Aromatase Inhibitors in the Treatment of Male Infertility
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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
Exclusion criteria
- 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
- Cryptorchidism
- Vasectomy reversal
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
20 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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