Endometrial Receptivity Diagnosis via mRNA Expression Analysis

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Solution Overview

Problem

Current methods for determining the receptive status of the endometrium are unreliable, as existing techniques, such as histological and imaging methods, fail to clearly distinguish between receptive and non-receptive phases, and gene marker methods have not proven reliable for indicating the optimal window for embryo implantation during IVF procedures.

Innovation Solution

A method using a biological sample from a female patient to determine the receptive status of the endometrium by analyzing the mRNA expression levels of specific gene sets, including at least 5-20 genes, to identify whether the endometrium is in the mid-secretory phase, which is considered receptive for embryo implantation, using quantitative RT-PCR and oligonucleotide probes for accurate mRNA expression analysis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If histological and imaging methods are used to monitor endometrium status, then the procedure is non-invasive or minimally invasive, but the ability to clearly distinguish receptive and non-receptive phases is insufficient

Engineering Contradiction:
Improvedistinguishing accuracy of endometrial phasesVSAvoidcomplexity of diagnostic method
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces mechanical/histological examination methods with molecular biology techniques (gene expression analysis). Instead of visually examining tissue samples under microscopy, the invention uses mRNA expression level measurements to objectively and precisely determine endometrial receptivity status, thereby achieving clear distinction between phases while moving away from complex histological procedures

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The invention changes the measurement parameter from histological morphology to molecular biology parameters (mRNA expression levels of specific genes). By monitoring the expression levels of receptivity marker genes, the method achieves precise quantification of endometrial status, enabling clear differentiation between receptive and non-receptive phases through numerical data rather than subjective visual assessment

Inventive Principle:
Principle #35Parameter changes

2Reliability

If single gene marker methods are used to determine endometrial receptivity, then the test is simple, but the reliability of results is insufficient

Engineering Contradiction:
Improvereliability of receptivity determinationVSAvoidnumber of genes analyzed
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines multiple gene marker analyses into a single comprehensive test. Instead of relying on a single gene marker, the invention simultaneously measures the expression levels of multiple receptivity marker genes (including but not limited to LIF, IGFBP1, PAEP, and GREM1) to collectively determine endometrial receptivity status, thereby enhancing result reliability through multi-parameter assessment

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The invention creates a composite diagnostic approach by integrating multiple gene expression data points into a unified receptivity assessment. The combination of multiple gene markers forms a composite indicator system that provides more robust and reliable determination of endometrial status compared to any single marker alone

Inventive Principle:
Principle #40Composite materials

3Productivity

If the implantation window is not precisely identified, then the IVF procedure can be performed without additional testing, but the chance of successful embryo implantation decreases

Engineering Contradiction:
Improvesuccess rate of IVF procedureVSAvoidadditional time for gene expression analysis
Core Design Contradiction:
ProductivityVSLoss of time

Solution Approach 1:

The patent performs preliminary assessment of endometrial receptivity status before embryo transfer. By conducting gene expression analysis in advance to determine whether the endometrium is in a receptive state, the method allows clinicians to optimize the timing of embryo transfer, ensuring procedures are performed during the optimal implantation window to maximize success rates

Inventive Principle:
Principle #10Preliminary action

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

This method provides diagnostic accuracy in determining the receptive status of the endometrium, allowing for more reliable timing of embryo implantation during IVF procedures, improving the chances of successful pregnancy by identifying the optimal window of implantation.

Implementation Method 1

determining the mRNA expression levels of at least 5, 8, 10, 15 or 20, preferably at least 10 genes selected from the genes in the gene sets

Methodology Applied
Scientific EffectPolymerase Chain Reaction (PCR):

Implementation Method 2

quantitative RT-PCR

Methodology Applied
Scientific EffectReverse Transcription:

Implementation Method 3

oligonucleotide probes for accurate mRNA expression analysis

Methodology Applied
Scientific EffectHybridization:

Data Source

PatentEP3545107A2Determination of the receptive status of the endometrium
Publication Date: 2019.10.02 QUANTBIO KFT

AI summary

The invention relates to a method for determining the receptive or non-receptive status of the endometrium using a biological sample from a subject of reproductive age, preferably from a human female patient. Moreover, the invention relates to a test kit suitable for performing the method, as well as the use of oligonucleotides suitable for the amplification of gene sets for the determination of the receptive or non- receptive status of the endometrium.