NCT01165619终止不适用
Detailed Clinical, Biochemical and Genetic Characterization in GnRH Deficiency Disorders
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Serum/plasma markers
研究概览
简要总结
In this study, we will measure levels of reproductive hormones and metabolic markers in subjects with isolated GnRH deficiency disorders and compare them to healthy control populations. Our goals are (1) to chart the range of hormonal and metabolic biomarkers in healthy subjects and those with reproductive disorders and (2) to correlate reproductive and metabolic phenotypes with genetic changes within patients with reproductive disorders and healthy controls.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Over the age of 18 for men
- •Between the ages of 18 and 40 for women
- •For reproductive disorder population: Current or previous diagnosis of Idiopathic Hypogonadotropic Hypogonadism or Hypothalamic Amenorrhea
排除标准
- •chronic disease (hypertension, high cholesterol, diabetes, asthma, etc)
- •polycystic ovarian syndrome for women
- •prescription medication use (other than allergy meds) for control populations
- •irregular menstrual cycles for healthy female control population (cycle length longer than 35 days or shorter than 25 days. cycle length varies by more than 5 days. less than 9 periods per year)
结局指标
主要结局
Serum/plasma markers
时间窗: baseline
At the study visit, serum and plasma samples will be taken to measure levels of reproductive hormones and metabolic markers in the subjects' blood.
次要结局
- Genetics(baseline)
研究者
研究点 (1)
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