NCT04482517已完成不适用
Reproductive Outcomes of Different Sperm Selection Techniques; Density Gradient Centrifugation, Testicular Sperm, PICSI, and MACS for ICSI Patients With Abnormal Sperm DNA Fragmentation
Ganin Fertility Center2 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2017年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
Comparing the reproductive outcomes of different sperm selection techniques; Density gradient centrifugation (DGC), Testicular sperm (Testi), Physiological ICSI (PICSI), and Magnetic activated cell sorting (MACS) in abnormal sperm DNA fragmentation (SDF) ICSI patients.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female age was ≤37 years
- •Female should has 5≥ metaphase II oocytes
- •Males having abnormal SDF levels ≥ 20.3% by TUNEL assay
- •Abstinence from 1 to 2 days
- •Males having at least 1 million total motile progressive count
排除标准
- •Leukocytospermia
- •Presence of varicocele.
- •Known genetic abnormality
- •Use of sperm donation or cryopreserved sperm
- •Use of Oocyte donation
- •Use of gestational carrier
- •Presence of any of the endometrial factors that affect embryo implantation such as hydrosalpings, adenomyosis or previous uterine infection
- •Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation
结局指标
主要结局
Clinical pregnancy rate
时间窗: 14 days following embryo transfer
Defined as clinical pregnancy per transfer
Implantation rate
时间窗: 6- 8 weeks following embryo transfer
Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 6 over number of embryo transferred.
Ongoing pregnancy rate
时间窗: 20 weeks of gestation
Defined as the proportion of pregnancies that completed more than 20 weeks of gestation
次要结局
- Cleavage rate(3 days)
- Miscarriage rate(20 weeks of gestation)
- Blastulation rate(5-6 days)
- High quality blastocyst rate(5-6 days)
研究者
研究点 (2)
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