Effect of Omega 3 Fats on Sperm Quality and Sexual Function

Study Overview
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Brief Summary
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This study compares the effects of omega 3 fats plus folic acid with placebo plus folic acid on sperm quality and sexual function in infertile men. It will also evaluate the effects on sexual fuction of a sub-therapeutic dose of a PDE 5 inhibitor versus placebo in subjects continuing on both omega 3 fats and folic acid.

Detailed Description
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Infertile men commonly have difficulty timing sexual relations around the time of ovulation. There is a high incidence of abnormal sperm morphology in infertile men. Omega 3 fats are known to increase the production of nitric oxide, which is the mediator of the male response, and folic acid is an important cofactor in the production of nitric oxide. Omega 3 fats are also important in the structure and function of cell membranes. There is a high incidence of deficient intake of omega 3 fats and folic acid in the U.S. population. Both folic acid and omega 3 fats are available as nutritional supplements and the doses used in this study are doses commonly recommended as nutritional supplements. Comparison: Omega 3 fats plus folic acid will be compared with placebo plus folic acid in men age 35 to 55 attempting pregnancy with normal or mildly impaired semen quality. They will fill out dietary questionaires, questionaires regarding sexual function, and will have measurements of serum nitrates, blood pressure, and semen quality before and during use of these nutritional supplements. In men continuing on both omega 3 fats and folic acid, we will compare the effects of a sub-therapeutic dose of a PDE 5 inhibitor versus placebo on their sexual function.

Official Title
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Effect of Omega 3 Fats on Sperm Quality and Sexual Function in Infertile Men Age 35-55

Conditions
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Infertility

Intervention / Treatment
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* Drug: omega 3 fats
* Drug: folic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: infertile men age 35 to 55 expressing difficulty timing relations to their partner's ovulation Exclusion Criteria: hypertension, heart disease or other systemic diseases fatty fish intake more than twice per week marked semen abnormalities (less than 10 million sperm per ml, less than 20 % A plus B motility, more than 1 million WBC per HPF) use of anticoagulants must be willing to not take PDE 5 inhibitors during the study use of other supplements is prohibited during the study

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: omega 3 fats|1,000 mg daily|
|Drug: folic acid|800 micrograms daily|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionaires regarding sexual function |  | every 30 days | 
| Semen analysis |  | every 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure |  | every 30 days | 
| serum nitrate levels |  | every 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infertility, semen quality, sexual function, blood pressure, omega 3 fats, folic acid