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临床试验/NCT01983696
NCT01983696Unknown不适用

The Effect of Low Oxygen Tension on the Early Development of Human Embryo in IVF/ICSI

Shanxi Provincial Maternity and Children's Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
embryo quality

研究概览

简要总结

To investigate the effect of low oxygen tension during in vitro culture in terms of embryo quality and outcomes of pregnancy in vitro fertilization/ Intracytoplasmic sperm injection

详细描述

The oocytes will be divided into two parts(two groups) form one patient. The two groups of oocytes will be cultured seperately in the incubator with the concentrations of 5% CO2,6%O2,89% N2(low oxygen concentration) verse 6% CO2,20% O2,74% N2(in atmosphere).

A series of observational measurement(embryo quality and outcomes of pregnancy) will be performed.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • Fresh cycles of in vitro fertilization/intracytoplasmic sperm injection and emrbyo transfer (IVF/ICSI-ET)
  • ≥ 10 oocytes after oocyte retrieval

排除标准

  • ≥ 3 transfer or oocyte retrieval cycles
  • PGD/PGS cycles
  • half-ICSI/rescure ICSI
  • fluid in the uterine cavity, abnormal endometrium, uterine abnormalities,pelvic inflammation
  • acute maternal problems.
  • One or both spouses have an abnormal karyotype (including polymorphism)

结局指标

主要结局

embryo quality

时间窗: up to 6 days after fertilization

Embryo morphology was assessed on day 2, day 3 day 4 day 5 day and 6 by considering the number of blastomeres, symmetry and granularity of blastomeres, type and percentage of fragmentation, presence of multinucleated blastomeres, and degree of compaction. Gardner's blastocyst scoring system is used for blastocyst assessment

次要结局

未报告次要终点

研究者

发起方
Shanxi Provincial Maternity and Children's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shi Wenhao

Assisted Reproductive Technology Center

Shanxi Provincial Maternity and Children's Hospital

研究点 (1)

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