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!
The ARTC Digital Lab Playbook February Quality Audit focuses on documenting the biennial IVF lab policy and procedures review. When should IVF Lab policies be updated? What elements make an effective policy? How should they be reviewed? What is sufficient evidence that each policy has been reviewed?! This month’s quality audit answers all of these questions and more!
IVF Lab Policy and Procedure Review
This quality management process ensures policies and procedures are up-to-date, and that all staff members who must comply with your policy or monitor their implementation have been throughly trained. It may be useful for your organization to develop a communication strategy that identifies everyone who needs to be aware and comply with the policy. Scheduled review dates ensure continuous improvement when:
A gap/need is identified.
A serious or critical incident has occurred, requiring an urgent review.
Changes occur in the operating environment
Changes in laws, regulations, government policies, or CAP.
There are several objectives to policy and procedure review and sign off. The CAP All Common checklist, COM.10200 says that the laboratory director must review and approve all new technical policies and procedures, as well as substantial changes to existing documents, before implementation. A paper or electronic signature review of records is required, but a secure electronic signature is highly recommended. When a policy or procedure is discontinued, a paper or electronic copy must be retained for at least two years, with a record of the initial date of use, and retirement date.
With respect to procedures, the CAP says that a complete procedure manual should be available in a paper-based, electronic, or web-based format at the workbench or in the work area. A schedule should be developed where roughly 1/24 of all technical policies and procedures are reviewed monthly, in order to minimize the burden on the laboratory and reviewer(s).
After review, a paper or electronic signature must be recorded at the level of each policy or procedure. A single signature on a Title Page or Index is not sufficient to record that each policy or procedure has been carefully reviewed.
According to CAP general requirement GEN.20375, IVF laboratories must have a document control system to manage policies, procedures, and forms that are subject to CAP accreditation. All of these objectives are easily met by the documents and forms control module in ART Compass.
Effective policies clearly state:
Purpose: A statement that explains the goal(s) the policy is intended to achieve.
Findings: Brief statements of fact and /or statistics that outline the issue being addressed and support the need for the policy.
Definitions: Detailed explanations of the key terms in the policy.
Provisions: The main policy provisions state the prohibitions and/or requirements of the
policy and identify the parties to whom the provisions apply.
Exemptions: Any exemptions or exceptions to the prohibitions or requirements that are necessary to achieve the purpose of the policy.
Enforcement: An Enforcement section identifies the parties responsible for enforcement, outlines the enforcement procedures, any penalties or fines that may be imposed, and any appeal process.
Implementation: The implementation section states the effective date for the policy and the steps to
disseminate and publicize the policy.
One Month Schedule of Annual Policy and Procedure Updates, Review, and Sign Off 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”.
| Research and Analysis | Analyze CAP Checklist to determine if new policies need to be written or existing policies updated. Cap Checklist Management Tools are available in ART Compass. |
| Distribution | The policies and procedures has been distributed to those expected to implement it and follow up feedback will be sought to ensure the policy is understood and applied. Use the “Assign” function in ART Compass! |
| Dates | Check that policies and procedures include the implementation date when the policy becomes active, dates and notes about changes or edits, and end use dates. |
| Review Schedule | Policy includes a review date – recommended 1/24 per month to completion every two years. |
| Supporting Documents | Supporting documents, such as forms, checklists or guidelines that will assist staff to implement policy have been developed. |
| Policy Scope | The scope of the policy lists all staff positions with responsibility for implementing the policy. |
| Critical or Panic Values | Policies identify what constitutes a breach of the policy and what the consequences are, and/or panic values that require immediate notification of a physician. |
| Sign Off! | IVF Lab Director, Medical Director and Technologists acknowledge they have read and understand the policies and procedures, supporting documents, and checklists. All employees can record their sign off on each P&P in ART Compass. |
The CAP requires various policies. Do you have a policy to address each of the following?
| GEN.20310 | Written QM policy and processes for performing a root cause analysis or investigation of non-conforming events |
| GEN.20340 | Written policy for the handling of recalls and notifications |
| GEN.20374 | The laboratory has a policy for ensuring compliance with applicable national, federal, state (or provincial), and local laws and regulations. |
| GEN.20377 | Written policy for retention of records, specimens, and slides |
| GEN.20450 | The laboratory follows a written policy for the management and correction of laboratory records, including quality control data, temperature logs, and intermediate test results or worksheets. |
| GEN.26791 | The laboratory has a written policy that addresses compliance with the CAP terms of accreditation. |
| GEN.40492 | The laboratory has a written policy regarding correction of information on specimen labels. |
| GEN.40506 | Written policy defining criteria for storage of and access to specimens collected by chain-of-custody procedures |
| GEN.40509 | Written policy addressing restricted access to secured records and record retention. |
| GEN.40935 | Personnel receiving verbal or phone orders read back the entire order to verify accuracy of transcription. |
| GEN.41304 | There is a written policy to ensure that patient data are accessible in a timely manner only to those individuals who are authorized to review test results. |
| GEN.41345 | Written policy defining test reporting turnaround time and process for communication of delays in turnaround time |
| GEN.43325 | Written policy defining mechanism for data protection |
| GEN.54200 | Written policy for continuing laboratory education |
| GEN.59980 | The laboratory has a written policy for restricting access to the laboratory to authorized individuals. |
| GEN.74400 | There is a written policy that prohibits smoking, vaping, eating, gum chewing, drinking, application of cosmetics and lip balm, manipulation of contact lenses, and mouth pipetting in all technical work areas. |
| GEN.77300 | The laboratory has a policy to protect personnel from excessive noise levels. |
| 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 | |
| July | |
| August |
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 | |
| July | |
| August |
The ART Compass platform makes managing space and supplies easy! In December we focus on tissue inventory, supplies management, and discard workflows! December is a great time for most IVF labs to prepare for the coming year’s IVF cycles by performing inventory of both embryos (visually comparing what is in the tank to what is in the cryostorage database) and reagents and supplies, disposing of embryos that are not usable or no longer needed out of tanks, deep cleaning the lab, organizing storage spaces, and archiving records to make space for the next year’s cycles!
What do the CAP guidelines say about “space and supplies”, ie. cryostorage, physical storage, and reagents traceability and inventory?
Specimen Storage and Disposition
| GEN.40506: Secured Specimen Storage | The original specimens (in the original container) and appropriately labeled aliquots are maintained in an appropriate manner when not in the possession of an authorized individual. |
| GEN.40507: Specimen Retention and Storage | Specimen retention and storage conditions are defined for each type of specimen tested by the laboratory using a chain-of-custody procedure. |
| RLM.08000: Specimen Handling | There is a system to verify and maintain the identity of the specimen throughout receipt, storage, processing, and disposition. |
| RLM.12400: Specimen Storage/Long-Term Disposition | There is a written procedure regarding the length of storage, informed consent and long-term disposition of cryopreserved gametes or embryos. |
| RLM.03975: Specimen Handling and Disposition | Records allow for the tracking of the disposition for gametes or embryos handled or stored. |
Records and Inventory
| GEN.40509: Secured Records | The chain-of-custody collection records, security logs, and testing records are retained for an appropriate period of time, no less than two years and following applicable laws and regulations, in a limited-access, secured (locked) area that is only accessible to authorized laboratory personnel. |
| GEN.61900: Inventory Control | There is an effective supply inventory control system in operation. |
| RLM.12000: Inventory | Records are available for the current inventory of all specimens that have been stored in its cryobanks. |
Embryo Cryostorage Inventory
A precise inventory is maintained for all embryos in storage by IVF laboratory staff. Once a year, the embryo inventory should be visually checked and confirmed with the embryo database. Patients who no longer wish to store their frozen embryos have several options. Frozen embryos may be discarded as medical waste. They may be donated for research studies, quality control or training of junior embryologists. When embryos are donated for lab use, they are thawed, studied scientifically, and then discarded after a few days. Typical research topics include new techniques for freezing or thawing embryos, new embryo culture methods, PGT-A or genetics studies and more!
Make some space! Embryo Discards
Embryo discards tend to pile up during the year. To discard frozen embryos, a consent form is typically signed (by both partners) and notarized or witnessed by IVF clinic staff. Many labs have a 30-60-day “cool down” waiting period, before at least two embryologists are needed to fulfill the patients’ wishes to discard embryos. Because multiple people are needed to properly locate the embryos in the storage tank and carefully confirm the identity, this is a time consuming a laborious process often superseded by the day–to–day demands of running an embryology lab. The embryologists will typically sign and date the consent form and other storage documents, attesting that they performed and witnessed the disposition according to the patients’ wishes and these should be kept permanently in the laboratory files. It is a good practice to provide written confirmation of the disposal of the embryos to the physician and patient chart.
Reagents and Supplies Inventory
Inventory control is vital to deliver quality IVF services. A carefully managed inventory ensures that the right quantities of reagents and consumables are available at the right time and place. It prevents waste from expired reagents (over-ordering), duplicate orders, or improper storage. All purchased supplies, reagents, and consumables should be included in the laboratory inventory. Information in the inventory should include lot number, date received, date put into use, expiration date, and special storage requirements. Inventory control management includes monitoring the physical storage environment (temperature, humidity, exposure to sunlight), keeping stock levels consistent with procedure numbers, conducting physical inventories, and disposing of expired products in a timely manner. You will want to ensure that the SDS and 510K folders in ART Compass are up-to date.
Tips to manage Space and Supplies
Designate a Place for Everything
Make sure everything in your lab has a specific place. Designate specific, clearly-labeled storage locations for each reagent or category of reagents to ensure that newly-delivered items can easily be found by all embryologists. Create a schedule to go through your reagents and remove expired and obsolete reagents from your storage space.
Label Everything
Establish a consistent labeling system that all embryologists and lab techs use to label aliquots and shared solutions. Don’t forget to also label shelves and cupboards, which can remind people of where items belong and help keep storage areas organized.
Create an Ordering Information Spreadsheet in ART Compass.
Keep an updated lab inventory and ensure all lab members update the LQMS module in ART Compass when receiving new items. A basic lab inventory spreadsheet can be created under “Documents and Forms” containing reagent names and ordering information (i.e. vendor, catalog number, price, etc.) Lot numbers and expiration dates may be included for good laboratory practice.
For larger IVF labs, create and maintain an ordering spreadsheet where embryologists can add items and quantities they need ordered for a given week. A designated member, such as the IVF supervisor, can then order these items in bulk for the entire lab.
One Month Schedule of Space and Supplies (Tissue Discards, Cryostorage, and Supplies Inventory) 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”
| Check Consents and Disposition Directives, Perform Tissue Discards | Witnessing this procedure is non negotiable! Don’t forget, you can use the image archive function in ART Compass to record any part of this process., and permanently amend it to the patient record. |
| Prepare to Ship Tissues to long term storage. | Long term fertility preservation samples, and other types of samples for long term storage can be prepared now for transfer in the new year. Long term storage facilities include: Reprotech, Cryopoint, Fairfax Cryobank, California Cryobank, Ovation, TMRW. |
| Review Discard Policy and Process. Pull 10 discards to ensure the process has been followed. | A few good process points: Store tissue discards in a separate binder. Scan tissue discards into a separate (digital) folder. Don’t forget to mark tissue as “discarded” in cryostorage so the patient is not billed! |
| Review previous year’s cycle numbers, gas and dewar costs, and forecast needs for coming year. Review dewar and cryostorage options for coming year. | Calculate how fast you will fill up space: High capacity tank options are MVE 6000, Vitrostash among others. |
| Make or update a list of all supplies and reagents | Log into the web version of ARTC. Navigate to the white tab, LQMS. Update reagents list and then record lot #, expiration date, date into stock and into service. Use your phone’s camera to image product invoices, certificates of analysis and store them permanently. |
| Update the SDS folder in ART Compass with current safety data sheets. | Log into the web version of ARTC. Navigate to the green tab, Documents and Forms. We have pre-populated your SDS folder with Vitrolife, Fujifilm/Irvine Scientific and Cooper products! |
| Count pieces in storage, check expiration dates, discard expired products. | Take an inventory of plastics, reagents, and other stocks! Discard expired reagents. |
| Update the 510K folder in ART Compass with products that have FDA approval. Discontinue use of products when a suitable approved device is available. | Log into the web version of ARTC. Navigate to the green tab, Documents and Forms. We have pre-populated your SDS folder with Vitrolife, Fujifilm/Irvine Scientific and Cooper products! |
| Update Standing Orders for the new year. |
| September | FDA Audit |
| October | Staff Audit |
| November | Patient Satisfaction and Security |
| December | Space and Supplies |
| January | Preventative Maintenance, Air Quality, and Deep Clean |
| February | Biennial P&P Updates, Review, and Sign Off |
| March | General IVF lab CAP Inspection Preparations |
| April | |
| May | |
| June | |
| July | |
| August |
This post is all about IVF patient satisfaction and HIPAA Compliance! We provide you with a month’s schedule of specific quality assurance activities to keep your IVF lab compliant with FDA Title 21 Code of Federal Regulations (CFR) Part 1271 and College of American Pathologist inspections. In the month of November, we will tackle CAP Checklist items GEN.20335- Customer Satisfaction and GEN.41303- Patient Confidentiality, and provide background on HIPAA and CAP requirements.
Remember to start each month’s quality audit off by opening the ART Compass mobile app or web platform and navigating to Surveys -> IVF Lab Quality Playbook and then marking each activity as “in progress” before assigning the monthly survey to your staff. When taking your quality systems from good to great, this is a GREAT way to perform a staff- training activity, and document and ensure quality audits are performed continuously throughout the year and not just before an inspection!
To satisfy CAP requirements, your IVF laboratory must measure the satisfaction of clients (e.g., healthcare providers, patients, referring laboratories, nurses) for IVF laboratory services every two years (minimally). The laboratory must also ensure that internal and external storage and transfer of data maintains patient confidentiality and security. Written procedures must address patient confidentially during transfer of data to external referral laboratories or other service providers. This must include cloud based computing (eg, for storage of confidential data). Lastly, the IVF laboratory must audit compliance with the procedures at least annually.
Patient Satisfaction
The College of American Pathologists says “Satisfaction metrics are important for understanding the needs of clients to improve laboratory services. Experience has shown that surveys are more informative if they are conducted anonymously and allow for open ended comments. The sample size should be adequate. A numeric satisfaction scale allows for calculation of statistics.”
Is your IVF lab following these recommendations for IVF patient satisfaction?
Is your IVF patient experience data actionable?
Staying on top of patient service issues is challenging, even with a well-equipped patient experience team. Most healthcare organizations use traditional paper surveys to track and monitor patient satisfaction metrics, but cutting-edge IVF Practices, healthcare administrators, and chief experience officers need real-time insights that are tied to patient experience goals. IVF clinics often operate on the narrowest of margins, which means losing even one patient over poor customer service is one too many! Complicating matters, most IVF clinics still use traditional paper surveys to track and monitor patient satisfaction metrics, putting them at a huge disadvantage in terms of identifying service recovery opportunities. Some IVF clinics may even intentionally make it difficult or unappealing for the customer to provide feedback with inaccessible surveys that are difficult to access or time consuming to fill out.
The ART Compass platform makes it easy for patients to provide real-time feedback — and even easier for fertility doctors (reproductive endocrinologists and infertility specialists or REIs) to improve service and IVF patient satisfaction based on this feedback. The ART Compass patient app includes intake forms, satisfaction surveys, and other types of surveys for patient education and shared decision making with physicians. Critically, this shifts the focus onto the patient and promotes a culture of service excellence.
The goals of patient satisfaction are;
Higher patient satisfaction and loyalty
Staff see how better experience impacts their role
More informed patient decision-making
Enable continuous improvement
Leverage evidence-based frameworks
HIPAA Compliance
Showcase your comprehensive commitment to healthcare data security with the ART Compass platform!
What is HIPAA and what is its purpose? HIPAA, the Healthcare Insurance Portability and Accountability Act, was signed into law on August 21, 1996. HIPAA’s overarching goal is to keep patients’ protected health information (PHI) safe and secure, whether it exists in a physical or electronic form. HIPAA was created to improve the portability and accountability of health insurance coverage for employees moving between jobs. HIPAA was also created to deal with waste, fraud, and abuse in health insurance and delivery of healthcare, as well as to promote the use of medical savings accounts, provide coverage for employees with pre-existing medical conditions, and simplify the administration of health insurance.
HIPAA’s goal is to keep patients’ protected health information (PHI) safe and secure, whether it exists in a physical or electronic form. If your company stores or processes any sort of PHI, you must be HIPAA-compliant. To become HIPAA-compliant, your company must establish clear policies and procedures for how you manage PHI. The HIPAA Privacy Rule requires all Covered Entities to have a signed Business Associate Agreement (BAA) with any Business Associate they engage with that may come in contact with PHI. Every IVF Lab has risks. Take some time to identify the unique risks for your IVF Lab and the patients whose PHI you process, describe their cause, and outline steps you’ve taken to lessen their potential impact.
Your IVF Lab will want to develop and implement a system for tracking policies, processes, procedures, documents, and related compliance materials. Your goal is to maintain compliance with HIPAA’s various component elements, to track any changes in ongoing HIPAA regulations, and to establish and maintain organizational processes for gathering compliance metrics.
Achieving HIPAA compliance isn’t a matter of proving the IVF lab’s adherence to a single static standard. HIPAA’s rules and requirements are intentionally broad and flexible to accommodate the range of types and sizes of covered entities and business associates that create, access, process, or store protected health information (PHI), and that must thus comply with HIPAA.
The ART Compass HIPAA Promise
Cloud environments are widely used across the United States to store PHI. At ART Compass, we only use Amazon Web Servers and products that are HIPAA compliant, Amazon provides extensive documentation for their HIPAA Compliant products.
There are many features built into ARTC for security- for example the “admin” account type provides Human Resources functions to immediately cut off staff access in the event of untimely separation. We also require that laboratory staff accounts to be accepted by the IVF lab director, and all email accounts must be verified. Our mobile apps leverage smartphone biometric technology- either thumbprint or Face ID, couples with “automatic timeouts” to further ensure privacy.
On the patient app side, patients will invite their own partner to join the medical record. A “One Time Password” (OTP) is sent to the partner via email, which must be authenticated by adding the email of the patient. Additionally, we provide a “separate records” feature in the event a couple must separate their medical records.
ART Compass sends data to the database using the REST API. The REST API was developed with the laravel framework. Protecting patient data at this point of transmission has been identified as a critical factor, so for this we use the “Passport authentication” method in laravel to authenticate the information, while avoiding security threats during data transfer. Statistical reports will also be visible in the administrative panel, access to which is controlled by login and authentication that has also been developed in the laravel framework.
The ART Compass Database is also protected with encryption techniques so that the raw values of the database cannot be decoded, including passwords. A MySQL database provides security by default, and data is transferred using “Passport” as an authentication technique allowed by HIPAA.
We provide a standard Business Associate Agreement for compliance with HIPAA Rules and Regulations (in your app under Settings -> Legal Agreements).
One Month Schedule of Patient Satisfaction and HIPAA related IVF Lab QA Activities
Start each month by answering “In Progress” to each question, then assign this survey to junior staff using the “assign” button. This will document both continuing education and quality assurance activities.
| Proctor patient satisfaction surveys | Easily collect data with the ART Compass Patient App! |
| Compile results of surveys and distribute to relevant departments | Review positive and negative feedback. Define actionable goals, |
| Review incident or occurrence reports relating to HIPAA compliance | Ensure that staff know what constitutes a HIPAA breach, and how to document and report a breach. Quality systems should track security incidents, document, and report all breaches. |
| Referral Providers Satisfaction Surveys | Survey the Physicians who refer patients to the IVF practice. Do they have any valuable feedback to ensure high levels of patient care? |
| Review the U.S.Dept of Health and Human Services Office for Civil Rights Audit Protocol | Perform a readiness assessment and evaluate your IVF lab’s security processes. https://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/audit/protocol/index.html |
| Schedule annual HIPAA training for all employees. | Distribute HIPAA Policies and ensure staff read and attest to their review. (you can use ART Compass to document yearly policy sign off activities. |
| Assess HIPAA Knowledge with the ARTC HIPAA Survey. | Assign staff the HIPAA Compliance survey (continuing education) to document employee processes, training, and attestations |
| Build a year-round risk management program to continuously assess risk. | Understanding the ins and outs of HIPAA compliance means understanding the costs or non-compliance and integrates continuous monitoring to manage the risks of non compliance. |
| Occasionally, contractors (ATime or Puah) will have access to patient data. | Ensure that any contractors have signed a BAA or NDA. |
| Institute an annual review process, with the ARTC IVF Lab Digital Playbook! | Annually assess compliance activities against HIPAA rules, and updates to HIPAA. |
| September | FDA Audit |
| October | Staff Audit |
| November | Patient Satisfaction and Security |
| December | Space and Supplies |
| January | Preventative Maintenance, Air Quality, and Deep Clean |
| February | Biennial P&P Updates, Review, and Sign Off |
| March | General IVF lab CAP Inspection Preparations |
| April | |
| May | |
| June | |
| July | |
| August |
IVF treatment is emotionally and physically stressful, financially demanding, and requires the patient to become “high information” in a very technical sub specialty of medicine. This reality is reflected in a common saying in the “TTC” (trying to conceive) community; “Infertility patients earn an honorary degree in reproduction”. Meaning IVF patients need to learn so much during the course of their treatment that they could practically earn a degree. IVF clinics often operate on the narrowest of margins, which means losing even one patient over poor customer service is one too many. Despite the stumbling blocks, IVF patient satisfaction can be increased!
The paradigm of “shared decision making” – a patient-centered, individualized approach to the informed consent process that involves discussion of the benefits and risks of available treatment options in the context of a patient’s values and priorities, is of paramount importance in the field of IVF, where the financial burdens often fall on the patients and the stakes are so high. In my experience, I have seen patients re-mortgage their house, prospective grandparents cash out retirement accounts, and infertility patients move jobs, states, or even countries to obtain IVF coverage!
The manner in which fertility doctors communicate with patients affects their confidence in the physician and in the final IVF treatment decisions made. Many studies have shown that healthcare consumers crave a retail-like patient experience, they are seeking “self-service” options, automated communication options, more payment options, a so-called ‘digital front door’, and mobile app capabilities that provide instant access to medical records and test results. Failure to deliver on these capabilities can push patients to change REIs, even when the clinical aspect of their infertility care is satisfactory. It is abundantly clear, IVF patients lose confidence in IVF clinics that do not use a digital product, particularly a mobile app, to manage the IVF consumer experience.
The ART Compass (ARTC) patient IVF app links all of the IVF cycles together on a single dashboard, and includes intake forms to collect demographic and medical histories, patient satisfaction surveys, and other types of surveys to promote patient education and shared decision making with REI physicians. Critically for IVF practices that implement ARTC, this shifts the focus onto the patient and promotes a culture of IVF service excellence.
We launched our patient survey tools just 6 months ago to fulfill the regulatory requirements of the IVF lab, but already our results are yielding interesting and actionable results for IVF clinics. Thus far, most survey respondents (> 78%) said that certain aspects of IVF treatment information provision should be improved. 83% of users stated that the quality of communication and the provision of treatment support were critically important in the context of shared decision making. We also identified negative experiences, which affected women’s perceptions of the whole IVF process; such as, being given unrealistic expectations of treatment success, feelings of vulnerability to the pressures of media and society, and a sense of being ‘unprepared’ for the major steps of IVF ‘decision-making’ process were reported. Most importantly, “insufficient information” or information that appeared to be ‘generic’ and not specific to the individual couple were identified most often from the patient satisfaction surveys completed. Certainly, transforming the IVF patient experience with a cutting-edge digital infertility software like ARTC aligns IVF practices with consumer needs and can boost revenue by attracting and retaining new patients, streamlining operations, and supporting clinical care.
IVF Labs that implement ART Compass for IVF data management report higher patient satisfaction and loyalty, that staff can see how their role impacts patient experience, IVF patients feel better informed for decision-making, and that it enables continuous improvement in their healthcare organization.
The importance of the embryologist’s role in embryo freezing, also called cryopreservation, has grown with the rise in pre-implantation genetic testing and “freeze-all” strategies. Embryo cryopreservation and maintenance is considered to be a standalone sub-discipline of reproductive medicine. Embryo cryopreservation allows women undergoing IVF to have just ONE cycle, but continue to have embryos to use in the future. It helps to reduce the risk of Ovarian Hyperstimulation Syndrome (OHS), and allows for the endometrium to fully recover after ovarian stimulation.
History of Cryopreservation
The idea of maintaining the viability of living reproductive cells and tissues of various species and humans for long-term storage has been around for almost 50 years. Dr. Alan Trounson and Linda Mohr achieved the first human pregnancy from a frozen (8 cell) embryo in 1983 and the first live birth, baby Zoe, in 1984. In 2017, Emma Wren Gibson was born from an embryo that had been frozen for nearly 25 years – possibly the longest gap between conception and birth since IVF began.
Overall, embryo cryopreservation has decreased the number of fresh embryo transfers performed, and maximized the effectiveness of IVF cycles.
- Data shows that women who had fresh and frozen embryo transfers obtained an 8% increase in additional births using cryopreserved embryos.
- Randomized clinical trails (Coates 2017 and Magdi 2017) show that vitrification of blastocysts and frozen embryo transfer (FET) is superior.
Vitrification for embryo freezing
Through efforts to constantly improve cryopreservation techniques, we are now able to preserve cells and tissues through a process called vitrification – transforming cells from a liquid state directly to a glass like state. This is done by replacing all the water in cells (dehydration) with a cryopreservation agent, and then by cooling the embryos to extremely low temperatures, such as −195.79°C (the boiling point of the liquid nitrogen). Cooling down biological objects to such degrees prevents any biological activity, including all the biochemical reactions involved in cell death!
Roles & Responsibilities of Embryologists
When cryopreservation methods fail, dreams and families are lost. Several high profile cases of liquid nitrogen storage failures, as well as the selection and transfer of the “wrong” embryo have been nightmare scenarios for the IVF industry. They highlight the embryologist’s important role in cryopreserving and storing embryos. Some of the roles and responsibilities of embryologists are:
- To label, separate, and store embryos that are potentially infectious (for example, created with HIV+, Hepatitis + eggs or sperm) for use by a sexually intimate couple, for use by an unrelated gestational surrogate, or in cases of embryo adoption.
- To understand embryo inheritance in cases of death, or use by either party in cases of separation and divorce.
- To discard embryos that are genetically abnormal, or after individuals have completed building their families.
- To collect and organize legal consents to store frozen embryos, to thaw embryos for transfer (or biopsy), or discard the tissues.
- To correctly label, identify, and select embryos for transfer.
- Maintain liquid nitrogen dewars at all times – over holidays and weekends- with optimal and adequate levels of freezing cold liquid nitrogen.
- Detect environmental changes, inspect the condition of storage vessels, and, maintain alarm systems and liquid nitrogen gas supplies.
- Ship (and receive) frozen embryos (and eggs and sperm) all around the world!
Image by Sam Jotham Sutharson
Pollution BPA and toxins- something we don’t often hear about when speaking about fertility! That doesn’t mean there aren’t some things to be aware of regarding air pollution and toxins in certain everyday materials! Scroll down to find out why you need to learn about the relationship between pollution and fertility. And while we’re at it, let’s try and keep our amazing planet CLEAN for the generations to come! We must fight to keep our home healthy as it is OUR responsibility.
Pollution BPA and toxins: There is a growing body of evidence that suggests air pollution can have a negative impact on fertility. Women exposed to increased concentrations of nitrogen dioxide, carbon monoxide, and ambient particulate matter had lower rates of conception following fertility treatment and higher chances of early pregnancy loss compared with women exposed to lower concentrations of these pollutants. Men living in areas with higher air pollution are also more likely to have a higher proportion of abnormally shaped sperm. Ultimately, there is a limit to how much individuals can control their own air pollution exposures. Outdoor pollution is one of those problems we can only address through collective action.
BPA: Bisphenol A, known as “BPA” is an industrial chemical that has been used to make certain plastics and resins since the 1960s. In recent years, science has shown that exposure to BPA can result in reproductive endocrine disorders and neurobehavioral problems. Many manufacturers have started to use other chemicals as substitutes for BPA. Products containing these substitutes are sometimes marketed as “BPA-Free.” Plastics that do not contain bisphenol, however, may not necessarily be any safer than those that do. Be weary of marking claims!
Toxins: “Natural” does not always mean safe, especially when you are trying to conceive or are pregnant. Proceed with caution and care when using even the most natural of “Nature’s Remedies”. Try to minimize your overall exposure to toxins.
A few quick tips-
- Read labels on cleaning solutions and gardening products
- Minimize eating deep sea fish such as swordfish, shark, king mackerel and tilefish all of which have a more concentrated level of mercury
- Check for lead-based paint in your home (in older homes).
OHSS: the dreaded ovarian hyperstimulation syndrome, a rare but significant side effect of IVF.
Today’s post is all about ovarian hyperstimulation syndrome! It is one of the hurdles one might face when undergoing an IVF cycle so we want to help clear up what the risk factors are and what might help reduce the risk of developing it!
OHSS occurs in 1-10% of IVF patients. Risk factors for OHSS include:
- young age
- development of many ovarian follicles under stimulation
- extreme elevated serum estradiol concentrations
- use of hcg for final oocyte maturation and/or release
- continual use of hCG for luteal support
- the occurrence of a pregnancy (resulting in hCG production).
The risk of OHSS is smaller when using GnRH antagonist protocol instead of GnRH agonist protocol for suppression of ovulation during ovarian hyperstimulation. The underlying mechanism is that, with the GnRH antagonist protocol, initial follicular recruitment and selection is undertaken by endogenous endocrine factors prior to starting the exogenous hyperstimulation, resulting in a smaller number of growing follicles when compared with the standard long GnRH agonist protocol. Have more questions about OHSS?
Assisted Hatching: What is it and why does my IVF Clinic do it?
Assisted hatching is a laboratory procedure that is sometimes performed along with in vitro fertilization (IVF) treatment. Assisted hatching is where an opening is created in the zona pellucida of an embryo. This is the outer coating (shell) of proteins. The embryo naturally breaks out of this shell as it grows. By doing this, it assists the embryo in hatching and attaching to the wall of the uterus for implantation.
The hope is that assisted hatching might give the embryo extra room to expand, less stress escaping the zona to implant in the uterine wall, and finally lead to a pregnancy. Studies suggest that assisted hatching might help improve pregnancy chances for certain groups of patients. Assisted hatching may help improve pregnancy chances in women who have failed to get pregnant in previous IVF cycles and those with a poor prognosis (who are not likely to conceive).
During assisted hatching, the outer shell of the embryo is artificially weakened by making a small hole in the zona pellucida.
Assisted Hatching: What is it and why does my IVF Clinic do it?
It may help improve pregnancy chances in women who have failed to get pregnant in previous IVF cycles and those with a poor prognosis (who are not likely to conceive).
Reasons to Perform Assisted Hatching
If you had PGT performed on your embryos, then they were hatched before being biopsied. However, they may be hatched again with the laser after the embryo is thawed. We typically only freeze embryos that we think are destined for success-no matter what their grade is. The grade is simply a snapshot in time, and can change after biopsy/freezing and thawing. A top quality embryo can thaw terribly and vice versa. There is some evidence that assisted hatching helps embryos implant.
Potential Risks
Some people think that IVF in general may increase the risk of having a twin pregnancy. Influencing factors include the oocyte age being < 35 years old, prolonging the embryo culture, micromanipulation of the zona pellucida after procedures such as intracytoplasmic sperm injection (ICSI) or assisted hatching (AH), and after fresh embryo transfer. (Tarlatzis 2002; Jian 2004; Knopman 2014; Kanter 2015).