Treating male infertility secondary to sperm oxidative stress

Abstract

A profertility composition for administration to infertile men with sperm oxidative stress is disclosed. The composition comprises a unique combination of a pharmaceutically acceptable vitamin E, vitamin D, vitamin C, selenium, zinc, folate, lycopene, at least one carnitine source, and optionally Coenzyme Q10. Also disclosed are methods of treating male infertility.

What is claimed is: 
     
         1 . A method of overcoming oxidative stress in a subject in need thereof, comprising at least daily administering to said subject a composition comprising:
 vitamin C,   a folate,   a pharmaceutically acceptable zinc salt,   a pharmaceutically acceptable selenium source,   a carnitine blend comprising acetyl-L-carnitine and propionyl-L-carnitine, or pharmaceutically acceptable forms thereof,   natural vitamin E, and   lycopene,   
       wherein the duration of treatment is from about 6 weeks to about 12 months; and 
       wherein the amounts of vitamin C, folate, zinc salt, selenium source, carnitine blend, natural vitamin E, and/or lycopene are selected to reduce/control % DNA damage to less than or equal to 20%, and/or reduce/control % chromatin defect to less than or equal to 10%. 
     
     
         2 . The method of  claim 1 , wherein the composition further comprises vitamin D and/or coenzyme Q10, wherein the amounts of vitamin C, folate, zinc salt, selenium source, carnitine blend, natural vitamin E, lycopene, vitamin D and/or coenzyme Q10 are selected to reduce/control % DNA damage to less than or equal to 20%, and/or
 reduce/control % chromatin defect to less than or equal to 10%.   
     
     
         3 . The method of  claim 1 , wherein the oxidative stress is manifested as male infertility or reduced male fertility in the subject. 
     
     
         4 . The method of  claim 2 , wherein the oxidative stress is manifested as male infertility or reduced male fertility in the subject. 
     
     
         5 . The method of  claim 4 , wherein the folate comprises L-5-methyltetrahydrofolate, the zinc salt comprises zinc gluconate, the selenium source comprises L-selenomethionine, and the carnitine blend comprises acetyl-L-carnitine.HCL and propionyl-L-carnitine.HCL. 
     
     
         6 . The method of  claim 5 , wherein vitamin C is present in about 30 to about 90 mg, L-5-methyltetrahydrofolate is present in about 300 to about 600 μg, zinc gluconate is present in about 6 to about 11 mg, L-selenomethionine is present in about 27.7 to about 55 μg, the carnitine blend is present in about 75 to about 800 mg, vitamin D is present in about 20 to about 60 μg, natural vitamin E is present in about 38 to about 235 mg, lycopene is present in about 5 to about 15 mg, and coenzyme Q10 is present in up to about 30 mg. 
     
     
         7 . The method of  claim 5 , wherein vitamin C is present in about 60 mg, L-5-methyltetrahydrofolate is present in about 500 μg, zinc gluconate is present in about 11 mg, L-selenomethionine is present in about 55 μg, the carnitine source is present in about 400 mg, vitamin D is present in about 40 μg, natural vitamin E is present in about 150 mg, lycopene is present in about 10 mg, and coenzyme Q10 is present in about 20 mg. 
     
     
         8 . The method of  claim 1 , wherein vitamin C, the folate, the zinc salt, the selenium source and the carnitine blend are supplied together in a capsule; and vitamin D, natural vitamin E, lycopene and coenzyme Q10 are supplied together in a softgel, wherein the capsule and the softgel are administered together. 
     
     
         9 . The method of  claim 7 , which is effective to overcome the effects of oxidative stress on sperm as indicated by % DNA damage. 
     
     
         10 . The method of  claim 7 , which is effective to overcome the effects of oxidative stress on sperm as indicated by % chromatin defect. 
     
     
         11 . The method of  claim 9 , which is effective to overcome infertility in vivo as indicated by restoration of pregnancy rate and/or survival rate of offspring. 
     
     
         12 . The method of  claim 10 , which is effective to overcome infertility in vivo as indicated by restoration of pregnancy rate and/or survival rate of offspring. 
     
     
         13 . The method of  claim 6 , wherein the relative weight ratio of natural vitamin E to L-5-methyltetrahydrofolate is about 120:1 to 400:1. 
     
     
         14 . The method of  claim 6 , wherein the relative weight ratio of natural vitamin E to L-5-methyltetrahydrofolate is about 300:1. 
     
     
         15 . The method of  claim 6 , wherein the relative weight ratio of natural vitamin E to the carnitine blend is about 0.25:1 to 0.55:1. 
     
     
         16 . The method of  claim 6 , wherein the relative weight ratio of natural vitamin E to the carnitine blend is about 0.375:1 
     
     
         17 . The method of  claim 6 , wherein the relative weight ratio of L-5-methyltetrahydrofolate to the carnitine blend is about 0.0007:1 to about 0.005:1. 
     
     
         18 . The method of  claim 6 , wherein the relative weight ratio of L-5-methyltetrahydrofolate to the carnitine blend is about 0.00125:1.