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临床试验/NCT00460642
NCT00460642已完成不适用

Use of GnRH Antagonist (Cetrotide) Protocol, Instead of Agonist, to Prepare Recipients for Embryo Transfer

Institute for Human Reproduction (IHR)2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2007年1月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
130
试验地点
2
主要终点
Clinical Pregnancy Rate

研究概览

简要总结

26% of all ART cycles performed in the USA in 2003 (CDC data) are frozen embryo transfers (FET) and transfer of embryos resulting from egg donation (ED) to recipients. The typical protocol used to prepare a recipient for ET involves GnRH agonist (Lupron, Tap Pharmaceuticals) to down regulate the patient. A GnRH antagonist, such as Cetrotide (EMD Serono), is comparable to GnRH agonist and FDA approved to prevent spontaneous ovulation with ART treatment, and its usage decreases significantly the number of injections that the patient receives with treatment. The working hypothesis for this study is that the GnRH antagonist (Cetrotide) can be used instead of an agonist to achieve effective down regulation in FET and ED cycles. Presumably, patients will prefer Cetrotide over Lupron because of the markedly fewer injections required.

研究设计

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

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •History of infertility before cryopreserving the embryos or inability to conceive from her own oocytes (based on age and/or a serum FSH > 15 IU/L).
  • •Any patient desiring to become pregnant as a result of transferring frozen-thawed embryos generated using her own or donor oocytes.
  • •Subject is in good health as determined by the Investigator on the basis of medical history, physical examination and laboratory screening tests.
  • •A negative pregnancy test prior to starting treatment with estrogens.

排除标准

  • •Women with a history of liver and/or kidney disease
  • •Hypertension: systolic pressure over 180 mm Hg or diastolic pressure over 105 at any study visit, measured twice 6 hours apart despite active treatment for hypertension.
  • •Liver function tests of two times than the upper limit of normal
  • •Women with active sever endometriosis.

结局指标

主要结局

Clinical Pregnancy Rate

次要结局

  • Delivery Rate

研究者

发起方
Institute for Human Reproduction (IHR)
申办方类型
Other

研究点 (2)

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