Obesity, Oligospermia
Conditions
Keywords
Obesity, Low sperm count, Male infertility
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.
Interventions
DRUGAnastrozole
1 mg qd for 4 months
DRUGPlacebo
Placebo Comparator
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
16 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy Rate | 4 months | Partner pregnancy rate during study participation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo once daily | 10 |
| Anastrozole 1 milligram daily | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Placebo | Anastrozole | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 20 | 7 / 20 |
| serious Total, serious adverse events | 0 / 10 | 1 / 10 |
Outcome results
Primary
Pregnancy Rate
Partner pregnancy rate during study participation
Time frame: 4 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Pregnancy Rate | 0 participants partner |
| Anastrozole | Pregnancy Rate | 1 participants partner |