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. an Ultra Morphology Section Method - Intracytoplasmic Morphology Selected Sperm Injection (IMSI)
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 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 defined as Moderate OTA or Isolated Teratozoospermia with less than 4% morphologically normal spermatozoa
- •Patients with 0.5- 7% normal sperm according to MSOME analysis
- •Females with normal FSH and AMH values
- •Females who have retrieved at least 6 oocytes in previous cycles
- •Couples who have had at least 2 failed IVF-ICSI cycles
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
干预措施: Standard ICSI procedure for sperm injection into oocyte (Other)
IMSI Procedure
The IMSI procedure is the injection of normal ultramorphological spermatozoa that have been selected using an inverted microscope with magnification of 6300x (MSOME)
干预措施: MSOME (Device)
IMSI Procedure
The IMSI procedure is the injection of normal ultramorphological spermatozoa that have been selected using an inverted microscope with magnification of 6300x (MSOME)
干预措施: IMSI Procedure (Other)
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 IMSI 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 IMSI methods will be compared.
次要结局
- Pregnancy rate(Three years)
- Implantation rate(Three years)
- Miscarriage rate(Three years)
- Live birth rate(Three years)