Celiac Disease and Infertility Among Men and Women in Denmark: Prevalence of Celiac Disease Among Men and Women Treated in Danish Public Fertility Clinics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 900
- 试验地点
- 2
- 主要终点
- Prevalence of celiac disease
研究概览
简要总结
The purpose of this study is to estimate the prevalence of celiac disease in a population of men and women newly referred to fertility treatment in Danish public fertility clinics.
详细描述
Aims of the study:
-
To investigate the prevalence of CD in a cohort of men and women referred to fertility treatment in Danish fertility clinics
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To compare individuals diagnosed with CD to individuals without the disease to investigate:
-
possible predictive symptoms of CD (fertility history, gastrointestinal symptoms, co-morbidity)
-
semen quality among men
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To investigate the effect of a gluten free diet on semen quality (DNA fragmentation) in men diagnosed with CD before and after 3 months treatment with a gluten free diet
-
To investigate correlation between sCD163 and histological changes in the small-bowel
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To investigate the correlation between level of sCD163 and level of macrophages in biopsies
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To evaluate the performance of a rapid point-of-care serologic CD screening test in a population of men and women referred to fertility treatment
Hypothesises of the study:
- CD increases the risk of infertility in both men and women
- Predictive symptoms of CD can be identified and used to select future risk-groups
- Untreated CD in men has a negative effect on semen quality and semen quality improves by treatment with a gluten free diet
- Level of sCD 163 correlates with degree of inflammatory lesions in the small-bowel
- Level of sCD163 correlate with level of macrophages in the mucose-tissue of the small-bowel
- The rapid point-of-care test is an efficient tool for CD case finding in an adult population
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •Men and women referred to fertility treatment in a fertility clinic in Denmark, (couples)
- •Age > 18 years
- •Able to read and understand the Danish language
排除标准
- •Lack of capacity to consent for themselves
- •Individuals not living in Denmark
- •Single women
- •Homosexual couples
结局指标
主要结局
Prevalence of celiac disease
时间窗: Referral to fertility clinics over a period of two years
Celiac disease confirmed by histological lesions of the small-bowel
次要结局
- Gastrointestinal symptoms of undiagnosed celiac disease(One week symptoms)
- Soluble CD163 mg/L(baseline)