Correlating In Vitro Fertilization Outcomes After Euploid Blastocyst Transfer With Sperm DNA Fragmentation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 323
- 试验地点
- 2
- 主要终点
- IVF/ICSI Pregnancy Outcomes with euploid blastocyst transfer based on sperm DNA fragmentation
研究概览
简要总结
The purpose of this study is to determine if sperm DNA fragmentation is associated with in vitro fertilization (IVF) outcomes when euploid embryos are transferred.
详细描述
The purpose of this study is to determine if sperm DNA fragmentation is associated with in vitro fertilization (IVF) outcomes when euploid embryos are transferred. Euploid embryos are those that have a complete set of chromosomes (46, XX or 46, XY). Sperm DNA fragmentation refers to sperm DNA that is damaged or has an altered structure. The sperm chromatin structure assay (SCSA) is a method to evaluate sperm DNA Fragmentation.
Couples will undergo a routine IVF cycle at Reproductive Medicine Associates of New Jersey. Semen specimens collected on the day of ICSI will undergo semen analysis as per routine. An aliquot of semen (0.5- 1mL) will be collected for subsequent evaluation of DNA fragmentation by the Sperm Chromatin Structure Assay (SCSA) testing at SCSA Diagnostics. All embryo biopsies will undergo CCS analysis in the genomics laboratory, Foundation for Assessment and Enhancement of Embryonic Competence.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completing first IVF/ICSI cycle at Reproductive Medicine Associates of New Jersey
- •Couple undergoing CCS (Comprehensive Chromosome Screening)
- •Female age 35-40 years
- •Male will have to refrain from ejaculation no less than 2 days but no greater than 5 days prior semen specimen production on day of oocyte retrieval
排除标准
- •Known genetic abnormality
- •Use of sperm donation or cryopreserved sperm
- •Use of Oocyte donation
- •Use of gestational carrier
- •Use of testicular aspiration or biopsy procedures to obtain sperm
- •Presence of varicosele
- •Presence of hydrosalpinges that communicate with endometrial cavity
- •Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation
结局指标
主要结局
IVF/ICSI Pregnancy Outcomes with euploid blastocyst transfer based on sperm DNA fragmentation
时间窗: 28 months
rates of fertilization, blastulation, implantation, sustained implantation, delivery and miscarriage
次要结局
- Relationship between semen analysis parameters and sperm DNA fragmentation(28 months)
- Correlation between sperm DNA fragmentation and embryonic aneuploidy(28 months)