Multicentric Randomized Controlled Study to Determine a Tailored Strategy for Controlled Ovarian Stimulation in IVF Based on AMH, BMI and AFC
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- number of mature follicles
研究概览
简要总结
The study objective is to develop a tailored based strategy for ovarian stimulation in IVF patients using AMH, BMI, antral follicle count (AFC).
300 patients will be randomized in 2 arms:
- control group: standard care rec FSH.
- study group: modified dose of Rec FSH based on AFC with a correction factor based on BMI and basal AMH level.
Primary endpoints: number of mature follicles and eggs collected at egg retrieval; amount of rec FSH used.
Secondary endpoints: fertilization rate; cleavage rate; clinical pregnancy rate; inhibin B and AMH levels during ovarian stimulation.
详细描述
The study objective is to develop a tailored based strategy for ovarian stimulation in IVF patients using AMH, BMI, AFC and inhibin B.
300 patients will be stimulated with rec FSH and an antagonist pituitary inhibition protocol, and randomized (at random computer generated numbers) in 2 arms:
- control group: standard care recFSH based on age, basal FSH and AFC.
- study group: modified dose of Rec FSH based on AFC with a correction factor based on BMI and basal AMH level.
FSH administration: 20IU per antral follicle (from 2-5mm) corrected as follows:
Correction factor for
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 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female infertile patients eligible for IVF treatment
排除标准
- •polycystic ovaries
- •untreated thyroid pathology
- •hypogonadotropic hypogonadism
- •untreaed hyperprolactinemia
- •study drug hypersensitivity
- •previous OHSS
- •unilateral ovariectomy
- •genital malformation
研究组 & 干预措施
study group
modified dosage of recFSH for controlled ovarian stimulation based on AMH, BMI and AFC
干预措施: recFSH (Drug)
control group
standard care recFSH
干预措施: recFSH (Drug)
结局指标
主要结局
number of mature follicles
时间窗: 2 years
number of oocytes retrieved
时间窗: 2 years
rec FSH dose used
时间窗: 2 years
次要结局
- AMH level during stimulation(2 years)
- Inhibin B level during stimulation(2 years)
- clinical pregnancy rate(2 years)
- fertilization rate(2 years)
- cleavage rate(2 years)
研究者
Wyns
MD, PhD
Cliniques universitaires Saint-Luc- Université Catholique de Louvain