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Effect of Omega 3 Fats on Sperm Quality and Sexual Function
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Infertility | Drug: omega 3 fats Drug: folic acid | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (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 |
- 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 ]
| Enrollment: | 6 |
| Study Start Date: | January 2007 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
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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.
Eligibility| 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
Contacts and LocationsPlease 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 |
More Information
| Responsible Party: | David R. Meldrum, M.D., Scientific Director, Reproductive Partners Medical Group |
| ClinicalTrials.gov Identifier: | NCT00406874 History of Changes |
| Other Study ID Numbers: |
RPMG-1 |
| Study First Received: | November 30, 2006 |
| Last Updated: | June 3, 2013 |
Keywords provided by David R. Meldrum, M.D., Reproductive Partners Medical Group:
|
infertility semen quality sexual function |
blood pressure omega 3 fats folic acid |
Additional relevant MeSH terms:
|
Infertility Genital Diseases, Male Genital Diseases, Female Folic Acid Vitamin B Complex |
Hematinics Vitamins Micronutrients Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 23, 2017