World Embryologist Day, is a special day in the world of healthcare as we come together to celebrate World Embryologist Day. On this occasion, we take a moment to recognize and honor the remarkable achievements of embryologists worldwide. These dedicated professionals play a pivotal role in both clinical embryology and groundbreaking research that continually advances the industry. Today, we delve into the fascinating stories of a few pioneering embryologists who have transitioned from their “hands-on” roles to becoming visionary leaders in technology startups. Let’s explore how they are leveraging cutting-edge technologies to make a profound impact on millions of lives.
The Crucial Role of Embryologists in Family Building:
Embryologists are unsung heroes in the realm of assisted reproductive technology (ART). They skillfully work behind the scenes, performing crucial tasks like in vitro fertilization (IVF), embryo culture and grading, and cryopreservation, to name a few. The success of countless couples’ dreams of starting a family owes a great deal to the dedication and expertise of these professionals, and is celebrated on World Embryologist Day, the birthdate of the world’s first IVF baby, Louise Joy Brown.
As technology and research continually evolve, so do the opportunities for embryologists to expand their horizons beyond the confines of a laboratory. Many of them have ventured into the world of startups, where they now play pivotal roles in driving innovation and creating groundbreaking solutions.
Empowering through Technology Startups:
We had the privilege to interview some incredible embryologists who have embraced their passion for cutting-edge technology and translated it into fruitful roles as executives and CEOs in tech startups. Their journey from being “hands-on” working embryologists to driving innovation has been truly inspiring.
AI Driven Embryo Selection Advancements:
Daniella Gilboa, CEO at AIVF, a renowned embryologist, shared her experience of transitioning to the tech world. As the CEO of a fertility-focused startup, AIVF, she spearheads the development of AI-powered embryo selection algorithms. This technology revolutionizes the embryo screening process, significantly increasing the chances of a successful pregnancy while reducing emotional and financial burdens for couples undergoing IVF.
She says “I sometimes have flashbacks to my first week in an IVF lab. Which was overwhelming. About 20 years ago. It took me a couple of days to fall in love with this amazing profession. There’s a moment in time where it’s the embryologist, the patient and the physician, in the same room, just moments before embryo transfer. It’s this moment that encapsulates everything. It’s this moment when you know you can change people’s lives. I am honored to be an embryologist and more so, to lead the development of the next generation of IVF.”
Gamete and Embryo Cryostorage Breakthroughs:
Cynthia Hudson, VP Clinical Strategy at TMRW Life Sciences formerly a hands-on embryologist, is now the VP of Clinical Strategy at TMRW, specializing in gamete and embryo cryostorage automation. She leads a team of researchers working on innovative automated cryostorage hardware and software. This breakthrough robotics technology has far-reaching implications for individuals facing fertility challenges and those considering delaying parenthood by freezing gametes for long term storage.
She says “There is so much demand for fertility care that it will take all of us, and more, to solve the access to care problem. My path went from working as an embryologist to designing technology for embryologists to use in the laboratory. If we can improve the efficiency, safety, and standard of care, we can help more people that need us.”
The Power of Precision: PGT Technologies
Among the remarkable stories of embryologists transitioning to leadership roles in technology startups, we find those who have embarked on a journey into the realm of Preimplantation Genetic Testing (PGT). PGT is a cutting-edge technology that enables embryologists to screen embryos for genetic abnormalities before they are replaced. At the heart of their mission lies the development of advanced PGT technologies that offer unparalleled precision in identifying genetic anomalies in embryos.
Charlene Alouf, PhD, HCLD, Medical Science Liaison, Genomic Prediction says “It has been an amazing transition – especially from someone with decades of experience that started during a very remedial time in IVF technology. I really have gotten to know so many in the field and that is 50% of the satisfaction!”
Sheela Ali, PhD, HCLD, VP of Science and Innovation, Progenesis, “I have spent the last 15 years dedicating my career to human IVF, many times sacrificing personal time to my work. I have such a strong passion for the field and an even stronger passion for the families we are helping build. My time as an embryologist and laboratory director were monumental in identifying gaps in automation and technology for our IVF field. I made the decision to use my experience, education and skills to help bridge the gap between new and emerging technologies and their proper availability and application in the IVF and Andrology laboratories by joining Progenesis. I find that the growth in my career has been exceptional as I broadened my reach by helping laboratories improve their practices, ultimately improving patient care and cycle outcomes. As the VP of Science and Innovation, with a single webinar, hands on workshop or conference, I address larger laboratory and clinical groups to maximize the positive impact, which ultimately translates to improved efficiencies. I can develop and grow the technology for the betterment of the patient and laboratory staff alike by assessing the current needs of the laboratory and clinicians. I am an advocate for progressive and improved laboratory practices and strive to propose solutions and workflows that will reduce hardships of my fellow embryologists and andrologists. I have been fortunate that the relationships I have built over the years with my peers are strong and supportive. It has been an exhilarating journey thus far and I look forward to continuously bringing the latest and greatest technologies to IVF laboratories.”
Global Professional Education Clinical Support In addition to the groundbreaking work of embryologists in technology startups, another essential aspect of the field is the Global Professional Education Clinical Support. Highly skilled embryologists, like Sourima Biswas Shivhare, of Cooper Surgical Fertility Solutions strive to strengthen the global community of embryologists and contribute to the continuous improvement of reproductive healthcare on a global scale.
She says “It has been liberating; in my current role, I am truly able to embrace my love and curiosity for the field and help the field move forwards. Let’s say there are tools in a true ‘clinical scientists’ toolbox, which aren’t ‘allowed’ to be utilized in the regular lab. This makes them obliged, due to their love for the field, to move out in the direction of roles that are conducive and nurturing of the true scientist. Bottom line, embryologists are being used/trained as technicians, not given the scope to nurture their brains. Having even the most basic understanding of the potential and the necessity for automation in the lab, in fact we should be training more brains than hands.”
On the Occasion of Word Embryologist Day 2023
On this World Embryologist Day, we celebrate the achievements of embryologists worldwide and the profound impact they have on countless lives. These passionate individuals not only excel in clinical embryology but are also instrumental in driving technological advancements that shape the future of reproductive healthcare.
As we applaud their dedication, let us also acknowledge the remarkable journey of those who have embraced leadership roles in technology startups. Their vision, paired with their expertise, has given rise to cutting-edge solutions that hold the promise of helping millions achieve their dreams of building a family.
Together, as a global community, we honor and appreciate the invaluable contributions of these exceptional individuals, and we look forward to a future where technology and human ingenuity continue to work hand in hand for the betterment of reproductive health worldwide. Happy World Embryologist Day!
Want to skip straight to Stumping ChatGPT? Scroll down!
Introduction to Chatbots
In the world of artificial intelligence (AI) the superlative “overnight” is not unwarranted. ChatGPT, is an artificial intelligence powered chat robot (chatbot) with 175 billion parameters in its natural language processing model that has become wildly popular, seemingly overnight.
You have probably heard that ChatGPT is capable of passing business, law, and medical board examinations, has qualified as a level-3 coding engineer at Google (with a $180K starting salary!), diagnosed a rare (1 in 100,000) condition in seconds, can outperform most students in microbiology, and even earn a passable grade in a 12th-grade AP literature test.
I use ChatGPT every day, and it is quickly surpassing my use of other search engines. It responds to my queries with concise, human-like, detailed and referenced answers, solves elaborate problems, and answers intricate questions, and most importantly, it keeps learning from past inquiries to make the answers align to exactly the information I am looking for.
Women’s healthcare —historically underfunded— stands to benefit enormously from new AI technologies as long as the current limitations are understood and overcome. ChatGPT is not yet HIPAA compliant and there are currently many concerns about data privacy and integrity. My working assumption is that it was trained on all the digital data ever produced by humans. However, no one really knows what it was trained on. Lastly, ChatGPT occasionally makes up answers and has been known to completely fabricate references and citations (more on that later as I describe my experience stumping ChatGPT!).
Thinking for US
Academics and teachers have been wringing their hands and shedding bitter tears as they strive to prevent and detect plagiarism that goes beyond simply copying words, to much more complex intellectual phenomena— if you ask the computer to THINK for you, have you plagiarized the essence of humanity?
Can you plagiarize reasoning, planning, problem solving, abstract thinking, the comprehension of complex ideas? Should one believe what an AI tells you? Should you allow a computer to inspire you? Soothe your soul? Write your annual Christmas card? Even as I write this post, I’ve had to revise my anthropomorphic language – did it “write”? Did it “respond” to me? Did it “tell me” something?
With the advent of the “Information Era” we were forced to develop new philosophies for teaching and learning. Our kids (and us!) no longer waste time memorizing information (ie. the periodic table of the elements), instead we are experts at finding information and knowing how to use it. The advent of the AI Era (Augmented Intelligence Era?) will likely call for a similar restructuring of the way we think about education and learning.
The large publishing houses have all adopted a policy that ChatGPT cannot be an author, because it can’t take responsibility for the words it “wrote” i.e., returned. Current best practice dictates that the author should disclose that ChatGPT was used as a tool in writing. However, that seems odd to me. Why should ChatGPT use be disclosed, any more than using the Dewey Decimal System at the public library, or using Google to search for information? I predict that as chatbot AI becomes normalized, that will fall to the wayside as a silly artifact of the early days of AI. (Natch, ChatGPT was used as a tool for writing this post!)
The Information
Humans are driven to build great libraries. Often, we name them after politicians, because they are as much political symbols of progress, enlightenment, and cultural heritage as they are bastions of critical thinking. As a democratizing force driving innovation, the betterment of humanity as a whole, and the empowerment of individuals or populace, they are often the target of political battles. I think of ChatGPT (and now, competing large language models, like Bard) much the same way. But then I immediately think of the State sponsored censorship of books and libraries under dictatorships, and draw mental parallels to the book bans currently underway in the USA. I think of the destruction of libraries and thousands of historical and rare archives, such during the modern Iraq War and Syrian Civil wars, and in ancient times, the multiple cycles of destruction of the Library of Alexandria, (Nalanda, Persepolis, Ebla, and Pergamum). Large language models differ from libraries and search engines, they don’t simply present the information to you for your own syntheses and analysis, but they digest it, think it over, and spit it out in an interpreted fashion. Therefore, not only can they be manipulated, but they can also be stumped as we have tested and proven in this experiment to stump ChatGPT.
The internet was initially conceived as a decentralized and open platform that would be resistant to censorship and tampering, the reality is that it is not immune to such actions. I think of how political rivals use “fake news” to manipulate public opinion, how states censor web access (or use it for surveillance). I think of the proliferation of misinformation about vaccines, GMOs, Lyme Disease and so many other health related topics has harmed and killed so many. I think of the way political rivals can instantly flame a conspiracy theory. And I wonder… what will happen when rival businesses or states start targeting AI tools like ChatGPT or other language models? How will these powerful tools be used to manipulate public discourse, spread misinformation, or exploit biases and weaknesses?
Stumping ChatGPT
I have pontificated enough on the abstract. Now back to the immediate! The fertility field is laden with obscure and highly specific information. I decided to see if I could stump ChatGPT. Most of my questions were answered correctly, instantly, and accurately, however, I was quickly able to reach athe accuracy limits, and cause it to generate incorrect answers.
I asked Chat GPT to describe different cryodevices (bold is my emphasis). “Cryotop: Cryotop is a device developed by the Japanese scientist Masashige Kuwayama in 1999. It consists of a thin, rectangular strip of polypropylene film with 12 or 16 small wells for holding embryos or oocytes. Cryotop is considered a closed system because the wells are sealed with a thin film of oil or mineral oil, which prevents contamination during vitrification. Cryotop is known for its high efficiency and low volume of vitrification solution.”
I asked ChatGPT what the earliest reported sperm donor pregnancy was and it gave me the following information, which I was not able to verify as being correct. On PubMed, the publications of Sherman J.K. date back to 1953, but I could not find this specific reference “Sherman J.K. (1954) Fertility following insemination with frozen human spermatozoa. American Journal of Obstetrics and Gynecology, 68(5), 1295-1297. It claimed “This paper reports the successful birth of John Randolph, the first baby born from frozen sperm, and provides details about the methods used to freeze and thaw the sperm.” I asked if that was correct, and it returned: “As I mentioned in my previous response, the first baby born from frozen sperm was John Randolph, born in January 1954 to a couple in Texas who had been unable to conceive due to the husband’s low sperm count. The husband’s sperm was frozen in liquid nitrogen for a year before being thawed and used for artificial insemination, resulting in the successful birth of their son.”
Lastly, I asked ChatGPT for information about the regulation of anonymous tissue donors, and it returned the following mix of accurate and inaccurate information (bold is the false): “Under FDA regulations, anonymous egg donors must be tested for communicable diseases, including HIV, hepatitis B and C, syphilis, and gonorrhea. Donors must also be screened for genetic disorders that could be passed onto offspring, such as cystic fibrosis and sickle cell anemia. In addition, donors must undergo a medical history review and provide information about their lifestyle habits, such as smoking and drug use.”
ChatGPT Fertility Inspiration
If you are looking for some fertility inspiration, can you turn to Chat GPT for emotional support? Let us know if you feel empowered or inspired when we asked ChatGPT to be the hype man of those suffering from infertility with this final message of support and hope. “If you’re waiting to get pregnant, the journey can be long and difficult. It’s easy to become overwhelmed with the daily routine of charting cycles, taking medications, and undergoing fertility treatments. But as the days get longer and warmer, it’s important to take a step back and appreciate the beauty of the season and the hope it brings. Just as the earth goes through cycles of growth and renewal, so do our bodies. With each new cycle, there’s the possibility of new life. Oocytes, or eggs, undergo a complex process of maturation before they can be fertilized. This process takes several months, and is influenced by a variety of factors, including age, genetics, and lifestyle choices. Spring is also a time for renewal. Take some time for self-care – pamper yourself, whether it’s with a relaxing bubble bath, a massage, or a day out in nature. Focus on activities that bring you joy and relaxation, and don’t forget to connect with loved ones. Our relationships are important for us to maintain a healthy mind and body.
You’re not alone on this journey. Reach out to friends, family, or a professional counselor if you’re feeling overwhelmed or just need a friendly face and listening ear.
As you embrace the season of spring, remember that your journey towards parenthood is also your journey of growth and renewal. Take a deep breath, appreciate the beauty in and around you, and hold on to the hope that your new beginning is just around the corner.”
Were you inspired, terrified, or convinced? Let us know in the comments!
Embryo Selection has been proposed as one of the top Infertility research priorities. Healthcare professionals, people with fertility problems and infertility researchers (healthcare funders, healthcare providers, healthcare regulators, research funding bodies and researchers) were brought together in an open and transparent process resulting in an article that was published in Human Reproduction in November 2020 outlining the top future infertility-related research priorities. The initial survey was completed by 388 participants from 40 countries, and 423 potential research questions were submitted. Fourteen clinical practice guidelines and 162 Cochrane systematic reviews identified a further 236 potential research questions.
The top 10 infertility research priorities for the four areas of male infertility, female and unexplained infertility, medically assisted reproduction and ethics, access and organization of care for people with fertility problems were identified. These top ten research priorities in each topic area outline the most pressing clinical needs as perceived by healthcare professionals, people with fertility problems and others, to assist research funding organizations and researchers to develop their future research agenda.
This post discusses research priority #4: What is the optimal method of embryo selection in IVF cycles?
- An article was published in Human Reproduction in November 2020 outlining the top future infertility-related research priorities. The top ten ART research priorities are;
- What are the causes of implantation failure?
- What is the optimal treatment for women undergoing IVF who are poor responders to increase live birth rates?
- What is the optimal method of sperm selection in IVF cycles?
- In couples with unexplained infertility, does IUI increase live birth rates when compared with other ARTs, including IVF?
- In couples with unexplained infertility, what is the optimal number of IUI cycles before moving to IVF?
- What is the optimal method of embryo selection in IVF cycles?
- What are the factors that affect cycle to cycle variability in the number and quality of oocytes produced in an IVF cycle?
- What is the optimal time interval between ovulation and IUI?
- What is the emotional and psychological impact on children born using donor gametes?
- What is the emotional and psychological impact of repeated fertility treatment failure?
- Why is Embryo Selection a research priority?
- The primary goal of embryo selection is to produce a live birth from a single embryo transfer and to minimize detrimental outcomes, like implantation failure, miscarriage, or birth defects.
- Noninvasive imaging (microscopy) systems for gametes and embryos is the primary grading and selection method
- Common:
There are three techniques for imaging live, transparent specimens.
Phase contrast passes light through the sample, so the image is light and dark based on the DENSITY of the sample. HMC (Hofmann Modulation Contrast) and DIC are very similar- both are rendering an image based on the rate of change in the optical path- the slope. However, they do it different ways. In HMC a filter is used to amplify certain signals- in this case, the signal is light that has refracted as it passed through the sample. In DIC light is split into parallel beams and directed at the specimen, then they are further affected as they pass through the specimen, then recombined and analyzed on the other side. DIC relies on waves of light interfering (or not) with each other. The major problem with phase contrast is that it produces “halos” of light. The major problem with DIC is that orientation of the sample matters a lot (so swimming sperm- as they change their orientation- would not be good to view with it). Additionally, you must use glass coverslips/ slides or plates with the same refractive index – whereas with HMC you can use a plastic dish, PVP etc all having different refractive indices than the sample.
- Rare:
- Polscope. Visualize meiotic spindle placement and formation with polarized light. Now we predict the position of the spindle by positioning the 1st polar body at 12 on the clock when we do our ICSI injections. But the spindle is not always there, and we can damage the chromosome apparatus during the injection causing the second polar body to not be able to extrude from the egg, and failed fertilization. If the spindle has not formed when we inject the egg usually dies. So the method we have now works for 90% of eggs. We don’t usually have access to this specialized microscope.
- MSOME and IMSI. Expensive experimental systems that require extended handling of the sperm, potential to cause more oxidative damage, lack of agreement on what marker of any indicates sperm DNA damage (vacuoles, cytoplasmic droplet)
- Time lapse monitoring. Expensive and most labs do not have it. Incubation system where the embryos are placed and grown continuously and monitored. Right now, we take embryos from their little culture chamber and inspect them at set time points. Usually at fertilization, day 3, and then 5/6/7. Time lapse can record things we miss in between those checks. Positive selection criteria include the positioning of the pronuclei and a small organelle called the nucleoli inside them, number of blastomeres, the absence of multinucleation, early cleavage to the two-cell stage, and a low percentage of cell fragments in embryos.
- Genetic screening selection techniques like PGT-A are peaking in several countries
- New controversy: polygenic trait selection of embryos
- There have been and continue to be many many controversies in genetic testing of embryos: namely, mosaic embryos and “segmental aneuploidy” embryos can self correct and make healthy pregnancies 30% of the time.
- Algorithmic and artificial intelligence scoring generated by computers is gradually enhancing our selection process, these are becoming more widely used.
- EMA by AiVF is a multi-module integrated platform that combines AI, computer vision, and big data to improve the success rates in patients undergoing IVF treatment. Its genetic evaluation tool can determine if the given embryo is genetically suitable for transfer by avoiding an invasive biopsy. AiVF has the largest embryo database in the world and the platform offers objective and automatic tools. One groundbreaking study from AiVF, tested the effectiveness of EMATM, AiVF’s multi-module integrated platform, which combines AI, computer vision, and big data. According to the study, EMATM detected significant differences between aneuploid and euploid embryos during the first five days of embryonic development. This was based on a retrospective study involving 2,500 embryos with PGT-A results – 1,000 euploid (genetically normal) embryos and 1,500 aneuploid (genetically abnormal) embryos. Aneuploid embryos were significantly more likely to reach each specific embryo developmental event later than euploid embryos and the time gaps between developmental milestones were also statistically longer in aneuploid embryos.
- In general, lack of video imaging systems for continuous monitoring and single step embryo culture systems, as well as lack of data handling methodologies, are holding these back from widespread deployment.
- The race has been on to find metabolomic markers for embryo selection
- What is the embryo using for energy and growth, and what are its waste products?
- The metabolomic profiling of embryo culture media has been performed through proton nuclear magnetic resonance (1H NMR). Researchers have discovered that the metabolomics profile is correlated with embryo reproductive potential. From the proton NMR spectrum, alanine, pyruvate, and glucose levels were reduced in the culture media of embryos that resulted in pregnancy. Glutamate levels were found to be higher compared to embryos that failed to implant, possibly due to its generation from α-ketoglutarate and ammonium, thereby lowering the potentially toxic ammonium to developing embryos. A sensitivity ― the ability to identify true implantations/pregnancies ― of 88.2 percent and a specificity ― the ability to correctly predict no implantations/pregnancies ― of 88.2 percent was achieved through 1H NMR
- Protein markers from the embryo culture medium
- Not too many have been discovered, but surely there are more. Healthy embryos will be producing characteristic proteins as they go about their work growing.
- In one study by Noci et al., soluble human leukocyte antigen-G (sHLA-G) was isolated and considered as a possible protein marker of embryo reproductive potential. The presence of sHLA-G shows no correlation with embryo morphology, and the lack of sHLA-G in culture media has a negative predictive value. In another study in which sHLA-G-positive embryos were transferred, implantation and pregnancy rates were 44 percent and 75 percent, respectively, compared to 14 percent and 23 percent of transferred sHLA-G-negative embryos.
- A protein biomarker that has been found to be upregulated and increased during embryo maturation into the blastocyst stage is a Day 5 secretome ― a set of proteins secreted from the cell ― resembling ubiquitin. Ubiquitin has been implicated in the turnover of key signaling molecules during implantation
- Other non-embryonic genomic markers (cumulus cells) have potential
- The cumulus cells (CCs) that surround the oocyte from fertilization until implantation have been analyzed and gene-profiled to gauge embryo potential: the likelihood of an embryo to implant and lead to a successful pregnancy. Several genes expressed in CCs have been correlated with predicting pregnancy, including cyclooxygenase 2 (COX2), steroidogenic acute regulatory protein (STAR), and pentraxin 3 (PTX3). Two upregulated biomarkers have been identified in the CCs of successful pregnancies, BCL2L11 and PCK1, which are involved in apoptosis of abnormal cells and gluconeogenesis.
The ARTC Digital Lab Playbook January Quality Audit focuses on documenting the IVF lab deep cleaning, preventative maintenance, and air quality. Most IVF labs appear to “shut down” for the week between Christmas and New Year. But we never really close! We are hard at work behind the scenes, ensuring that every instrument we use in the IVF lab and even the environment itself is strictly maintained to provide the best patient care.
Preventative Maintenance
IVF lab equipment must be properly installed, maintained, and calibrated to protect the quality of patient embryos. A great preventive maintenance routine includes cleaning, monitoring and repairs, and timely replacement of any component that shows signs of failure. A proactive and preventative approach allows the IVF Lab to predict potential problems, plan to move precious samples to properly functioning equipment, optimize maintenance schedules (e.g. equipment calibrations), and ensure that the lab can pivot when critical equipment is being repaired or replaced.
The future of IVF lab management includes assistance from Artificial Intelligence systems. In the realm of quality control and assurance, this is called predictive maintenance: knowing how to target future issues or failures before they happen, enabled by continuous monitoring of equipment, historical data, and development of predictive algorithms.
The IVF lab typically has numerous highly sophisticated instruments that need to be maintained, among them are; benchtop incubators, box incubators, warmers, heated surfaces for microscopes, isolettes, laminar flow hoods, pipettors, timers, thermometers, analytical balances, micromanipulators, inverted microscopes, water purifiers, and heating and ventilation systems with sophisticated filtration and pressure requirements.
The CAP generally requires preventative maintenance to be performed and documented.
| COM.30550 Instrument/Equipment Performance Verification | The performance of all instruments and equipment is verified prior to initial use, after major maintenance or service, and after relocation to ensure that they run according to expectations. |
| COM.30600 Maintenance/Function Checks | Appropriate maintenance and function checks are performed and records retained for all instruments (eg, analyzers) and equipment (eg, centrifuges) following a defined schedule, at least as frequent as specified by the manufacturer. |
| COM.30675 Instrument and Equipment Records | Instrument and equipment maintenance, function check, performance verification, and service and repair records (or copies) are promptly available to, and usable by, the technical staff operating the equipment. |
The CAP requires specific instrument preventative maintenance to be performed and documented.
| COM.30680 Microscope Maintenance | Microscopes are clean, adequate (eg, low, high dry and oil immersion lenses as appropriate for the intended use), optically aligned, and properly maintained with records of preventive maintenance at least annually. |
| COM.30700 Thermometric Standard Device | Thermometric standard devices must be recalibrated, re-certified, or replaced prior to the date of expiration of the guarantee of calibration or they are subject to requirements for non-certified thermometers. |
| COM.30820 Quantitative Pipette Accuracy and Reproducibility | Pipettes used for quantitative dispensing (eg, adjustable volume, micropipettes, dilutors, and analytic instruments with integral automatic pipettors) are checked for accuracy and reproducibility initially and according to the manufacturer’s recommended interval, or at least annually if not specified, and the results are recorded. |
| COM.30860 Analytical Balance Maintenance | Analytical balances are cleaned, serviced and checked at least annually by qualified service personnel. |
Air Quality and VOCs
New car smell, paint, dyer sheets, perfume, pine tree, and orange zest all have one thing in common; Volatile Organic Compounds (VOCs). Not all VOCs smell good, not all smell bad, and some have no odor at all. VOCs are nasty compounds like benzene, isopropanol and pentane, as well as particulate matter, carbon monoxide, nitrous oxide, sulphur dioxide and heavy metals. People have organs systems to combat these environmental stressors, lungs, spleen, kidneys, liver, antioxidants that can mop up free radicals and prevent major damage to cells. However, eggs, sperm, and embryos have been removed from the body and don’t have their own antioxidant systems.
Construction materials like MDF, PVC flooring, paints and adhesives, are the major source of VOCs indoors, while the compressed gasses that run our incubators are the major source of benzene, isopropanol and pentane; city air and natural disasters such as wildfires and heat waves bring the noxious gases and heavy metals. Laboratory plasticware, which is made from a variety of plastics like polyethylene, polystyrene, polycarbonate, polypropylene, and acrylic, release VOCs. All of these are bad for embryo development, and air quality unrefutably has been shown to impact pregnancy outcomes. Particle monitors and VOC counters are now important instruments for quality control. New laminar flow hoods and extensive “inline” gas filtration units for incubators, as well as standalone or ceiling / roof mounted air filtration systems with HEPA and VOC filters, and airflows and airlocks that maintain positive pressure are necessary for modern clean room IVF lab design. Currently, it has been generally recommended that IVF laboratories maintain total VOC levels below 400 to 800 ppb.
Deep Clean
The IVF lab must be kept clean and sterilized, but without the use of harsh cleansers and soaps, or disinfectants like ethanol that might emit harmful VOCs. Good practice points are to leave a specific pair of shoes for lab use only, wear clean scrubs that are put on in a clean room, always wear PPE to catch hair shedding (heads and beards!).
| GEN.42750 Computer Facility Maintenance | The computer facility and equipment are clean, well-maintained and adequately ventilated with appropriate environmental control. |
| GEN.61500 Environment Maintenance | Floors, walls and ceilings are clean and well-maintained. |
| GEN.61600 Environment Maintenance | Bench tops, cupboards, drawers and sinks are clean and well-maintained. |
One Month Schedule of Preventative Maintenance, Air Quality, and Deep Clean related IVF Lab QA Activities
The lab director or quality manager should start each month’s Quality Audit by answering “In Progress” to each question, then assign this survey to junior staff using the “assign” function. This will document both continuing education and quality assurance activities. As embryologists perform or learn about these activities, they can mark them as “complete”.
| Dust, starting at top of hoods and lab shelves and moving to floor level – clean all microscopes, wipe all electronics, cords, incubator and hood tops and stands, stools and chairs. Legs of tables and hoods. | Dust accumulation should be cleared quarterly and a deep dive undertaken once a year. Fine dust filters should be used. Low lint scrubs should be worn, and care should be taken to dispose Swifter cleaning cloths outside of the laboratory trash can. |
| Clean and sterilize all incubators and water trays | EmbryoSafe, Oosafe, IVF Prime, H2O2. Record name and date of cleaning. |
| Wipe all hoods and incubators | EmbryoSafe, Oosafe, IVF Prime, H2O2. Record name and date of cleaning. |
| Wipe outside of dewars and dewars roller stands | EmbryoSafe, Oosafe, IVF Prime, H2O2. Record name and date of cleaning. |
| Check Generator maintenance records | Schedule generator maintenance |
| Air Filters | PM air handling system and replace HEPA and other filters. Life Aire |
| Replace VOC in line filters, Carbon filters on top of hoods | Coda® Xtra Inline® Filters Unique VOC removing filter technology should be replaced every 3-6 months. |
| Purified Water System | Specify types and purity of water used, PM must include CFU |
| Alarms, O2 alarms | Smart-Vue (thermofisher) CO2/temp monitor system for incubators, Oceasoft, TempGenius, Pharma Watch |
| Pipettes | Sterilize and Calibrate |
| Thermometers | Sterilize and Calibrate, InnoCal Solutions, a division of Cole Parmer |
| Gas manifolds | PM |
| Incubators | Pharma Watch, Smart-Vue (thermofisher) CO2/temp monitor system for incubators |
| Isolettes | Use a double loop of tape or suction cup to remove glass |
| Microscopes | Sterilize and Calibrate – PM, Kohler, Objectives, Lasers |
| Analytical Balance | PM |
| Anti Vibration Tables | https://www.newport.com/c/microscope-isolation-platforms |
| Hoods | PM, Sterilize and Calibrate: ENV Services |
| VOC Detectors | Graywolf PPB and RAE Systems PPB, VOC and particle meters from CooperSurgical |
| Lab Pens | The Maverick Embryologist’s list of favorites: Pilot G-2 Ultra Fine 0.38mm, 0.5mm, Pilot G2 0.7 mm , Small sharpie extra fine point, not ultra. Paper Mate ink joy gel 0.5, Tul Retractable Gel Pens 0.5mm Needle Point in blue, Zebra F-301 Ballpoint Stainless Steel Retractable Pen, Fine Point, 0.7mm, Black Ink, Pentel EnerGel RTX Retract, Pentel Energel Needle Tip 0.3. |
| Order Spare Parts | CI-2 micropipette connector Narashige for connecting to a glass micropipette, Mouth pieces at the IVFStore |
| September | FDA Audit |
| October | Staff Audit |
| November | Patient Satisfaction and Security |
| December | Space and Supplies |
| January | PMs, Air Quality, and Deep Clean |
| February | Biennial P&P Updates, Review, and Sign Off |
| March | General IVF lab CAP Inspection Preparations |
| April | |
| May | |
| June | |
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Artificial intelligence is often not really associated with reproductive health! We always hear a lot of talk about medicine evolving and incorporating AI into its operations, as we live in a technology-filled world. I’m sure when you’ve heard this the first image that might pop into your head is robots replacing surgeons! However, Scientific American about Artificial Intelligence’s role in treating infertility? How does that work? Well, we’ve got some good news for you. Our CEO Dr. Carol Curchoe and one of our scientific advisory board members, Dr. Charles L. Bormann break it ALL down for you in a Scientific American post titled “What AI Can Do for IVF”!
Image by Matthew Henry
All about the post
Check out the article if you’re interested in what big-name companies have been incorporating AI into fertility treatments, and medicine in general. You can also gain some insight into what stage all of these ideas are in. Scientific progress is not an overnight feat, so it’s important to always stay updated with where discoveries are and how they are doing! As most AI ideas for fertility treatments are in the experimental phase, you might also want to look into what the accuracy rates are looking like right now. Our post covers that too!
Scientific American
Scientific American about Artificial Intelligence’s is All. Things. Science. It is one of the best ways to stay updated about all the new scientific discoveries and endeavors in our rapid-paced world! It’s not only limited to medicine. SA covers a broad range of fields including biology, chemistry, physics, math, space, and even politics among others!
We are honored that they decided to feature our article about up-and-coming AI strategies in assisted reproduction technology (ART).
We definitely want to help play our part in keeping the scientific community updated! We also want to note, SA doesn’t only have articles and publications but they’ve got podcasts and videos if you’re more into auditory and visual learning! I know I’m more of an auditory learner myself!
The importance of staying updated
Reading the newspaper or watching the news when you can is always important! It is also crucial to do so regarding scientific news regardless of whether you pursue a career in science or not. For example, exciting discoveries in medicine might concern you if they perhaps have to do with a condition a family member is suffering from. Medicine affects every one of us! And that applies to us now more than ever during this Covid-19 pandemic. At ART Compass, we try to play our part in sharing crucial information about infertility that doesn’t really get the spotlight it deserves.
Many people suffering from infertility are misunderstood or not really paid attention to. Their struggle is seen as “dramatic” and because of that, people don’t see the need to share important facts and information about infertility. We’re here to change that. For all the infertility warriors out there-we hear you and we’ve got your back! Always check our blog because we post constantly! And check out Scientific American too while you’re at it to get the latest information on what science is up to!
Reference:
Curchoe. C, Bormann. C, “What Can AI Do for IVF” Scientific American, Jan 2018, https://blogs.scientificamerican.com/observations/what-ai-can-do-for-ivf/