PCOS Risk Assessment Method Using Combined Hormonal and Cycle Data

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Solution Overview

Problem

Current methods for diagnosing polycystic ovary syndrome (PCOS) are subjective, error-prone, and lack a universal, objective test, making it difficult for less specialized physicians to accurately assess the risk, especially with the need for expertise in ultrasound analysis and multiple diagnostic tests.

Innovation Solution

A computer-implemented method using a data set including OA-value for menstrual cycle, HA-value for androgen status, and AMH-value, processed to combine these values into a single indicator of PCOS risk, compared to a reference population to objectively assess the risk, reducing reliance on subjective measurements and simplifying the diagnostic process.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If multiple diagnostic tests and ultrasound analysis are used to diagnose PCOS, then diagnostic accuracy is improved, but device complexity and operator expertise requirements increase

Engineering Contradiction:
Improvediagnostic accuracyVSAvoidcomplexity of diagnostic process
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent combines multiple diagnostic parameters (menstrual cycle data, androgen levels, AMH levels, ultrasound findings) into a single integrated risk score. This merging of multiple tests into one composite indicator simplifies the diagnostic process while maintaining comprehensive assessment, directly resolving the contradiction between diagnostic accuracy and process complexity.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent transforms qualitative clinical assessments and multiple quantitative measurements into a standardized numerical risk score with defined thresholds. This parameter transformation enables objective risk stratification (low, medium, high risk) without requiring complex interpretation of individual test results, reducing the expertise burden while preserving diagnostic precision.

Inventive Principle:
Principle #35Parameter changes

2Measurement precision

If ultrasound equipment and expert analysis are required for PCOS diagnosis, then measurement precision is improved, but ease of operation deteriorates

Engineering Contradiction:
Improvediagnostic accuracyVSAvoidease of diagnosis
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The patent introduces a computational risk assessment model as an intermediary between raw diagnostic data and clinical decision-making. This mediator automatically processes multiple parameters and generates an objective risk score, eliminating the need for subjective expert interpretation of ultrasound images and other test results, thereby improving ease of operation while maintaining precision.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces the mechanical/subjective process of expert ultrasound interpretation with an automated computational system. The risk assessment algorithm objectively combines data from multiple sources including ultrasound measurements, hormonal levels, and menstrual history, substituting human expert analysis with a standardized computational approach that is easier to implement and less prone to variability.

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

3Ease of operation

If subjective measurements are used in PCOS diagnosis, then ease of operation is improved, but measurement precision deteriorates

Engineering Contradiction:
Improveease of clinical assessmentVSAvoiddiagnostic accuracy
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The patent implements a structured feedback mechanism where the risk assessment model provides objective numerical scores based on input data, allowing clinicians to see exactly how each parameter contributes to the overall risk classification. This feedback loop replaces subjective judgment with transparent, data-driven assessment, improving measurement precision while maintaining ease of operation through clear, actionable results.

Inventive Principle:
Principle #23Feedback

Data Source

PatentUS20230221335A1A method of assessing a female's risk of having PCOS as well as products and uses relating thereto
Publication Date: 2023.07.13 ROCHE DIAGNOSTICS OPERATIONS INC
  • US20230221335A1 patent drawing
  • US20230221335A1 patent drawing
  • US20230221335A1 patent drawing

AI summary

The present invention relates to a method of assessing a female’s risk of having polycystic ovary syndrome (PCOS), a kit for use in assessing a female’s risk of having PCOS, the use of a marker combination in the assessment of a female’s risk of having PCOS, a computer system for use in a method according to the present invention as well as a computer program and a computer-readable storage medium comprising instructions, which when executed by a computer, cause the computer to carry out the method of the present invention.