Endometrial Receptivity Array Microarray for Objective Diagnosis
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Solution Overview
Problem
Current methods for determining endometrial receptivity in humans are inadequate, as histological studies are subjective, lack precision, and fail to distinguish between fertile and infertile women, while existing molecular techniques do not provide consistent results for predicting fertility or implantation success.
Innovation Solution
A specific microarray (Endometrial Receptivity Array or ERA) is designed to analyze the gene expression profile of the endometrium, using a computational prediction model to objectively evaluate the receptivity state by identifying key genes differentially expressed during the window of implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If histological studies are used to determine endometrial receptivity, then diagnostic capability is provided, but measurement precision and objectivity deteriorate due to subjectivity and inter-observer variability
Solution Approach 1:
The patent replaces manual histological examination (mechanical/visual inspection) with microarray technology and computational algorithms. The diagnostic process transitions from subjective visual assessment by pathologists to objective molecular profiling using gene expression analysis, where RNA samples are hybridized to microarray chips and analyzed through standardized computational pipelines, eliminating inter-observer variability while maintaining diagnostic capability
Solution Approach 2:
The invention shifts the diagnostic parameters from morphological features (histological appearance, glandular structure, stromal changes) to molecular parameters (gene expression levels, RNA transcript profiles). By measuring the expression levels of specific genes known to be differentially expressed during the window of implantation, the system achieves precise, quantifiable, and reproducible receptivity assessment that is independent of histological interpretation subjectivity
2Reliability
If histological criteria are used for endometrial dating, then diagnostic capability is maintained, but reliability deteriorates due to inability to distinguish fertile from infertile women
Solution Approach 1:
The patent replaces histological dating methods with molecular profiling through microarray analysis. Instead of relying on morphological appearance that cannot differentiate between fertile and infertile endometria, the system analyzes gene expression signatures that are specifically altered in receptive versus non-receptive states, providing reliable fertility prediction based on molecular rather than morphological characteristics
Solution Approach 2:
The invention creates a molecular copy or signature of endometrial receptivity status through gene expression profiling. By measuring the expression patterns of receptivity-associated genes, the system generates a molecular fingerprint that accurately reflects the functional state of the endometrium, enabling reliable discrimination of fertile from infertile women regardless of histological appearance
3Measurement precision
If microarray technology is implemented for endometrial receptivity assessment, then measurement precision and objectivity improve, but device complexity and manufacturing cost increase
Solution Approach 1:
The patent segments the diagnostic process into distinct modular components: sample collection (endometrial biopsy), RNA extraction and labeling, microarray hybridization, scanning and data acquisition, and computational analysis. Each module can be independently optimized, validated, and manufactured, allowing for standardized production protocols and reducing overall system complexity despite the advanced technology involved
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
The ERA microarray provides a precise and objective assessment of endometrial receptivity, improving diagnostic capabilities and predicting fertility status, with a high success rate in classifying samples as receptive or non-receptive, thereby aiding in infertility diagnosis and treatment.
Implementation Method 1
The method comprises: a) providing a microarray comprising a set of polynucleotide probes; b) providing a sample of RNA or cDNA synthesised from RNA; c) labelling said RNA or cDNA; d) hybridizing said labelled RNA or cDNA to the microarray
Data Source
AI summary
The present invention relates to determining the receptivity of human endometrium from a gene expression profile. More specifically, the invention consists of developing a specific expression microarray of endometrial receptivity (Endometrial Receptivity Array or ERA) which allows evaluating the receptive state of a human endometrium, as well as assessing said state for diagnostic and therapeutic purposes.