Cell-free DNA Analysis for Non-invasive Embryo Quality Assessment
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Solution Overview
Problem
Current methods for determining embryo quality in assisted reproductive technology (ART) are unreliable, as they lack objective criteria for selecting viable embryos, and existing genetic screening methods are invasive and not comprehensive, failing to accurately predict implantation success and genetic viability.
Innovation Solution
A non-invasive method involving the analysis of cell-free nucleic acids in embryo culture media using quantitative PCR and other techniques to assess embryo quality and detect genetic abnormalities, allowing for the selection of competent embryos capable of successful implantation and healthy development.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If classical morphological evaluation methods are used to select embryos, then the selection process is simple and quick, but the reliability of predicting implantation success is low
Solution Approach 1:
The patent uses cell-free DNA (cfDNA) as an intermediary biomarker in the culture medium to indirectly assess embryo quality and implantation potential. Instead of directly evaluating complex embryonic characteristics, the method measures cfDNA levels which serve as a mediator reflecting embryo competence, thereby improving prediction reliability without requiring direct complex embryonic analysis
Solution Approach 2:
The patent replaces subjective morphological evaluation (visual/mechanical assessment) with molecular biology techniques (quantitative PCR, next-generation sequencing) to objectively measure cfDNA levels and genetic abnormalities. This substitution transforms the evaluation from a subjective mechanical process to an objective molecular analysis, significantly improving prediction reliability
2Reliability
If invasive genetic screening methods are used to detect embryo abnormalities, then genetic quality assessment is improved, but embryo integrity and viability are compromised
Solution Approach 1:
The patent extracts cell-free DNA from the culture medium surrounding the embryo rather than extracting DNA directly from the embryo itself. This extraction approach allows genetic analysis to be performed on material already present in the culture environment, providing reliable genetic quality assessment without causing harm to the embryo
Solution Approach 2:
The culture medium serves as an intermediary that contains cfDNA shed by the embryo. By analyzing this intermediary substance, the method obtains genetic information about the embryo without directly manipulating or damaging the embryo, thus maintaining embryo integrity while achieving reliable genetic screening
3Productivity
If multiple-embryo transfer is used to maximize pregnancy rates, then pregnancy rates increase, but the risk of multiple pregnancies and complications increases
Solution Approach 1:
The patent performs preliminary assessment of embryo quality and implantation potential using cfDNA analysis before embryo transfer. By evaluating embryos in advance and selecting only the most competent ones, the method enables confident single-embryo transfer, thereby maintaining high pregnancy rates while avoiding the complications associated with multiple pregnancies
Solution Approach 2:
The patent uses cfDNA levels as feedback indicators of embryo quality and implantation potential. This feedback information allows clinicians to make informed decisions about embryo selection and transfer strategy, optimizing the balance between achieving pregnancy and avoiding multiple pregnancies by selecting embryos with the highest likelihood of successful implantation
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 method provides a reliable, non-invasive means to evaluate embryo quality and genetic integrity, enhancing the chances of successful pregnancy and reducing the risk of genetic abnormalities, thereby improving IVF outcomes.
Implementation Method 1
determining the quality of the embryo in view of the level obtained in step iii) wherein step iii) is performed by quantitative PCR
Data Source
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AI summary
The present invention relates to methods for determining the quality of embryos in the context of Assisted Reproductive Technology. The selection of high-quality embryos is crucial for maximizing the chances of pregnancy during ART procedures. The present inventors have detected the presence of cell free nucleic acids in the culture medium where the embryo is grown under in vitro fertilization conditions. The present inventors have further determined that embryo quality can be evaluated by specifically detecting and studying said cell-free DNA. Accordingly, the present invention relates to in vitro non invasive methods for determining the quality of an embryo by determining the level of cell-free DNA comprised in the culture medium where the embryo is grown and/or by detecting the presence and/or expression level of specific nucleic acid sequences in the cell free DNA extracted from the culture medium where the embryo is grown.