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 C, selenium, zinc, folic acid, lycopene and at least one carnitine source.

1 - 30 . (canceled) 
     
     
         31 . A composition comprising
 a pharmaceutical active ingredient and an antioxidant combination comprising   at least one source of vitamin E,   at least one source of vitamin C,   selenium or a pharmaceutically acceptable form thereof,   zinc or a pharmaceutically acceptable form thereof,   lycopene,   a folate or folic acid or suitable salts thereof, wherein the composition is substantially free of any traces of vitamin A, vitamin K, and garlic.   
     
     
         32 . The composition of  claim 31 , wherein the vitamin C source is ascorbic acid and wherein upon administration of said composition for a sufficient period of time to a subject at least one index for measuring DNA damage is reduced post-treatment by at least 2.5% as compared to the pretreatment levels of the same index in said subject. 
     
     
         33 . The composition of  claim 31 , further comprising calcium, magnesium, copper, N-acetyl cysteine, or a combination thereof. 
     
     
         34 . The composition of  claim 31 , wherein said vitamin E source is selected from the group consisting of alpha-tocopherol, beta-tocopherol, gamma-toceopherol, delta-tocopherol, alpha-tocotrienol, beta-tocotrienol, gamma-tocotrienol, delta-tocotrienol, and any combination thereof. 
     
     
         35 . The composition of  claim 31 , further containing lipoic acid. 
     
     
         36 . The composition of  claim 31 , wherein the carnitine source is acetyl-L-carnitine and/or propionyl-L-carnitine. 
     
     
         37 . The composition of  claim 31  wherein the vitamin E source is in amounts ranging from 50 IU-1500 I.U. and the vitamin C source is in amounts of about 10 mg-600 mg. 
     
     
         38 . The composition of  claim 31 , wherein the composition is in a tablet dosage form selected from the group consisting of an immediate release tablet, an extended or pulsatile release tablet, a chewable tablet, a chewable lozenge, a quick chew, a quick dissolve and combinations thereof. 
     
     
         39 . The composition of  claim 37 , wherein the ratio of vitamin E to vitamin C is at least 1 IU to 1 mg weight percent of the composition. 
     
     
         40 . The composition of  claim 37 , wherein the lipoic acid is alpha-lipoic acid in amounts of about 50-600 mg. 
     
     
         41 . The composition of  claim 31 , wherein the pharmaceutical active ingredient is selected from the group consisting of an aromatase inhibitor, an anti-inflammatory, an antibiotic and a combination thereof. 
     
     
         42 . A method of treating a patient in need comprising administering to said patient a composition comprising
 a pharmaceutical active ingredient and an antioxidant combination comprising   at least one vitamin E selected from the group consisting of alpha-tocopherol, beta-tocopherol, gamma-tocopherol, delta-tocopherol, alpha-tocotrienol, beta-tocotrienol, gamma-tocopherol, delta-tocopherol, and any combinations thereof;   at least one source of vitamin C;   selenium or a pharmaceutically acceptable form thereof;   zinc or a pharmaceutically acceptable form thereof,   folic acid or a pharmaceutically acceptable folate source;   lycopene;   at least one source of carnitine selected from the group consisting of propionyl-L-carnitine; acetyl-L-carnitine; or a combination thereof; and at least one pharmaceutically suitable excipient and optionally calcium, magnesium, copper or combinations thereof,   wherein the composition is substantially free of any traces of vitamin A, vitamin K, and garlic.   
     
     
         43 . The method of  claim 42  wherein said folic acid or folate source is administered in an amount ranging from about 0.1 mg to about 5.0 mg. 
     
     
         44 . The method of  claim 42 , wherein the vitamin C source is ascorbic acid and vitamin E is selected from the group consisting of alpha-tocopherol, beta-tocopherol, gamma-tocopherol, delta-tocopherol, alpha-tocotrienol, beta-tocotrienol or a combination thereof. 
     
     
         45 . The method of  claim 42 , wherein the vitamin C is administered to the patient in an amount ranging from about 10 mg to about 1000 mg. 
     
     
         46 . A kit comprising
 a pharmaceutical active ingredient and an antioxidant combination comprising   at least one source of vitamin E,   at least one source of vitamin C,   selenium or a pharmaceutically acceptable form thereof,   zinc or a pharmaceutically acceptable form thereof,   lycopene,   
       a folate or folic acid or suitable salts thereof, wherein the composition is substantially free of any traces of vitamin A, vitamin K, and garlic. 
     
     
         47 . The kit of  claim 46  further comprising an educational information and direction of use. 
     
     
         48 . The kit of  claim 46 , wherein the pharmaceutical active ingredient is selected from the group consisting of an aromatase inhibitor, an anti-inflammatory, an antibiotic and a combination thereof.