Noninvasive Progesterone Monitoring via Urine PdG Optical Detection

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Solution Overview

Problem

Current methods for evaluating corpus luteum functionality, particularly in relation to progesterone levels, are invasive, time-consuming, and impractical for daily monitoring, often requiring blood tests that are costly, inconvenient, and provide delayed results, limiting accurate tracking of menstrual cycles and timely intervention.

Innovation Solution

A method utilizing specially configured urine or saliva tests with test strips that provide near-instantaneous results for progesterone or its analytes, allowing daily evaluation over multiple days, using a diagnostic test system with optical signals to detect PdG levels, and a mobile application for recording and interpreting results.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If serum-based progesterone testing is used, then measurement precision is improved, but ease of operation deteriorates and loss of time increases

Engineering Contradiction:

Improveprogesterone level detection accuracyVSAvoidtesting convenience

Core Design Contradiction:

Measurement precisionVSEase of operation

Solution Approach 1:

The patent uses urine as an intermediary medium to indirectly measure progesterone levels. Instead of directly testing serum progesterone which requires blood draws, the system tests for pregnanediol glucuronide (PdG) in urine, which is a metabolite of progesterone. This intermediary approach maintains measurement precision while dramatically improving ease of operation, allowing users to simply collect urine samples at home without needing medical professionals for blood draws.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Measurement precision

If lab-based progesterone testing is used, then measurement precision is improved, but loss of time deteriorates

Engineering Contradiction:

Improveprogesterone level detection accuracyVSAvoidresult delivery time

Core Design Contradiction:

Measurement precisionVSLoss of time

Solution Approach 1:

The patent replaces the mechanical/chemical laboratory analysis system with an optical detection system. The test strip contains antibodies that bind to PdG in the urine sample, and this binding is detected through optical signals (color changes) that can be read immediately by a handheld device or even visually interpreted. This substitution eliminates the need for lengthy laboratory processing, providing results within minutes while maintaining precision through calibrated optical detection.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The testing system is designed for self-service, allowing users to independently collect urine samples, apply them to test strips, and obtain results without requiring laboratory visits or medical professional intervention. The immediate optical readout enables users to interpret results on-site, eliminating the time loss associated with sample transport, laboratory processing, and result delivery that characterizes traditional lab-based testing.

Inventive Principle:

Principle #25Self-service

3Productivity

If single-day progesterone testing is used, then productivity is improved, but reliability deteriorates

Engineering Contradiction:

Improvetesting efficiencyVSAvoidcorpus luteum function assessment accuracy

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

The patent implements periodic testing through a multi-day protocol where users test on consecutive days (typically days 7-10 post-ovulation) to track progesterone trends. This periodic approach maintains productivity by using efficient rapid tests each day while improving reliability through trend analysis. The system evaluates the pattern of results across multiple days rather than relying on a single measurement, accounting for natural physiological variations and providing a more accurate assessment of corpus luteum function.

Inventive Principle:

Principle #19Periodic 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

Enables efficient, non-invasive, and immediate monitoring of progesterone levels, facilitating accurate tracking of menstrual cycles and timely intervention, reducing anxiety and improving diagnostic capabilities for corpus luteum functionality issues.

Implementation Method 1

specially configured urine or saliva tests with test strips that provide near-instantaneous results for progesterone or its analytes, allowing daily evaluation over multiple days, using a diagnostic test system with optical signals to detect PdG levels

Methodology Applied

Scientific EffectOptical detection:

Data Source

PatentUS11029321B2Method of evaluating corpus luteum function by recurrently evaluating progesterone non-serum bodily fluids on multiple days

Publication Date: 2021.06.08 MFB FERTILITY INC

AI summary

Disclosed herein are methods, for use in association with specially configured devices, systems, and kits, for performing immunoassay tests to detect for at least progesterone or analytes of progesterone on a sample in association with diagnosing problems and issues associated with corpus luteum functionality. The immunoassay devices and methods may be used in conjunction with diagnostic reader systems and/or a base unit for obtaining a sensitive read-out of the immunoassay results. The immunoassay devices and methods may utilize a competitive binding-like assay and a sandwich binding assay to detect at least progesterone or analytes of progesterone in a sample.