Status:

COMPLETED

HOP-2A - Intratesticular Hormone Levels

Lead Sponsor:

University of Washington

Conditions:

Healthy

Male Infertility

Eligibility:

MALE

18-50 years

Brief Summary

The purpose of this investigational study is to find out what hormones are present in healthy male testicles using fine needle aspiration.

Detailed Description

We will collect a very small amount of fluid from each testicle. Participation will last up to 12 weeks. The study involves a minimum of 4 visits, the screening visit and procedure Day, fine needle as...

Eligibility Criteria

Inclusion

  • males between 18 and 50 years of age
  • sperm count greater than 20 million/ml, greater than 50% motility, and greater than 15% normal morphology
  • in good general health based on normal screening evaluation (consisting of a medical history, physical exam, normal sperm count, normal serum chemistry, hematology and baseline T, LH, and FSH levels)
  • body mass index ≥18 and ≤32 kg/m2
  • must agree not to participate in another research study involving drug exposure for the duration of the study

Exclusion

  • men in poor general health, with abnormal blood results
  • sperm counts \<20 million/ml on two tests
  • chronic, ongoing alcohol or drug abuse
  • participation in a long-term male contraceptive study within the past three months
  • history of testicular or scrotal surgery
  • history of infertility
  • abnormal testicular exam
  • abnormal DRE
  • chronic pain syndrome
  • use of steroids, testosterone, or medications which might interfere with androgen metabolism including ketoconazole, glucocorticoids
  • known bleeding disorder
  • use of medications which may affect bleeding time (ongoing aspirin or anti-inflammatory use, coumadin)

Key Trial Info

Start Date :

September 1 2008

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 1 2009

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT00756561

Start Date

September 1 2008

End Date

December 1 2009

Last Update

June 13 2016

Active Locations (1)

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University of Washington

Seattle, Washington, United States, 98195