NCT02195947已完成4 期
Does the Addition of Growth Hormone to the Invitro Fertilization/ Intracytoplasmic Sperm Injection Antagonist Protocol Improve Outcome in Poor Responders? A Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- Live birth rate
研究概览
简要总结
The effect of use of the growth hormone with antagonist protocol on the outcome of the IVF/ICSI cycles in poor responders.
详细描述
Two groups of poor responder female patients planned to receive the antagonist IVF/ICSI protocol are randomized to whether or not to add growth hormone to their protocol.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •females fulfilling the criteria of the ESHRE consensus 2011:
- •at least two of the following three features must be present:
- •dvanced maternal age (≥40 years) or any other risk factor for POR
- •previous POR (≤3 oocytes with a conventional stimulation protocol)
- •an abnormal ovarian reserve test (i.e. AFC ,5-7 follicles or AMH ,0.5 -1.1 ng/ml).
排除标准
- •women who suffer from any other cause of infertility other than poor ovarian reserve
- •refusal of the patient to consent for using her data in the study.
研究组 & 干预措施
Antagonist and Growth hormone
Experimental
HMG IM daily was administrated from day 2 of the cycle. The GnRH antagonist (Cetrotide, Serono, Geneva, Switzerland) was given when the leading follicle was from 12 to 14 mm, at a daily dose of 0.25 mg SC. Growth hormone (Norditropin, Novo nordisk) was administrated on day 6 of HMG stimulation daily in a dose of 2.5 mg S.C. 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: Up to 9 months
次要结局
- Clinical pregnancy rate(Up to 5 weeks)
研究者
研究点 (1)
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