A Phase 2 interventional study of omega 3 fats and folic acid in Infertility, sponsored by Reproductive Partners Medical Group. Terminated at 1 site in United States. Open to male participants aged 35 Years to 55 Years. Per ClinicalTrials.gov, last updated 2013-06-04.
Sponsored by Reproductive Partners Medical Group · Phase 2, Interventional, and Treatment
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.
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.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's enrollment of 6 is below the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →This is the only study on the registry with Reproductive Partners Medical Group as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1,000 mg daily
800 micrograms daily
Questionaires regarding sexual function
Time frame: every 30 days
Semen analysis
Time frame: every 30 days
blood pressure
Time frame: every 30 days
serum nitrate levels
Time frame: every 30 days
This study is terminated, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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