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临床试验/NCT01202123
NCT01202123已完成不适用

Post Marketing Surveillance of MENOPUR

Ferring Pharmaceuticals19 个研究点 分布在 1 个国家目标入组 2,501 人开始时间: 2008年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,501
试验地点
19
主要终点
Number of follicles per cycle

研究概览

简要总结

The purpose of this study is to evaluate the safety and efficacy of highly purified (HP) menotrophine to Korean women.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Anovulation in women (WHO group II)
  • Controlled ovarian hyperstimulation cases for ART

排除标准

  • Hypersensitivity to MENOPUR
  • Pregnancy, lactation or contraindication to pregnancy
  • Ovarian cysts not related to polycystic ovarian syndrome
  • Abnormal uterine bleeding
  • Tumors in uterus, ovaries and breasts
  • Ovarian hyperstimulation syndrome
  • Thromboembolism or history of it
  • Infertile due to other reason than anovulation
  • High FSH level indication primary ovarian failure

结局指标

主要结局

Number of follicles per cycle

时间窗: Up to 6 weeks

An ART cycle: From ovulation (number and size) to when chemical pregnancy test results are recorded

次要结局

  • Number of adverse events(Up to 6 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (19)

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