The Effect of Sorting of Non-apoptotic and Apoptotic Spermatozoa Using Flow Cytometry on the Outcome of Intracytoplasmic Sperm Injection.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Ongoing pregnancy rate
研究概览
简要总结
In assisted reproductive technology (ART) semen needs to be processed. Commonly used methods rely on physical properties of the spermatozoa, such as the swim-up methods and density gradient centrifugation. It is now known that current processing of spermatozoa does not prevent the admixture of spermatozoa with damaged genetic material. The latter have a negative impact on the outcome of ART. The investigators developed a new method for the processing of spermatozoa with intact genetic material based on flow cytometry and sorting (FACS) and on staining using a deye, YoPro. The investigators aim at examining the effect of this novel method of sperm sorting on the outcome of ART.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 22 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •infertile couples needing treatment with ICSI
- •male infertility as defined by the WHO 2010 criteria
- •age of the treated women should be between 22 and 39 years of age.
- •normal ovarian reserve, as defined by basal FSH-concentration below 10 IU/l and AMH-concentration above 10 pmol/l.
- •signed consent form.
排除标准
- •normal male infertility, as defined by the WHO 2010 criteria
- •age of the treated women below 22 years and above 39 years
- •reduced ovarian reserve, as defined by an elevated basal FSH-concentration or reduced AMH-concentration.
- •Not more than two preceding unsuccessfull treatments with ICSI
- •Severe disease of the male or female partner, such as HIV, hepatitis, or psychiatric illness.
- •Participation in another study.
- •lack of a signed consent form.
研究组 & 干预措施
YoPro and FACS
Spermatozoa to be used for ICSI will be stained with the YoPro Dye and then be sorted with FACS to select non-YoPro stained spermatozoa, known to have significantly less fragmented DNA.
干预措施: Staining of spermatozoa with the YoPro dye and sorting of the stained spermatozoa with FACS (Procedure)
Swim-up
Spermatozoa will be processed using the conventional swim-up me
干预措施: Swim-up (Procedure)
结局指标
主要结局
Ongoing pregnancy rate
时间窗: Week 12 of gestation
次要结局
- Number of diploidic fertilized oocytes.(one day after intracytoplasmic sperm injection)