Corifollitropin Alfa (Elonva) Versus Follitropin Beta in High Responders: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Number of oocytes retrieved
研究概览
简要总结
The purpose of this randomized controlled trial (RCT) is to compare a single injection of corifollitropin-alfa versus daily injections of follitropin beta regarding the number of oocytes retrieved, hormonal profile and follicle development in patients with high response undergoing ovarian stimulation for in vitro fertilization treatment using a gonadotropin-releasing hormone (GnRH) antagonist protocol combined with GnRH agonist trigger and cryopreservation of all embryos.
详细描述
Corifollitropin alfa, a novel fusion protein lacking luteinizing hormone (LH) activity, has a longer elimination half-life and extended time to peak levels than recombinant follicle stimulating hormone (rFSH). A single injection of corifollitropin alfa may replace seven daily injections follitropin beta during the first week of ovarian stimulation, reducing patient discomfort.
The purpose of this RCT is to compare a single injection of corifollitropin-alfa versus daily injections of follitropin beta regarding the number of oocytes retrieved, as well as hormonal profile and follicle development in patients with high response undergoing ovarian stimulation for IVF using a GnRH antagonist protocol. In addition, incidence of unexpected ovarian hyperstimulation syndrome (OHSS) will be evaluated, although it is anticipated that GnRH agonist triggering will eliminate occurrence of the syndrome.
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
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: 18-40 years
- •Polycystic ovaries (PCO) or polycystic ovary syndrome (PCOS)
- •no endometriotic cyst
排除标准
- •Patients with poor response
- •Patients using human chorionic gonadotropin (hCG) for triggering final oocyte maturation.
研究组 & 干预措施
Puregon
Patients will undergo ovarian stimulation using daily injections of recombinant FSH (Puregon), as performed traditionally in IVF cycles
干预措施: Puregon (Drug)
Elonva
Patients will undergo ovarian stimulation using a single injection of corifollitropin alfa (Elonva)
干预措施: Elonva (Drug)
结局指标
主要结局
Number of oocytes retrieved
时间窗: Day of oocyte retrieval (Day 0)
次要结局
- Follicle development(Day of triggering final oocyte maturation = last day of ovarian stimulation (Day -2 prior to oocyte retrieval))
- Fertilization rate(Day 1 after oocyte retrieval)
- Incidence of severe OHSS(up to 5 days post oocyte retrieval)
- Blastocyst formation rates(Day 5/6 after oocyte retrieval)
- Number of blastocysts cryopreserved(Day 5/6 after oocyte retrieval)