Aromatase Inhibitors in the Treatment of Male Infertility

• Sponsor: University of Utah (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00440180
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 87
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Oligospermia	Drug: Anastrozole; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• 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: Mar 1, 2007
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pregnancy Rate [4 months]

   Partner pregnancy rate during study participation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 80 Years
• Sexes 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

Locations

	Site	City	State	Country	Postal Code
1	University of Utah	Salt Lake City	Utah	United States	84132

Sponsors and Collaborators

• University of Utah

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Utah
• ClinicalTrials.gov Identifier: NCT00440180
• Other Study ID Numbers: IRB_00016246
• First Posted: Feb 26, 2007
• Last Update Posted: Apr 6, 2016
• Last Verified: Mar 1, 2016

• Keywords provided by University of Utah: Obesity; Low sperm count; Male infertility
• Additional relevant MeSH terms: Infertility; Oligospermia; Anastrozole

Study Results

Participant Flow

Arm/Group Title	Placebo	Anastrozole
Arm/Group Description	Placebo once daily	1 milligram daily
Period Title: Overall Study
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Placebo	Anastrozole	Total
Arm/Group Description	Placebo once daily	1 milligram daily	Total of all reporting groups
Overall Participants	10	10	20
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	10 100%	10 100%	20 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	10 100%	10 100%	20 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Anastrozole
Arm/Group Description	Placebo once daily	1 milligram daily
Measure Participants	10	10
Number [participants partner]	0 0%	1 10%

Adverse Events

Arm/Group Title	Placebo		Anastrozole
Arm/Group Description	Placebo once daily		1 milligram daily
All Cause Mortality
	Placebo		Anastrozole
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Anastrozole
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		1/10 (10%)
Blood and lymphatic system disorders
Axillary Lymphadenopathy	0/10 (0%)	0	1/10 (10%)	1
Other (Not Including Serious) Adverse Events
	Placebo		Anastrozole
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/20 (15%)		7/20 (35%)
General disorders
Increased Liver Enzymes	2/20 (10%)	2	2/20 (10%)	2
Headache	1/20 (5%)	1	5/20 (25%)	5

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.