HOP-2A - Intratesticular Hormone Levels

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-12-31

Brief Summary

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

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Detailed Description

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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 aspiration of the testes (about 1-1.5 hours each) and two follow-up visits (about 30-45 minutes). Over the course of the study, you will have a little less than a 1/3-cup of blood drawn (roughly 2-3 tablespoons at each visit).

Conditions

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Healthy Male Infertility Prostate Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes