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临床试验/NCT00461916
NCT00461916已完成4 期

Half-Dose Depot Triptorelin Versus Reduced-Dose Daily Buserelin in a Long Protocol of Controlled Ovarian Stimulation for ICSI/ET

Tehran University of Medical Sciences2 个研究点 分布在 2 个国家目标入组 182 人开始时间: 2005年5月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
182
试验地点
2
主要终点
Number of retrieved oocytes

研究概览

简要总结

The purpose of this study is to determine whether half-dose depot triptorelin are as effective as reduced-dose daily buserelin in the controlled ovarian stimulation for intracytoplasmic sperm injection and embryo transfer

详细描述

Significant doubts remain about which type of GnRH agonists [GnRHa] administration to be used in controlled ovarian stimulation [COS] cycles. The use of a single-dose depot long-acting GnRHa instead of a daily low dose preparation would be more comfortable for patients, however, inducing a profound pituitary desensitization, it increases the number of gonadotropin ampoules and the duration of the COS cycle without improving pregnancy rates or other clinical outcomes. Thus, some authors recommend a reduction of both dose and/or duration of GnRHa administration. Halving the dose of depot triptorelin, for instance, has been studied against its full dose administration since 1992 with rather similar clinical outcomes. Half-dose depot leuprolide acetate has also resulted in comparable clinical outcomes with standard daily injections in long GnRHa protocol. Reducing the daily doses of short acting GnRHa has been advocated to demonstrate equivalent results to standard doses. To our knowledge, however, the reduced daily doses have not been evaluated against half dose depot forms in long GnRHa protocols.

Thus, we originally compared a half-dose depot triptorelin with reduced daily doses of short-acting buserelin in a long protocol for intracytoplasmic sperm injection and embryo transfer [ICSI/ET] 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
Double

入排标准

年龄范围
— 至 35 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Candidate for ICSI/ET
  • 35 years old or younger
  • Serum FSH less than 10 IU/l on day three of the previous menstrual cycle
  • No more than two previous IVF/ICSI attempts
  • No planned percutaneous epididymal sperm aspiration [PESA]
  • No planned testicular sperm extraction [TESE]
  • No known history or risk of severe hyperstimulation
  • No evidence of hydrosalpinx
  • No major systemic disease
  • No uterine abnormality
  • No previous ovarian surgery

排除标准

  • 未提供

结局指标

主要结局

Number of retrieved oocytes

次要结局

  • Ectopic pregnancy rate
  • Number of days of gonadotropin stimulation
  • Number of hMG ampoules
  • Number of follicles at hCG administration
  • Quality of oocytes
  • Quality of embryos
  • Poor response rate
  • Oocyte fertilization rate
  • Ineffective intervention rate
  • Clinical pregnancy rate
  • Multiple pregnancy rate
  • Miscarriage rate
  • Implantation rate
  • Biochemical pregnancy rate

研究者

申办方类型
Other

研究点 (2)

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