G-CSF Supplemented Medium for IVF Embryo Culture in Patients Undergoing IVF
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
- 否
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
Fabio Scarpellini
Clinical Director
Centre for Endocrinology and Reproductive Medicine, Italy
