The Luteal Phase After GnRHa Trigger - a Proof of Concept Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Levels of progesterone in the mid-luteal phase.
研究概览
简要总结
The purpose of this study is to investigate levels of progesterone in the luteal phase after various stimulations in the follicular phase and treatment with GnRH antagonist protocol followed by GnRHagonist as induction of ovulation.
详细描述
The purpose of this study is to investigate levels of progesterone in the luteal phase after various stimulations in the follicular phase and treatment with GnRH antagonist protocol followed by GnRHagonist as induction of ovulation. Furthermore the aim is to explore whether the luteal phase can be supported with small daily boluses of hCG without the administration of exogenous P, while maintaining good reproductive outcome.
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
- 25 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women from the age of 25 up to 40
- •Serum-FSH and serum-LH levels under 12 IU/L
- •Length of period between 25 and 34 days
- •BMI between 18 and 30
排除标准
- •less than 2 ovaries
- •uterine abnormalities
- •PCOS or UL-PCO (more than 11 follicles over 12 mm in 1 ovary
研究组 & 干预措施
hCG in the late follicular phase + luteal phase
干预措施: hCG(r-hCG, Ovitrelle, Merck-Serono, Hellerup, Denmark) in the late follicular phase + luteal phase (Drug)
hCG in the follicular phase + luteal phase
干预措施: hCG(r-hCG, Ovitrelle,Merck-Serono, Hellerup, Denmark) in the follicular phase + luteal phase (Drug)
LH in the luteal phase
干预措施: LH(r-LH,Luveris, Merck-Serono, Hellerup, Denmark) in the luteal phase (Drug)
vaginal progesterone and estradiol in the luteal phase
干预措施: vaginal progesterone(Crinone; Merck-Serono, Hellerup, Denmark) and estradiol(Estrofem; Novo Nordisk, Copenhagen, Denmark) in the luteal phase (Drug)
结局指标
主要结局
Levels of progesterone in the mid-luteal phase.
时间窗: up to 1-1½years.
次要结局
未报告次要终点
研究者
Helle Olesen Elbaek
Clinical Director, M.D.
Regionshospitalet Viborg, Skive