Klinefelter Fertility Preservation
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Klinefelter Syndrome: Are we Missing the Optimal Time for Fertility Preservation?|
- Sperm retrieval rates based on age [ Time Frame: Assessed at the end of the 6 month study period ] [ Designated as safety issue: No ]Results of testicular biopsies will be reviewed for each patient during the 6 month study period
- Correlation between sperm retrieval rates and physical and biochemical markers [ Time Frame: Assessed at the end of the 6 month study period ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||March 2013|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
|Experimental: Single arm||
Procedure: Testicular Biopsy
Micro-dissection testicular sperm extraction for sperm retrieval
|Contact: Leena Nahata, MD||617-355-7476 ext email@example.com|
|United States, Massachusetts|
|Boston Children's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Leena Nahata, MD 617-355-7476 ext 2460 firstname.lastname@example.org|
|Sub-Investigator: Leena Nahata, MD|
|Principal Investigator: Richard Yu, MD, PhD|
|Sub-Investigator: Laurie Cohen, MD|
|Sub-Investigator: Ilina Rosoklija, MPH|