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临床试验/NCT04417569
NCT04417569已完成不适用

A Proof of Concept Study to Determine the Rise of Progesterone Levels After Human Chorionic Gonadotrophin (hCG) Trigger in Stimulated Cycles of IVF/ICSI

ART Fertility Clinics LLC1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年2月4日最近更新:
适应症
干预措施
相关药物

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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