A Comparative Study of Sibling Oocytes, Which Examines Two Sperm Selection Methods for Top Quality of Spermatozoa , Prior Intracytoplasmic Sperm Injection (ICSI) Performance, and Their Effect on Embryo Quality and IVF Outcome: A Common Selection Method Based on Morphology (ICSI) vs. a Selection Method for Mature Spermatozoa With CD44 Receptors for Hyaluronic Acid (PICSI - Physiological Selected Intracytoplasmic Sperm Injection)
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Comparison of fertilization rate
研究概览
简要总结
The aim of this research is to compare sibling oocytes using two sperm selection methods for choosing the best quality spermatozoa before they are injected into oocytes and the influence of each of these methods on embryo quality and IVF outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males aged 18-60
- •Females aged 18-35
- •Males with mild OTA (oligo terato astheno zoospermia) and at least one failed IVF cycle
- •Males with normozoospermia with at least 2 unexplained failed IVF cycles
- •Females with normal FSH and normal AMH values
- •Females who have retrieved in previous cycles at least 6 oocytes
排除标准
- •Couples who have been exposed to heavy smoking, drugs and chronic diseases
- •Males who have undergone testicular surgery (TESE) or defined as severe OTA
- •Females with egg factor infertility
研究组 & 干预措施
ICSI Procedure
The ICSI procedure is the standard procedure of selection and injection of sperm into the oocyte using a standard ICSI petri dish.
干预措施: ICSI petri dish (Device)
PICSI Procedure
The PICSI procedure is based on a selection of mature spermatozoa with CD44 receptors and their injection into the oocyte using the PICSI petri dish that has been coated with hyaluronic acid on its bottom.
干预措施: PICSI petri dish (Device)
结局指标
主要结局
Comparison of fertilization rate
时间窗: Three years
Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The fertilization rates of the ICSI and PICSI methods will be compared.
Comparison of embryo quality
时间窗: Three years
Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The embryo quality of the ICSI and PICSI methods will be compared.
次要结局
- Live birth rate(Three years)
- Implantation rate(Three years)
- Pregnancy rate(Three years)
- Miscarriage rate(Three years)