. Recently, it has been showed that culture medium supplemented with G-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 undergoing IVF. 180 infertile women undergoing IVF no more than 37 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 G-CSF supplemented culture medium or in normal culture in micro drop of 30microliters under oil until the day of transfer (day five or blastocyst sage embryos). A maximum of two embryos will be transferred. The pregnancy rate, implantation rate and number of blastocyst developped will be the outcomes considered

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 38 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • infertility
  • healthy condition,
  • good ovarian reserve (AMH levels more than 1microg/ml)

排除标准

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

结局指标

主要结局

pregnancy rate

时间窗: 12 months

The number of patients become pregnant after IVF where G-CSF medium is used divided for the number of patients treated

implantation rate

时间窗: 12 months

The number of embryos implanted after IVF where G-CSF medium is used divided for the number of embryos transferred

次要结局

  • number of blastocyst developped(12 months)

研究者

发起方
Centre for Endocrinology and Reproductive Medicine, Italy
申办方类型
Network
责任方
Principal Investigator
主要研究者

Fabio Scarpellini

Clinical Director

Centre for Endocrinology and Reproductive Medicine, Italy

研究点 (2)

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