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临床试验/EUCTR2006-001143-59-GB
EUCTR2006-001143-59-GB进行中(未招募)1 期

A prospective, randomised study comparing two fixed daily doses (150 IU versus 225 IU) of recombinant FSH for ovarian stimulation during in-vitro fertilisation treatment in predicted low and intermediate responders based on antral follicle count on 3D ultrasound - Randomised study of 150 IU versus 225 IU of rFSH in non-PCO women

School of Human Development0 个研究点目标入组 184 人开始时间: 2006年5月5日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
184

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

入选标准

  • --Female subjects aged between 20 and 38 years
  • -Subjects undergoing first, second or third cycle of IVF/ICSI treatment.
  • -Subjects with basal FSH level of 10 or less.
  • -Subjects must have both the ovaries.
  • -Absence of antral follicle count ¡Ý12 with in an ovary and/or an ovary volume of >10cm3 on 3D ultrasound.
  • -Subjects who have not had any ovarian surgery in the past.
  • -Subjects, who have a body mass index (BMI) of 20 to 35
  • -Subjects in study groups must have a regular spontaneous menstrual cycle of 21 to 35 days.
  • 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
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • -Subjects who have an ovarian cyst (>20 mm) at the 1st scan in the early follicular phase. It can interfere with ovarian follicle monitoring.
  • -Subjects whose infertility caused by endocrine abnormalities such as poly cystic ovarian syndrome, hyperprolactinemia and abnormal thyroid function.
  • -Subjects with any contraindications to IVF/ICSI treatment.
  • -Subjects, who are taking concurrent corticosteroids/ Metformin.

研究者

发起方
School of Human Development

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