PICSI vs. MACS for Abnormal Sperm DNA Fragmentation ICSI Cases: a Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 396
- 试验地点
- 1
- 主要终点
- Ongoing pregnancy rate
研究概览
简要总结
On the day of ICSI, choosing the best sperm by either PICSI or magnetic activated cell sorting (MACS) in cases with abnormal DNA is not fully investigated. This study helps in solving this problem by using two known techniques to achieve that purpose.
详细描述
Sperm DNA fragmentation has shown a negative correlation with fertilization rate, embryo quality, and implantation rate. And a positive correlation with miscarriage rate in the 1st trimester.
Sperm selection methods like PICSI and MACS have been developed for selecting a healthy mature non apoptotic sperm with healthy membrane for Oocyte injection so as to obtain best embryo quality and achieve higher ongoing pregnancy rates.
A sperm selection technique based on sperm membrane binding to hyaluronic acid (PICSI Dish), the main substrate of the oocyte zonapellucida, could improve the likelihood of obtaining better sperm for ICSI with non fragmented DNA. Another sperm selection technique based on Magnetic activated cell sorting (MACS) that depends on the binding of protein Annexin V to phosphatidylserine which is a marker for apoptosis, giving a resulting (eluted) spermatozoa without DNA fragmentation.
In order to determine which sperm selection technique is better for dealing with DNA fragmentation patients we need to study both techniques on two different groups of 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
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males diagnosed of abnormal DNA fragmentation index ( > 19%).
- •Males with mild to moderate OTA (oligoteratoasthenozoospermia).
- •Male aged 18-60 years.
- •Female aged 18-40 years.
- •Normo responder ( > 5 mature oocytes)
- •Male will have to refrain from ejaculation no less than 1 day but no greater than 3 days prior semen specimen production on day of oocyte retrieval
排除标准
- •Males with normalDNA fragmentation index (<19%)at the initial assessment.
- •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
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
- Comparison of Blastocyst quality rate(5-6 days)
- Comparison of Pregnancy rate(14 days following embryo transfer)
- Comparison of implantation rate(6- 8 weeks following embryo transfer)
- Comparison of cleavage rate(3 days)
- Comparison of Blastulation rate(5-6 days)
研究者
Eman Hasanen
Clinical Embryologist
Ganin Fertility Center