View Clinical Trial (Medical Research Study)
The Role of Aromatase Inhibitors in the Treatment of Infertility in Obese Male
| City: |
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Salt Lake City |
| State: |
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Utah |
| 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, the investigators 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, the investigators 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:
The investigaotrs 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. The investigators 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 the investigators expect will show an increase in testosterone, LH
and FSH levels and a decrease in estrogen levels associated with active treatment.
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| 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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| NCT ID: |
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NCT00440180 |
| Primary Contact: |
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Principal Investigator
Ahmad O Hammoud, MD
University of Utah
Ahmad O Hammoud, MD
Phone: 801-587-3795
Email: ahmad.hammoud@hsc.utah.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Salt Lake City, Utah 84132
United States
Ahmad O hammoud, MD
Phone: 801-587-3795
Email: ahmad.hammoud@hsc.utah.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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