G-CSF Biomarker Assay for Non-Invasive Embryo Selection
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Solution Overview
Problem
Assisted fertilization procedures, such as IVF and ICSI, have low implantation rates and are costly and traumatic for patients, with current embryo selection methods requiring interference with embryos and leading to multiple pregnancies and related complications.
Innovation Solution
A method and kit for determining the implantation potential of embryos by measuring granulocyte-colony stimulating factor (G-CSF) levels in follicular fluid, allowing for ranking of embryos without interference and optimizing the selection of those with highest implantation potential.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple embryos are transferred to increase pregnancy success, then the pregnancy rate improves, but the risk of multiple pregnancies and related complications increases
Solution Approach 1:
The patent changes the selection parameter from morphological assessment to molecular biomarker detection (G-CSF levels). By measuring G-CSF concentration in follicular fluid, the system identifies embryos with high implantation potential, enabling selection of a single high-quality embryo that achieves pregnancy rates comparable to transferring multiple embryos without the associated risks
Solution Approach 2:
The patent replaces the mechanical/morphological assessment system with a biochemical detection system. Instead of visually evaluating embryo structure and development, the system uses immunoassay technology to detect G-CSF molecular markers, providing an objective quantitative measure of implantation potential that enables more precise embryo selection
2Measurement precision
If embryo selection is based on morphology or HLA-G production, then implantation potential can be assessed, but interference with the embryo is required
Solution Approach 1:
The patent uses G-CSF as an intermediary biomarker that reflects embryo quality without requiring direct manipulation of the embryo. The G-CSF protein produced by cumulus cells surrounding the oocyte serves as a non-invasive indicator of embryo implantation potential, allowing assessment while the embryo remains undisturbed in its natural environment
Solution Approach 2:
The patent performs G-CSF measurement in the follicular fluid before embryo transfer. This preliminary biochemical assessment identifies which embryos have high implantation potential, allowing clinicians to select the best embryo for transfer without needing to interfere with embryo morphology or perform additional manipulations after fertilization
3Reliability
If assisted fertilization procedures are performed, then pregnancy can be achieved, but the procedure is costly and psychologically traumatic for patients
Solution Approach 1:
The patent performs G-CSF measurement on all retrieved oocytes before proceeding with embryo transfer. This preliminary screening identifies which embryos have high implantation potential, allowing clinicians to focus resources on transferring only the most promising embryo(s). This reduces the need for repeated costly procedures and minimizes patient psychological trauma from multiple failed attempts
Solution Approach 2:
The patent implements a feedback mechanism where G-CSF levels provide quantitative information about embryo quality. This feedback allows clinicians to make informed decisions about which embryos to transfer, optimizing the balance between procedure cost, patient well-being, and pregnancy success probability
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
This approach increases implantation rates, reduces the number of embryos transferred, and decreases multiple pregnancy risks, thereby improving the efficiency and success of assisted fertilization while minimizing costs and trauma for patients.
Implementation Method 1
The respective levels of FF G-CSF may be measured using an immunoassay
Data Source
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AI summary
A kit for determining for a female subject implantation potential of embryos obtained or to be obtained by assisted fertilization comprising at least means for measuring, for a plurality of oocytes collected from said subject, the level of follicular fluid granulocyte-colony stimulating factor (G-CSF) present in the follicular fluid (FF) of a follicle of each collected oocyte, which means comprises at least one reagent suitable for detection of levels of FF G-CSF or FF G-CSF mRNA. It also relates to a use of the kit. It also relates least one reagent useful for the detection of follicular fluid granulocyte-colony stimulating factor (FF G-CSF) or FF G-CSF mRNA, for use in a treatment of infertility of the subject. The kit can comprise a plurality of syrings to aspirate FF of each collected oocyte or a holding means therefor.