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临床试验/NCT00948805
NCT00948805Unknown3 期

Evaluation of the Luteolytic Effect of a Gonadotropin Releasing Hormone (GnRH) Agonist After the Administration of Human Chorionic Gonadotropin (hCG) in the Initial Follicular Phase a Its Influence on the Prognosis of in Vitro Fertilization Treatment

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 25 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
3 期
入组人数
25
试验地点
1
主要终点
Frequency of functional rescue of corpus luteum

研究概览

简要总结

This study was designed to evaluate the ability of gonadotropin releasing hormone (GnRh) agonist to prevent the rise of progesterone during controlled ovarian stimulation for in vitro fertilization (IVF) after the administration of human Chorionic Gonadotropin (hCG) on the first day of menses.

详细描述

The aim of this study is to evaluate the efficacy of a GnRH agonist in preventing the functional rescue of corpus luteum in women submitted to controlled ovarian stimulation with administration of hCG on the first day of menses and to evaluate its effect on pregnancy rate and ovarian steroidogenesis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 38 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • age >21 and < 38 years old
  • polycystic ovarian syndrome
  • risk for ovarian hyperstimulation syndrome

排除标准

  • recurrent abortion
  • endometriosis
  • more than 3 IVF failures
  • use of oral contraceptive pills in the preceding 3 months
  • low response to gonadotropins

研究组 & 干预措施

GnRH agonist

Experimental

3,6 mg of goserelin acetate (GnRH agonist) will be administered on the 21st day of the menstrual cycle previous to ovarian stimulation. 250 mg of hCG will be administered on the first day of menses and a starting dose of 150 IU of FSH will be started 2 days later as a part of a long ovarian stimulation protocol. Ovulation will be triggered with a 250 mg of hCG when at least 2 follicles attain 18mm and to accommodate oocyte retrieval within 36 hours.

干预措施: GnRH agonist (Drug)

Control

Active Comparator

250 mg of hCG will be administered on the first day of menses and a starting dose of 150 IU of FSH will be started 2 days later as a part of a long ovarian stimulation protocol. Ovulation will be triggered with a 250 mg of hCG when at least 2 follicles attain 18mm and to accommodate oocyte retrieval within 36 hours.

干预措施: Control (Drug)

结局指标

主要结局

Frequency of functional rescue of corpus luteum

时间窗: 6 months

次要结局

  • Pregnancy rate(6 months)
  • Levels of serum steroids(6 months)
  • Levels of serum gonadotropins(6 months)

研究者

申办方类型
Other

研究点 (1)

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