Soluble CD163 Biomarker for Accurate Embryo Implantation Selection

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Solution Overview

Problem

Current methods for determining fertility of ova and embryos in infertility treatment lack a reliable biomarker to predict the likelihood of implantation and pregnancy, leading to suboptimal embryo selection and low pregnancy success rates.

Innovation Solution

Utilizing soluble CD163 concentration in human body fluids, such as follicular fluid or serum, as a biomarker to determine the fertility of ova and embryos by measuring its concentration through immunoassays, enabling the selection of embryos with high implantation potential.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If morphological evaluation methods (Veeck classification, Gardner classification) are used to select embryos, then the selection process is simple and quick, but the accuracy of predicting implantation potential is insufficient

Engineering Contradiction:
Improveaccuracy of implantation predictionVSAvoidcomplexity of evaluation system
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent introduces soluble CD163 as an intermediary biomarker that mediates between embryo quality and implantation outcome. This soluble protein serves as a measurable indicator that correlates with implantation potential, allowing clinicians to objectively assess embryo quality without relying solely on subjective morphological evaluation. The biomarker acts as a bridge connecting embryo characteristics to clinical outcomes.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces the mechanical/visual morphological evaluation system with a biochemical measurement system. Instead of relying on visual assessment of embryo structure by clinicians, the invention uses immunoassay techniques to measure soluble CD163 concentration, providing an objective quantitative metric that substitutes for subjective morphological grading.

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

2Reliability

If multiple embryos are transferred to increase implantation rate, then the pregnancy success rate improves, but the physical burden on the patient increases

Engineering Contradiction:
Improvepregnancy success rateVSAvoidphysical burden on patient
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent enables preliminary selection of high-quality embryos before transfer by measuring soluble CD163 levels. This preliminary assessment allows clinicians to identify embryos with the highest implantation potential in advance, so that transferring a single carefully selected embryo can achieve the same pregnancy success rate that previously required transferring multiple embryos.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent changes the selection criterion from the number of embryos transferred to the quality parameter measured by soluble CD163 concentration. By shifting the focus from quantity to quality through this biochemical parameter, the system achieves high pregnancy success rates with single embryo transfer, eliminating the need for multiple embryo transfer and its associated physical burdens.

Inventive Principle:
Principle #35Parameter changes

3Ease of operation

If top-quality embryos are selected based on morphology, then the selection process is straightforward, but implantation may still fail

Engineering Contradiction:
Improveease of embryo selectionVSAvoidimplantation success
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent introduces feedback through soluble CD163 measurement that provides information about the actual implantation potential of embryos. This feedback mechanism allows clinicians to verify whether morphologically top-quality embryos truly have high implantation potential, and to adjust selection decisions based on the biochemical marker data, thereby improving reliability while maintaining ease of operation.

Inventive Principle:
Principle #23Feedback

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 an objective numerical basis for embryo selection, increasing the rate of pregnancy establishment by identifying embryos with high fertility potential.

Implementation Method 1

utilizing soluble CD163 concentration in human body fluids... as a biomarker to determine the fertility of ova and embryos by measuring its concentration through immunoassays

Methodology Applied
Scientific EffectAntibody-antigen binding:

Data Source

PatentEP4276109B1Biomarker for determining fertility, and determining method using same
Publication Date: 2026.02.04 TOSOH CORP
  • EP4276109B1 patent drawingFigure 1~2
  • EP4276109B1 patent drawingFigure 3~4
  • EP4276109B1 patent drawingFigure 5~6

AI summary

An object of the present invention is to provide a biomarker that enables selection of an embryo having a high rate of implantation and pregnancy, that is, an embryo having high fertility, from embryos obtained through embryo culture after in vitro fertilization in infertility treatment, and a criterion therefor. Provided is a criterion that enables identification of an ovum suitable for implantation and pregnancy based on measurement of the concentration of soluble CD163 which is present in follicular fluid collected at the same time as an ovum in ovum pick up in infertility treatment, or which is present in serum immediately before the ovum pick up.