An important but inconvenient truth is that not all experts are created equal.
They’re all professionals. They’re all qualified to play. They all have knowledge and subject-matter expertise. Still, some are better than others.
The field of embryology is no different. Embryologists go through rigorous training. The field has high performance standards that embryologists must pass before they’re allowed to practice, and they are continually evaluated through proficiency and competence tests. That process screens out unqualified candidates, so bad embryologists aren’t unleashed on an unknowing public.
Nonetheless, when it comes to qualified embryologists, some are excellent–most often made that way through years of experience–whereas others are simply good.
When experienced embryologists train new ones, they pass on their techniques for performing manual manipulations. Much of the IVF laboratory procedure depends on manual techniques, so many of the procedures carry with them a technical signature, unique to whomever is performing the task, which has an impact on the procedure’s outcomes. Training and experience can influence and improve an embryologist’s ability, but a lack of standardized training procedures causes a lack of uniformity both between and within labs.
Automating IVF can help optimize outcomes for patients by removing those technical signatures. Automation can replace many of the manual components of IVF, so the procedure’s complicated steps will yield uniform and predictable outcomes from laboratory to laboratory.
Automation and Standardization: Improving Outcomes for Patients
Turning an egg into an embryo takes dozens of steps. Embryologists must undergo time-intensive training and practice to learn how to perform each one. Regardless of the quality of training received, the reliance on manual techniques makes each one subject to human error.
IVF labs are rigorous about quality control and employ critical oversight of technical production. They use key performance indicators to measure how each embryologist is performing daily and set benchmarks for continued improvement. However, some embryologists consistently perform better than others, and even the best embryologists can have a bad day.
ICSI- intracytoplasmic sperm injection– is an example of an IVF procedure in which automation could reduce risk, increase consistency, and improve outcomes.
ICSI was originally developed to treat male-factor infertility– and remains the only treatment in the IVF lab available to facilitate fertilization in those cases. Clinicians today often opt to treat patients using ICSI rather than traditional IVF because, unlike embryologists, clinicians have patient-facing roles. When a patient’s eggs fail to become fertilized, clinicians must deliver that devastating news. For cases where the male does not cause infertility, there’s no evidence that injecting sperm into an egg increases the likelihood of fertilization compared to traditional IVF. Nonetheless, many patients who experience unsuccessful egg fertilization think that if the egg had been injected with sperm, then it would have fertilized. As a result, clinicians often decide to pursue ICSI because they want to assure the patient that fertilization did not occur despite the sperm entering the egg.
This practice has become so common that some clinics in the U.S. only perform IVF via ICSI.
However, substituting traditional IVF with ICSI comes with tradeoffs.
ICSI is a complicated procedure– more complicated than traditional IVF– which makes it more prone to human error in the lab. The procedure contains many manual and time-sensitive steps, and embryologists must also undergo lengthy training before they are capable of conducting it with acceptable outcomes.
To perform ICSI, embryologists must first manipulate the eggs, removing their surrounding nurse cells so that they can see inside. Then, they use two micro-manipulators to inject the eggs directly in the center. This part of the procedure requires using hydraulics to perform microscopic movements with glass tools under high-power magnification.
One downfall of ICSI is that penetration of the egg cell membrane with the ICSI pipet can rupture the egg. For many ICSI procedures, the loss rate for eggs can be five percent or even higher. By performing quality control studies, labs can monitor the loss rate of eggs during ICSI and investigate whether the losses are resulting from the biology of the egg or the experience and performance of the injector.
By automating parts of the ICSI process, we can simplify the technique and increase uniformity among embryologist’s performances. Automation devices such as Fertilis’s microICSI can help embryologists consistently achieve high-quality outcomes across cases. Fertiils’s device removes the need for one of the micro-manipulators, and it uses a channel to guide embryologists’ pipettes to the injection site on the egg.
With the assistance of this type of automation, embryologist trainees acquire competence more quickly, reducing the amount of training time needed to obtain the level of expertise required for the procedure. At the same time, it provides accomplished embryologists with the ability to produce uniformly excellent technical execution across a variety of cases.
It can also improve the performance of embryologists with initially poorer performance records, thereby improving outcomes and promoting uniformity from lab to lab and embryologist to embryologist.
Democratizing IVF via Automation and Standardization
Demand for IVF continues to rise throughout Canada, the U.S., Australia, Europe, and Asia. However, many developing nations are also beginning to experience a surge in the demand, especially as women’s education and workforce participation increases.
Access to IVF in these countries is currently constrained by, among other things, capacity. The demand for services exceeds the number of clinics and embryologists available to provide them. Because the current process for embryologist training is time consuming and often relies on already established clinics for delivering the education, these countries are at a disadvantage when it comes to combating the embryologist shortage.
By reducing the time required to train embryologists and perform IVF procedures, automation can help democratize access to IVF.
Less training time means that more embryologists can enter the field more quickly. Decreasing the amount of manual manipulation required to perform IVF procedures means that newer embryologists can perform procedures once reserved for those with years of expertise, and reduced procedural time means that embryologists can treat more patients in the same amount of time, providing a much needed economic benefit too. Combined, these improvements in efficiency and cost can increase access to fertility services for underserved regions and populations.
Moreover, by helping embryologists perform to a uniform standard that results in consistently high-quality outcomes for patients, automation can help guarantee that all patients have access to the same quality of treatment, regardless of where they live. Technology that automates IVF can optimize outcomes for all patients, ensuring that as underserved populations gain access to fertility treatment, that treatment will be of the highest quality. Because with automation, every lab should be able to produce the same quality of outcomes from laboratory procedures.