Compositions and methods for determining receptivity of an endometrium for embryonic implantation
Inventors
Munne, Santiago • Horcajadas, Joson A. • Aizpurua, Jon
Assignees
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Publication Number
US-12336836-B2
Publication Date
2025-06-24
Expiration Date
Abstract
Provided herein are methods and kits for determining receptivity status of an endometrium for embryonic implantation.
Core Innovation
The invention relates to predicting endometrial receptivity status for embryonic implantation in a human subject. A first biological sample is obtained from the human subject at a first time point within a menstrual cycle, and a gene expression profile is determined for a panel of genes using reverse transcription polymerase chain reaction analysis. The panel of genes comprises specified genes including ARG2, GPX3, MUC1, APOD, and SCGB2A2.
The determined gene expression profile of the panel is compared with gene expression profiles of the same panel of genes in receptive, non-receptive, pre-receptive, and post-receptive endometrial receptivity reference groups. Based on the correspondence of the determined profile to one of the reference-group profiles, the human subject is identified as having a receptive, non-receptive, pre-receptive, or post-receptive endometrial status. The described analysis uses classification based on predefined reference groups and includes high-throughput RT-qPCR with principal component analysis and discriminant functional analysis.
The invention further includes transferring a pre-implantation embryo into the human subject identified as having a receptive endometrial status. Validation is described on 306 endometrial samples, including differential expression results and accurate classification, with concordance reported in patient subsets.
Claims Coverage
The document includes one independent claim. It sets out a workflow with gene-expression profiling of a specified panel, comparison to receptive/non-receptive/pre-receptive/post-receptive reference group profiles, classification of the subject’s endometrial receptivity status, and transferring a pre-implantation embryo when the subject is classified as receptive.
Predicting endometrial receptivity status by RT-PCR gene panel comparison to reference groups
A method of predicting endometrial receptivity status for embryonic implantation in a human subject by providing a first biological sample within a menstrual cycle, determining a gene expression profile of a panel of genes using reverse transcription polymerase chain reaction analysis, comparing the determined gene expression profile with reference group profiles for receptive, non-receptive, pre-receptive, and post-receptive endometrial receptivity, and identifying the human subject as having one of the corresponding endometrial statuses based on profile correspondence.
Embryo transfer when receptive
Transferring a pre-implantation embryo into the human subject identified as having a receptive endometrial status.
Overall claim coverage centers on classifying endometrial receptivity status using a predefined RT-PCR gene panel and reference-group comparisons across receptive, non-receptive, pre-receptive, and post-receptive categories, followed by embryo transfer when the subject is identified as having a receptive endometrial status.
Stated Advantages
Enables accurate classification of endometrial receptivity status compared to receptive/non-receptive/pre-receptive/post-receptive reference groups and reporting concordance with ERA in patient subsets.
Documented Applications
Determining endometrial receptivity status for embryonic implantation in a human subject in the context of assisted reproductive treatment (including IVF) by using gene-expression profiling and reference-group comparison.
Transferring a pre-implantation embryo when the human subject is identified as having a receptive endometrial status.
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