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临床试验/NCT01468441
NCT01468441已完成不适用

Effect of Ovarian Stimulation Using Recombinant FSH and GHRH Antagonist in Alternate Days on ICSI Outcomes

Fertility - Assisted Fertilization Center1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2011年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
96
试验地点
1
主要终点
cost of treatment

研究概览

简要总结

The present prospective study was designed to compare the effects of administering a daily dose of gonadotrophin releasing hormone (GnRH) antagonist vs. an alternate-day dosage of GnRH agonist on ovarian response and in vitro fertilization (IVF) outcome in patients stimulated with recombinant follicle-stimulating hormone (FSH) and human chorionic gonadotrophin (hCG) microdose.

详细描述

Inclusion criteria were as follows: women of good physical and mental health, under 37 years old, with regular menstrual cycles of 25-35 days, normal basal FSH and luteinizing hormone (LH) levels, body mass index (BMI) less than 30 kg/m2, presence of both ovaries and intact uterus, absence of polycystic ovaries, endometriosis, or gynaecological / medical disorders and a negative result in a screening for sexually transmitted diseases.

No patient had received any hormone therapy for at least 60 days preceding the study. Eligible patients who agreed to participate were randomized in two treatment groups. Patients were allocated to a GnRH analogue treatment group according to a computer-generated randomization table.

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
Single (Participant)

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

  • women of good physical and mental health
  • under 37 years old, with regular menstrual cycles of 25-35 days
  • normal basal FSH and LH levels
  • BMI less than 30 kg/m2
  • presence of both ovaries and intact uterus
  • absence of polycystic ovaries
  • endometriosis, or gynaecological / medical disorders and a negative result in a screening for sexually transmitted diseases
  • all patients signed a written informed consent form
  • no patient had received any hormone therapy for at least 60 days preceding the study.

排除标准

  • 未提供

研究组 & 干预措施

GnRH agonist

Experimental

Administration of GnRH agonist in alternate days, recombinant FSH and hCG microdose for ovarian stimulation.

干预措施: Triptorelin (Drug)

GnRH antagonist

Active Comparator

Daily administration of GnRH antagonist, recombinant FSH and hCG microdose for ovarian stimulation.

干预措施: Cetrorelix (Drug)

结局指标

主要结局

cost of treatment

时间窗: One month

次要结局

  • Implantation and pregnancy rates(2 months)

研究者

发起方
Fertility - Assisted Fertilization Center
申办方类型
Other
责任方
Sponsor

研究点 (1)

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