Klinefelter Fertility Preservation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01817296
First received: March 13, 2013
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Klinefelter Syndrome
Procedure: Testicular Biopsy

Study Type: Interventional
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?

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 15
Study Start Date: March 2013
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single arm Procedure: Testicular Biopsy
Micro-dissection testicular sperm extraction for sperm retrieval

  Eligibility

Ages Eligible for Study:   12 Years to 25 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01817296

Locations
United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hospital Boston
  More Information

No publications provided

Responsible Party: Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01817296     History of Changes
Other Study ID Numbers: 4093
Study First Received: March 13, 2013
Last Updated: May 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
Klinefelter
Fertility

Additional relevant MeSH terms:
Klinefelter Syndrome
Sex Chromosome Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Gonadal Disorders
Endocrine System Diseases
Hypogonadism

ClinicalTrials.gov processed this record on July 28, 2014