A Prospective Randomised Study to Evaluate the Effect of Triggering Ovulation With GnRHa (Buserelin) and Low Dose hCG (Pregnyl) as Compared to the Use of Conventional Doses of hCG (Pregnyl)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 384
- 试验地点
- 1
- 主要终点
- Frequency of Moderate to Severe OHSS.
研究概览
简要总结
The purpose of this study is to possibly further improve the clinical outcome and explore the incidence of OHSS in patients, who have final oocyte maturation with GnRHa (Buserelin) in GnRH antagonist IVF/ICSI cycles
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
- 20 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient complying with the conditions for IVF or ICSI treatment
- •Female age over 20 years and under 40 years
- •Normal regular cycle and patients with oligomenorrhea
- •BMI > 18 and < 35
- •each patient contributes with one cycle only
排除标准
- •Significant disturbances in the woman (diabetes, epilepsy, liver/renal/heart disease, metabolic disorder)
- •Patients with > 25 follicles on the day of triggering ovulation
研究组 & 干预措施
A
More than 14 follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl)
干预措施: Buserelin and Pregnyl (Drug)
B
More than 14 follicles with a diameter of > 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)
干预措施: Pregnyl (Drug)
C
14 or less follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5)
干预措施: Buserelin and Pregnyl (Drug)
D
14 or less follicles with a diameter of > 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)
干预措施: Pregnyl (Drug)
结局指标
主要结局
Frequency of Moderate to Severe OHSS.
时间窗: From the date of triggering ovulation until 2 weeks after pregnancy test. group C and D. 12 days after pregnancy test
次要结局
- Pregnancy Rate(from stimulation day 1 until last ultrasound scan 7 weeks after a positive pregnancy test)
研究者
Peter Humaidan
Prof. M.D. D.M.Sc.
Regionshospitalet Viborg, Skive