Effect of Omega 3 Fats on Sperm Quality and Sexual Function
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effect of Omega 3 Fats on Sperm Quality and Sexual Function in Infertile Men Age 35-55|
- Questionaires regarding sexual function [ Time Frame: every 30 days ] [ Designated as safety issue: No ]
- Semen analysis [ Time Frame: every 30 days ] [ Designated as safety issue: No ]
- blood pressure [ Time Frame: every 30 days ] [ Designated as safety issue: No ]
- serum nitrate levels [ Time Frame: every 30 days ] [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Drug: omega 3 fats
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00406874
|United States, California|
|Reproductive Partners medical Group|
|Redondo beach, California, United States, 90277|
|Principal Investigator:||David R Meldrum, M.D.||Reproductive Partners Medical Group|