FSH and hCG Composition for Infertility Treatment

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Solution Overview

Problem

Current pharmaceutical compositions for controlled ovarian stimulation in infertility treatments often have limitations, such as reduced pregnancy rates and increased miscarriage risks due to high serum LH levels, and do not effectively produce a sufficient number of top-quality embryos.

Innovation Solution

A composition comprising recombinant follicle-stimulating hormone (FSH) and human chorionic gonadotropin (hCG) is administered at specific doses and durations to provide enhanced LH activity, optimizing follicular development and embryo quality, with FSH doses ranging from 75 to 250 IU/day and hCG doses from 140 to 190 IU/day, starting on day one of treatment and continuing for two to twenty days.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If high-dose LH activity is provided through urinary derived hMG preparations, then follicular development is stimulated, but pregnancy rates are reduced and miscarriage rates are increased

Engineering Contradiction:
Improvefollicular developmentVSAvoidpregnancy rate
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The patent changes the parameters of LH activity delivery by using recombinant hCG with specific LH activity (10-20 IU per day) instead of urinary derived hMG, and by precisely controlling the ratio between FSH and LH activity. This parameter optimization resolves the contradiction by providing sufficient LH support for follicular development while avoiding the harmful effects of excessive LH that reduce pregnancy rates and increase miscarriage rates.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If conventional COS regimens use FSH alone or with minimal LH activity, then pregnancy safety is maintained, but the number of top-quality embryos is insufficient

Engineering Contradiction:
Improvepregnancy safetyVSAvoidnumber of top-quality embryos
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The patent merges recombinant FSH with recombinant hCG in a specific combination therapy, where FSH provides the primary follicular stimulation and hCG provides optimized LH activity support. This combination achieves both pregnancy safety and enhanced production of top-quality embryos by synergistically combining the benefits of both hormones at optimized doses.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The treatment protocol creates a composite hormonal regimen combining FSH and hCG with specific activity ratios, analogous to composite materials in engineering. This composite approach allows the system to achieve properties (both safety and embryo quality) that neither component could achieve alone at the same cost.

Inventive Principle:
Principle #40Composite materials

3Productivity

If urinary derived hMG preparations are used to provide LH activity, then follicular development is supported, but the amount of LH activity is insufficient for optimal embryo quality

Engineering Contradiction:
Improvefollicular developmentVSAvoidLH activity amount
Core Design Contradiction:
ProductivityVSManufacturing precision

Solution Approach 1:

The patent changes the parameter of LH activity precision by using recombinant hCG which allows for exact dosing control (10-20 IU per day), unlike urinary derived hMG where LH activity is variable and difficult to precisely control. This enables accurate delivery of the optimal LH amount needed for producing top-quality embryos.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentEP2621517B2Composition for use in treating infertility
Publication Date: 2023.10.11 FERRING BV
  • EP2621517B2 patent drawingFigure 1

AI summary

A product comprising follicle stimulating hormone (FSH) and human chorionic gonadotropin (hCG) for the treatment of infertility.