The one treatment available for male infertility is extremely difficult to perform. But a new, streamlined approach to the process promises to significantly improve its success rate.
Half of all couples seeking in vitro fertilisation (IVF) need treatment for male infertility, whether due to low sperm count, aberrant sperm motility or abnormal morphology.
Yet there has been very little innovation to the only available treatment option for men with low sperm counts – intracytoplasmic sperm injection (ICSI).
Not all IVF clinics offer to perform this tricky procedure, which is prone to error. The success rate is dependent on the skill level of the embryologist who performs it — making it even more challenging for couples struggling to conceive due to male infertility to start a family.
However, a team of researchers from the University of Adelaide are working to improve the IVF success rate through the development of a groundbreaking 3D-printed microdevice that streamlines the ICSI procedure.
Time for a change
In embryology labs, the ICSI procedure is currently performed using two tiny suction and injection devices, according to lead researcher Dr Kylie Dunning from the Robinson Research Institute.
“The embryologist or scientist has to look down a microscope, then manipulate one pipette using joysticks to pick up an egg,” she told create. “Using the other pipette, they then have to pick up a single sperm, and align those two pipettes in [a] three-dimensional space to perform the injection.”
Securing eggs with the tiny suction device is extremely challenging, with rough handling potentially leading to irreversible damage.
But the challenges for the embryologist don’t end there. Let’s say numerous eggs were collected from the female patient. The embryologist has to keep track of which eggs have been injected and which haven’t, with the entire process taking place within the same microlitre volume of medium under paraffin oil.
“It takes a highly-skilled embryologist to perform this technical procedure, and it takes many years to become good at it,” Dunning said.
“We know there is a direct correlation between the number of times the scientist has performed the procedure in a clinic [and] the outcome resulting in a fertilised embryo.”
A revolutionised approach
Until recently, it wasn’t possible to 3D print devices small enough to hold individual eggs to perform the procedure.
But device inventor Jeremy Thompson was keen to harness technological advancements to realise his vision.
“The device was designed using the 3D modelling software SolidWorks 3D CAD, and reflected the ideas I have had for more than 20 years aimed at developing micro-medical technology to automate IVF,” Thompson told create.
Smaller than a pinhead in size, the device contains pods to house single eggs which are picked up with fine forceps and docked in a supporting device called a garage.
“That way, the embryologist knows exactly where the eggs are, allowing them to perform the sperm-injection procedure through a port in the device that directly allows access to the egg at exactly the right point,” Dunning said.
The micro-device streamlines the process, meaning embryologists no longer need to pick up an egg, hold it under suction then find a sperm.
“Instead, the eggs are all in this device. It’s also easier to keep track of which eggs have been injected and which haven’t,” she added.
Offering new hope
A paper demonstrating the benefits of the new process through microinjection of mouse eggs found there was a significant reduction in time needed to conduct the ICSI procedure using the microdevice.
Several steps from the traditional process, including pipette setup and egg holding, are no longer needed. The ICSI success rate will likely benefit from a significant boost, Dunning said.
“With this new process, an embryologist … can become highly skilled at ICSI, and hopefully we won’t see the variability in success across different clinics and different embryologists,” she said.
The microdevice has since gone through preclinical trials and is in the process of being commercialised by the medtech company Fertilis, co-founded by Thompson.
“We are working to a timetable that it may be available in 2025, following regulatory approvals in selected countries,” he explained.
While the initial focus is on the ICSI procedure, the long-term view is that fertilised eggs can be left in the micro-device garage — allowing embryos to develop within the structure until they can be implanted into the patient.
“Hopefully it can be a one-stop shop, where embryologists can perform the injection and embryo culture in the one device,” Dunning said.