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| Sponsor: | University of Utah |
|---|---|
| Information provided by (Responsible Party): | Ahmad Hammoud, University of Utah |
| ClinicalTrials.gov Identifier: | NCT00440180 |
Purpose
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 with low sperm counts.
Patients participating in this study will be randomly assigned (by chance) to treatment in one of two study arms: Group A: Anastrozole 1mg per day for 4 months and Group B: Placebo for 4 months. Neither patients nor doctors will know in which treatment group they are.
Screening assessments will take place prior to the start of treatment. During this time, demographic data and medical history will be reviewed and recorded. Also, testicular exam, sperm count and laboratory blood analysis will be performed. Over the course of study, semen and blood analysis including hormonal profile (testosterone, estrogen, follicle stimulating hormone and luteinizing hormone) will be recollected.
At the conclusion of the trial, the investigators expect the group that received anastrozole to have an improved sperm count, increased testosterone and decreased estrogen levels.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity Oligospermia |
Drug: Anastrozole Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Role of Aromatase Inhibitors in the Treatment of Infertility in Obese Male |
| Estimated Enrollment: | 50 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Group B
Placebo
|
Drug: Placebo
Placebo Comparator
Other Name: Placebo
|
|
Experimental: Group A
Anastrozole
|
Drug: Anastrozole
1 mg qd for 4 months
Other Name: Arimidex
|
The role of aromatase inhibitors in the treatment of infertility (due to hypogonadism) in obese Male
Background:
The incidence of male infertility is increasing in the western world in parallel with an increase in obesity. It is estimated that in the United States sperm counts may be decreasing by as much as 1.5% each year (Swan et al, 2000). It is proposed that increased estrogen levels associated with obesity cause hypogonadism and male infertility via inappropriate suppression of gonadotropins and direct adverse effects on spermatogenesis. The link between obesity and its likely effects on the endocrine function of the male reproductive axis underlie the mechanistic justification for this novel trial of a medical therapy for hypogonadism and male infertility associated with obesity.
Study design:
The investigaotrs designed a double blind, randomized, placebo control trial of the aromatase inhibitor Anastrozole to treat men that are overweight (BMI ≥ 30 kg/m2) and oligospermic (sperm count ≤ 20 × 106/mL and ≥ than 3 × 106/mL). After enrollment, patients will be randomized to receive Anastrozole 1mg/d or placebo for 4 months. Semen analysis and hormonal profile (FSH, LH, Estradiol, total and free Testosterone will be measured at the start and the conclusion of the study. The primary outcome will be sperm density. Secondary outcomes will be other sperm parameters including: total count per ejaculate, total motile sperm per ejaculate, and sperm morphology. The investigators will also follow the change in FSH and LH, testosterone and estrogen levels, and will seek correlation between endocrine change and semen parameters. Based on a power analysis, a total of 50 patients will be included in the study. Study design and reporting will comply with the CONSORT (Consolidated Standards of Reporting Trials) guidelines.
Anticipated results:
The study will evaluate the research hypothesis that inhibition of aromatase will result in improvements in sperm density, as well as secondary semen analysis parameters (e.g. morphology and motility). Supporting endocrine data will be obtained as part of this clinical protocol that the investigators expect will show an increase in testosterone, LH and FSH levels and a decrease in estrogen levels associated with active treatment.
Eligibility| Ages Eligible for Study: | 16 Years to 80 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Ahmad O Hammoud, MD | 801-587-3795 | ahmad.hammoud@hsc.utah.edu |
| United States, Utah | |
| University of Utah | Recruiting |
| Salt Lake City, Utah, United States, 84132 | |
| Contact: Ahmad O hammoud, MD 801-587-3795 ahmad.hammoud@hsc.utah.edu | |
| Principal Investigator: | Ahmad O Hammoud, MD | University of Utah |
More Information
| Responsible Party: | Ahmad Hammoud, MD, University of Utah |
| ClinicalTrials.gov Identifier: | NCT00440180 History of Changes |
| Other Study ID Numbers: | IRB_00016246 |
| Study First Received: | February 22, 2007 |
| Last Updated: | November 20, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Obesity Low sperm count Male infertility |
|
Infertility Infertility, Male Obesity Oligospermia Genital Diseases, Male Genital Diseases, Female Overnutrition Nutrition Disorders Overweight Body Weight |
Signs and Symptoms Anastrozole Aromatase Inhibitors Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
