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View Clinical Trial (Medical Research Study)
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Aromatase Inhibitors in the Treatment of Male Infertility - NCT00440180-84132 (Clinical Trial 163711)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy163711.aspx
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| City: |
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Salt Lake City |
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State:
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UT |
| Zip Code: |
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84132 |
| Conditions: |
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Obesity - Oligospermia |
| Purpose: |
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Obesity is associated with an increase in blood levels of estrogen. Estrogen or "female
hormone" is believed to have a negative effect on sperm production. Aromatase inhibitors
such as anastrozole work to decrease the production of estrogen and increase testosterone in
the body. By decreasing the level of estrogen, sperm production should improve. In this
study, we will try to determine the benefit of anastrozole in obese men with low sperm
counts.
Patients participating in this study will be randomly assigned (by chance) to treatment in
one of two study arms: Group A: Anastrozole 1mg per day for 4 months and Group B: Placebo
for 4 months. Neither patients nor doctors will know in which treatment group they are.
Screening assessments will take place prior to the start of treatment. During this time,
demographic data and medical history will be reviewed and recorded. Also, testicular exam,
sperm count and laboratory blood analysis will be performed. Over the course of study, semen
and blood analysis including hormonal profile (testosterone, estrogen, follicle stimulating
hormone and luteinizing hormone) will be recollected.
At the conclusion of the trial, we expect the group that received anastrozole to have an
improved sperm count, increased testosterone and decreased estrogen levels.
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| Study summary: |
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The role of aromatase inhibitors in the treatment of infertility (due to hypogonadism) in
obese Male
Background:
The incidence of male infertility is increasing in the western world in parallel with an
increase in obesity. It is estimated that in the United States sperm counts may be
decreasing by as much as 1.5% each year (Swan et al, 2000). It is proposed that increased
estrogen levels associated with obesity cause hypogonadism and male infertility via
inappropriate suppression of gonadotropins and direct adverse effects on spermatogenesis.
The link between obesity and its likely effects on the endocrine function of the male
reproductive axis underlie the mechanistic justification for this novel trial of a medical
therapy for hypogonadism and male infertility associated with obesity.
Study design:
We designed a double blind, randomized, placebo control trial of the aromatase inhibitor
Anastrozole to treat men that are overweight (BMI ≥ 30 kg/m2) and oligospermic (sperm count
≤ 20 × 106/mL and ≥ than 3 × 106/mL). After enrollment, patients will be randomized to
receive Anastrozole 1mg/d or placebo for 4 months. Semen analysis and hormonal profile (FSH,
LH, Estradiol, total and free Testosterone will be measured at the start and the conclusion
of the study. The primary outcome will be sperm density. Secondary outcomes will be other
sperm parameters including: total count per ejaculate, total motile sperm per ejaculate, and
sperm morphology. We will also follow the change in FSH and LH, testosterone and estrogen
levels, and will seek correlation between endocrine change and semen parameters. Based on a
power analysis, a total of 50 patients will be included in the study. Study design and
reporting will comply with the CONSORT (Consolidated Standards of Reporting Trials)
guidelines.
Anticipated results:
The study will evaluate the research hypothesis that inhibition of aromatase will result in
improvements in sperm density, as well as secondary semen analysis parameters (e.g.
morphology and motility). Supporting endocrine data will be obtained as part of this
clinical protocol that we expect will show an increase in testosterone, LH and FSH levels
and a decrease in estrogen levels associated with active treatment. |
| Criteria: |
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Inclusion Criteria:
1. Male partner of a couple presenting for infertility work up after one year of
unprotected intercourse.
2. Moderate oligozoospermia (defined as mean sperm count ≤ 20 × 106/mL and ≥ than 3 ×
106/mL) of at least two separate occasions spanning a minimum of two weeks.
3. Obese men BMI ≥ 30
4. FSH and LH levels < 10 mIU/mL
Exclusion Criteria:
1. Severe Oligozoospermia: Sperm count < than 3 × 106/mL, including azoospermia.
2. Age less than 18 or greater than 65 years
3. Pyospermia or leukospermia: defined by white blood cells ≥1 million leukocytes per
milliliter of semen.
4. Cryptorchidism
5. Vasectomy reversal
6. Regular use of tobacco products
7. BMI < 30
8. Use of anabolic steroids or testosterone replacement
9. All patients with abnormal initial liver function tests "AST or ALT" will be excluded
form the study. |
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| Study is available at: |
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University of Utah
Salt Lake City, UT 84132
United States
Primary Contact:
Ahmad O hammoud, MD
Email: ahmad.hammoud@hsc.utah.edu
Phone: 801-587-3795
Secondary Contact:
Ahmad O Hammoud, MD
Email: ahmad.hammoud@hsc.utah.edu
Phone: 801-587-3795 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 15, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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