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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01817296
Other study ID # 4093
Secondary ID
Status Completed
Phase N/A
First received March 13, 2013
Last updated May 14, 2014
Start date March 2013

Study information

Verified date May 2014
Source Children's Hospital Boston
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Male
Age group 12 Years to 25 Years
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Testicular Biopsy
Micro-dissection testicular sperm extraction for sperm retrieval

Locations

Country Name City State
United States Boston Children's Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital Boston

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sperm retrieval rates based on age Results of testicular biopsies will be reviewed for each patient during the 6 month study period Assessed at the end of the 6 month study period No
Secondary Correlation between sperm retrieval rates and physical and biochemical markers 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. Assessed at the end of the 6 month study period No
Secondary Correlation between sperm retrieval rates and neurocognitive survey data 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. Assessed at the end of the 6 month study period No
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