Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Aromatase Inhibitors in the Treatment of Male Infertility

This study has been terminated.
(Not able meet target enrollment.)
Information provided by (Responsible Party):
University of Utah Identifier:
First received: February 22, 2007
Last updated: March 8, 2016
Last verified: March 2016
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.

Condition Intervention Phase
Drug: Anastrozole
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Aromatase Inhibitors in the Treatment of Infertility in Obese Male

Resource links provided by NLM:

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Pregnancy Rate [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Partner pregnancy rate during study participation

Enrollment: 20
Study Start Date: March 2007
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Group B
Drug: Placebo
Placebo Comparator
Experimental: Group A
Drug: Anastrozole
1 mg qd for 4 months
Other Name: Arimidex


Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00440180

United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Principal Investigator: Ahmad O Hammoud, MD University of Utah
  More Information

Responsible Party: University of Utah Identifier: NCT00440180     History of Changes
Other Study ID Numbers: IRB_00016246 
Study First Received: February 22, 2007
Results First Received: February 5, 2016
Last Updated: March 8, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Utah:
Low sperm count
Male infertility

Additional relevant MeSH terms:
Infertility, Male
Genital Diseases, Male
Genital Diseases, Female
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents processed this record on October 25, 2016