Comparison of Sequential CFA vs CFA +rFSH for Elective Fertility Preservation.. The 2-shot Protocol.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- Number of MII oocytes retrieved
研究概览
简要总结
This randomized was designed as non-inferiority trial aiming to compare the number of MII oocytes with 2-shot of Corifollitropin alpha (CFA) sequential administration: 150μg at stimulation day (SD) 1 and 100μg at SD 5 and 1-shot of CFA administration 150μg at SD 1 following by rFSH 200IU daily from SD 8 in women undergoing elective fertility preservation in a progestin-primed ovarian stimulation (PPOS) protocol and GnRH-agonist (GnRH-a) triggering.
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
- 否
入选标准
- •Anti-Mullerian hormone (AMH) ≤3ng/ml (AMH result of up to one year will be valid)
- •Between 18 and 40 years old
- •BMI >18 and <30 kg/m2
- •Body weight > 50 kg for > 36 years
- •Able to come to the Center to comply with the procedures of the study: blood tests, appointments and drug dispensation.
排除标准
- •Medically indicated fertility preservation
- •AFC > 20
- •Polycystic ovarian syndrome (PCOS) according to the Rotterdam criteria
- •History of untreated autoimmune, endocrine or metabolic disorders
- •Contraindication for hormonal treatment
- •Recent history of severe disease requiring regular treatment (clinically significant concurrent medical condition that could compromise subject safety or interfered with the trial assessment).
研究组 & 干预措施
150μg CFA at stimulation day (SD) 1 and 100μg CFA at SD 5
干预措施: 150μg CFA (Elonva®) at stimulation day (SD) 1 and 100μg CFA(Elonva®) at SD 5 (Drug)
150μg CFA at SD 1 following by rFSH 200IU daily from SD 8
干预措施: 150μg CFA (Elonva®) at SD 1 following by rFSH (Puregon®) 200IU daily from SD 8 until the day of the trigger (Drug)
结局指标
主要结局
Number of MII oocytes retrieved
时间窗: Trough study completion, an average of 10-20 days.
Number of MII oocytes retrieved
次要结局
- Total number of oocytes retrieved(Trough study completion, an average of 10-20 days.)
- FSH(Up to oocyte pickup, an average of 10-20 days.)
- LH(Up to oocyte pickup, an average of 10-20 days.)
- PROGESTERONE(Up to oocyte pickup, an average of 10-20 days.)
- Estradiol(Up to oocyte pickup, an average of 10-20 days.)
- OHSS(Until 15 days after day of oocyte pick-up)
- FertiQoL(from stimulation day 1 until the day of oocyte pick-up,10-20 days after the beggining of the stimulation.)
- Length of stimulation(up to 18 days)
- Adverse events(up to 20days)