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HOP-2A - Intratesticular Hormone Levels (HOP-2A)

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ClinicalTrials.gov Identifier: NCT00756561
Recruitment Status : Completed
First Posted : September 22, 2008
Results First Posted : July 19, 2013
Last Update Posted : June 13, 2016
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease
Healthy Male Infertility Prostate Disease

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 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).

Study Design

Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Intratesticular Hormone Levels in Healthy Young Men
Study Start Date : September 2008
Primary Completion Date : January 2009
Study Completion Date : December 2009


Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Intratesticular Hormones in Normal Men [ Time Frame: 6-weeks ]
    Average between right and left testis for each subject and serum hormone concentration in 10 normal men


Biospecimen Retention:   Samples Without DNA
serum blood, testicular tissue

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy males
Criteria

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00756561


Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: John K Amory, MD, MPH University of Washington
More Information

Additional Information:
Publications:

Responsible Party: John Amory, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00756561     History of Changes
Other Study ID Numbers: 34593-B
First Posted: September 22, 2008    Key Record Dates
Results First Posted: July 19, 2013
Last Update Posted: June 13, 2016
Last Verified: May 2016

Keywords provided by John Amory, University of Washington:
Fine Needle Aspiration
Male Health
Male Contraception

Additional relevant MeSH terms:
Infertility
Infertility, Male
Prostatic Diseases
Genital Diseases, Male
Genital Diseases, Female
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs