EUCTR2009-012847-40-GB进行中（未招募）1 期
A Randomised Study Comparing Two Different Regimens of Ovarian Stimulation Using Pergoveris and Cetrorelix for Controlled Ovarian Superovulation in Assisted Conception Treatment. - Pergoveris and Cetrorelix for controlled ovarian stimulation
HS Lothian0 个研究点目标入组 80 人开始时间: 2009年10月20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
- 入组人数
- 80
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
- •-healthy female;
- •-aged 21 – 38 years;
- •- undergoing IVF treatment for unexplained, tubal or male factor subfertility;
- •-regular menstrual cycles (24-35 days);
- •-both ovaries present (no previous surgery on ovaries);
- •-able to understand protocol;
- •-able to give informed consent.
- •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
- •-polycystic ovarian syndrome
- •-endometriosis (severe) requiring treatment;
- •-serum AMH level < 6 pmol/l at screening;
- •-known history of poor ovarian response during assisted conception treatment;
- •-3 or more failed IVF/ICSI cycles (defined as failure to achieve pregnancy and live birth);
- •-allergic to investigational compounds;
- •-contraindication to any of the study medication
- •-lactation;
- •-use of depot hormonal contraceptive within a period of six months or use of oral contraceptive within eight weeks prior to start of COS treatment;
- •-hypertension (systolic >155 mm Hg; diastolic >90mmHg);
- •-history of alcohol or drug abuse;
- •-abnormal biochemistry/haematology results at screening;
- •-administration of investigational drugs within 20 days of Screening
- •-not able to give informed consent.
研究者
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