Aromatase Inhibitors in the Treatment of Male Infertility

The Role of Aromatase Inhibitors in the Treatment of Infertility in Obese Male

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.

Study Overview

• Status: Terminated
• Conditions: Obesity; Oligospermia
• Intervention / Treatment: Drug: Placebo; Drug: Anastrozole

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Arimidex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy Rate	Partner pregnancy rate during study participation	4 months

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Ahmad O Hammoud, MD, University of Utah

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: February 22, 2007
• First Submitted That Met QC Criteria: February 23, 2007
• First Posted (Estimate): February 26, 2007

Study Record Updates

• Last Update Posted (Estimate): April 6, 2016
• Last Update Submitted That Met QC Criteria: March 8, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Obesity; Male infertility; Low sperm count
• Additional Relevant MeSH Terms: Infertility, Male; Infertility; Oligospermia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Anastrozole
• Other Study ID Numbers: IRB_00016246