Klinefelter Fertility Preservation

Not Applicable

Completed

• Conditions: Klinefelter Syndrome
• Interventions: Procedure: Testicular Biopsy

• Registration Number: NCT01817296
• Lead Sponsor: Boston Children's Hospital

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 Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-13
• Study First Submitted QC: 2013-03-20
• Study First Posted: 2013-03-25
• Primary Completion: 2014-04
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-14
• Last Update Posted: 2014-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	Testicular Biopsy	-

Primary Outcome Measures

Name	Time	Method
Sperm retrieval rates based on age	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

Secondary Outcome Measures

Name	Time	Method
Correlation between sperm retrieval rates and physical and biochemical markers	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	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.

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States