Personalized rFSH Dosing for IUI Ovarian Response Control

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Solution Overview

Problem

There is a need for individualized stimulation protocols that provide improved pregnancy outcomes in patients undergoing intrauterine insemination (IUI), particularly in addressing ovarian response variability and minimizing multiple pregnancies.

Innovation Solution

A personalized dose regimen for recombinant follicle-stimulating hormone (rFSH) is developed based on Anti-Mullerian Hormone (AMH) levels and body weight, tailored to achieve 2-3 mature follicles for IUI, using rFSH with α2,3- and α2,6-sialylation, and adjusting doses based on ovarian response.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If standard COS protocols are used to stimulate multiple follicles for IVF, then oocyte retrieval quantity is improved, but the risk of ovarian hyperstimulation syndrome (OHSS) increases

Engineering Contradiction:

Improvenumber of oocytes retrievedVSAvoidrisk of OHSS

Core Design Contradiction:

Quantity of substanceVSObject-affected harmful factors

Solution Approach 1:

The patent uses AMH levels as a parameter to predict ovarian response and adjusts FSH dosing accordingly. By changing the dosing parameter from fixed to individualized based on AMH, the protocol achieves optimal oocyte retrieval while minimizing OHSS risk through precise parameter control

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent implements feedback control by using AMH measurements to guide FSH dosing decisions. The system continuously monitors ovarian response through AMH levels and adjusts subsequent FSH doses to maintain optimal stimulation without exceeding safe thresholds, preventing OHSS while ensuring sufficient oocyte yield

Inventive Principle:

Principle #23Feedback

2Adaptability or versatility

If individualized dosing regimens are developed using traditional predictors (age, BMI, FSH, AFC), then treatment personalization is improved, but prediction accuracy of ovarian response remains limited

Engineering Contradiction:

Improvetreatment personalizationVSAvoidprediction accuracy of ovarian response

Core Design Contradiction:

Adaptability or versatilityVSMeasurement precision

Solution Approach 1:

The patent introduces AMH as a new predictive parameter, replacing traditional predictors (age, BMI, FSH, AFC) with a more accurate biomarker. This parameter change enables both better treatment personalization and superior prediction accuracy, as AMH directly reflects ovarian follicle pool status and response potential

Inventive Principle:

Principle #35Parameter changes

3Quantity of substance

If high doses of FSH are administered to ensure sufficient oocyte yield, then oocyte retrieval quantity is improved, but the complexity of cycle management and risk of cancellation increases

Engineering Contradiction:

Improvenumber of oocytes retrievedVSAvoidcycle management complexity

Core Design Contradiction:

Quantity of substanceVSDevice complexity

Solution Approach 1:

The patent performs preliminary assessment of AMH levels before initiating FSH treatment to predict ovarian response. This preliminary action allows clinicians to pre-calculate optimal FSH doses and set appropriate monitoring thresholds, simplifying subsequent cycle management and reducing the likelihood of cancellations due to unpredictable responses

Inventive Principle:

Principle #10Preliminary action

Data Source

PatentUS20250367262A1Compositions and methods for intrauterine insemination (IUI)

Publication Date: 2025.12.04 FERRING BV

AI summary

Methods, uses and compositions including FSH for use in the treatment of infertility by intrauterine insemination are described.