Effect of Omega 3 Fats on Sperm Quality and Sexual Function
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ClinicalTrials.gov Identifier: NCT00406874 |
Recruitment Status :
Terminated
(reports indicating that increased folic acid intake may increase colin cancer)
First Posted : December 4, 2006
Last Update Posted : June 4, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Infertility | Drug: omega 3 fats Drug: folic acid | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 6 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, 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 |
Study Start Date : | January 2007 |
Actual Primary Completion Date : | December 2007 |
Actual Study Completion Date : | December 2007 |

- Drug: omega 3 fats
1,000 mg daily
- Drug: folic acid
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 ]

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Ages Eligible for Study: | 35 Years to 55 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Responsible Party: | David R. Meldrum, M.D., Scientific Director, Reproductive Partners Medical Group |
ClinicalTrials.gov Identifier: | NCT00406874 |
Other Study ID Numbers: |
RPMG-1 |
First Posted: | December 4, 2006 Key Record Dates |
Last Update Posted: | June 4, 2013 |
Last Verified: | June 2013 |
infertility semen quality sexual function |
blood pressure omega 3 fats folic acid |
Infertility Folic Acid Hematinics Vitamin B Complex Vitamins |
Micronutrients Nutrients Growth Substances Physiological Effects of Drugs |