Follicular Phase Endocrine Characteristics During Ovarian Stimulation and GnRH Antagonist Co-treatment for IVF; Randomized Trial Comparing Corifollitropin Alfa (Elonva) Initiated on Cycle Day 2 or 4.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Consumption of rFSH at the end of the follicular phase
研究概览
简要总结
The purpose of the present study is to analyse if corifollitropin alfa, an agent for prolonged ovarian stimulation, administered from day 4 can be clinically used instead of day 2 onwards for a controlled ovarian hyperstimulation (COH) in an antagonist protocol.
详细描述
Corifollitropin alfa is a new recombinant gonadotrophin with sustained follicle-stimulating activity. It offers novel and effective treatment option for potential normal responder patients undergoing ovarian stimulation with GnRH antagonist co-treatment for IVF or in vitro fertilisation resulting in a high ongoing pregnancy rate, equal to that achieved with daily rFSH. Normally, this medication is started on day 2 of the cycle. In the present randomised trial, we want to evaluate whether this agent can be clinically used when started on day 4 of the cycle.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 36 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •< 36 years old on day of randomisation
- •FSH < 12 (in the early follicular phase)
- •Normal ultrasound scan, i.e. presence of both ovaries, without evidence of abnormality within 6 months prior to randomisation.
- •Regular menstrual cycles of 21-35 days, presumed to be ovulatory.
- •Weight > 60 kg
- •< 3 previous trials
- •Randomisation at out-patient clinic
排除标准
- •≥ 36 years old on day of randomisation
- •Endometriosis ≥ grade 3
- •Poor responders (development of < 4 follicles in a previous IVF/ICSI cycle)
- •Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)
研究组 & 干预措施
Day 2 group
Patients undergo a standard treatment with a classical start of corifollitropin alfa in a GnRH antagonist protocol.
干预措施: corifollitropin alfa (Drug)
Day 4 group
Patients undergo an ovarian stimulation, but start on day 4 with corifollitropin alfa
干预措施: corifollitropin alfa (Drug)
结局指标
主要结局
Consumption of rFSH at the end of the follicular phase
时间窗: up to 9 months
The purpose is to assess the additional need for recFSH in each treatment group
次要结局
- Pregnancy rate(Up to 9 months)
研究者
Blockeel Christophe
MD, PhD
Universitair Ziekenhuis Brussel