How does Embryoly work?
Embryoly is a standalone software powered by Artificial Intelligence that assists In Vitro Fertilization (IVF) experts with their decision-making.
It analyzes embryo videos captured by time-lapse microscopes as well as clinical data describing the patients and their IVF journey giving you a score ranging from 0 to 1 that predicts the likelihood of each embryo to lead to a clinical pregnancy (detected fetal heartrate). Embryoly is in constant evolution, and we’re adding new features regularly.
What type of data is analyzed by your AI to make its prediction?
Videos of developing fresh, frozen, D2 and D5 embryos are analyzed, including embryos generated with sperm and oocyte donors and from patients with a diverse range of age and infertility conditions.
We collected up to 90 different types of clinical data describing the patients, donors & IVF treatment. Our algorithms perform a pre-selection of 8-10 clinical factors that are deemed to be the most impactful which we ask you to fill on our platform. These biomarkers can be updated over time as we keep diversifying our database.
Does your product work with every TLS ?
Embryoly has been trained on videos originating from multiple time-lapses, including MIRI, GERI, Embryoscope and Embryoscope +
How do you assess your performances?
To benchmark ImVitro’s algorithm performances, we first curated a test dataset of ~500 videos of embryos representing a varying range of patients, embryo quality, clinics and microscopes for us to assess our performances in different clinical settings
10 embryologists participated in our trial: embryologists were asked to assess whether an embryo could lead to a clinical pregnancy based on the video of its development alone, or in combination with the clinical data describing the patients and their IVF journey. Each video was evaluated by at least 3 embryologists, and the majority vote was compared to the prediction of our algorithm.
We use a McNemar test to demonstrate statistical difference between the accuracy, specificity and sensibility of the embryologist's predictive capacity and that of our algorithms, and a Fisher test to compare negative and positive predictive value. We then assess our performances in different clinical contexts: for women over or under 35, for embryos of poor or good quality, for embryos transferred at D2 or D5. Please contact us for more information on our performances.
What if I don't have access to all the asked clinical data?
We are well aware that not all clinics collect the same data and we have worked hard at homogenizing it prior to using it to train our algorithm. You are allowed to leave certain fields empty, however the more empty fields are left the lower the performances.
How can I compare my performances to that of your algorithms?
We can send you ~100 videos to evaluate, corresponding to embryos for which we know whether there was or not a clinical pregnancy. We’ll then send you a detailed study comparing our performances to yours to allow a fair comparison on a similar dataset.
Will our lab need special equipment to connect to your product?
Embryoly is a Software as a Service (Saas) platform : all you need is a web browser (Chrome by Google is preferred, Edge by Microsoft and Firefox by Mozilla) and a stable internet connection in your lab or office.
Do we need to inform patients that we are using this platform?
It is your responsibility to inform your patients of which tools assist you in the lab. At any rate, the IVF doctor remains the final decision-maker.
We ask doctors to inform new patients that their data could be re-used for our research purposes, so they can oppose it if need be. We can provide a template for the information notice, and the doctors can inform us via email if a patient is opposed to having their data re-used for our research, while still being able to benefit from our tool.
Communication is at the heart of our work, and we produce material destined to patients to help them get familiar with AI technologies. We can ship this material to your clinic if you wish.
Is the data from patients secure? Is it anonymized ?
Data privacy and protection is a top priority for us. We ensure patient data is managed in complete security and in accordance with the local regulations in force, and never ask for directly identifying information (e.g. name). In particular, our databases are encrypted and securely hosted on Amazon Web Services (AWS), and all data used to monitor our performances over time and help with our continuous research is anonymized beforehand.
Is your interface safe to use?
The CE Marking is a certification proving a medical device compliance with the requirements of the European Commission. Without a CE mark, a medical device cannot be sold in Europe. The CE Mark is also accepted in other countries outside Europe, please contact us to know if your country is eligible, or requires only extra steps that we can take to let you use our tool.
We obtained the CE Marking for our medical device in May 2021, demonstrating that our product meets the health, safety, and environmental protection standards of the European Economic Area (EEA).
We continuously ensure compliance with the CE Marking requirements while designing and developing our product, and perform continuous risk assessments, product documentation, performance comparisons and clinical evaluations. Our platform does not present any risk to the user’s nor the patient’s health.
Finally, we are about to receive the ISO 13485 certification for our Quality Management System, proving our quality approach fulfills the same requirements as those of our partners.
Are there published studies for embryoly ?
We are currently writing a paper with our 10+ partner embryologists which we want to submit in a scientific peer-reviewed journal in 2022. We also communicate our findings regularly to our partners who are taking an active part in our research.
Is Embryoly commercialized?
At this stage we are still looking for users to keep improving the integration of our tool in the lab and their daily work thanks to their feedback.
Please contact us to learn how to work with us. Let’s shape the future of IVF together!