Aromatase Inhibitors in the Treatment of Male Infertility

NCT ID: NCT00440180

Last Updated: 2016-04-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2014-06-30

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.

Conditions

Obesity; Oligospermia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group B

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo Comparator

Group A

Anastrozole

Group Type: EXPERIMENTAL

Anastrozole

Intervention Type: DRUG

1 mg qd for 4 months

Interventions

Anastrozole

1 mg qd for 4 months

Intervention Type: DRUG

Placebo

Placebo Comparator

Intervention Type: DRUG

Other Intervention Names

Arimidex

Eligibility 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ahmad O Hammoud, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Utah

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

IRB_00016246

Identifier Type: -

Identifier Source: org_study_id