Phase II Study for the Treatment of Poor Ovarian Responders With Corifollitropin Alfa Followed by hpHMG in a Short GnRH Agonist Protocol
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Ongoing pregnancy rate
研究概览
简要总结
The purpose of the present study is to examine the level of ovarian response and the pregnancy rates among poor ovarian responders treated with a novel treatment protocol with 150μg corifollitropin alfa followed by 300IU hMG in a short GnRH agonist protocol.
详细描述
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"
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- 未提供
研究组 & 干预措施
Corifollitropin alfa+hMG
干预措施: Triptorelin (Drug)
Corifollitropin alfa+hMG
干预措施: Corifollitropin alfa (Drug)
Corifollitropin alfa+hMG
干预措施: hpHMG (Drug)
结局指标
主要结局
Ongoing pregnancy rate
时间窗: 10 to 12 weeks of gestation
次要结局
- Number of oocytes retrieved(Day of oocyte retrieval)
- Cycles with embryo transfer(Day of Embryo transfer)
研究者
Nikolaos P. Polyzos
Principal investigator
Universitair Ziekenhuis Brussel