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临床试验/NCT01817296
NCT01817296已完成不适用

Klinefelter Syndrome: Are we Missing the Optimal Time for Fertility Preservation?

Boston Children's Hospital2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Sperm retrieval rates based on age

研究概览

简要总结

Klinefelter syndrome occurs in 1 in 600 males and is a common cause of infertility in men. It appears scar tissue forms in these boys' testicles, leading to progressive destruction over their lifetimes. Advanced reproductive technology can be used to surgically retrieve sperm from these individuals, but these methods have a 50% failure rate in adult Klinefelter patients. Younger men have higher success rates, suggesting that adolescence and young adulthood may be the best time to extract sperm, but these techniques have not been studied in Klinefelter patients younger than 26 years of age. Additionally, there is currently no way to predict which Klinefelter patients will have success with these methods and which of them will not. This trial will explore sperm extraction in Klinefelter syndrome in an age range (12-25 years) that has never been studied, with the ultimate hope of improving the potential for fertility in these patients. The specific goals of this study are to determine the ideal age for sperm retrieval in Klinefelter patients and to establish factors that can be used to predict which of these patients will have a higher likelihood of success with advanced reproductive technology. The hypothesis is that younger Klinefelter patients will have higher sperm retrieval rates.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 25 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

  • diagnosed 47,XXY (Klinefelter syndrome)
  • 12-25 years of age

排除标准

  • testosterone therapy within past 6 months
  • history of surgery, injury, or infection in the testicle
  • solitary testicle

结局指标

主要结局

Sperm retrieval rates based on age

时间窗: Assessed at the end of the 6 month study period

Results of testicular biopsies will be reviewed for each patient during the 6 month study period

次要结局

  • Correlation between sperm retrieval rates and physical and biochemical markers(Assessed at the end of the 6 month study period)
  • Correlation between sperm retrieval rates and neurocognitive survey data(Assessed at the end of the 6 month study period)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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