Klinefelter Fertility Preservation

Klinefelter Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01817296
• Other study ID #: 4093
• 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. 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

• Klinefelter Syndrome

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