Revolutionizing Fertility Treatment with a MicroICSI Device

Intracytoplasmic Sperm Injection (ICSI) 

ICSI serves as a fertility intervention, where viable sperm is directly injected into an individual's eggs within a laboratory setting. This technique facilitates the formation of an embryo, constituting a variation of IVF. Healthcare practitioners predominantly employ ICSI in cases where male infertility poses challenges to an individual's capacity to achieve conception. 

In a groundbreaking development, Fertilis has announced the introduction of its microICSI prototyped device to streamline the only fertility treatment procedure available for men with low sperm counts. This device — set to revolutionize the field of ART — aims to enhance the efficiency, safety, and success rates of ICSIs. 

Features and Advantages 

Fertilis’ prototyped microICSI device combines the functionality of an ICSI dish with unique features that eliminate the need for a holding pipette, resulting in two fundamental benefits: Firstly, the device's holding feature positions the oocyte without the use of a vacuum, minimizing stress on the oocyte and improving the potential for embryo development. Secondly, by securely positioning oocytes within the dish, the microICSI device eliminates the need for a holding pipette micromanipulator, making the ICSI procedure more efficient and traceable. 

"We wanted to create a device that reduced the technically challenging aspects impacting ICSI success, particularly oocyte handling and traceability,” said Jeremy Thompson, PhD, embryologist, and co-founder of Fertilis, explaining the inspiration behind the development of the microICSI device to LifeSciencesIntelligence. “We hope this device will make ICSI easier to learn and make the technique more available as the need for this skilled procedure increases." 

Limitations 

The conventional ICSI technique has its limitations, including the risk of transmitting genetic and epigenetic abnormalities, a bias toward treating male factor infertility that may result in the use of sperm with suboptimal genetic integrity, subjective sperm selection criteria leading to the injection of abnormal sperm, potential damage to the oocyte during the procedure, an increased risk of multiple pregnancies, and the cost and time constraints associated with the complex and labor-intensive nature of ICSI. 

"ICSI is a complex, multi-tasking micromanipulation technique that was being conducted over millions of cycles of IVF,” said Thompson, recognizing the need for improvement. “How can we make it easier, quicker, and safer for both the egg and embryologists — and ultimately benefit patients?" 

A vital advantage of the microICSI device is its ability to reduce physical stress on oocytes during injection. Unlike conventional ICSI, which applies suction to the oocyte using a holding pipette, the microICSI device is designed to match the shape of the oocyte and securely hold it in place without suction. This reduction in stress on the oocyte during injection contributes to improved outcomes. 

"The number of porcine blastocysts produced was increased by 56% for microICSI, meaning an extra embryo was produced compared to conventional ICSI,” said David Gardner, PhD, co-founder of Fertilis, highlighting the positive outcomes observed in porcine models. “The time to inject individual oocytes was also 12 seconds faster on average for microICSI."  

Incorporating 3D-Printing Technology for Precision 

To deliver the increased precision in handling eggs and embryos that microICSI can provide, Fertilis turned to 3D-printing technology. 

"To create parts with very precisely crafted features, we utilized a technology known as 2-photon polymerization (2PP) with printers from UpNano in Vienna,” explained Thompson. “This technology allows us to print at a resolution of 160 nanometers, much finer than any other available technology." 

The implementation of the microICSI device in clinical settings is expected to have a profound impact on fertility clinics and ART procedures. With increased traceability, reduced chance of error, and faster injection times for individual oocytes, the device can potentially improve implantation and pregnancy rates from a single collection cycle. 

“Faster completion of ICSI using the microICSI device compared to conventional ICSI provides increased lab workflow efficiencies. It reduces complexity and the number of movements the embryologist requires, making it easier for both experienced practitioners and those newer to ICSI, who can be trained more quickly," elaborated Gardner. 

In addition to its clinical advantages, the microICSI device offers benefits beyond fertility treatments. 

"At the simplest level, microICSI is a tool to make certain kinds of cell manipulation less damaging and easier to perform. A range of cell therapies might benefit from such a capability," Thompson said, highlighting its potential for other cell manipulation procedures. 

While the microICSI device shows promise, ethical and regulatory aspects must be addressed before its implementation in human fertility treatments. Regulatory clearance is essential to ensure the device meets the necessary standards and guidelines to guarantee patient safety. 

"There will be future versions of microICSI, but the broader development of a range of devices to reduce infertility is the most exciting thing," concluded Gardner. 

As Fertilis continues to push the boundaries of reproductive medicine, the microICSI device stands as a testament to the transformative potential of cutting-edge healthcare technology. With its innovative design and promising outcomes, the device is poised to revolutionize the field of ART, offering new hope to individuals and couples struggling with infertility. 

Editor's Note: This article has been modified to convey that the microICSI device is presently in the prototype phase and is not yet commercially accessible.