A Randomized Controlled Trial to Compare the Efficacy Between Pergoveris and Follitropin Alfa in Ovarian Stimulation in Patients Aged ≥ 35 Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Clinical pregnancy
研究概览
简要总结
To compare the efficacy between LH supplementation (Pergoveris) and non-LH supplementation (Follitropin alpha) in patients aged ≥ 35 years undergoing IVF treatment.
Study hypothesis: Pergoveris (LH supplementation) is better than follitropin alpha (non-LH supplementation) for ovarian stimulation in aged IVF patients.
详细描述
A randomized controlled single center study.
Based on the difference of 19.1% in the clinical pregnancy rate between the two treatment groups, with and without LH supplementation, in a previous study, with 90% power and a 2-sided P-value of 0.05, the number of subjects required was 109 per group (total 218). The recruitment target was 120 subjects per group (total 240) to allow for dropouts.
Eligible subjects were randomized in blocks of 4 via a computer generated random number list to either the Pergoveris arm or the follitropin alpha arm.
Ovarian stimulation was performed by using GnRH antagonist protocol.
Follitropin alfa (recombinant FSH) was administered on day 2 or day 3 of the menstrual cycle. The first FSH dose was determined according to each individual patient, based on the process as follows:
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
- 35 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age ≥ 35 years
- •body mass index <28 kg/m2
- •had ≤ 3 previous IVF attempts
- •receiving a GnRH-antagonist protocol
- •agreement to participate in the study, and to disclose any medical events to the investigator. The subject must be willing and able to comply with the protocol requirements for the duration of the study.
- •have given written informed consent with the understanding that the subject may withdraw consent at any time
排除标准
- •participating in another interventional clinical trial
- •PCOS or WHO group 1
- •have uterine abnormalities
- •have endocrine disorders such as hyperprolactinemia, thyroid disorders
研究组 & 干预措施
Pergoveris (FSH and LH)
150 IU of recombinant FSH and 75 IU of recombinant LH (Pergoveris) daily subcutaneous injection
干预措施: Pergoveris (FSH and LH) (Drug)
Follitropin alpha (FSH)
150 IU of recombinant FSH (follitropin alpha or Gonal-F) daily subcutaneous injection
干预措施: Follitropin alpha (FSH) (Drug)
结局指标
主要结局
Clinical pregnancy
时间窗: 7 weeks after embryo transfer
Clinical pregnancy is defined by the image gestational sac under ultrasonography.
Live birth
时间窗: at the time of delivery
Live birth is defined if a live newborn delivered.
次要结局
- Total FSH international units (IU) used for stimulation(Measure at the time when stimulation finishes, eg. in average 10-11 days, maximum 20 days)
研究者
Manh Tuong Ho
Doctor
Vietnam National University