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!
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 |
Could Medicare cover fertility treatments, as the U.S. is faces an unusual population problem: fewer babies are being born each year. Demographer Brady Hamilton noted that fertility rates are reaching record lows, since the annual fertility rate has dropped to 59 births per 1,000 women. The decrease in fertility rates is due to the changing trends in women’s social behavior, since more women are opting to delay both marriage and childbirth. In fact, more babies are now being born to women in their late 30s up to their 40s. This trend in delayed childbearing is a big concern as fertility rates decline with age. Though some companies—notably Facebook and Google—are beginning to include IVF and other fertility treatments as part of their employee benefit packages, most do not. This puts the United States far behind other countries.
For example, in Spain since 2006, all women aged 18 or older have access to reproductive technology—including artificial insemination and in vitro fertilization (IFV). Women up to 50 are accepted by Spanish clinics, and they don’t discriminate against same-sex or single ladies, either. They also have 200 treatment centers—more than any other European country. In Denmark, IVF and artificial insemination, sperm mobility measures and basically anything you or your partner would need are 100% free of charge. Since 2006, ACT is not only limited to heterosexual couples but extends to same-sex duos and single women, too. It’s estimated that 8 to 10 percent of babies born in Denmark are by ART. Israel provides two IVF Cycles up to age 45 for free, In Australia the government covers half for the first IVF cycle and more for subsequent cycles, and the provinces of Canada all have varying levels of tax credits.
Qualifications for Medicare Coverage?
Medicare is widely known as health insurance for older adults aged 65 and above. However, individuals at a reproductive age can also apply for Medicare coverage under certain circumstances. For instance, you can apply for Medicare if you have an End-Stage Renal Disease that typically requires transplants or regular dialysis. Medicare Advocacy also points out that younger people with disabilities can apply for Medicare coverage. Furthermore, people with Alzheimer’s disease, mental illness, multiple sclerosis, and Parkinson’s disease are also qualified, if their doctors deem that they meet specific criteria. As such, consult with your doctor so that they can assess whether you can qualify for Medicare coverage for your health and fertility concerns.
Medicare and Fertility Treatments?
Does Medicare cover fertility treatments? There are different Medicare plans, and each of them offers various coverages. The Kaiser Family Foundation points out that reasonable and necessary services associated with treatment for infertility are covered under Medicare. This means that your doctor must consider a fertility treatment as a necessary medical option for you to qualify for coverage. As such, treatment can only be provided if the infertility is caused by a medical condition. However, patients under the original Medicare program can only use Part B for medically necessary fertility treatments, since it covers doctor’s services and outpatient care.
Couples struggling with infertility can also get more medical coverage through Medicare Advantage plans.
Medicare Houston outlines that these plans offer more benefits, such as prescription drug coverage for necessary medical cases involving infertility. Besides including part B and prescription drug coverage, individuals under Advantage plans also benefit from working with a wider network of doctors, hospitals, and providers. Therefore, you have more options if you want to consult a fertility doctor regarding your case.
The fertility rates in the US have been decreasing over the past years. Many people of childbearing age are struggling with infertility due to certain health conditions, making the extent that Medicare cover fertility treatments an ever more pressing need for the general population. To learn more about news and issues concerning fertility, check out the other resources on ART Compass. We have plenty of informative articles as well as our own lab management software for embryologists and IVF clinics.
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.
Staff Quality Assurance
Staff quality assurance audits are extremely important for IVF labs! Competency and related metrics are the number one most cited IVF laboratory inspection deficiency. Embryology and andrology procedures are subjective, complex, and difficult to standardize. The lack of rigorously standardized laboratory protocols and strict quality control (QC) confounds even the best laboratories. Easily ensuring compliance with LQMS, CLIA, and WHO standards is an invaluable tool for clinics and laboratory directors. Accurate laboratory test results depend on staff being competent to perform a range of procedures and competency assessments are part of a laboratory’s quality documents, and should be periodically reviewed and used for continuous improvement.
Staff Management
You may have spent 25 years attaining the highest levels of precision and accuracy in your embryology procedures., but has anyone ever taught you how to manage staff? A rock solid team and happy balanced working environment are the keys to effective staff management and longevity of embryology teams. Teams that have played together for a long time are winning teams, teams with high embryologist turnover and burnout are constantly destabilized. In the ARTC IVF Lab Playbook, the month of October is all about preparing for the coming year. Effective staff management is a skill that IVF lab Directors can learn. Here are our suggestions!
One Month Schedule of Staff related IVF Lab QA Activities
The lab director or quality manager should each month by answering “In Progress” to each question, then assign this survey to junior staff using the “assign” function. As activities are completed or learned about, each item is marked “Complete”. This will document both continuing education and quality assurance activities.
| Competency assessments for each procedure in lab. Particularly, for clinical decisions. | Give your answers first in the ART Compass app, then assign surveys to staff: Some fun ones? Where to nick sperm tail. Where to hatch on Day 3. How to hatch blast for FET, choose to freeze or discard, to biopsy or culture more, fertilization, egg maturity, grading for day 3 / blast systems. For FETs, transfer or thaw another? |
| Eye color survey | Staff meeting to review why seeing the color red is important in an embryology lab. Assign “All About Media and pH” and “Color Vision” in ARTC. Document color vision for staff file. |
| Training documents up to date | Review training stats, 6 month review, one year review for trainees. |
| Annual procedure evaluations | Document 6 CAP checklist items for fully trained embryologists yearly. |
| Assess the IVF Lab Supervisor’s ability to supervise. | Embryology supervisors must have at least one year of supervisory experience in all aspects of embryology performed by the laboratory or a minimum of 60 cycles over a period of not less than six months. Furthermore, the performance of section directors/technical supervisors, general supervisors should be separately assessed and satisfactory. |
| Lab Director Annual Review | Lab directors can benefit from a Lean 6 Sigma approach. Gather performance reviews from someone below you, at the same level as you, and above you. What are your blind spots? Where do you excel? |
| Continuing Education Review and plan for upcoming year | There must be a functional continuing laboratory education program adequate to meet the needs of all personnel. The ARTC IVF Lab playbook provides suggestions for CE activities for each month, and methods for easy documentation and automated follow up. Additionally, discuss with staff research interests, desire to attend conferences and dates, and plan the advanced off-site plan for continuing education. |
| Staff degree or certificate posted | Certificates can be posted above computer work stations. |
| Update personnel records. | Upload job descriptions, CV, resume, transcripts for foreign degrees, and continuing education certificates to your ARTC profile. |
| Update Organization Chart | There must be an organizational chart for the laboratory, or a narrative description that describes the reporting relationships among the laboratory’s owner or management, the laboratory director, section director(s)/technical supervisor(s), technical consultant(s), clinical consultant(s), and supervisor(s)/general supervisor(s), as appropriate. |
| Order Holiday or World Embryologist Day Gifts | Great gifts for embryologists can be found here, here and here! |
| Plan Holiday Party | Where will your team celebrate the years achievements and accomplishments, and bond together outside of work? A restaurant, bar, or park? |
CLIA regulations require laboratories to participate in some form of proficiency testing (PT) for every test that they perform on patient specimens at an interval of not less than twice per year. Accrediting agencies may have their own PT requirements for non-diagnostic tests or services such as those provided by the Embryology laboratory. Examples of testing that requires a minimum of an alternative assessment (not external PT) include sperm morphology, sperm motility, sperm choice for ICSI, where to nick a sperm tail and all embryology procedures/tests; oocyte maturity, fertilization check, day 3 grading, day 3 hatching, blastocyst grading, decision to freeze, decision to biopsy, decision to transfer or thaw another among others.
ART Compass provides HIPAA-compliant ways to assess the clinical decision making of ART laboratory staff for andrology and embryology competency. The competency assessment modules provide standardized instructions to test-takers and can be used to measure inter and intra- technologist variability between embryologists. Competency assessment surveys have been designed to allow the ART/ IVF laboratory director to gain insight into the clinical decision making of the most senior staff and compare that to junior staff members. For example, for choice of sperm for ICSI, or top choice of embryo for cryopreservation, biopsy, and transfer, and inform the key performance indicators (KPIs) used to continuously monitor and assess culture conditions. Mobile application technology was designed to allow standardized specimens to be served to each technologist at each study site simultaneously, allowing even very small IVF clinics to compare an individual technician’s values to the mean of all technicians and to technicians in a central laboratory. Test pictures, videos, and written test questions are randomly refreshed from a large database of multimedia files to eliminate bias.
Current assessments methodologies are extremely limited, perhaps to just one cleavage stage embryo and one blastocyst image every 6 months, and they cannot be customized to a lab’s own grading system or clinical question(s) of interest to that particular lab. ART Compass assessments are unlimited and completely customizable- from the images to the buttons to the test directions and the pre-test video can deliver learning content or instructions and demonstrations. They have also been validated and you can read more in JARG and Human Reproduction.
ART Compass Features
The mobile app documents ALL aspects of laboratory information assessment, not just for embryos and sperm but including; basic lab, continuing education, biohazard safety, handwashing, color vision, and FDA regulations among many others. ART Compass provides standard forms used by all employees. It documents competency assessment records, time and date stamps results, and is completely confidential. These records become part of the laboratory’s quality documents, and can be periodically reviewed and used for continuous improvement and quality assurance.
| WHO Competency Assessment Procedure Recommendations | ART Compass Features |
| The assessor contacts the employee in advance to inform her/ him that the assessment will be done at a prearranged time. | Push notifications, employee dashboard, application inbox. |
| The assessment can be done while the employee is performing tasks using routine sample images. | Smart-phone design allows for integration into daily work flow. Multimedia image and video databases eliminate bias and are more similar to routine sample analysis. |
| The assessment is done by a specified method previously described and is recorded in a digital “logbook.” | Standardized test protocols and check for understanding modules. A digital record is permanently saved to the administrator console and displayed in director and technologist dashboards. |
| The results of the assessment are shared with the employee. | Technologist dashboard |
| A remedial action plan is developed defining required retraining. | The app communicates specific steps to be taken to correct the problem with related deadlines, date and time stamped, through the inbox. For example, the employee may need an updated version of the standard operating protocol (SOP). |
| The employee is asked to acknowledge the assessment, related action plan, and reassessment. | Inbox records the interaction and response and date and time stamps it. Tests attempted, completed and passed, or tests to be re-attempted are prominently displayed through badges on the technologist dashboard. |
Additionally, pictures, videos, and written test questions are randomly refreshed every month from a large database of multimedia files to eliminate bias (being familiar with images and expected answers for example) for an ART laboratory’s quality assurance plan.
Evaluating and documenting competency of personnel responsible for testing is required at least semiannually during the first year the individual tests patient specimens, and at least annually thereafter. Competency assessment must be performed for testing personnel for each test that the individual is approved by the laboratory director to perform. The following six (6) procedures are the minimal CLIA regulatory requirements for assessment of competency for all personnel performing laboratory testing.
| CLIA Requirements | ART Compass Annual Procedure Evaluation |
| Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. | Observation of Performance |
| Monitoring the recording and reporting of test results | Test Report Completion |
| Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records | QC/PT/PM Records |
| Direct observations of performance of instrument maintenance and function checks | Instrument Maintenance |
| Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples | Peer Assessment |
| Assessment of problem solving skills | Problem Solving |
September is a great time to perform an FDA Compliance quality assurance audit in your IVF Lab! Visit the IVF Lab Playbook.
| 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 and ICSI have many similarities. However, the differences between them are very important. This post is dedicated to defining the differences between IVF and ICSI.
The introduction of intracytoplasmic sperm injection (ICSI) has resulted in a choice of fertilization methods between conventional in vitro fertilization by insemination (IVF) and fertilization by ICSI. Fertilization by insemination relies on the normal healthy functions of the sperm, and those can be bypassed by injection directly into the oocyte. Severe oligospermia (low sperm concentration), asthenozoospermia (low motility), or teratozoospermia (abnormal morphology) are all good reasons to use ICSI. However, many clinics routinely use 100% ICSI no matter what the diagnosis is. In the case of IVF, unexpected complete fertilization failure (CFF) in an individual cycle is a well-known phenomenon and is a risk to the success of IVF cycles. There are two techniques used to fertilize eggs during IVF: conventional insemination (simply referred to as IVF) or intra-cytoplasmic sperm injection (ICSI).
Before a man’s sperm can fertilize a woman’s egg, the head of the sperm must attach to the outside of the egg. Once attached, the sperm pushes through the outer layer to the inside of the egg (cytoplasm), where fertilization takes place.
Sometimes the sperm cannot penetrate the outer layer, for a variety of reasons. The egg’s outer layer may be thick or hard to penetrate or the sperm may be unable to swim. In these cases, a procedure called intracytoplasmic sperm injection (ICSI) can be done along with in vitro fertilization (IVF) to help fertilize the egg. During ICSI, a single sperm is injected directly into the cytoplasm of the egg.
Conventional Insemination:
In this technique, a woman’s eggs are surrounded by sperm in a petri-dish and ultimately one sperm fertilizes the egg. Conventional insemination (IVF) largely recreates the “best sperm wins” dynamic of natural conception. The fear with IVF is that in 10 – 15% of cases, patients experience total fertilization failure (TFF) where none of their eggs fertilize. That seldom happens with ICSI. Performing PGT after IVF is not recommended. Additionally, the embryologist will not know how many eggs were mature at the time of retrieval, or what their quality was.
ICSI:
In this technique an embryologist selects a single sperm from a man’s semen sample and injects it directly into the egg. The chief issue with ICSI is that this microsurgery costs an additional $1,500 – $3,000, can only be performed on “mature eggs” (ruling out ~20% of eggs that are retrieved), 5 – 15% of eggs are damaged in the process, success rates vary by embryologist.
ICSI is used in 90% of IVF cases that involve male factor infertility (issues with the man’s sperm count or motility) and 60% of cases that don’t.
Apart from the way the sperm is introduced to the egg, there are not too many other differences. The egg retrieval and the monitoring of the embryo remain the same. The transfer of the embryo does as well. The success rates for ICSI (50-80%) are higher than IVF without ICSI (50%). This does not however represent the pregnancy rates which are slightly higher for IVF without ICSI (27% vs. 24%). Live birth and birth defect rates have been reported to be quite similar between the methods.
ICSI Vs PICSI
Before a man’s sperm can fertilize a woman’s egg, the head of the sperm must attach to the outside of the egg. Once attached, the sperm pushes through the outer layer to the inside of the egg (cytoplasm), where fertilization takes place.
Sometimes the sperm cannot penetrate the outer layer, for a variety of reasons. The egg’s outer layer may be thick or hard to penetrate or the sperm may be unable to swim. In these cases, a procedure called intracytoplasmic sperm injection (ICSI) can be done along with in vitro fertilization (IVF) to help fertilize the egg. During ICSI, a single sperm is injected directly into the cytoplasm of the egg.
Why would I need ICSI?
ICSI helps to overcome fertility problems, such as:
-The male partner produces too few sperm to do artificial insemination (intrauterine insemination [IUI]) or IVF.
-The sperm may not move in a normal fashion.
-The sperm may have trouble attaching to the egg.
-A blockage in the male reproductive tract may keep sperm from getting out.
-Eggs that did not fertilize by traditional IVF, regardless of the condition of the sperm.
–In vitro matured eggs are being used.
-Previously frozen eggs are being used.
Will ICSI work?
ICSI fertilizes 50% to 80% of eggs. But the following problems may occur during or after the ICSI process:
Some or all of the eggs may be damaged.
The egg might not grow into an embryo even after it is injected with sperm.
The embryo may stop growing.
Once fertilization takes place, a couple’s chance of giving birth to a single baby, twins, or triplets is the same if they have IVF with or without ICSI.
ICSI was developed for men with poor sperm quality and quantity. Low sperm count, sperm motility, and abnormal morphology can be indications for ICSI. Abnormal morphology (shape of sperm) has been linked to poor fertilization. Fertilization can now be achieved for men where it previously seemed impossible. It is now used exclusively in some clinics, and it is especially important for couples who want to have their embryos genetically tested.
One of the reasons why it is so widely used now is so that the embryologists can look at the eggs and know the quality and maturation right after the egg retrieval. In conventional IVF, the egg quality and maturity is essentially a mystery because the eggs are surrounded by cells until the day after the fertilization. Fertilization rates are generally higher after ICSI compared to conventional IVF. The more embryos you have the better the chance of pregnancy!
One variation of ICSI is called “PICSI” which stands for physiological ICSI, and uses a specialized dish coated in a substance called hyaluronan. Healthy sperm are attracted to that enzyme and stick to it, they are later used to inject the egg with.
What if your IVF Lab does ICSI, But you want to try conventional IVF?
It’s in your best interest to do what the clinic does 99% of the time and not try to be one successful person on a procedure they do 1% of the time. Clinics have switched to ICSI for very very good reasons. It increases our patients success rates. It decreases chances of contaminating DNA from sperm during PGT. The embryologist will be able to examine and inject the nicest looking sperm. Think about it this way, you are preparing for the “Olympics” of baby making. We want to do anything in our power to shave 1 second off your timing so you can WIN the gold. A take home baby as quickly as possible.
Veering from the established standard of care for a lab (any lab) introduces another possibility to the mix; one of them making an error.
Why are you hesitating? Some people want it to be as natural as possible, but that’s not a good reason. Everything about the lab environment is not natural. Yes, fertilization failures do happen. This is not the thing to leave to chance, as you will get more than enough of that after the embryo is transferred back to your uterus. Allow the lab to do the procedures that give the highest success rates.
Anxiety and Mood Swings Life’s challenges are part of the human condition and yet none are immune from the ravages of existence. They arise for reasons you cannot comprehend and leave you feeling like a wounded bird, with broken wings. Is anxiety associated with IVF? Does IVF cause anxiety? Are there certain medications that cause anxiety? ALL those answers can be found in our blog post today!
Anxiety and Mood Swings? Stress, pre-existing depression, and anxiety from not being able to fall pregnant, combined with hormone therapy, invasive time-consuming tests and procedures, and complicated medication schedules all contribute to the stress and anxiety we feel undergoing IVF. While there have been numerous studies documenting the psychological burden of fertility treatment, there have only been a few studies specifically investigating the role of hormones during ovulation induction.
Infertility is often a silent struggle. Patients who are struggling to conceive report feelings of depression, anxiety, isolation, and loss of control. Depression levels in patients with infertility have been compared with patients who have been diagnosed with increased cancer risk. It is estimated that 1 in 8 couples (or 12% of married women) have trouble getting pregnant or sustaining a pregnancy.
Despite the prevalence of infertility, the majority of infertile women do not share their stories with family or friends, thus increasing their psychological vulnerability. The inability to reproduce naturally can cause feelings of shame, guilt, and low self-esteem. These negative feelings may lead to varying degrees of depression, anxiety, distress, and a poor quality of life. There are science backed ways to improve these feelings, and mindfulness and meditation are proven strategies to help!
Patients who undergo assisted reproductive treatment (ART) are at significant risk of experiencing psychiatric disorders and it is important to recognize, acknowledge, and assist our patients as they cope with their infertility diagnosis and treatment.
Gonadotropin-releasing hormone agonists suppress a woman’s menstrual cycle, effectively causing menopause. GnRH agonists have been associated with depression in women who are taking it to treat endometriosis. A more recent study of the effect of GnRH agonists on mood during its use for ovulation induction did not show an increase in depression. In a study of the effect of clomiphene citrate and human menopausal gonadotropin (stimulates follicle growth), both have been shown to be associated with significant mood symptoms.
Despite many efforts to break the silence on infertility and pregnancy loss, fertility and miscarriage remain taboo subjects.
Those suffering don’t share their experiences with others. Non-members of the infertility-and-loss club don’t know how to react or what to do when they are told of a friend’s struggle. Some honestly are uncomfortable hearing about it at all.
The stigma is strong. Why? With 1 in 8 couples experiencing infertility– and up to 25 percent of pregnancies ending in miscarriage – why as a society are we so uncomfortable discussing these relatively common life events?
Most causes of infertility and miscarriage are not under the direct control of a couple. However, even when a person knows this, the nagging feeling that “this is all my fault” pulls at them.
Shame can only survive in dark corners.
It’s time we break the silence on infertility (miscarriage!). It’s time we stop feeling ashamed of medical problems over which we have little control.
De-stress
Take care of yourself to lower stress levels, which appears to increase fertility treatment success.
Most forms of self care focus on a healthier body, which directly translates to a healthier reproductive system.
Focus on what you can do. Live. Right now. Every day. Don’t make this all about the wait. Make it about you.
Anxiety and Mood Swings, Meditation, and other forms of mindfulness are known to stress relievers, and those who practice mindfulness on a regular basis report being more content, balanced, and physically healthier.
Scheduling a telehealth appointment with a fertility doctor may be easier than ever before. You may be able to explore some deeper queries that may arise such as donor eggs, sperm, using a gestational surrogate.
Shove the journal articles aside, unplug from the treadmill of infertility and fertility treatment research, tips and information – and enjoy something mindless for a change- magazine or novels!
Take a good walk or hike: Researchers have found spending time outdoors – even just 10 to 15 minutes in a green space or with a view of the trees/landscape immediately decreases stress and anxiety and mood swings, revives dulled minds, and boosts the immune system.
You know that exercising keeps you healthy. It makes you strong and helps you stay in shape. But it also improves your mood and your sleep. It reduces stress and anxiety and mood swings. It helps your brain to function better.
Infertility Warriors, of all people, need a functioning brain. For all the reasons listed above. That’s why you need to move your physical body in this period of waiting. Not too much, not too little.
If you are following the guidance about things that will put your body in its optimum state to get pregnant — your weight, foods to avoid/eat, cut down/stop drinking alcohol and smoking, cut back on caffeine and take vitamins — you may have a hard time finding ways to treat yourself during your journey.
Find some small and special treats that won’t throw off your fertility diet goals- a single macaron, a decadent dark chocolate.
Spend time with friends that lift you up and spend time together as a couple.
Although it may feel like infertility has taken over your life, it doesn’t define you or your achievements in life. You are amazing and strong!
Struggling with infertility can be an extremely lonely process. A lot of people struggling don’t tell friends or family, but it is so important to get support from somewhere. Infertility can leave you questioning everything — your future, your relationship, and most crucially your mental health.
Talking through your thoughts with someone who understands will help validate your feelings and make you feel less alone. It will also help you see more clearly to be able to take positive action to change how you feel and increase your chances of getting pregnant.
Research has found that feelings of depression and anxiety peak around three years post-infertility diagnosis. However, six years post-diagnosis, couples are feeling stronger, and depression and anxiety symptoms lessen.
Bromelain to Brazil Nuts- IVF Myths
IVF Myth No. 1: Eating pineapple core for five days after embryo transfer can up one’s chances of conception.
The fruit contains bromelain, an enzyme with anti-inflammatory, anticoagulant and blood-thinning properties. Much of the bromelain is concentrated in the core. There are a lot of stories about pineapple’s effectiveness, but not a lot of data backing it up. Some fertility doctors prescribe low-dose baby aspirin — also a blood thinner — to help improve blood flow to the uterus, so the idea is that pineapples could mimic that effect.
IVF myth No. 2: Eating Brazil nuts during the two-week wait can lead to a healthy pregnancy.
Brazil nuts are packed with selenium. One study (published in the journal Metallomics) found that selenium helps promote healthy egg follicles in female cows, and that same study also found that levels of GPX-1 (a protein found in selenium) were much higher in women who got pregnant after a single embryo transfer.
However, too much selenium can be toxic, so stay within the recommended daily allowance typically just 55 micrograms, with the highest maximum amount being 400 micrograms daily.
Gestational Carriers
What is a gestational carrier? A gestational carrier (GC), is not the same as a surrogate. A surrogate is someone who donates her egg and then subsequently carries the child; she is genetically linked to that baby. Today, such cases of true surrogacy are very rare. In the case of a gestational carrier, the woman carrying the pregnancy is in no way biologically related to the child she is carrying; the eggs and sperm are derived from the “intended parents” (or possibly an egg or sperm donor), through the process of In Vitro Fertilization (IVF). The egg is fertilized in the lab, and then the embryo (or embryos) is placed into the uterus of the gestational carrier.
– Absent uterus, either congenital, which means you were born with, or from surgery.
– Abnormalities of the uterus such as severe intrauterine scarring from Asherman’s syndrome or multiple benign tumors of the uterus called fibroids
– If carrying a pregnancy is too risky where the woman or baby’s life would be in danger (Turner’s Syndrome, or pulmonary hypertension, for example).
Other circumstances to use a GC include a single male, or in the LGBTQ population of a gay male couple, or single transgender female. Lastly, there may be a strong consideration for a GC if the woman has undergone multiple uterine surgeries for example, fibroid tumors, and also cesarean sections, where the uterine muscle may be weakened to result in complications near the end of the pregnancy as well as when recurrent miscarriage is unexplained following a thorough evaluation and multiple treatments.
According to the American Society for Reproductive Medicine, 859 surrogacy and gestational carrier cycles were performed in the United States in 2010.
Have you ever wondered how The Development of IVF came to be? When certain discoveries took place? In this post, we’ve included some of the milestones that were reached during the process of developing IVF! It’s important to appreciate the hard work of countless scientists across the field who made this happen.
Image by Sarah Pflug
The Development of IVF, Can you believe there was a time prior to the 1800s when we did not know what cells were involved in reproduction? We did not know that a sperm and an egg are required to fuse, forming a zygote that will continue to divide until it becomes an embryo, a fetus, and then a full-grown baby. After the discovery of microscopic sperm and eggs, our whole view of reproductive health changed. We started to explore the causes of miscarriages and infertility, and a multitude of scientific endeavors manipulating eggs, sperm and embryos in the lab followed.
One of the first assisted reproductive acts that were performed in the 1800s was artificial insemination. It ended in a miscarriage, but another attempt at insemination quickly followed, but this time donor sperm was used. Something to note here is that the couple opting for the insemination was not notified of the use of donor sperm. Such a lack of transparency is unthinkable in today’s infertility medicine.
Then came some girl power! In the 1900s Miriam Menkin, a scientist in Dr. Rock’s lab made a serendipitous discovery that ultimately led to the success of Development IVF. She had finally stumbled across the fusion of a sperm and egg outside the human body, a discovery would have been undoubtedly delayed without her. By 1978 the world finally had its first-ever successful IVF pregnancy. The 1980s had more scientific endeavors in store for the world as well. Ovarian stimulation was a significant discovery.
Being able to control the ovaries to produce eggs just at the right time for collection, was a game-changer. There was a shift from using human chorionic gonadotropin (hCG) to using gonadotropin-releasing hormone and GnRH antagonists which allowed for more control over stimulating oocytes. This, however, also led to the discovery of ovarian hyperstimulation syndrome, which is a side effect of excessive stimulation of the ovaries that can lead to renal failure and possibly even death. This may potentially be the result of the follicles as once they are in the body, they could produce high levels of estradiol. After this realization, physicians now monitor follicles after they have been stimulated and patients are continually checked to know if they are at high risk for developing OHSS.
Infertility clinics, one of the pivotal aspects of fertility care, were also created in the 1900s. It’s crazy to imagine a time where if a couple was struggling with infertility, there was not necessarily a place to go for help. Another crucial piece of the puzzle was our understanding of the importance of embryo culture. Ensuring that your embabies are growing in a healthy and safe environment matters! That is why developing the perfect medium for them to grow in is essential for their wellbeing. Sugars, growth factors, and amino acids are examples of what are found in this medium that supports the embryo during it’s critical initial developmental stages.
Today’s reproductive health looks a lot different from decades ago. Today we have preimplantation genetic testing (PGT) to find out whether an embryo has a genetic defect that might affect its ability to survive in the uterus or lead to health conditions once the embryo is a full-grown baby. This is done by removing a small number of cells from the trophectoderm of the blastocyst (Ie. the outer layer of cells of the blastocyst).
The DNA of those few cells is then multiplied to have a large enough sample of genetic material to “read” and then it is analyzed by genetic sequencing! Another development we have been able to make is to reduce the likelihood of multiple births. We realized that transferring one embryo decreases the chances of having multiple babies. Embryo grading systems are used in combination with PGT to know which embryos have a high chance of surviving in the womb. Embryos with the best chances of establishing a pregnancy will be transferred first.
The development of IVF is just a few of the discoveries and achievements in the field of reproductive medicine. There are a lot more, especially female scientists, that were essential to getting to where we are today. We can only hope that we continue to grow as a field and do our best to ensure infertile couples receive the treatment they desire and can finally hold their baby in their arms. Embryologists and medical professionals all across the field of reproductive medicine work to give parents that one beautiful moment that every mother and father dream of.
References:
Eskew, Ashley M, and Emily S Jungheim. “A History of Developments to Improve in vitro Fertilization.” Missouri medicine vol. 114,3 (2017): 156-159.
“The birth and history of IVF.” RMA Network