New hope for IVF patients as global study published in Human Reproduction shows AI can effectively assess genetic integrity of embryos

SAN FRANCISCO,June 28,2022 -- Human Reproduction journal has published the ground-breaking results of an international clinical study,where a novel AI algorithm called Life Whisperer Genetics was developed by AI healthcare company Presegen to assess the genetic integrity of embryos using only images. The assessment is non-invasive,low-cost,and provides results instantly. This is in stark contrast with PGT-A,the standard method used in IVF today,which requires an invasive and potentially risky biopsy to remove a portion of the embryo,followed by an expensive and time-consuming genetic testing procedure.

The study was conducted with IVF clinics globally,including Ovation Fertility (USA),IVF-Life (Europe),Alpha IVF & Women's Specialists (SE Asia),and Wings IVF (India). Results showed that the AI algorithm could identify whether an embryo was genetically normal,or 'euploid'. Identification of euploid embryos can result in improved clinical outcomes,such as a better chance at pregnancy success.

Presagen's Chief Medical Science Officer Dr Sonya Diakiw explained "Because this assessment is based on images alone,it is not as accurate as PGT-A itself,which involves actual DNA sequencing. But we are finding that PGT-A results themselves can be variable,as they depend on the embryo sample being tested. PGT-A only tests 5 cells from a total of around 200,so it is not always representative of the entire embryo. Life Whisperer Genetics is a whole-embryo assessment of genetic integrity that does not require any invasive procedures,which can be used to prioritize embryos for use in IVF procedures."

The technology was evaluated prospectively on patients in Europe in collaboration with the IVF-Life Group. Dr Jon Aizpurua from IVF-Life said "Life Whisperer Genetics can be used for patients as a pre-screen,to ensure we only genetically test embryos that are likely to be normal,saving patients time and money. For patients who are not comfortable with invasive genetic tests,or in countries like Germany where invasive genetic tests are not permitted,Life Whisperer Genetics is a viable alternative to help select embryos that are most likely to be euploid."

Prospective studies were also performed in collaboration with Alpha IVF & Women's Specialists in Malaysia. Chief Embryologist Adelle Yun Xin Lim said "Computer vision with AI may revolutionise IVF treatment and this new technique is another milestone of AI in IVF. The technique will help doctors and embryologists around the world to predict the chromosome status of embryos in a rapid and non-invasive manner enabling the prioritization of embryos that are likely to be euploid for transfer or for further confirmatory PGT testing,leading to a faster time to pregnancy and reducing the cost of the treatment."

Ovation Fertility's VP of Scientific Advancement,Dr Matthew (Tex) VerMilyea said "This new product is very exciting. In some ways it is like a 'Rapid Antigen Test (RAT)' for embryo assessment,providing a non-invasive,instantaneous evaluation of genetic integrity,which will have massive potential for the US market when it receives FDA approval."

Life Whisperer Genetics is already available for IVF clinics and their patients in over 40 countries globally. It can be used in combination with Life Whisperer Viability,which assesses if an embryo is likely to lead to a pregnancy. International clinical studies have shown that Life Whisperer Viability can perform better than embryologists' current manual embryo assessment methods. Together,Life Whisperer Viability and Life Whisperer Genetics provide a comprehensive assessment of embryo quality.

Paper Title

Development of an artificial intelligence model for predicting the likelihood of human embryo euploidy based on blastocyst images from multiple imaging systems during IVF

https://academic.oup.com/humrep/advance-article/doi/10.1093/humrep/deac131/6604228

Authors

S. M. Diakiw1,J. M. M. Hall1,2,3,M. D. VerMilyea4,5,J. Amin6,J. Aizpurua7,L. Giardini7,Y. G. Briones7,A. Y. X. Lim8,M. A. Dakka1,T. V. Nguyen1,D. Perugini1,M. Perugini1,9

Life Whisperer Diagnostics (a subsidiary of Presagen),San Francisco,CA,USA,and Adelaide,SA,Australia

Australian Research Council Centre of Excellence for Nanoscale BioPhotonics,The University of Adelaide,Adelaide,Australia

School of Physical Sciences,Faculty of Sciences,Australia

Ovation Fertility,Nashville,Tennessee,USA

Texas Fertility Center,Austin,Texas,USA

Wings IVF Women's Hospital,Ahmedabad,Gujarat,India

IVF-Spain,Alicante,Spain

Alpha IVF & Women's Specialists,Petaling Jaya,Selangor,Malaysia

Adelaide Medical School,Faculty of Health Sciences,Australia

Paper Abstract

STUDY QUESTION

Can an artificial intelligence (AI) model predict human embryo ploidy status using static images captured by optical light microscopy?

SUMMARY ANSWER

Results demonstrated predictive accuracy for embryo euploidy,and showed a significant correlation between AI score and euploidy rate,based on assessment of images of blastocysts at Day 5 after IVF.

MAIN RESULTS AND THE ROLE OF CHANCE

Overall accuracy for prediction of euploidy on a blind test dataset was 65.3%,with a sensitivity of 74.6%. When the blind test dataset was cleansed of poor quality and mislabeled images,overall accuracy increased to 77.4%. This performance may be relevant to clinical situations where confounding factors,such as variability in PGT-A testing,have been accounted for. There was a significant positive correlation between AI score and the proportion of euploid embryos,with very high scoring embryos (9.0-10.0) twice as likely to be euploid than the lowest scoring embryos (0.0-2.4). When using the genetics AI model to rank embryos in a cohort,the probability of the top-ranked embryo being euploid was 82.4%,which was 26.4% more effective than using random ranking,and ~13-19% more effective that using the Gardner score. The probability increased to 97.0% when considering the likelihood of one of the top two ranked embryos being euploid,and the probability of both top two ranked embryos being euploid was 66.4%. Additional analyses showed that the AI model generalized well to different patient demographics and could also be used for evaluation of Day 6 embryos and for images taken using multiple time-lapse systems. Results suggested that the AI model could potentially be used to differentiate mosaic embryos based on the level of mosaicism.

WIDER IMPLICATIONS OF THE FINDINGS

These findings collectively support the use of this genetics AI model for evaluation of embryo ploidy status in a clinical setting. Results can be used to aid in prioritizing and enriching for embryos that are likely to be euploid for multiple clinical purposes,including selection for transfer in the absence of alternative genetic testing methods,selection for cryopreservation for future use,or selection for further confirmatory PGT-A testing,as required.

About Presagen and Life Whisperer

Presagen is an AI healthcare company that is changing the way clinics,patients,and medical data from around the world are connected through AI. Its platform,The Social Network for Healthcare,connects clinics and patients globally,and enables collaboration and data sharing to create scalable AI healthcare products that are affordable and accessible for all. The decentralized network democratizes the creation of AI products,promotes collaboration through incentives,and protects data privacy and ownership. With a focus on improving Women's Health outcomes globally,Presagen's first product,Life Whisperer,is being used by IVF clinics globally to improve pregnancy outcomes for couples struggling with fertility. With a vision of creating the largest network of clinics,and medical data from around the world,Presagen is driving the future of AI Enhanced Healthcare.

About Ovation Fertility

Ovation® Fertility is a national network of reproductive endocrinologists and scientific thought leaders focused on reducing the cost of having a family through more efficient and effective fertility care. Ovation's IVF and genetics laboratories,along with affiliated physician practices,work collaboratively to raise the bar for IVF treatment,with state-of-the-art,evidence-based fertility services that give hopeful parents the best chance for a successful pregnancy. Physicians partner with Ovation to offer their patients advanced preconception carrier screening; preimplantation genetic testing; donor egg and surrogacy services; and secure storage for their frozen eggs,embryos and sperm. Ovation also helps IVF labs across America improve their quality and performance with expert off-site lab direction and consultation. Learn more about Ovation's vision of a world without infertility at www.OvationFertility.com.

About IVF-Life

IVF-Life is a group of fertility clinics specialized in complex cases. Centres located inSpain and the UK have the latest advances in Reproductive Medicine and outstanding professionals in this field. The constant innovation and a firm commitment to technology keep IVF-Life at the forefront in the assisted reproduction field treating patients from all over the world with ahigh degree of success. IVF-Life perform a comprehensive range of treatments and diagnostic tests with the aim to provide effective solutions to a wide variety of fertility problems.

About Alpha IVF & Women's Specialists

Alpha IVF group comprises IVF centres in Kuala Lumpur,Penang and Singapore. Alpha IVF is a world-class fertility treatment provider bringing the most advanced fertility technologies and excellent success rates in achieving the goal of having a baby. Alpha IVF consists of a team of highly qualified and skilled doctors,scientists and nurses that deliver international standards of patient care. As the name Alpha suggests,the team have pioneered numerous innovative fertility treatments. Alpha IVF offers its patients access to a network of fertility experts and facilities fully equipped with a full range of cutting-edge laboratories,innovative technologies such as Artificial Intelligence,Next Generation Sequencing (NGS),100% post-warm survival rate for embryo cryopreservation,time-lapse embryo monitoring,PIEZO-ICSI,sperm separation technologies and many others. Continuous R&D have led Alpha IVF to achieve numerous world firsts and innovative fertility treatment protocols both regionally and globally.

About Wings

Wings IVF comprises a chain of leading fertility clinics across India,with more than 12,000 live births through IVF. Wings hospitals are state of art specialty hospitals & clinics providing all infertility treatments and IVF. They provide top quality,comprehensive,holistic care to women of India at a reasonable cost. An interdisciplinary team of expert and caring professionals is committed to meeting the physical as well as emotional and spiritual needs for each woman and her family. The Wings Hospitals have been designed and furnished to provide a high level of fertility care with comfort and privacy.