Clinical Trial: Klinefelter Fertility Preservation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: Boston Children’s Hospital

Current Primary Outcome: Sperm retrieval rates based on age [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Correlation between sperm retrieval rates and physical and biochemical markers [ Time Frame: Assessed at the end of the 6 month study period ]
    Results of testicular biopsies will be correlated to physical and biochemical markers for each patient after all of the data have been collected, during the 6 month study period.
  • Correlation between sperm retrieval rates and neurocognitive survey data [ Time Frame: Assessed at the end of the 6 month study period ]
    Results of testicular biopsies will be correlated to neurocognitive survey data for each patient after all of the data have been collected, during the 6 month study period.


Original Secondary Outcome: Same as current

Information By: Boston Children’s Hospital

Dates:
Date Received: March 13, 2013
Date Started: March 2013
Date Completion:
Last Updated: May 14, 2014
Last Verified: May 2014