New "System Medicine" Approach for the Development of Primary Prevention Strategies for Comorbidities in Infertile Men
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Genetic profile
研究概览
简要总结
By applying a "system medicine" approach, the project aims to identify new biomarkers and/or prognostic tools aimed at developing personalized strategies to prevent the onset of comorbidities in infertile men.
详细描述
By applying a "system medicine" approach, the project aims to identify new biomarkers and/or prognostic tools aimed at developing personalized strategies to prevent the onset of comorbidities in infertile men.
The findings will provide new insights into the relationship between male infertility and somatic health, and shed light on the role of the microbiome in modulating the activity of the immune system. A "signature" of lack of immunological tolerance and biomarkers could be useful to predict future oncologic and non-oncological comorbidities in infertile men. This will let the development of a more clinically reliable and cost-effective personalized primary/secondary prevention strategy in a population at high risk of clinically relevant diseases.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Signature of the informed consent;
- •Be adults aged > 18;
- •Caucasian race;
- •Documented diagnosis of primary male infertility with pure male factor;
排除标准
- •Failure to obtain informed consent;
- •Patients with a known history of haematological disease;
- •Patients undergoing antibiotic treatments in the last 6 months
结局指标
主要结局
Genetic profile
时间窗: Baseline
Data on karyotype and microdeletions of the Y chromosome
Semen volume
时间窗: Baseline
Semen volume (ml)
Body mass index
时间窗: Baseline
Dataon Body mass index
Thyroid-stimulating hormone
时间窗: Baseline
Data on thyroid-stimulating hormone (mU/L)
Semen concentration
时间窗: Baseline
number of spermatozoa (million/ml)
Testosterone
时间窗: Baseline
data on testosterone (ng/dL)
Medical anamnesis
时间窗: Baseline
Data collection on Charlson Comorbidity Index (CCI), partner's age, partner's health status;
Objective examination
时间窗: Baseline
presence of varicocele; testicular size and number
Follicle-stimulating hormone
时间窗: Baseline
Data on follicle-stimulating hormone (mIU/ml)
Luteinizing hormone
时间窗: Baseline
Data on luteinizing hormone (mIU/dl)
Anti-Müllerian hormone
时间窗: Baseline
Data on Anti-Müllerian hormone (ng/ml)
Inhibin B
时间窗: Baseline
Data on Inhibin B (UI/mL)
Prolactin
时间窗: Baseline
Data on Prolactin (µg/l)
Osteocalcin levels
时间窗: Baseline
Data on osteocalcin levels (ng/ml)
Spermatozoa motility and morphology
时间窗: Baseline
motility and morphology of spermatozoa (%)
次要结局
未报告次要终点
研究者
Andrea Salonia
Professor
IRCCS San Raffaele