Healthy, Male Infertility, Prostate Disease
Conditions
Keywords
Fine Needle Aspiration, Male Health, Male Contraception
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 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).
Interventions
None listed
Sponsors
University of Washington
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intratesticular Hormones in Normal Men | 6-weeks | Average between right and left testis for each subject and serum hormone concentration in 10 normal men |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited through news media (newspaper, website) and college campus bulletin boards in Seattle, WA, between September - December 2008. All visits were at the University of Washington, Seattle, WA.
Pre-assignment details
15 screened, 3 did not meet inclusion criteria (2 for abnormal semen parameters, 1 for abnormal liver function), 1 decided not to enroll, and 1 did not complete study procedures because of study end. Data analysis was performed on the first 10 of 11 subjects completing procedures.
Participants by arm
| Arm | Count |
|---|---|
| Healthy Normal Males Men, 18-50 years of age, in good health | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Healthy Normal Males |
|---|---|
| Age, Continuous Between 18 and 50 years | 23 years |
| Body Mass Index (BMI) | 25.9 kg/m^2 |
| Follicle Stimulating Hormone (FSH) | 1.8 IU/L |
| Luteinizing Hormone (LH) | 3.7 IU/L |
| Serum Dihydrotestosterone (DHT) | 0.20 ng/mL |
| Serum Estradiol (E2) | 0.025 ng/mL |
| Serum Testosterone (T) | 3.0 ng/mL |
| Sex/Gender, Customized Male | 10 participants |
| Sperm concentration | 75 millions/mL |
| Testis volume | 25 mL |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Intratesticular Hormones in Normal Men
Average between right and left testis for each subject and serum hormone concentration in 10 normal men
Time frame: 6-weeks
Population: per protocol
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intratesticular Concentration | Intratesticular Hormones in Normal Men | Testosterone | 486 ng/mL |
| Intratesticular Concentration | Intratesticular Hormones in Normal Men | Dihydrotestosterone | 3.7 ng/mL |
| Intratesticular Concentration | Intratesticular Hormones in Normal Men | Estradiol | 2.7 ng/mL |
| Serum Concentration | Intratesticular Hormones in Normal Men | Testosterone | 3.0 ng/mL |
| Serum Concentration | Intratesticular Hormones in Normal Men | Dihydrotestosterone | 0.20 ng/mL |
| Serum Concentration | Intratesticular Hormones in Normal Men | Estradiol | 0.025 ng/mL |