Compositions and methods for reducing the likelihood of preterm labor in recipients of artificial insemination

Abstract

Methods and kits for preventing or reducing the likelihood of preterm labor in a recipient of artificial insemination are provided. The methods include administering into a recipient of artificial insemination in need of such treatment an effective amount of granulocyte colony stimulating factor (G-CSF).

1 - 38 . (canceled) 
     
     
         39 . A method for reducing the likelihood of preterm labor in a recipient of artificial insemination, comprising administering to the recipient of artificial insemination an effective amount of a composition comprising granulocyte colony-stimulating factor (G-CSF). 
     
     
         40 . The method of  claim 39 , wherein said artificial insemination is intrauterine insemination, intravaginal insemination, intracervical insemination, or intratubal insemination. 
     
     
         41 . The method of  claim 39 , wherein said composition is administered parenterally. 
     
     
         42 . The method of  claim 39 , wherein said composition is administered enterally. 
     
     
         43 . The method of  claim 39 , wherein said composition is administered topically. 
     
     
         44 . The method of  claim 39 , wherein said composition is administered by inhalation. 
     
     
         45 . The method of  claim 39 , wherein said composition is administered prior to said artificial insemination. 
     
     
         46 . The method of  claim 39 , wherein said artificial insemination comprises a controlled ovarian hyperstimulation procedure prior to insemination, and wherein said composition is administered before, during, or after the time of controlled ovarian hyperstimulation. 
     
     
         47 . The method of  claim 39 , wherein said composition is administered daily for one to thirty-five consecutive days. 
     
     
         48 . The method of  claim 39 , wherein said composition is administered daily until the end of first trimester. 
     
     
         49 . The method of  claim 39 , wherein said composition is administered daily until said recipient presents a normal Th1 response or a normal Th2 response or both. 
     
     
         50 . The method of  claim 39 , wherein said G-CSF is administered at a dose of between 0.1 mcg/kg/day to 600 mcg/kg/day. 
     
     
         51 . The method of  claim 50 , wherein said G-CSF is administered at a dose of between 1 mcg/kg/day to 100 mcg/kg/day. 
     
     
         52 . The method of  claim 51 , wherein said G-CSF is administered at a dose of between 1 mcg/kg/day to 50 mcg/kg/day. 
     
     
         53 . The method of  claim 52 , wherein said G-CSF is administered at a dose of between 1 mcg/kg/day to 10 mcg/kg/day. 
     
     
         54 . The method of  claim 53 , wherein said G-CSF is administered at a dose of between 1 mcg/kg/day to 2 mcg/kg/day. 
     
     
         55 . The method of  claim 54 , wherein said G-CSF is administered at a dose of about 1.5 mcg/kg/day to 1.7 mcg/kg/day. 
     
     
         56 . The method of  claim 39 , wherein said G-CSF is administered in the form of a nucleotide sequence encoding G-CSF. 
     
     
         57 . The method of  claim 39 , wherein said composition further comprises an additive. 
     
     
         58 . The method of  claim 57 , wherein said additive is selected from the group consisting of cytokines that suppress Th1 immune response, cytokines that enhance Th2 immune response, cytokines that support successful pregnancy through non-immunologic mechanisms, anti-inflammatory agents, and inhibitors of pro-inflammatory cytokines. 
     
     
         59 . The method of  claim 57 , wherein said additive is selected from the group consisting of interferon alpha, interferon beta, macrophage colony stimulating factor (M-CSF), granulocyte macrophage colony stimulating factor (GM-CSF), leukemia inhibitory factor (LIF), transforming growth factor beta (TGF-beta), interleukin-1 (IL-1), IL-3, IL-4, IL-6, IL-7, IL-8, IL-9, IL-10, IL-11, IL-13, IL-14, IL-15, IL-19, IL-20, IL-21, IL-22, IL-24, IL-25, IL-26, IL-27, IL-28, IL-29, IL-30, IL-31, IL-32, IL-33, and IL-35. 
     
     
         60 . The method of  claim 57 , wherein said additive comprises an immunosuppressive agent. 
     
     
         61 . The method of  claim 60 , wherein said immunosuppressive agent comprises vitamin D3 (1,25 dihydroxycholecalciferol), analogs thereof, or corticosteroids. 
     
     
         62 . The method of  claim 61 , wherein said corticosteroid is prednisone or methylprednisolone.