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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00440180
Recruitment Status : Terminated (Not able meet target enrollment.)
First Posted : February 26, 2007
Results First Posted : March 7, 2016
Last Update Posted : April 6, 2016
Sponsor:
Information provided by (Responsible Party):
University of Utah

Study Description
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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 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 or disease Intervention/treatment Phase
Obesity Oligospermia Drug: Anastrozole Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Aromatase Inhibitors in the Treatment of Infertility in Obese Male
Study Start Date : March 2007
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Anastrozole

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Group B
Placebo
 Drug: Placebo
Placebo Comparator
Experimental: Group A
Anastrozole
 Drug: Anastrozole
1 mg qd for 4 months
Other Name: Arimidex


Outcome Measures
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Primary Outcome Measures :
  1. Pregnancy Rate [ Time Frame: 4 months ]
    Partner pregnancy rate during study participation


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00440180


Locations
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United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Ahmad O Hammoud, MD University of Utah
More Information
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Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00440180    
Other Study ID Numbers: IRB_00016246
First Posted: February 26, 2007    Key Record Dates
Results First Posted: March 7, 2016
Last Update Posted: April 6, 2016
Last Verified: March 2016
Keywords provided by University of Utah:
Obesity
Low sperm count
Male infertility
Additional relevant MeSH terms:
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Infertility
Oligospermia
Infertility, Male
Anastrozole
Antineoplastic Agents, Hormonal
Antineoplastic Agents
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