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Fertility Assessment in Patients With Klinefelter Syndrome

NCT02461303 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 6

Last updated 2018-07-24

No results posted yet for this study

Summary

Klinefelter syndrome is characterized by primary testicular failure and progressive infertility. The objective of this study is to determine if sperm are present and can be observed in semen samples of adolescent and young adult Klinefelter patients and to determine whether the presence of sperm correlates with physical and/or clinically obtained hormone measures of pubertal development.

This study was designed in order to answer the following questions:

1. Is it possible to retrieve sperm for cryopreservation from semen samples of adolescent and young adult Klinefelter patients?
2. Does the presence of sperm correlate with the physical and/or endocrine measures that are assessed during routine clinical evaluations of pubertal development in the KS patient population?
3. If sperm retrieval is possible, what is the optimal age at which sperm retrieval should be attempted?

Conditions

  • Klinefelter Syndrome

Interventions

OTHER

Counseling

Subjects will be counseled on the impact of KS on the reduced fertility potential, and about providing a semen sample for semen analysis. Semen analysis is the gold standard for fertility preservation in adult patients, but is only rarely considered by post-pubertal adolescent and young adult patients and their families. Only the semen analysis parameters will be used by the study for the comparison with physical and endocrine measures to assess whether spermatogenesis in these patients coincides with pubertal development. All potential frozen samples will be stored for the patient's future use, and samples will not be used for research experiments.

Sponsors & Collaborators

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Kyle Orwig, PhD · University of Pittsburgh

Eligibility

Min Age
12 Years
Max Age
25 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-07
Primary Completion
2017-12-12
Completion
2017-12-12

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02461303 on ClinicalTrials.gov