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临床试验/NCT00823472
NCT00823472终止4 期

Among IVF Patients Undergoing Fixed Antagonist Protocols With Recombinant FSH, Does Administration of Recombinant FSH From Cycle Day 5 Onwards Compared With Cycle Day 2 Onwards, Yield a Higher Number of Good Quality Embryos?

UMC Utrecht2 个研究点 分布在 2 个国家目标入组 147 人开始时间: 2009年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
发起方
UMC Utrecht
入组人数
147
试验地点
2
主要终点
Proportion of Top Embryos Per OPU.

研究概览

简要总结

Background of the study:

Milder stimulation protocols have the advantage of being less expensive and more patient-friendly. Moreover, recent evidence suggests that mild stimulation protocols lead to lower embryo aneuploidy rates compared to conventional treatment regimens. Although with mild stimulation protocols the expected number of oocytes retrieved will be lower, pregnancy rates have shown to be similar possibly because embryo quality outfavours embryo quantity.

Objective of the study:

The aim of the study is to determine whether cycle day (CD) 5 start of stimulation will lead to better quality of embryos, based on morphology, than CD 2 start, in IVF with GnRH antagonist co-treatment started on a fixed day.

Study design:

Prospective randomized trial comparing two different starting days of ovarium stimulation (day 2 versus day 5) for IVF treatment.

Intervention:

One group wil start on cycle day 2 with stimulation of the ovaries with recombinant FSH. The other group will start on cycle day 5. Both group will start suppressing the gonadotrophin production of the the pituitary gland on cycle day 6 with a GnRH antagonist.

Primary study parameters/outcome of the study:

Primary outcome parameter is number of top embryos per ovum pick up.

Secondary study parameters/outcome of the study:

Secondary outcome measures are duration of stimulation, cancellation rate, fertilization rate, number of cumulus oocyte complexes obtained, number of mature oocytes obtained, number of top embryos per started cycle, amount of IU recFSH, and clinical pregnancy rate.

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 36 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female age < 36 years
  • FSH < 12 IU/l
  • BMI 18-29 kg/m2
  • Regular cycle (25-35 days)
  • No major uterine or ovarian abnormalities
  • No previous IVF cycles
  • Written informed consent

排除标准

  • Oocyte donation
  • Medical contra indication for pregnancy or IVF treatment
  • Endometriosis ≥ grade 3
  • Polycystic Ovarium Syndrome (PCOS)
  • Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)

研究组 & 干预措施

Start rFSH cycle day 2

Experimental

干预措施: Mild stimulation (Drug)

Start rFSH on cycle day 5

Experimental

干预措施: Mild stimulation (Drug)

结局指标

主要结局

Proportion of Top Embryos Per OPU.

时间窗: 1 year

Proportion of top embryos per ovum pick-up

次要结局

  • Number of Cumulus Oocyte Complexes Obtained(one year)

研究者

发起方
UMC Utrecht
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bart CJM Fauser

Professor

UMC Utrecht

研究点 (2)

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