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临床试验/NCT01980563
NCT01980563已完成不适用

Optimizing Ovarian Stimulation for IVF and ICSI

University Hospital, Ghent1 个研究点 分布在 1 个国家目标入组 416 人开始时间: 2011年1月1日最近更新:
适应症
干预措施

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

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

Active Comparator

干预措施: ultrasound (Procedure)

combined monitoring

Active Comparator

干预措施: ultrasound (Procedure)

combined monitoring

Active Comparator

干预措施: combined monitoring (Procedure)

ultrasound

Active Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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