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Microfluidics for in vitro fertilization: from science to clinical validation
Virginia Pensabene1, Federica Agate2, Andreia Santos Miranda3
1School of Electronic and Electrical Engineering, University of Leeds, Leeds, UK.
Microfluidic technologies are advancing IVF treatments, with significant patent growth but limited clinical translation. Challenges remain in regulatory approval and demonstrating long-term clinical benefits for widespread adoption.
Area of Science:
- Reproductive Medicine and Assisted Reproductive Technologies (ART)
- Biotechnology and Biomedical Engineering
- In Vitro Fertilization (IVF)
Background:
- Microfluidic technologies have been developed for In Vitro Fertilization (IVF) over the past 20 years.
- Recent advancements focus on oocyte/sperm processing, embryo development support, and fertility preservation.
Purpose of the Study:
- To analyze the development and clinical translation of microfluidic technologies in IVF.
- To identify key applications, challenges, and regulatory barriers for clinical adoption.
- To review the patent landscape and clinical trial status of microfluidic IVF solutions.
Main Methods:
- Literature review of scientific publications (PubMed, Google Scholar) from 2013-2025.
- Analysis of clinical trials (ClinicalTrials.gov) and patent data (Lens.org, espacenet.com) from 2000-2025.
- Keywords: Microfluidic, IVF, Assisted Reproductive Technology, fertility, reproduction.
Main Results:
- Over 130 publications in the last 5 years propose new microfluidic IVF solutions.
- 1405 patents filed in 20 years, but only 19 clinical trials initiated since 2009.
- Clinical trials primarily focus on sperm sorting and embryo culture; benefits over traditional methods require further research.
- Key barriers include need for long-term data, standardization, and regulatory hurdles.
Conclusions:
- Microfluidics shows promise in gamete processing, embryo culture, and fertility preservation.
- Integration with AI and sensing technologies can enhance precision and automation.
- Overcoming regulatory and clinical validation challenges is crucial for future adoption in IVF clinics.
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