Back to results

Aromatase Inhibitors in the Treatment of Male Infertility

Primary Purpose

Obesity, Oligospermia

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Anastrozole

Placebo

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Low sperm count, Male infertility

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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

Sites / Locations

University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Group B

Group A

Arm Description

Placebo

Anastrozole

Outcomes

Primary Outcome Measures

Pregnancy Rate

Partner pregnancy rate during study participation

Secondary Outcome Measures

Full Information

NCT ID

NCT00440180

First Posted

February 22, 2007

Last Updated

March 8, 2016

Sponsor

University of Utah

1. Study Identification

Unique Protocol Identification Number

NCT00440180

Brief Title

Aromatase Inhibitors in the Treatment of Male Infertility

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Terminated

Why Stopped

Not able meet target enrollment.

Study Start Date

March 2007 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Utah

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Oligospermia

Keywords

Obesity, Low sperm count, Male infertility

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group B

Arm Type

Placebo Comparator

Arm Description

Placebo

Arm Title

Group A

Arm Type

Experimental

Arm Description

Anastrozole

Intervention Type

Drug

Intervention Name(s)

Anastrozole

Other Intervention Name(s)

Arimidex

Intervention Description

1 mg qd for 4 months

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo Comparator

Primary Outcome Measure Information:

Title

Pregnancy Rate

Description

Partner pregnancy rate during study participation

Time Frame

4 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmad O Hammoud, MD

Organizational Affiliation

University of Utah

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Utah

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Aromatase Inhibitors in the Treatment of Male Infertility

We'll reach out to this number within 24 hrs