Completed

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

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What is being tested

Testicular Biopsy

Procedure
Who is being recruted

Congenital Abnormalities+13

+ Urogenital Diseases

+ Endocrine System Diseases

From 12 to 25 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorBoston Children's Hospital
Last updated: May 15, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

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.

Principal SponsorBoston Children's Hospital
Last updated: May 15, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

15 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 12 to 25 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Congenital AbnormalitiesUrogenital DiseasesEndocrine System DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGonadal DisordersHypogonadismCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDisorders of Sex DevelopmentUrogenital AbnormalitiesChromosome DisordersSex Chromosome DisordersGenetic Diseases, InbornFemale Urogenital DiseasesMale Urogenital DiseasesSex Chromosome Disorders of Sex DevelopmentKlinefelter Syndrome

Criteria

2 inclusion criteria required to participate
12-25 years of age

diagnosed 47,XXY (Klinefelter syndrome)

3 exclusion criteria prevent from participating
history of surgery, injury, or infection in the testicle

solitary testicle

testosterone therapy within past 6 months

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Boston Children's Hospital

Boston, United StatesOpen Boston Children's Hospital in Google Maps
CompletedOne Study Center