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临床试验/NCT01908569
NCT01908569终止不适用

Application of MACS (Magnetic-activated Cell Sorting) and Time-lapse Technology (Embryoscope) in Assisted Reproduction Patients With Good Prognosis

IVI Sevilla2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2013年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
66
试验地点
2
主要终点
Clinical pregnancy rate

研究概览

简要总结

The MACS technique (magnetic-activated cell sorting) is based on the usage of microbeads, magnetic particles with a diameter of 35 nanometers joined to the compound annexin V. Annexin V is a protein with a high affinity for the molecule phosphatidylserine. This system allow us to eliminate those spermatozoids which have begun the apoptosis and have phosphatidylserine residues on their membrane surface. Using this technique, the apoptotic spermatozoids will join the microbeads and consequently be retained in a column applying a magnetic field.

Recent studies show the benefits of spermatozoid selection using MACS and the improvement in mobility, viability, DNA fragmentation and fertilization potential. It has also been observed an improvement in the embryo cells division rate, clinical pregnancy rates and spermatozoid survival after thawing. However, it is necessary to perform new clinical studies in order to evaluate the real potential of this technology and its safety.

The purpose of this study is to evaluate the effect of the MACS technique on the clinical results of good-prognosis patients who are going through IVF/ICSI treatments in order to achieve a pregnancy.

The hypothesis of this study is that the application of the MACS technique in assisted reproduction treatments is associated with a better embryo quality and pregnancy rates.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 38 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • <38 years
  • >10 follicles with a diameter of ≥10 mm the day before the follicular puncture

排除标准

  • Patients subject to preimplantation genetic diagnosis treatments

研究组 & 干预措施

NO MACS + Time-lapse technology

Active Comparator

The sperm capacitation will be performed through a density gradient. This sperm will be used in the IVF/ICSI treatment of the patient and the embryos obtained will be cultured using time-lapse technology (Embryoscope).

干预措施: NO MACS (Other)

MACS + time-lapse technology

Experimental

The sperm capacitation will be performed through a density gradient. After that, it will be subjected to the MACS technique in order to select the non-apoptotic spermatozoids. This sperm will be used in the IVF/ICSI treatment of the patient and the embryos obtained will be cultured using time-lapse technology (Embryoscope).

干预措施: MACS (Other)

结局指标

主要结局

Clinical pregnancy rate

时间窗: 14 months

次要结局

  • Implantation rate(14 months)
  • Pregnancy rate(14 months)
  • Embryo quality(14 months)

研究者

发起方
IVI Sevilla
申办方类型
Other
责任方
Sponsor

研究点 (2)

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