Comparison of the Effect of Microfluid Sperm Sorting Chip and Density Gradient Methods on Pregnancy Success in Intrauterine Insemination Cycles ; a Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 176
- 试验地点
- 2
- 主要终点
- Compare microfluid chip and density-gradient methods in terms of embryo quality
研究概览
简要总结
Microfluidic chips are one of the methods of sperm separation to eliminate DNA fragmentation in sperm. It is thought that the separation of sperm by centrifugation in the classical gradient density (Percoll) method used in sperm separation in IVF and IUI cycles leads to the increase of reactive oxygen radicals in sperm and this leads to sperm DNA fragmentation. Studies comparing Percoll and microfluidic chip method in terms of sperm, embryo quality and pregnancy rates are limited. In this context, it is aimed to investigate the effect of Percoll or Microfluidic Chip Technology on the quality of sperms and embryos obtained with these sperms and their pregnancy rates prospectively.
详细描述
The increase in infertility rate due to environmental and physiological conditions leads to an increase in the use of assisted reproductive techniques. Isolation of living and morphologically normal live sperm is an integrated procedure in commonly used IVF / ICSI(intracytoplasmic sperm injection) / IUI(intrauterine insemination) procedures. Although current IUI procedures result in a successful pregnancy of around 10-15%, the process can be greatly compromised if the selected sperm is abnormal. Microfluidic chips are one of the recommended sperm separation methods to eliminate DNA fragmentation in sperm. It is thought that the separation of the sperm by centrifugation in the classical gradient density (Percoll) method which is used in the separation of sperm in the IUI cycles, causes the increase of reactive oxygen radicals in sperm and this leads to sperm DNA fragmentation. Studies comparing Percoll and microfluidic chip method in terms of sperm, embryo quality and pregnancy rates are limited. In this context, it is aimed to investigate the effect of Percoll or Microfluidic Chip Technology on the quality of sperms and embryos obtained with these sperms and their pregnancy rates prospectively.
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
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years(Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Apply to the infertility clinic due to unexplained infertility and mild male factor (total motile sperm count >5 million)
- •Volunteer
排除标准
- •Inadequate follicle development with medication
- •Embryo does not have the appropriate quality for transfer
- •Tubal pathology
- •Total motile sperm count < 5 million
- •Refuse to participate in research
结局指标
主要结局
Compare microfluid chip and density-gradient methods in terms of embryo quality
时间窗: average of 6 months
Embryo morphology will be assessed on day 3 using the standard criteria of the number of blastomeres and extent of fragmentation and blastomere asymmetry. Top quality embryos on day 3 will be designated as embryos with 7-8 cells, ≤10% fragmentation, and symmetric blastomeres. Using these criteria, the rate of top quality embryos will be analyzed.
Compare microfluid chip and density-gradient methods in terms of IUI success
时间窗: average of 6 months
measure the clinical pregnancy rate by using serum beta-HCG (human chorionic gonadotropin) level
次要结局
未报告次要终点
