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临床试验/NCT00920361
NCT00920361已完成不适用

Designated Drug Use Investigation 1 of Follistim Injection

Organon and Co0 个研究点目标入组 1,664 人开始时间: 2005年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
1,664
主要终点
Number of retrieved oocytes

研究概览

简要总结

To evaluate dosage and administration method, efficacy and safety of Puregon and the relationship between background factors of patients and dose and administration method.

Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Patients who underwent IVF

排除标准

  • Patients with tumors of ovary, breast, uterus, pituitary or hypothalamus
  • Pregnant or possible pregnant women, or lactating women
  • Patients with undiagnosed atypical vaginal bleeding
  • Patients with a history of hypersensitivity to any of the ingredients of this product.
  • Patients with ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease

研究组 & 干预措施

1

Patients who underwent IVF

干预措施: Follitropin beta (Drug)

结局指标

主要结局

Number of retrieved oocytes

时间窗: 2 months, from initiation of treatment to confirmation of pregnancy.

次要结局

  • Pregnancy outcome(2 months, from initiation of treatment to confirmation of pregnancy.)

研究者

申办方类型
Industry
责任方
Sponsor

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