Use of a combination of d-aspartic and l-aspartic acids or salts thereof for the treatment of male infertility

Abstract

The present invention concerns the use of a combination consisting of D-aspartic and L-aspartic acids or L-aspartic acid used alone to stimulate the procreative activity in the man by increment of spermatozoon number and motility.

1 - 14 . (canceled) 
     
     
         15 . A composition for use in the treatment of male infertility comprising one or more pharmaceutically acceptable excipient(s) and/or coadjuvant(s) and:
 a) a combination of D-aspartic acid or one or more alkaline or alkaline earth metal salts thereof and L-aspartic acid or one or more alkaline or alkaline earth metal salts thereof; or   b) comprising L-aspartic acid or one or more alkaline or alkaline earth metal salt(s) thereof alone.   
     
     
         16 . The composition according to  claim 15 , wherein said composition consists of one or more pharmaceutically acceptable excipient(s) and/or coadjuvant(s) and:
 a) a combination of D-aspartic acid or one or more alkaline or alkaline earth metal salt(s) thereof and L-aspartic acid or one or more alkaline or alkaline earth metal salts thereof; or   b) L-aspartic acid or one or more alkaline or alkaline earth metal salt(s) thereof alone.   
     
     
         17 . The composition according to  claim 15 , wherein the concentration of D-aspartic acid or salts thereof is from 50% to 99.5% and the concentration of L-aspartic acid or salts thereof is from 0.05% to 50%, said percentages based on total weight of D-aspartic and L-aspartic acids or salts thereof in said composition. 
     
     
         18 . The composition according to  claim 15 , wherein the concentration of D-aspartic acid or salts thereof is from 50% to 80% and the concentration of L-aspartic acid or salts thereof is from 20% to 50%, said percentages based on total weight of D-aspartic and L-aspartic acids or salts thereof. 
     
     
         19 . The composition according to  claim 15 , wherein said coadjuvants are selected form the group consisting of amino acids, ketoacids, vitamins, minerals, reproductive function stimulating hormones, kallikrein, antibiotics, anti-inflammatory agents, antiandrogens, androgens, pentoxifilline, gonadotropine, gonadotropine releasing hormone (GnRH), adrenergic stimulators, dietetic supplements, anti-oxidants, and ketoacids. 
     
     
         20 . The composition according to  claim 19 , wherein said amino acids are selected from the group consisting of alanine, arginine, carnitine, cysteine, glutamine, glycine, leucine, lysine, isoleucine, methionine, ornithine, phenylalanine, threonine, tryptophan, valine, and serine. 
     
     
         21 . The composition according to  claim 19 , wherein said vitamins are selected from the group consisting of vitamin A, C, D3, E, K, B1, B2, B6, B12, PP, biotin (H), folic acid, lipoic acid and Q10 coenzyme. 
     
     
         22 . The composition according to  claim 19 , wherein said minerals are selected from the group consisting of magnesium, potassium, zinc, manganese, molybdenum, chromium, selenium, calcium, iron, copper, iodine, phosphorus, and fluorine. 
     
     
         23 . The composition according to  claim 21 , wherein the concentrations of vitamins are: vitamin A from 0.0048% to 0.024%, vitamin C from 0.36% to 3.6%, vitamin D3 from 0.00003% to 0.00015%, vitamin E from 0.06% to 0.6%, vitamin K from 0.00042% to 0.0021%, vitamin B1 from 0.0084 to 0.042%, vitamin B2 from 0.0096% to 0.048%, vitamin B6 from 0.012% to 0.06%, vitamin B12 from 6×10 −6 % to 3×10 −5 %, vitamin PP from 0.108% to 0.54%, biotin from 0.0009% to 4.4×10 −5 %, folic acid from 0.0012% to 0.006%, said percentages being % weight based on total composition weight. 
     
     
         24 . The composition according to  claim 22 , wherein the concentrations of minerals are: magnesium from 3.2% to 9%, potassium from 0.4% to 4%, zinc from 0.09% to 0.45%, manganese from 0.02% to 0.07%, molybdenum, chromium or selenium from 0.0003% to 0.002%, calcium pantothenate from 0.04% to 0.15%, iron from 0.084% to 0.021%, copper from 0.02% to 0.1%, iodine from 0.0009% to 0.0045%, phosphorus from 2.5% to 20%, fluorine from 0.005% to 0.02%, calcium from 3.24% to 16.2%, said percentages being % weight based on total composition weight. 
     
     
         25 . The composition according to  claim 15 , wherein the concentrations of amino acids in addition to D-aspartic and L-aspartic acids is from 0.6% weight to 10% weight based on total composition weight. 
     
     
         26 . The composition according to  claim 15 , wherein said composition further comprises folic acid, vitamin B6, vitamin B12, potassium sorbate and sodium benzoate. 
     
     
         27 . The composition according to  claim 26 , wherein said folic acid concentration is from 0.002% to 0.006%, said Vitamin B6 concentration is from 0.02% to 0.06%, said Vitamin B12 concentration is from 1×10 −5 % to 3×10 −5 %, said potassium sorbate concentration is from 0.002 to 0.008%, and said sodium benzoate concentration is from 0.002 to 0.008%. 
     
     
         28 . A method of treating male infertility comprising the administration of a composition according to  claim 15  to an infertile male subject wherein said infertility of said male subject is not obstructive infertility as characterized by oligo and/or astenozoospermia with or without hypogonadotropic hypogonadism. 
     
     
         29 . The method according to  claim 28 , wherein the daily dose of said composition is from 0.001 g/day to 10 g/day.