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临床试验/EUCTR2015-002214-77-ES
EUCTR2015-002214-77-ES进行中(未招募)1 期

Prospective randomized clinical trial to test the efficacy of a biosimilar recombinant FSH (Bemfola) vs. urinary FSH (Fostipur) in an oocyte donation program - Bemfola vs. Fostipur

IVI Madrid0 个研究点开始时间: 2015年9月11日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Female

入选标准

  • Patients aged 18-35 years who meet the criteria for entry into the program and IVI Donors are to receive gonadotropins.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 130
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Those identified for Oocyte Donation Program in IVI
  • - Patient with a basal antral count> 20 follicles in total or <6 antral follicles per ovary
  • - Patients with comorbidities that, in the opinion of the investigator, may interfere with the treatment of ovarian stimulation
  • - The presence of ovarian cysts that judgment of the investigator would interfere with the stimulation or may pose a risk to the donor
  • - BMI <18 kg / m2
  • - BMI> 30 kg / m2
  • - Severe hypersensitivity to drugs with similar structure

研究者

发起方
IVI Madrid

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