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临床试验/NCT01601249
NCT01601249撤回1 期

A Prospective Comparison Between Conventional IVF Embryo Grading and Polscope Based Grading

Hadassah Medical Organization1 个研究点 分布在 1 个国家开始时间: 2012年9月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
撤回
试验地点
1
主要终点
Occurrence of clinical pregnancy

研究概览

简要总结

Selecting one or two IVF embryos with the highest potential to implant is extremely important for the success of the treatment- obtaining pregnancies and avoiding multi-fetal gestations. The currently used IVF embryo grading method is based solely on embryo morphology (cleavage rate and fragmentation) just before the transfer, which is not very well correlated with the implantation potential of each embryo. Oocyte quality and adequacy are the most important factors determining the biological quality and implantation potential of the embryo. It impossible to grade oocytes using plain optical systems, other than maturity and gross anomalies.

Polscope systems allow to visualize intra ooplasmic structures and determine their retardance, as well as that of the Zona Pellucida. The investigators hypothesize that grading embryos using the oocyte's parameters as visualized by polscope is superior to conventional morphology and correlates better with their implantation potential.

Here the investigators will perform a prospective randomized controlled trial to examine this hypothesis.

详细描述

Each embryo will be graded in accordance to polscope based parameters; the presence of a spindle in the oocyte, its retardance, the distance between the spindle and the PB, and the thickness and retardance of the ZP.

In the experimental group the embryos for transfer will be selected based on these parameters, whereas in the control group they will be selected based on conventional morphologic criteria.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

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

  • Age 18-38, (near) normal MF, normal uterus, >4 aspirated oocytes, intent to transfer 1-2 embryos.

排除标准

  • Severe MF problems, uterine anomalies, PGD, RIF.

研究组 & 干预措施

Polscope based embryo grading

Experimental

Embryos for transfer will be selected based on highest polscope scores, unless are not grade 1-2 by conventional morphology

干预措施: Embryo selection based on polscope grading or morphology (Procedure)

Morphology based embryo grading

Active Comparator

Conventional embryo grading and decision making

干预措施: Embryo selection based on polscope grading or morphology (Procedure)

结局指标

主要结局

Occurrence of clinical pregnancy

时间窗: within 2 weeks after ET

次要结局

  • Live birth(up to 40 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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