Treatment of Poor Ovarian Responders With Corifollitropin Alfa Followed by hpHMG in a Short GnRH Agonist Protocol
Phase II Study for the Treatment of Poor Ovarian Responders With Corifollitropin Alfa Followed by hpHMG in a Short GnRH Agonist Protocol
研究概览
详细说明
Corifollitropin alfa reaches maximum concentrations (Cmax), between 25 and 45 h after injection , a time interval which is significantly shorter as compared to treatment with rFSH. The investigators hypothesized that this rapid increase in the serum FSH concentration may result in a significantly higher exposure of the small antral follicles to constant high levels of FSH during the early follicular phase, securing not only the recruitment of the follicles, but also the continued growth.
In the current study the investigators examine whether administration of corifollitropin followed by 300IU hMG in a short GnRH agonist protocol may result in acceptable pregnancy rates in poor ovarian responders fulfilling the "Bologna criteria"
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Brussels、比利时、1090
- Centre for Reproductive Medicine UZ Brussel
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Patients should fulfill the "Bologna criteria" for poor ovarian response
At least two of the following three features must be present:
i. Advanced maternal age (≥40 years) or any other risk factor for POR (poor ovarian response); ii. A previous POR (≤3 oocytes with a conventional stimulation protocol); iii. An abnormal ovarian reserve test (i.e. AFC <7 follicles or AMH <1.1 ng/ml).
Two episodes of POR after maximal stimulation are sufficient to define a patient as poor responder in the absence of advanced maternal age or abnormal ORT (ovarian reserve test).
Exclusion Criteria:
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学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Corifollitropin alfa+hMG
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Triptorelin 0.1 mg/1 ml solution daily from day 1 or 2 of the cycle onwards
Corifollitropin alfa 150μg (single dose) on day 2 or 3 of the cycle
300IU hMG daily from day 7 following Corifollitropin alfa until the day of ovulation triggering
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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持续妊娠率
大体时间：妊娠 10 至 12 周
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妊娠 10 至 12 周
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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回收的卵母细胞数量
大体时间：取卵日
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取卵日
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胚胎移植周期
大体时间：胚胎移植日
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胚胎移植日
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合作者和调查者
调查人员
- 首席研究员：Nikolaos P Polyzos, MD PhD、Universitair Ziekenhuis Brussel
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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