Analisi Del Profilo Sierico Steroideo Basale e Dopo Stimolo Con Gonadotropina Corionica Umana (HCG) Nei Soggetti Affetti da Sindrome di Klinefelter (SK).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Testosterone
研究概览
简要总结
The study design included six visits. During the first visit (visit 0), the subjects underwent physical examination(height, weight, body mass index (BMI), arm span, and upper segment measurement) and testicular ultrasound (US) for the calculation of testicular volume. At 0800 h of day 0, all subjects provided a basal blood sample immediately followed by a single intramuscular injection of hCG of 5000 IU. Further five visits were performed each of five following consecutive days after the hCG injection. A blood sample was taken at each visit after an overnight fast
详细描述
Blood samples were centrifuged at 2955 g for 15 min. Sera were transferred into plain polypropylene tubes and stored at -20°C until assayed. P, 17OHP, AS, DHEA, and TS were determined by LC-MS/MS at the laboratory of the Centre for Applied Biomedical Research of the S. Orsola-Malpighi Hospital, Alma Mater Studiorum, University of Bologna, Bologna, Italy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Klinefelter syndrome diagnosis at kariotype evaluation for the study group
- •Healthy age-matched men in the control group
排除标准
- •previous or ongoing androgen therapy
研究组 & 干预措施
Klinefelter syndrome
13 men with diagnosis of Klinefelter syndrome were stimulated with human chorionic gonadotropin (hCG)
干预措施: human chorionic gonadotropin (Drug)
Control
12 healthy age-related men were stimulated with human chorionic gonadotropin (hCG)
干预措施: human chorionic gonadotropin (Drug)
结局指标
主要结局
Testosterone
时间窗: visit 1 (Day 1)
Using mass spectrometry
次要结局
- Testicular volume(visit 0 (Baseline))
- Steroids(Visit 5 (Day 5))
研究者
Manuela Simoni
Ordinary Professor
Azienda USL Modena