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临床试验/NCT02338206
NCT02338206已完成2 期

Growth Hormone Adjuvant Therapy With Long Down Regulation Protocol in Poor Responders Undergoing In Vitro Fertilization Cycles: a Randomized Control Trial

Woman's Health University Hospital, Egypt1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2015年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
240
试验地点
1
主要终点
Live birth rate

研究概览

简要总结

The long down regulation protocol is widely used in the in vitro fertilization cycles, now it will be assessed regarding its efficacy, in poor responder females undergoing in vitro fertilization cycles, alone and after the addition of growth hormone.

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
20 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Poor responder females are those who posses two out of these three criteria:
  • Female age ≥40 years
  • Females who have at least one previous cancelled IVF cycle
  • POR according to AFC ≤ 5 or low AMH value.

排除标准

  • Females over 45 years
  • Females with FSH more than 20 IU/l
  • Females with previous ovarian surgery
  • Females suffering from causes of infertility other than poor ovarian response
  • Females refusing to be enrolled in the study

研究组 & 干预措施

Long + Growth hormone

Active Comparator

Patients in this group were given a long protocol of pituitary down-regulation with triptorelin (Decapeptyl; Ferring, Switzerland) starting on the day 21 of preceding cycle at a dose of 0.1 mg/day, subcutaneously along with Growth hormone (Norditropin, Novo nordisk) co-treatment daily in a dose of 2.5 mg S.C. till the day of hCG administration.. On the second day of menstruation, Human menopausal gonadotrophin HMG (75 IU, Merional, IBSA) was started, and this was associated with reduction of triptorelin dose to 0.05 mg/day. This reduced daily dose, in addition to HMG and growth hormone, were continued till the day of hCG administration.

干预措施: Growth hormone (Drug)

结局指标

主要结局

Live birth rate

时间窗: 12 months

Fresh, Frozen, Cumulative

次要结局

未报告次要终点

研究者

发起方
Woman's Health University Hospital, Egypt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dina Mohamed Refaat Dakhly

lecturer of obstetrics and gynecology

Woman's Health University Hospital, Egypt

研究点 (1)

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