Assessment of the IVF Outcome Parameters After Sperm Selection by Adhesion to Zona Pellucida Proteins
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 368
- 试验地点
- 2
- 主要终点
- Embryo quality
研究概览
简要总结
The aim of this study is to analyze the effect of a sperm selection method by adhesion to partners' zona pellucida proteins on the assisted reproduction treatment (ART) outcome parameters.
详细描述
The success rate after treatment by in-vitro fertilisation (IVF) depends on the sperm selection process. Classical sperm selection techniques are based on the spermatozoa morphology and motility, therefore are not able to measure the sperm ability to recognise the oocyte. Furthermore it is known that semen samples showing higher adherence rate to zona pellucida have higher fertilisation potential than spermatozoa that fail to bind to zona proteins.
There have been numerous reports on applying partner' native zona pellucida in sperm selection prior ICSI. However, these studies imply the whole native zona pellucida, while this study will focus on the application of acid-solubilized zonae pellucidae.
Here in this study, the aim is to assess the fertilisation rate, the number and quality of the formed embryos, implantation and ongoing pregnancy success after sperm selection for ICSI by their ability to adhere to immobilized zona pellucida proteins.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis for primary or secondary infertility
- •Healthy females
- •Clinical diagnosis for unexplained infertility
- •Females between 20 and 45 years old.
- •Males between 20 and 50 years old.
- •At least 3 retrieved oocytes per follicular puncture with at least 1 oocyte at germinal vesicle (GV) or metaphase I (MI) stage
排除标准
- •Presence of low quality oocytes
- •Females with endometrial or ovarian infertility factor
结局指标
主要结局
Embryo quality
时间窗: 2 to 6 days after ICSI
Morphological evaluation of the cultured embryos will be conducted 120 or 144 hr following sperm injection. Blastocysts scoring will be performed on day 5 or 6 depending on the blastocoel cavity expansion and on the inner cell mass and trophectoderm cells integrity.
Implantation rate
时间窗: 14 days after embryo transfer
Defined as high levels of human chorionic gonadotropin (hCG) in the peripheral blood per transfer.
Fertilisation rate
时间窗: 24 hours after ICSI
Defined as number of fertilized oocytes (presence of 2 pronuclei) per total number of injected oocytes.
Clinical pregnancy rate
时间窗: 6 weeks after embryo transfer
Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 6 per number of embryo transferred.
次要结局
未报告次要终点