Methods of treating infertility

Abstract

The present invention relates to improved assisted reproductive technology using highly purified menotropin (HP-hMG) to stimulate follicle development in controlled ovarian stimulation, particularly in women at risk of a high ovarian response to controlled ovarian stimulation.

1 - 28 . (canceled) 
     
     
         29 . A kit for conducting controlled ovarian stimulation in a woman at risk of a high ovarian response to in vitro fertilization after controlled ovarian stimulation, comprising:
 an amount of highly purified menotropin (HP-hMG) composition comprising HP-hMG that provides at least one dose of HP-hMG of about 75 IU to about 300 IU HP-hMG;   a gonadotropin-releasing hormone (GnRH) antagonist composition comprising a GnRH antagonist; and   a composition comprising human chorionic gonadotrophin (hCG) or a GnRH agonist.   
     
     
         30 . The kit according to  claim 29 , wherein the amount of HP-hMG composition provides at least one dose of HP-hMG selected from about 75 IU, about 100 IU, about 150 IU, about 200 IU, about 225 IU and about 300 IU. 
     
     
         31 . The kit of  claim 29 , wherein the amount of HP-hMG composition is sufficient to provide at least 5 doses of HP-hMG. 
     
     
         32 . The kit of  claim 29 , wherein the amount of HP-hMG composition is sufficient to provide at least 5 doses of at least 150 IU HP-hMG per dose. 
     
     
         33 . The kit of  claim 32 , wherein the amount of HP-hMG composition is sufficient to additionally provide one or more additional doses of about 225 IU HP-hMG per dose. 
     
     
         34 . The kit of  claim 29 , wherein the amount of HP-hMG composition is sufficient to provide 1-20 doses of HP-hMG. 
     
     
         35 . The kit of  claim 29 , wherein the amount of HP-hMG composition is sufficient to provide 1-20 doses of HP-hMG, where each dose provides from about 75 IU to about 300 IU HP-hMG. 
     
     
         36 . The kit of  claim 29 , wherein the HP-hMG composition is provided as a powder for reconstitution in one or more vials containing about 75 IU HP-hMG per vial. 
     
     
         37 . The kit of  claim 29 , comprising an amount of the composition comprising human chorionic gonadotrophin (hCG) or GnRH agonist effective to trigger final follicular maturation. 
     
     
         38 . The kit of  claim 29 , wherein the GnRH antagonist comprises ganirelix acetate, and wherein the kit comprises an amount of the GnRH antagonist composition sufficient to provide at least one 0.25 mg dose of ganirelix acetate 
     
     
         39 . A kit for conducting controlled ovarian stimulation in a woman having a serum anti-Müllerian hormone (AMH) level greater than or equal to 5.0±0.5 ng/ml, when measured using a Beckmann-Coulter Gen 2 assay or a comparable AMH level measured by a different method, comprising:
 an amount of a highly purified menotropin (HP-hMG) composition comprising HP-hMG that provides at least one dose of HP-hMG of about 75 IU to about 300 IU HP-hMG; 
 a gonadotropin-releasing hormone (GnRH) antagonist composition comprising a GnRH antagonist; and 
 a composition comprising human chorionic gonadotrophin (hCG) or a GnRH agonist. 
 
     
     
         40 . A kit for increasing for increasing the proportion of euploid blastocysts produced by in vitro fertilization after controlled ovarian stimulation, comprising:
 an amount of a highly purified menotropin (HP-hMG) composition comprising HP-hMG that provides at least one dose of HP-hMG of about 75 IU to about 300 IU HP-hMG;   a gonadotropin-releasing hormone (GnRH) antagonist composition comprising a GnRH antagonist; and   a composition comprising human chorionic gonadotrophin (hCG) or a GnRH agonist.   
     
     
         41 . A kit for reducing early pregnancy loss after in vitro fertilization after controlled ovarian stimulation of a woman at risk of a high ovarian response to controlled ovarian stimulation, comprising:
 an amount of a highly purified menotropin (HP-hMG) composition comprising HP-hMG that provides at least one dose of HP-hMG of about 75 IU to about 300 IU HP-hMG;   a gonadotropin-releasing hormone (GnRH) antagonist composition comprising a GnRH antagonist; and   a composition comprising human chorionic gonadotrophin (hCG) or a GnRH agonist.   
     
     
         42 . An assisted reproductive technology method for treating a woman at risk of a high ovarian response to in vitro fertilization after controlled ovarian stimulation, comprising:
 selecting a woman at risk of a high ovarian response to controlled ovarian stimulation having a serum anti-Müllerian hormone (AMH) level greater than or equal to 5.0±0.5 ng/ml, when measured using a Beckmann-Coulter Gen 2 assay or a comparable AMH level measured by a different method and an antral follicle count (AFC) of greater than or equal to 10 in both ovaries combined prior to stimulation; and then   administering to the selected woman an amount of highly purified menotropin (HP-hMG) effective to stimulate follicle development, wherein the amount of HP-hMG administered is selected from about 75 IU/day to about 300 IU/day.   
     
     
         43 . The method of  claim 41 , wherein the amount of HP-hMG administered comprises about 150 IU for at least 5 days followed by 225 IU for at least one day.