NCT02091128已完成不适用
Pregnancy Chances in Classic Galactosemia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Pregnancy incidence despite POI diagnosis
研究概览
简要总结
With this study, in which the incidence of pregnancy in classic galactosemia patients is studied, we aim to provide new insights to improve counselling. Our hypothesis is that the chance that a galactosemic woman with POI becomes pregnant is higher than the 5-10% that has been reported for women with POI due to other causes. Chance of spontaneous pregnancy will be evaluated through semi standardized interview in women with classic galactosemia aged 18 years or older. During the interview, questions will be asked regarding fertility and pregnancy.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Classic galactosemia diagnosed by GALT enzyme activity assay or GALT-gene mutation analysis
- •Eighteen years of age or older
- •Diagnosed with POI defined as symptoms of hypergonadotrophic hypogonadism measured by serum concentrations of FSH and estradiol
- •Capable of giving informed consent
排除标准
- •Any known congenital or acquired disease or disorder negatively affecting pubertal development and/or fertility.
结局指标
主要结局
Pregnancy incidence despite POI diagnosis
时间窗: day 1
Will be assessed during semi-standardized interview
次要结局
- Hormonal replacement therapy usage(day 1)
- Menstrual history(day 1)
- Whether women have tried to conceive(day 1)
- Time to pregnancy (in case a participant has been pregnant)(day 1)
研究者
研究点 (1)
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