Klinefelter Fertility Preservation

NCT01817296 | Completed DMC

• 1 other identifier: 4093
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Klinefelter Syndrome

Keywords

Klinefelter; Fertility

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Correlation between sperm retrieval rates and physical and biochemical markers

  Assessed at the end of the 6 month study period

• Correlation between sperm retrieval rates and neurocognitive survey data

  Assessed at the end of the 6 month study period

Study Arms (1)

Single arm

EXPERIMENTAL

Procedure: Testicular Biopsy

Interventions

Testicular Biopsy PROCEDURE

Micro-dissection testicular sperm extraction for sperm retrieval

Single arm

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• diagnosed 47,XXY (Klinefelter syndrome)
• years of age

You may not qualify if:

• testosterone therapy within past 6 months
• history of surgery, injury, or infection in the testicle
• solitary testicle

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• 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.

  PMID: 26746120 DERIVED

MeSH Terms

Conditions

Klinefelter Syndrome

Condition Hierarchy (Ancestors)

Sex Chromosome Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Sex Chromosome Disorders; Chromosome Disorders; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Gonadal Disorders; Endocrine System Diseases; Hypogonadism

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2013
• First Posted: March 25, 2013
• Study Start: March 1, 2013
• Primary Completion: April 1, 2014
• Last Updated: May 15, 2014

Record last verified: 2014-05

Locations

US (1)