Optimizing Ovarian Stimulation for IVF and ICSI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 416
- 试验地点
- 1
- 主要终点
- The number of mature oocytes obtained.
研究概览
简要总结
Monitoring ovarian stimulation for in vitro fertilization (IVF) and intracytoplasmatic sperm injection (ICSI) can be simplified by reducing the procedure to measuring follicles by ultrasound. Proponents of a simplified procedure claim that the procedure can be reduced to simple monitoring by ultrasound while maintaining results (numbers of mature oocytes, percentage of pregnancy and live birth rates). On the other hand simultaneous blood sampling for measuring hormone levels is still the state of the art in many clinics. A large review (Cochrane review) stated that "although there was no clear evidence for a better outcome, combined cycle monitoring was still recommended until it could be proven that ovarian hyperstimulation can be avoided without hormonal monitoring". Investigators therefore perform a study that compares the results between 2 groups: those with ultrasound monitoring and those with combined monitoring. Deciding when to plan the retrieval of the oocytes can depend on subtle differences in the number of large follicles measured by ultrasound, but also on hormonal levels in the blood of the patient. Therefore the investigators planned a randomized study in the group of patients with combined monitoring. The investigators examined if delaying the moment for planning the moment of oocyte retrieval by 24 hours had any effect on the number of mature oocytes and pregnancy rates and what the effect of rising progesterone levels might be. The investigators hypothesis was that combined monitoring could lead to better results since recent studies have thought that rising progesterone levels, if found, have a negative impact on pregnancy rates. On the other hand the investigators expect to find that waiting for larger follicles in cases with normal progesterone levels lead to a better oocyte yield.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •absence of ovarian cysts
- •both ovaries present
排除标准
- •ovarian cysts
- •not both ovaries present
研究组 & 干预措施
ultrasound
干预措施: ultrasound (Procedure)
combined monitoring
干预措施: ultrasound (Procedure)
combined monitoring
干预措施: combined monitoring (Procedure)
ultrasound
干预措施: combined monitoring (Procedure)
结局指标
主要结局
The number of mature oocytes obtained.
时间窗: 1 day
次要结局
- The number of fertilized oocytes/good quality embryos(at the moment of egg retrieval up to embryo transfer, assessed up to 100 months)
- Pregnancy rate(12 months after egg retrieval)
- clinical pregnancy rate(12 months after egg retrieval)
- ongoing pregnancy rate(12 months after egg retrieval)
- live birth rate for each individual transferred embryo(12 months after egg retrieval)
