NCT02058082已完成不适用
Randomized Control Trial on the Use of Testicular Versus Ejaculated Spermatozoa for IVF/ICSI on Pregnancy Outcomes for Men With High Sperm DNA Damage
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- Live birth rates
研究概览
简要总结
The purpose of this study is to determine whether couples undergoing IVF/ICSI with male factor infertility, specifically with elevated sperm DNA damage, should testicular sperm extraction be utilized to improve their reproductive outcomes.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age
- •be considered infertile (>1 year of unsuccessful attempts of conception
- •Male partner with persistent sperm DNA damage, DFI>=30%
- •candidates for intracytoplasmic sperm injection (ICSI)
排除标准
- •significant female factor infertility contributing to the couple's infertility
- •female partner older than 38 years
- •male or female patients with genetic abnormalities
- •patients unable or unwilling to give consent after properly informed
- •couples unsuitable for IVF/ICSI
- •male patients in whom testicular procedures were contraindicated
结局指标
主要结局
Live birth rates
时间窗: Up to 1 year
次要结局
- sperm DNA damage(Mesaured at baseline, 3 months and on the day of Intracytoplasmic sperm injection (ICSI) procedure)
- pregnancy rate(6 to 8 week ultrasound)
- rate of spontaneous abortion(after a clinical pregnancy has been established, up to 10 months after procedure)
- embryo cleavage rate(Day 3 post oocytes retrieval)
- blastocyst rate(Day 5 post oocytes retrieval)
- birth defects(1-year following delivery)
- oocyte fertilization rates(at approximately 18 hrs post Intracytoplasmic sperm injection (ICSI))
研究者
Kirk Lo
Associate Professor, Division Urology Mount Sinai Hospital, University Toronto
Mount Sinai Hospital, Canada
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