Age-Based rFSH Dosing for Controlled Ovarian Stimulation

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Solution Overview

Problem

Current controlled ovarian stimulation (COS) protocols in assisted reproductive technologies face challenges in achieving an adequate ovarian response while minimizing the risk of ovarian hyperstimulation syndrome (OHSS) and optimizing pregnancy outcomes, particularly for patients of different age groups.

Innovation Solution

Customized recombinant follicle-stimulating hormone (rFSH) dosing regimens based on patient age, with starting doses of 15 μg/day for patients ≥35 years and 12 μg/day for patients ≤34 years, allowing incremental adjustments of ±3 μg/day, and the use of GnRH agonist triggers for excessive responders, along with cryopreservation of embryos to enhance cumulative pregnancy rates.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If standard COS protocols use fixed FSH dosing regimens, then treatment simplicity is maintained, but ovarian response optimization and OHSS risk reduction are compromised

Engineering Contradiction:
Improveovarian responseVSAvoiddosing regimen complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The patent applies parameter changes by adjusting FSH dosage based on patient age groups and AMH levels. Specific dosage ranges are defined for different age groups (≤34 years: 150-225 IU, 35-42 years: 225-300 IU, ≥43 years: 300-375 IU), and further refined by AMH concentration levels. This personalized parameter adjustment optimizes ovarian response while reducing OHSS risk without requiring complex monitoring protocols.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent implements local quality by tailoring the FSH dosage to individual patient characteristics, specifically age and AMH level. Each patient receives a customized dosage within the recommended ranges based on their specific profile, rather than a universal fixed dose. This localized treatment approach improves efficacy while maintaining manageable protocol complexity.

Inventive Principle:
Principle #3Local quality

2Productivity

If high FSH doses are administered to maximize oocyte yield, then ovarian response improves, but the risk of OHSS increases

Engineering Contradiction:
Improveoocyte yieldVSAvoidOHSS risk
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The patent resolves this contradiction by establishing FSH dosage parameters that are optimized for each patient's age and AMH level, avoiding both under-dosing and excessive dosing. The recommended dosage ranges ensure sufficient oocyte yield while staying within safe limits that prevent OHSS development.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent incorporates feedback mechanisms through monitoring ovarian response parameters (antral follicle count, AMH levels, follicle growth) during treatment. Based on these feedback signals, the FSH dosage can be adjusted to maintain optimal oocyte yield while preventing OHSS risk, creating a dynamic balance between productivity and safety.

Inventive Principle:
Principle #23Feedback

3Reliability

If individualized dosing based on multiple parameters is implemented, then treatment optimization improves, but protocol complexity and monitoring requirements increase

Engineering Contradiction:
Improvetreatment optimizationVSAvoidprotocol complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent simplifies individualized dosing by using age and AMH level as the primary parameters for determining FSH dosage ranges. While other factors like antral follicle count are considered, the core dosing decision relies on these two readily available parameters, maintaining treatment optimization without excessive protocol complexity.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent achieves reliable treatment optimization through localized dosing recommendations for specific age-AMH combinations, while maintaining overall protocol simplicity. The structured approach with defined dosage ranges for different patient profiles provides reliable guidance without requiring complex real-time adjustments or extensive monitoring infrastructure.

Inventive Principle:
Principle #3Local quality

Data Source

PatentUS20250325637A1Compositions and methods for controlled ovarian stimulation
Publication Date: 2025.10.23 FERRING BV

AI summary

Methods using and compositions including FSH for use in the treatment of infertility are described, wherein the dose is selected based on the patient's age to optimise cumulative efficiency and/or reduce OHSS risk.