Status:
TERMINATED
Aromatase Inhibitors in the Treatment of Male Infertility
Lead Sponsor:
University of Utah
Conditions:
Obesity
Oligospermia
Eligibility:
MALE
16-80 years
Phase:
PHASE3
Brief Summary
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 wor...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00440180
Start Date
March 1 2007
End Date
June 1 2014
Last Update
April 6 2016
Active Locations (1)
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1
University of Utah
Salt Lake City, Utah, United States, 84132