Endometrial miRNA Profiling for Precise Receptivity State Detection
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Solution Overview
Problem
Existing methods for determining endometrial receptivity, such as histological and microarray-based approaches, are time-consuming and lack specificity, making it difficult to reliably distinguish between receptive and non-receptive states of the endometrium for embryo implantation.
Innovation Solution
A method using a miRNA expression profile of 167 specific miRNAs, analyzed by qPCR or other technologies, to determine a receptivity predictive score through a computer-based algorithm, classifying the endometrial status into pre-receptive, receptive, or post-receptive states.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If histological and imaging methods are used to assess endometrial status, then the examination can be performed, but the process is time consuming and cannot clearly distinguish between receptive and non-receptive states
Solution Approach 1:
The patent transitions from traditional histological and imaging parameters to molecular parameters (gene expression levels of specific marker genes). This parameter change enables clear distinction between receptive and non-receptive states through quantitative gene expression analysis, while the use of targeted marker genes and automated analysis reduces the time required compared to comprehensive histological examination.
Solution Approach 2:
The patent replaces mechanical histological examination and imaging methods with molecular biology techniques (gene expression analysis). This substitution uses biochemical reactions and automated detection systems instead of manual microscopic examination, improving both precision in distinguishing endometrial states and reducing examination time through higher throughput capabilities.
2Measurement precision
If microarray-based ERA test is used, then gene expression levels can be measured, but significant amounts of tissue samples are required and specificity is lower compared to qPCR
Solution Approach 1:
The patent changes the detection parameter from microarray hybridization signals to qPCR amplification signals. This parameter change increases measurement specificity because qPCR provides quantitative data with higher signal-to-noise ratio and better dynamic range. Simultaneously, the sensitivity improvement allows detection from smaller tissue samples containing fewer RNA molecules.
Solution Approach 2:
The patent uses qPCR amplification to create multiple copies of target gene sequences from minimal starting material. This copying process exponentially amplifies the target RNA/DNA sequences, enabling detection and quantification from very small tissue samples that would be insufficient for microarray analysis, while maintaining high specificity through sequence-specific primer binding.
3Reliability
If traditional methods are used to determine endometrial receptivity, then the process can be completed, but reliability in determining the optimal window for embryo implantation is insufficient
Solution Approach 1:
The patent shifts from subjective histological assessment parameters to objective molecular parameters (expression levels of specific marker genes). This parameter change dramatically improves reliability because gene expression levels provide quantifiable, reproducible data that objectively indicates the window of implantation, reducing variability and subjectivity inherent in traditional methods.
Solution Approach 2:
The patent employs a multi-gene expression profile panel that serves multiple functions: it determines endometrial receptivity status, identifies the optimal implantation window, and can potentially predict response to treatment. This universal molecular approach replaces multiple separate traditional assessments with a single comprehensive test, improving reliability while the standardized protocol actually simplifies the overall process.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Provides a more reliable and less invasive means to assess endometrial receptivity, improving the accuracy of determining the optimal window for embryo implantation.
Implementation Method 1
Methods based on the examination of gene expression levels have also been developed... quantitative polymerase chain reaction (qPCR) technology
Data Source
AI summary
The disclosure relates to a kit for determining an endometrial status and a method of determining a miRNA expression profile of an endometrial sample. The kit comprises: (a) one or more microRNA (miRNA) profiling chips targeting a plurality of miRNAs, and (b) instructions on (i) determining a miRNA expression profile of an endometrial sample from a woman, using the one or more miRNA profiling chips, and (ii) obtaining a receptivity predictive score based on the miRNA expression profile, using a computer-based algorithm, wherein the plurality of miRNAs comprise at least 167 miRNA s having the sequences of SEQ ID NOs: 1-167, respectively.


