Abstract: The present invention discloses biomarkers and biomarker combinations that have prognostic value as predictors of the developmental potential of individual IVF-derived human embryos. In particular, the biomarkers of this invention are useful to classify an embryo with implantation competence after uterine transfer or implantation incompetence. In addition, the biomarkers can be detected by non-invasive methods that do not harm the developing embryo. Also disclosed are kits for the prediction of developmental potential that detect the biomarkers of the invention, as well as methods using a plurality of classifiers to make a probable diagnosis of developmental potential.

Abstract: Reagents, methods, and kits are described that are useful for fertility testing and that in many cases provides much faster, convenient and rapid determination of male infertility. The reagents described include properly glycosylated human ZP3, ZP2, ZP1, glycosylated peptides thereof, fusion proteins such as green fluorescent protein—ZP3, non-covalent complexes of ZP2 with ZP3, fusion protein of ZP2–ZP3, solid phase materials such as agarose beads coated with binding agents such as ZP3, and other artificial zona. Methods are provided that, in many cases convert a complex biological event into a well defined biochemical binding event based on one or more of the reagents. Such methods are much easier to set up and monitor, allowing more convenient and inexpensive diagnostic testing for male fertility. The acrosome reaction is detected in other embodiments by virtue of quantitating one or more released substances.

Abstract: The present invention provides a method to determine sperm activity comprising the steps of: (a) contacting an appropriate concentration of human zona pellucida protein 3 with an appropriate amount of sperm under conditions permitting the formation of a complex between the human zona pellucida protein 3 and the sperm; and (b) determining the complex formed. The invention further provides a method to determine sperm activity comprising the steps of (a) contacting an appropriate concentration of human zona pellucida protein 3 with an appropriate amount of sperm under conditions permitting an acrosome reaction to occur; and (b) determining the extent of the acrosome reaction.

Abstract: The present invention provides a method to determine sperm activity comprising the steps of: (a) contacting an appropriate concentration of human zona pellucida protein 3 with an appropriate amount of sperm under conditions permitting the formation of a complex between the human zona pellucida protein 3 and the sperm; and (b) determining the complex form. The invention further provides a method to determine sperm activity comprising the steps of (a) contacting an appropriate concentration of human zona pellucida protein 3 with an appropriate amount of sperm under conditions permitting an acrosome reaction to occur; and (b) determining the extent of the acrosome reaction.