Recombinant fsh composition for treatment of infertility

Abstract

Preparations including FSH, for example recombinant FSH, for use in the treatment of infertility.

1 - 19 . (canceled) 
     
     
         20 . A method of treating infertility, comprising administering a follicle stimulating hormone (FSH) composition at a dose of or equivalent to from 9 μg to 24 μg FSH to a patient identified prior to treatment as having variant Ser/Ser at position 680 of the FSH receptor and an antral follicle count (AFC)≥8 in both ovaries combined. 
     
     
         21 . The method of  claim 20 , wherein the method comprises daily administration of the FSH composition. 
     
     
         22 . The method of  claim 20 , wherein the method comprises administering the FSH composition at a dose of or equivalent to from greater than 12 μg FSH to 24 μg FSH. 
     
     
         23 . The method of  claim 20 , wherein the FSH composition is administered starting on day one of treatment and continuing for from six to sixteen days. 
     
     
         24 . The method of  claim 20 , wherein the FSH is recombinant FSH. 
     
     
         25 . The method of  claim 20 , wherein the FSH is recombinant FSH that includes α2,3-sialylation and α2,6-sialylation. 
     
     
         26 . The method of  claim 20 , wherein the FSH is recombinant FSH that includes α2,3-sialylation and α2,6-sialylation, wherein from 1 to 99% of the total sialylation is α2,6-sialylation and from 99% to 1% of the total sialylation is α2,3-sialylation. 
     
     
         27 . The method of  claim 20 , wherein the FSH is recombinant FSH that includes α2,3-sialylation and α2,6-sialylation, wherein from 1 to 50% of the total sialylation is α2,6-sialylation and from 50% to 99% of the total sialylation is α2,3-sialylation. 
     
     
         28 . A method of treating infertility, comprising administering a follicle stimulating hormone (FSH) composition at a dose of or equivalent to from 9 μg to 24 μg FSH to a patient identified prior to treatment as having variant Ser/Ser at position 680 of the FSH receptor, wherein the FSH is recombinant FSH that includes α2,3-sialylation and α2,6-sialylation, wherein from 1 to 50% of the total sialylation is α2,6-sialylation and from 50% to 99% of the total sialylation is α2,3-sialylation, wherein the patient is identified prior to treatment as having an antral follicle count (AFC)≥8 in both ovaries combined. 
     
     
         29 . A method of treating infertility, comprising administering a follicle stimulating hormone (FSH) composition at a daily dose of from 9 μg to 24 μg FSH to a patient identified prior to treatment as having variant Ser/Ser at position 680 of the FSH receptor, wherein the FSH is recombinant FSH that includes α2,3-sialylation and α2,6-sialylation, wherein from 1 to 50% of the total sialylation is α2,6-sialylation and from 50% to 99% of the total sialylation is α2,3-sialylation, wherein the patient is identified prior to treatment as having an antral follicle count (AFC)≥8 in both ovaries combined.