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Klinefelter Fertility Preservation

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ClinicalTrials.gov Identifier: NCT01817296
Recruitment Status : Completed
First Posted : March 25, 2013
Last Update Posted : May 15, 2014
Sponsor:
Information provided by (Responsible Party):

March 13, 2013
March 25, 2013
May 15, 2014
March 2013
April 2014   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01817296 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Klinefelter Fertility Preservation
Klinefelter Syndrome: Are we Missing the Optimal Time for 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.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Klinefelter Syndrome
Procedure: Testicular Biopsy
Micro-dissection testicular sperm extraction for sperm retrieval
Experimental: Single arm
Intervention: Procedure: Testicular Biopsy
Nahata L, Yu RN, Paltiel HJ, Chow JS, Logvinenko T, Rosoklija I, Cohen LE. Sperm Retrieval in Adolescents and Young Adults with Klinefelter Syndrome: A Prospective, Pilot Study. J Pediatr. 2016 Mar;170:260-5.e1-2. doi: 10.1016/j.jpeds.2015.12.028. Epub 2015 Dec 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
Not Provided
April 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • testosterone therapy within past 6 months
  • history of surgery, injury, or infection in the testicle
  • solitary testicle
Sexes Eligible for Study: Male
12 Years to 25 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01817296
4093
Yes
Not Provided
Not Provided
Boston Children’s Hospital
Boston Children’s Hospital
Not Provided
Not Provided
Boston Children’s Hospital
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP