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临床试验/NCT01636505
NCT01636505Unknown3 期

The Results of Preimplantation Genetic Diagnosis and Preimplantation Genetic Screening of Embryos Obtained From GnRH-agonist Long and GnRH-antagonist Ovarian Stimulation Protocol

European Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2012年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
发起方
入组人数
200
试验地点
1
主要终点
The results of Preimplantation Genetic Diagnosis and Preimplantation Genetic Screening of embryos obtained from GnRH-agonist long and GnRH-antagonist ovarian stimulation protocol

研究概览

简要总结

The aim of this study is to performed a randomized controlled trial to evaluate the rate of genetic and chromosomal abnormalities in embryos obtained from GnRH-agonist long and GnRH-antagonist ovarian stimulation protocols.

Patients will be prospectively randomized in two groups: the first undergoing controlled ovarian stimulation in GnRH-agonist long protocol and the second following GnRH-antagonist ovarian stimulation regimen.

The end-points of the study include the number of genetically and chromosomally abnormal embryos, the pregnancy, the implantation and the healthy baby birth rate.

The patients included in PGS program were selected on the base of advanced maternal age, repeated pregnancy lost and implantation failure whereas the patients who were know to carry sex-linked or monogenic disorders were considered for PGD strategy.

The uterine abnormalities, endometriosis and endocrinal diseases were considered to be the exclusion factors.

研究设计

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

入排标准

年龄范围
18 Years 至 46 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • patients carrier genetic disease
  • advanced maternal Age
  • repeated IVF failure
  • recurrent pregnancy loss

排除标准

  • uterine abnormalities
  • endometriosis
  • endocrinal diseases

研究组 & 干预措施

short protocol

Active Comparator

gnrh agonist versus gnrh antagonist

干预措施: ghrh antagonist (cetrotide/orgalutran) (Drug)

long protocol

Active Comparator

干预措施: gnrh agonist (suprefact) (Drug)

结局指标

主要结局

The results of Preimplantation Genetic Diagnosis and Preimplantation Genetic Screening of embryos obtained from GnRH-agonist long and GnRH-antagonist ovarian stimulation protocol

时间窗: one year

difference in embryos' genetic and chromosomal quality using two different ovarian stimulation protocol

次要结局

未报告次要终点

研究者

发起方
European Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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