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Aromatase Inhibitors in the Treatment of Male Infertility
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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ClinicalTrials.gov Identifier: NCT00440180
(Not able meet target enrollment.)
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 and follow pregnancy outcomes.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
16 Years to 80 Years (Child, Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male partner of a couple presenting for infertility work up after one year of unprotected intercourse
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
Obese men BMI ≥ 30
FSH and LH levels < 10 mIU/mL
Severe Oligozoospermia: Sperm count < than 3 × 106/mL, including azoospermia
Age less than 18 or greater than 65 years
Pyospermia or leukospermia: defined by white blood cells ≥ 1 million leukocytes per milliliter of semen
Regular use of tobacco products
BMI < 30
Use of anabolic steroids or testosterone replacement
All patients with abnormal initial liver function tests "AST or ALT" will be excluded form the study