Back to resultsKlinefelter Fertility Preservation
Primary Purpose
Klinefelter Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Testicular Biopsy
Sponsored by
About this trial
This is an interventional treatment trial for Klinefelter Syndrome focused on measuring Klinefelter, Fertility
Eligibility 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
Sites / Locations
- Boston Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single arm
Arm Description
Outcomes
Primary Outcome Measures
Sperm retrieval rates based on age
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
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
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.
Full Information
NCT ID
NCT01817296
First Posted
March 13, 2013
Last Updated
May 14, 2014
Sponsor
Boston Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01817296
Brief Title
Klinefelter Fertility Preservation
Official Title
Klinefelter Syndrome: Are we Missing the Optimal Time for Fertility Preservation?
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Children's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Klinefelter Syndrome
Keywords
Klinefelter, Fertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Testicular Biopsy
Intervention Description
Micro-dissection testicular sperm extraction for sperm retrieval
Primary Outcome Measure Information:
Title
Sperm retrieval rates based on age
Description
Results of testicular biopsies will be reviewed for each patient during the 6 month study period
Time Frame
Assessed at the end of the 6 month study period
Secondary Outcome Measure Information:
Title
Correlation between sperm retrieval rates and physical and biochemical markers
Description
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.
Time Frame
Assessed at the end of the 6 month study period
Title
Correlation between sperm retrieval rates and neurocognitive survey data
Description
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.
Time Frame
Assessed at the end of the 6 month study period
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26746120
Citation
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.
Results Reference
derived
Learn more about this trial
Klinefelter Fertility Preservation
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