Unitary combination of fsh and hcg

Abstract

A novel ovulatory induction paradigm entails administration of hCG in combination with FSH during all stages of treatment, where the ratio of FSH to hCG is adjusted to optimize ovulatory stimulation and minimize complications. The use of compositions characterized by various FSH:hCG ratios enables the practitioner readily to tailor the treatment regimen and accommodate different therapeutic goals as well as individual patient responses to gonadotropin administration.

1 .- 41 . (canceled) 
     
     
         42 . A pharmaceutical composition consisting of FSH and hCG in at least one pharmaceutically acceptable carrier, wherein the amount of FSH and hCG is selected from the group consisting of: 50 IU FSH and 100 IU hCG; 50 IU FSH and 200 IU hCG; 75 IU FSH and 25 IU hCG; 75 IU FSH and 50 IU hCG; 75 IU FSH and 75 IU hCG; 75 IU FSH and 100 IU hCG; 150 IU FSH and 10 IU hCG; 150 IU FSH and 25 IU hCG; 150 IU FSH and 50 IU hCG; 150 IU FSH and 75 IU hCG; and 150 IU FSH and 100 IU hCG. 
     
     
         43 . A composition of  claim 42  free from any other proteins of mammal origin. 
     
     
         44 . A pharmaceutical composition according to  claim 42  wherein the amount of FSH and hCG is selected from the group consisting of 50 IU FSH and 100 IU hCG; and 50 IU FSH and 200 IU hCG. 
     
     
         45 . A pharmaceutical composition according to  claim 42 , wherein said FSH is human derived FSH. 
     
     
         46 . A pharmaceutical composition according to  claim 42 , in lyophilised form. 
     
     
         47 . A pharmaceutical composition according to  claim 42 , in unit dosage form. 
     
     
         48 . A pharmaceutical composition according to  claim 42 , in solid dosage form. 
     
     
         49 . A pharmaceutical composition according to  claim 48 , wherein the solid dosage form is selected from the group consisting of capsules, tablets, suppositories, pills, powders, and granules. 
     
     
         50 . A pharmaceutical composition according to  claim 42  in liquid form. 
     
     
         51 . A pharmaceutical composition according to  claim 50 , wherein the liquid form is supplied in a vial. 
     
     
         52 . A pharmaceutical composition according to  claim 50 , wherein the liquid form is supplied in a pre-filled syringe or cartridge. 
     
     
         53 . An assemblage comprising a first vial and a second vial, each of said vials containing a pharmaceutical composition according to  claim 42  wherein the amount of FSH and hCG differs between the first vial and the second vial. 
     
     
         54 . The use, in the manufacture of a medicament for inducing ovulation, of a pharmaceutical composition consisting of FSH and hCG in at least one pharmaceutically acceptable carrier characterised by an amount of FSH and hCG that is selected from the group consisting of 50 IU FSH and 100 IU hCG; 50 IU FSH and 200 IU hCG; 75 IU FSH and 25 IU hCG; 75 IU FSH and 50 IU hCG; 75 IU FSH and 75 IU hCG; 75 IU FSH and 100 IU hCG; 150 IU FSH and 10 IU hCG; 150 IU FSH and 25 IU hCG; 150 IU FSH and 50 IU hCG; 150 IU FSH and 75 IU hCG; and 150 IU FSH and 100 IU hCG. 
     
     
         55 . The use of  claim 54 , wherein the amount of FSH and hCG. is selected from the group consisting of 50 IU FSH and 100 IU hCG and 50 IU FSH and 200 IU hCG. 
     
     
         56 . The use according to  claim 54 , wherein at least two pharmaceutical compositions, characterised by an amount of FSH and hCG selected from said group, that is either the same or differs with respect to said amount, are for administration in series. 
     
     
         57 . The use according to  claim 56 , wherein each succeeding composition in said series contains an amount of hCG that is increased over the preceding composition in said series. 
     
     
         58 . The use according to  claim 56 , wherein the period of time between compositions of the series is selected from the group consisting of from 1 hour, 5 hours, 10 hours, 12 hours, 24 hours, 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, 10 days, 11 days, 12 days, 13 days, 14 days and 15 days. 
     
     
         59 . The use according to  claim 54 , wherein the composition further comprises pure FSH. 
     
     
         60 . The use according to  claim 54 , wherein the composition further comprises pure hCG. 
     
     
         61 . A product comprising one or more unit doses of an injectable formulation comprising a single pharmaceutical composition consisting of FSH and hCG in at least one pharmaceutically acceptable carrier, wherein the amount of FSH and hCG is selected from the group consisting of: 50 IU FSH and 100 IU hCG; 50 IU FSH and 200 IU hCG; 75 IU FSH and 25 IU hCG; 75 IU FSH and 50 IU hCG; 75 IU FSH and 75 IU hCG; 75 IU FSH and 100 IU hCG; 150 IU FSH and 10 IU hCG; 150 IU FSH and 25 IU hCG; 150 IU FSH and 50 IU hCG; 150 IU FSH and 75 IU hCG; and 150 IU FSH and 100 IU hCG. 
     
     
         62 . A product according to  claim 61  supplied in a pre-filled syringe or cartridge.