Corifollitropin Alfa Compared to Daily Rec FSH in Poor Responders Undergoing ICSI Using a GnRH Antagonist Protocol
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Total number of retrieved oocytes
研究概览
简要总结
Corifollitropin alfa has been shown to result in significantly more oocytes compared to daily recombinant follicle stimulating hormone (recFSH) (Devroey et al., 2009), probably due to the higher circulating FSH activity during the first days of stimulation. For this reason, the use of corifollitropin alfa might be beneficial in poor responders in whom the number of oocytes retrieved is crucial for success.
The purpose of this study is to evaluate the effectiveness of corifollitropin alfa treatment compared to daily recFSH in terms of the number of oocytes retrieved in a defined population of poor responder patients undergoing intracytoplasmic sperm injection (ICSI) using gonadotrophin releasing hormone (GnRH) antagonists.
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 (Outcomes Assessor)
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
- •Proven poor responders of couples with an indication for COS
- •≥ 18 and < 45 years of age
- •BMI ≥ 18 and ≤ 32 kg/m2
- •Regular spontaneous menstrual cycle (24-35 days)
- •Availability of ejaculatory sperm (use of donated and/or cryo-preserved sperm is allowed)
排除标准
- 未提供
研究组 & 干预措施
Corifollitropin alfa group
On day 2 of the cycle, a single subcutaneous (SC) dose of 150 μg Corifollitropin alfa (Elonva) will be administered.
GnRH antagonist (Orgalutran) 0.25 mg/day flexible initiation by a follicle of 14mm.
A daily dose of recFSH (450 IU/day) will be used from day 8 of stimulation until the day of hCG, if necessary.
Triggering of final oocyte maturation will be performed using 250 μg of rechCG.
干预措施: Corifollitropin alfa (Drug)
rec FSH group
On day 2 of the cycle, daily SC dose of min 450 IU recFSH (Puregon) will be administered.
GnRH antagonist (Orgalutran) 0.25 mg/day , flexible initiation by a follicle of 14mm.
Triggering of final oocyte maturation will be performed using 250 μg of rechCG.
干预措施: rFSH (Drug)
结局指标
主要结局
Total number of retrieved oocytes
时间窗: 36 h after human chorionic gonadotrophin (hCG) administration
次要结局
- Clinical pregnancy rate (evidence of intrauterine sac with fetal heart activity at 6-8 weeks of gestation)(At 6-8 weeks of gestation)
- Number of embryos transferred(2 days following oocyte retrieval)
研究者
E.M. Kolibianakis
Assistant Professor
Aristotle University Of Thessaloniki