Initiation of Ovarian Stimulation With Recombinant-human FSH (Bemfola®) in the Late Follicular Phase, a Randomised Controlled Pilot Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- total amount of COC (cumulus-oocyte-complex)
研究概览
简要总结
A randomised controlled open-label clinical trial to compare the outcome parameters after ovarian stimulation using recombinant-human FSH (follicle stimulating hormone), starting on day 2 of the cycle versus start in the late follicular phase of the cycle.
详细描述
Objective: To determine whether late follicular stimulation using recombinant-human FSH has comparable outcomes to treatment using recombinant-human FSH in early follicular phase in a flexible GnRH (Gonadotropin-releasing hormone) antagonist protocol, in oocyte donor patients.
Design: Open label, phase 3 randomized trial using a two-arm design with 1:1 allocation ratio
Patients: Oocyte donors (aged 18-36 years)
Intervention(s): Reference group: Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from day 2 of follicular phase onwards. Initiation of GnRH antagonist (ganirelix, 0.25mg/day) on stimulation day 6 till day of trigger.
Investigational group: Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from the late follicular phase of the menstrual cycle (evaluation trough ultrasound and hormonal assessment) onwards. Start of GnRH antagonist (ganirelix 0.25mg/day) when serum LH (Luteinizing Hormone) > 10 IU/L, till day of trigger.
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 36 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •oocyte donor patients
- •Age from 18 to 36 years
- •BMI 19 to 35
- •Regular menstrual cycle length i.e. 24-35 days
排除标准
- •Patients with AMH <1.1 ng/ml and/or AFC<7
- •Patients with FNPO (Follicle Number Per Ovary) ≥ 19 and/ord AMH >5ng/ml
- •Endometriosis grade 3-4
- •Oligo-amenorrhea
- •Any untreated endocrine abnormality
结局指标
主要结局
total amount of COC (cumulus-oocyte-complex)
时间窗: at oocyte aspiration
次要结局
- Consumption of gonadotrophins(during the ovarian stimulation)
- Total number of mature oocytes(at day of oocyte aspiration)
- Number of days needed for ovarian stimulation(during the ovarian stimulation)
- Endocrine profile(on menstrual cycle day 2 and 9, (extra days as per site protocol) and day of oocyte maturation trigger in reference group. On menstrual cycle day 2 and 12, (extra days as per site protocol) and day of oocyte maturation trigger in investigational group)
- Total medication cost(during the ovarian stimulation)
- Days of GnRH antagonist use(during the ovarian stimulation)