Diagnostic markers of human female infertility

Abstract

The subject invention pertains to methods and reagents for the diagnosis of female infertility, prognostic indicators for female infertility, compounds for the treatment of female infertility, compounds and methods for contraception. Methods and compounds are based on the levels of ebaf in endometrial tissue. Methods for diagnosing endometrial receptivity and bleeding function by screening a biological sample such as an endometrial tissue sample, or bodily fluid for the presence of ebaf. A contraceptive compound containing an effective amount of ebaf and a pharmaceutically acceptable carrier. A diagnostic kit for timing contraception containing reagents for screening a sample for the presence of ebaf. A method of treating endometrial irregularities by down-regulating the expression of ebaf.

1 . A method for detecting or diagnosing an endometrial irregularity in a female animal, said method comprising screening an endometrial tissue, an endometrial fluid, serum, saliva, or urine from the female animal for an abnormal level of an endometrial bleeding associated factor (ebaf) nucleic acid, or a protein encoded by an ebaf nucleic acid, wherein an abnormal level of said ebaf nucleic acid or said protein encoded by an ebaf nucleic acid is indicative of an endometrial irregularity in the female animal. 
     
     
         2 . The method according to  claim 1 , wherein said ebaf nucleic acid is RNA and said method comprises detecting the level of ebaf RNA by screening by Northern blot analysis. 
     
     
         3 . The method according to  claim 1 , wherein said method comprises determining the level of said protein encoded by said ebaf nucleic acid using an antibody or antisera that specifically binds to said protein. 
     
     
         4 . The method according to  claim 3 , wherein said method comprises screening by Western blot analysis. 
     
     
         5 . The method according to  claim 3 , wherein said method comprises screening using immunohistochemical staining. 
     
     
         6 . The method according to  claim 1 , wherein said endometrial irregularity is infertility. 
     
     
         7 . The method according to  claim 1 , wherein said endometrial irregularity is endometriosis. 
     
     
         8 . The method according to  claim 1 , wherein said endometrial irregularity is abnormal uterine bleeding. 
     
     
         9 . A method for diagnosis and prognosis of infertility, endometriosis, or menometrorrahgia in a female animal, said method comprising determining the level of an ebaf nucleic acid, or the level of a protein encoded by an ebaf nucleic acid, in an endometrial sample, endometrial fluid, a serum sample, a saliva sample, or a urine sample from the female animal; and correlating said level of ebaf nucleic acid or said level of said protein encoded by said ebaf nucleic acid with normal levels so as to provide a diagnosis or prognosis of infertility, endometriosis, or menometrorrahgia in the female animal. 
     
     
         10 . The method according to  claim 9 , wherein said ebaf nucleic acid is RNA and said method comprises detecting the level of ebaf RNA by screening by Northern blot analysis. 
     
     
         11 . The method according to  claim 9 , wherein said method comprises determining the level of said protein encoded by said ebaf nucleic acid using an antibody or antisera that specifically binds to said protein. 
     
     
         12 . The method according to  claim 11 , wherein said method comprises screening by Western blot analysis. 
     
     
         13 . The method according to  claim 11 , wherein said method comprises screening using immunohistochemical staining.