Prospective Randomized Trial Comparing Ovarian Stimulation in IVF-patients With Corifollitropin Alfa in Combination With Hp-FSH Versus Corifollitropin Alfa in Combination With Low Dose hCG
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- The financial costs of the stimulation in both groups
研究概览
简要总结
The study compares in a randomized controlled way two stimulation methods. One of these stimulation methods implements a new insight in ovarian follicular growth. If this novel method of stimulation proves to be as efficient as the classical stimulation protocols, there might be a dramatic reduction of the costs of the medical therapy in IVF, thus reducing also the overall IVf costs significantly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •IVF/ICSI patients
- •Cycle 1, 2, 3, 4
排除标准
- •Endocrinological diseases
研究组 & 干预措施
low dose hCG (Pregnyl)
Corifollitropin Alfa (Elonva) dosage depending on weight once administered first day of ovarian stimulation in combination 150IU low dose hCG from day 7 until final oocyte maturation.
干预措施: low dose hCG (Drug)
low dose hCG (Pregnyl)
Corifollitropin Alfa (Elonva) dosage depending on weight once administered first day of ovarian stimulation in combination 150IU low dose hCG from day 7 until final oocyte maturation.
干预措施: Corifollitropin Alfa (Drug)
hp-FSH (Menopur)
Corifollitropin Alfa (Elonva) dosage depending on weight once administered first day of ovarian stimulation in combination with hp-FSH until final oocyte maturation.
干预措施: hp-FSH (Drug)
hp-FSH (Menopur)
Corifollitropin Alfa (Elonva) dosage depending on weight once administered first day of ovarian stimulation in combination with hp-FSH until final oocyte maturation.
干预措施: Corifollitropin Alfa (Drug)
结局指标
主要结局
The financial costs of the stimulation in both groups
时间窗: 1 year
次要结局
- pregnancy rate(5 weeks)
- duration of the stimulation(one month)
- The number of MII oocytes obtained at the occasion of the oocyte retrieval(3 weeks)
- hormonal levels reached at time of induction of final maturation of the oocyte(3 weeks)
- the number of clinical OHSS patients(one month)
研究者
Dr. Decleer Wim
Principal Investigator
AZ Jan Palfijn Gent