A Proof of Concept Study to Determine the Rise of Progesterone Levels After Human Chorionic Gonadotrophin (hCG) Trigger in Stimulated Cycles of IVF/ICSI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Level of progesterone day of trigger
研究概览
简要总结
This study will determine the rise of progesterone levels after human chorionic gonadotrophin (hCG) trigger in stimulated cycles IVF/ICSI
详细描述
Studies have suggested that controlled ovarian hyperstimulation adversely affects endometrial receptivity. In ovarian stimulation cycles with exogenous gonadotrophins there is an ongoing debate regarding the effect of a late follicular phase progesterone level on reproductive outcomes. It is not yet clarified if an elevated serum progesterone level in the late follicular phase is a symptom or cause of an adverse effect on reproductive outcomes. A new hypothesis is evolving and gaining momentum providing a novel explanation for the association between late follicular phase progesterone rise and reproductive outcome. It is proposed that exogenous FSH (Follicle-stimulating hormone) administration results in supraphysiological levels of FSH, which induce an abundance of LH (luteinizing hormone) receptors on granulosa cells causing the follicles to become hypersensitive to LH-like activity (ie hCG trigger). Based on this hypothesis, the focus should be placed on the hCG trigger rather than on the late follicular phase progesterone rise.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 42 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females aged 18 to 42 years with regular menstrual cycles of 26-34 days
- •Undergoing ovarian stimulation for IVF/ICSI & PGS.
- •Receiving recombinant FSH for stimulation
- •hCG 5000iu IM as trigger injection for oocyte maturation.
- •Ovarian stimulation in GnRH-antagonist protocols
- •BMI 18- 35 kg/m2
- •Having 1 or 2 euploid embryos for transfer in spontaneous natural cycles.
排除标准
- •Poor ovarian reserve as defined by Bologna criteria
- •PCOS in accordance with Rotterdam criteria
研究组 & 干预措施
stimulated cycles
Patients will have blood drawn on five separate occasions: before and following hCG trigger on the day of final oocyte maturation and day of egg collection
干预措施: Ultrasound (Diagnostic Test)
stimulated cycles
Patients will have blood drawn on five separate occasions: before and following hCG trigger on the day of final oocyte maturation and day of egg collection
干预措施: hCG (Drug)
stimulated cycles
Patients will have blood drawn on five separate occasions: before and following hCG trigger on the day of final oocyte maturation and day of egg collection
干预措施: Blood test (Other)
结局指标
主要结局
Level of progesterone day of trigger
时间窗: 1 day
day of the hCG trigger between 1000h - 1200h, before trigger, 1 hour after trigger, 2 hrs after trigger
次要结局
- Level of progesterone day of egg retrieval(1 day)
