Compositions and methods for reducing the risk of spontaneous abortion in a human female

Abstract

Methods and kits for preventing or reducing the likelihood of implantation failure or miscarriage 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).

What is claimed is: 
     
         1 . A method for reducing the risk of spontaneous abortion, comprising administering an effective amount of a granulocyte colony stimulating factor (G-CSF) to a human female at risk of a spontaneous abortion, wherein the G-CSF is administered at a total dose ranging from about 10 μg/kg to about 100 μg/kg during the first 20 weeks of pregnancy. 
     
     
         2 . A method for reducing the risk of preterm labor, comprising administering an effective amount of a granulocyte colony stimulating factor (G-CSF) to a human female at risk of preterm labor, wherein the G-CSF is administered at a total dose ranging from about 10 μg/kg to about 100 μg/kg during the first 20 weeks of pregnancy. 
     
     
         3 . A method for reducing the risk of preeclampsia, comprising administering an effective amount of a granulocyte colony stimulating factor (G-CSF) to a human female at risk of preeclampsia, wherein the G-CSF is administered at a total dose ranging from about 10 μg/kg to about 100 μg/kg during the first 20 weeks of pregnancy. 
     
     
         4 . The method according to  claim 1 , wherein the G-CSF is administered for one day, two days, three days, four days, one week, two weeks, three weeks, or four weeks. 
     
     
         5 . The method according to  claim 1 , wherein the G-CSF is administered daily at a dose of about 0.1 μg/kg to 2 μg/kg. 
     
     
         6 . The method according to  claim 1 , wherein the G-CSF is administered daily for four weeks, three weeks, two weeks, or one week during the first trimester of pregnancy. 
     
     
         7 . The method according to  claim 1 , wherein the G-CSF is administered daily for four weeks, three weeks, two weeks, or one week during the second trimester of pregnancy. 
     
     
         8 . The method according to  claim 1 , wherein the G-CSF is administered daily through the second trimester of pregnancy. 
     
     
         9 . The method according to  claim 1 , wherein the G-CSF is administered daily through the 20 th  week of pregnancy. 
     
     
         10 . The method according to  claim 1 , wherein the G-CSF is administered for at least five consecutive days during the first and/or second trimester of pregnancy. 
     
     
         11 . The method according to  claim 1 , wherein the G-CSF is administered for at least five consecutive days during the first and/or second week of pregnancy. 
     
     
         12 . The method according to  claim 1 , wherein the G-CSF is administered parenterally, enterally, subcutaneously, percutaneously, transdermally, intradermally, intravenously, topically, by inhalation, or by implantation. 
     
     
         13 . The method according to  claim 1 , wherein the G-CSF is administered subcutaneously. 
     
     
         14 . The method according to  claim 1 , wherein the human female was a recipient of an assisted reproduction procedure. 
     
     
         15 . The method according to  claim 14 , wherein the assisted reproduction procedure is in vitro fertilization, artificial insemination, or gamete intrafallopian tube transfer. 
     
     
         16 . The method according to  claim 1 , wherein the G-CSF is administered with another active agent. 
     
     
         17 . The method according to  claim 16 , wherein the other active agent is an immunosuppressive agent, an anti-inflammatory agent, vitamin D, aspirin, heparin, intravenous immunoglobulin (IVIG), or progesterone. 
     
     
         18 . The method according to  claim 1 , wherein the G-CSF comprises filgrastim, nartograstim, or lenograstim. 
     
     
         19 . The method according to  claim 1 , wherein the human female is in the first trimester of pregnancy, or is in the first or second month of pregnancy. 
     
     
         20 . The method according to  claim 1 , wherein the human female previously had one or more spontaneous abortions, two or more spontaneous abortions, or recurrent spontaneous abortions.