1. Culture Systems: Stability, Flexibility and Workflow Integration

A robust culture system should allow clinics to maintain uninterrupted environmental control from oocyte retrieval all the way through blastocyst development. Consistent temperature, pH and low-oxygen gas environment remain foundational, but leading labs prioritise now also modularity and reduced dish handling.

When evaluating culture systems, embryologists look for:

• Minimal lid-opening events
• Small independent chambers
• Options for both standard and time-lapse culture
• Compatibility with validated media systems and dish formats

Genea Biomedx’s GERI system, especially when used with GEMS culture medium suite, is a good example of a system built for workflow logic—optimised to reduce variability while keeping handling simple for embryologists.

2. Benchtop Incubators: Why Mini Chambers Are Becoming the Standard

Gone are the days when large box incubators dominated the IVF lab. Today, the preferred IVF incubator is typically a benchtop incubator with small-volume chambers with fast recovery and minimal cross-patient interference.

Key advantages of modern benchtop IVF incubators include:

• Faster temperature and gas recovery
• Reduced contamination risk
• Individualised environments for patients’ embryos
• Improved workflow efficiency

Whether clinics are choosing a compact benchtop system or a more advanced platform, the priority should always be maintaining stability during peak activity times—especially important for high-volume labs.

3. Multi-Room Incubators: Scaling Without Compromise

A multiroom incubator offers a compromise between large box incubators and small benchtop incubators: multiple isolated chambers in one instrument footprint. This design gives embryologists the flexibility to work on individual patients without disturbing others.

Clinics may consider a multi-room system if their lab:

• Handles a high patient volume
• Needs backup chambers for risk mitigation
• Prefers a standardised environment across multiple modules

Systems like the Geri® incubator from Genea Biomedx exemplify this concept—each patient’s embryos have their own completely isolated chamber, reducing disturbance while supporting individualised culture.

4. Time-Lapse Incubators: Insight Without Interruption

Time-lapse incubators have reshaped modern embryology—not just by providing continuous imaging, but by eliminating the need to repeatedly remove embryos from culture for observation. When paired with built-in advanced embryo assessment options, including validated algorithms and AI solutions, time-lapse systems can support more objective embryo assessment and improved decision-making.

When evaluating a time-lapse platform, clinics should consider:

• Image quality and frame rate
• Image capture interval
• Number and adjustability of focal planes
• Chamber design—are each patient’s embryos isolated?
• Culture conditions – dry or humid or both
• Integrated morphokinetic and other annotation tools
• Data storage, export and reporting options
• AI-compatibility – whether bound to one system or offering flexibility to choose from the growing selection of options
• Ease of use during busy clinical cycles

The Geri® time-lapse incubator is a good example of a patient-centric device, combining uninterrupted culture with real-time imaging inside six fully independent micro-environments.

 

5. Matching Equipment to The Laboratory Goals

As embryologists assess their future equipment, they should take a step back and consider their lab’s objectives:

If they want to enhance embryo culture stability
→ Prioritise multi-chamber IVF incubators and low-disturbance culture systems.

If they are scaling up or standardising a larger clinic
→ A modular multiroom incubator allows predictable expansion with low operational variance.

If their goal is to improve selection accuracy and documentation
→ A time-lapse incubator will give deeper real-time insights without compromising culture conditions.

If they want streamlined, integrated workflows
→ Systems like Genea Biomedx’s Geri (for incubation) and GEMS (for media) can reduce variability and simplify day-to-day tasks.

Final Thoughts

• Choosing the right IVF equipment isn’t just about specs—it’s about aligning technology with the lab’s philosophy, workflow and patient load. Whether clinics are evaluating culture systems, upgrading IVF incubators or considering a shift to time-lapse technology, the best systems are those that support consistent, stable and patient-specific embryo care.

The post Choosing the Right Embryo Culture Incubator appeared first on Genea Biomedx.

In IVF (in vitro fertilisation), success begins at the very first step: your eggs. While much attention is placed on fertilisation and embryo development, one of the most critical factors influencing IVF success happens earlier—ensuring that the eggs retrieved are mature. But what exactly does it mean for an egg to be “mature,” and why is this so important? 

Let’s explore the science of egg maturity, from the early stages in your ovaries to their preparation in the lab. 

1. Not All Eggs Are Created Equal: Understanding Oocyte Stages 

Human eggs, known as oocytes, develop within fluid-filled sacs in the ovaries called follicles. As follicles grow, the oocytes inside undergo several key developmental stages. By the time of egg retrieval, each oocyte will be at one of the following stages: 

Germinal Vesicle (GV): 
These are immature oocytes, with a visible nucleus. They haven’t completed the necessary steps for fertilisation and are not viable for use in IVF. 

Metaphase I (MI): 
These oocytes are partway through maturation but haven’t completed meiosis. While they show some progress, MI eggs are still not ready to be fertilised. 

Metaphase II (MII): 
This is the gold standard in IVF. MII oocytes have completed the necessary cellular processes and are now ready to be fertilised by sperm. 

Only MII-stage oocytes can be fertilised successfully and go on to develop into viable embryos. That’s why achieving maturity is the key focus for both clinicians and embryologists throughout the IVF cycle. 

2. Ovarian Stimulation: Encouraging Multiple Eggs to Grow 

In a natural menstrual cycle, typically only one follicle matures and releases a single egg during ovulation. However, in IVF, the goal is to collect multiple eggs in one cycle to improve the chances of success. This is achieved through controlled ovarian stimulation using injectable gonadotrophins, such as FSH (follicle-stimulating hormone) and LH (luteinising hormone). 

Over the course of 8–14 days, hormone injections encourage the growth of multiple follicles. Your fertility team closely monitors the process with:

Transvaginal ultrasound scans to measure follicle growth 

Blood hormone tests, particularly estradiol (E2), which rises as follicles develop 

Once the follicles reach optimal size—usually around 18–22 mm—a final injection (commonly known as the trigger shot) is given. This prompt mimics the natural LH surge and helps the oocytes complete the final stage of maturation in preparation for retrieval. 

 

3. Egg Retrieval (Ovum Pick-Up)   

Exactly 36 hours after the trigger shot, the egg retrieval (also called ovum pick-up or OPU) is performed. This is a minor surgical procedure done under sedation, typically taking around 15–30 minutes. 

A thin needle is guided through the vaginal wall into each follicle using ultrasound guidance, allowing the clinician to aspirate the fluid and, hopefully, retrieve the oocyte within. 

However, it’s important to remember that not all retrieved oocytes will be mature. That’s where the embryologists step in. 

4. Denudation: Revealing the Egg’s True Stage 

Once the eggs are collected, they arrive in the embryology lab surrounded by cumulus cells—a cloud-like cluster of cells that protect and nourish the oocyte during development. To assess each egg’s stage of maturity, the embryology team performs a process called denudation. 

Using gentle enzymatic treatment and microscopic tools, the cumulus cells are removed so the egg’s structure becomes fully visible. This allows the embryologist to determine whether the oocyte is in the GV, MI, or MII stage. 

Only MII oocytes—those that have completed meiosis I and extruded the first polar body—are selected for fertilisation, typically through ICSI (intracytoplasmic sperm injection).  

If conventional IVF is chosen instead, the denudation process is not performed; instead, natural selection determines whether a sperm cell can successfully fertilise the oocyte within the droplet containing the cumulus cells. On the following day, during the fertilisation check, embryologists assess which oocytes have fertilised correctly. For those that have not, the exact reason often remains unknown—though one possible explanation is that the oocyte was not mature at the time of insemination. 

 

5. Why Egg Maturity Matters in IVF 

Egg maturity plays a crucial role in determining the outcome of your IVF cycle. Here’s why: 

Only mature (MII) eggs can be fertilised by sperm. GV and MI oocytes are biologically incapable of normal fertilisation. 

Higher maturity rates improve embryo development rates. The more MII eggs retrieved, the greater your chances of producing high-quality embryos. 

Immature eggs may arrest or develop abnormally. Even if immature eggs are injected with sperm, they rarely develop into viable embryos. 

This is why embryologists place such importance on accurately identifying and selecting mature eggs. Each mature egg is a potential step closer to creating an embryo—and ultimately, achieving a pregnancy.

6. Can Immature Eggs Ever Be Used? 

In some cases, immature oocytes may be placed in culture media to see if they mature in the lab, a process called in vitro maturation (IVM). However, this technique has lower success rates and is not routinely used in standard IVF cycles. 

For most patients, focusing on optimising ovarian stimulation and timing egg retrieval correctly remains the most effective way to maximise the number of mature eggs available. 

 

Summary: It’s Not Just About Quantity—It’s About Quality 

• After egg retrieval, you may hear a number: “We collected 12 eggs.” But the more important figure is how many of those were mature (MII). Why? Because only mature eggs have the potential to become embryos—and ultimately, a baby. 
• By understanding the stages of oocyte development and the steps taken to assess maturity, you can better appreciate the science and precision behind your IVF journey. 
• At every stage—from your ovaries to the lab—egg maturity is a defining factor in IVF success. 

The post From Ovaries to the Lab — Understanding Egg Maturity in IVF  appeared first on Genea Biomedx.

Embryology as a discipline has transformed dramatically with the development of increasingly sophisticated technologies, the emergence of IVF solution and equipment commercial manufacturers, automation and technological advancements. These developments have reshaped the daily work lives of embryologists. Here’s a brief overview of how this role has developed over the years and how the daily work has changed over the years.  

1978-1980s: The Pioneering Era  

Pioneering work by Patrick Steptoe, Robert Edwards and Jean Purdy: Studies leading to the birth of Louise Brown in 1978 marked the beginning of a new era in reproductive medicine. The success of this procedure was due to the pioneering work of embryologists like Jean Purdy, who is considered one of the first embryologists. 

Early Techniques: In the early days, embryologists focused on refining the basic techniques of IVF including egg retrieval, fertilisation, and embryo culture. The procedures were labour-intensive, often including also preparation of necessary tools and solutions, as there were no commercial suppliers of IVF products.  

1990s: Technological Advancements  

Introduction of ICSI: The 1990s saw the introduction of micromanipulation techniques including intracytoplasmic sperm injection (ICSI), a technique where a single sperm is injected directly into an egg. This advancement required embryologists to develop new skills, but improved success rates for male infertility significantly. 

Cryopreservation: Advances in cryopreservation techniques by slow freezing allowed for the freezing and storage of embryos, which provided more flexibility in IVF treatments and increased the chances of successful pregnancies. This, too, require

 

2000s: Enhanced Culture Systems and Genetic Screening  

Improved Culture Media and Incubators: The development of advanced culture media and benchtop incubators improved the quality of embryo culture, leading to higher success rates. These were accompanied by the emergence of suppliers of standardised, ready-made solutions, removing the need for in-house media manufacturing of media, as well as suppliers of specialised IVF incubators. . 

Preimplantation Genetic Diagnosis (PGD): Embryologists began using PGD to screen embryos for genetic disorders before implantation, which helped in preventing hereditary diseases. The required embryo biopsy techniques introduced yet another skill requirement for IVF embryologists. 

Vitrification: Improved gamete and embryo cryopreservation by vitrification improved success rates but also introduced a new and challenging manual process to the lab, leading to increased demand of highly skilled embryologists.  

2010s-Present: Integration of AI and Advanced Imaging 

Artificial Intelligence: The integration of AI in embryology is revolutionising the field by its promise of automated and standardised data and image analyses. AI algorithms and software solutions can now be used to assess embryo quality and predict implantation success, making the process more efficient and consistent

Time-Lapse Imaging: Advanced imaging technologies, such as time-lapse microscopy, allow embryologists to monitor embryo development continuously without disturbing embryo culture.  

 

Modern Role 

Today, embryologists are integral to fertility clinics, handling gametes (eggs and sperm), performing IVF procedures, monitoring embryo development and interacting with the patients. Their work involves a blend of scientific knowledge, technical skills and empathy, as they help individuals and couples achieve their dreams of parenthood. Despite some of the new technologies seemingly reducing the workload and skills requirements of embryologists, their role continues to be integral. Some of the advantages of recent developments lie in allowing embryologists to focus on tasks requiring human touch while relieving them from routine and monotonous tasks. 

Embryologists’ everyday work practices have been shaped significantly by modern technologies, and this trend is likely to continue as these technologies are adopted more widely and developed further. Some comparisons of the past and present changed work practices include: 

Before Automation: The Manual Era

• Embryo Observation: Embryologists checked embryos manually under a microscope at specific intervals, briefly exposing them to external conditions.  
• Big Box Incubators: Labs relied on traditional incubators with one big temperature and gas-controlled chamber where several patients’ embryos were cultured together, causing exposure to external elements at every door opening.  
• Embryo Selection: Decisions were based on a visual snapshot of embryo development at times fitting laboratory workflow and daily routines. This provided minimal and subjective information, making it harder to predict which embryos were the best ones for implantation.  
• Data Recording: All observations and results were recorded manually and logged by hand, resulting in vast quantities of paper-based documentation with limited accessibility beyond its storage location.   
• Witnessing: Manually double witnessing of procedures requires the presence of minimum of two embryologists in the lab at all times. It caused many interruptions to the embryologists’ workflows increasing the risk of human error.  

Before Automation: The Manual Era

• Time-lapse Incubators: Continuous monitoring and recording of embryo development allows embryologists to track embryo development throughout their culture period without disturbing them. More information leads to better decision making.  
• Stable Environment: While providing more information, timelapse incubators maintain optimal gas, humidity and temperature environment without disturbances, reducing stress on embryos.  
• AI-Assisted Embryo Selection: Artificial intelligence allows embryo assessment in repeatable and consistent manner, helping to identify the most viable embryos based on developmental patterns.  
• Digital Data Management: Daily laboratory operations, observations and results are recorded electronically, streamlining workflow and minimising mistakes, and maintaining an accessible record for auditing, KPI tracking, traceability and research purposes.  
• Witnessing: Unbiased electronic witnessing allows double witnessing to occur without interrupting another embryologist, and provides an unbroken chain of traceability of all steps of any given process. 
• Reduced Burnout: Automation alleviates repetitive tasks, allowing embryologists to focus on complex procedures and patient care.  

Impact of Changing Work Practices on IVF Success Rates  

• Improved Embryo Viability: Time-lapse imaging and AI-driven selection enhance implantation success.  
• More Efficient Workflow: Automation speeds up processes, reducing delays and increasing lab efficiency.  
• Reduction in Errors: Allows embryologist to focus on the science.  

Automation and technological advancements have revolutionized the science behind embryology, making IVF procedures more efficient and precise. These advancements have also reduced stress on both embryologists and the embryos they grow. 

The post Embryology: Then and Now   appeared first on Genea Biomedx.

What is Culture Media? 

Embryo culture media is a specially formulated aqueous solution designed to support the growth and early development of embryos in the laboratory during IVF procedures until they are ready to be transferred to the uterus. It mimics the natural conditions of the female reproductive tract by providing essential nutrients, energy sources, and an optimal balance of pH and osmolality to sustain embryo viability. 

Culture media typically contain: 

• – Carbohydrates (e.g. glucose, lactate, pyruvate) to provide energy. 
• – Amino acids to support protein synthesis and cell function. 
• – A pH buffer to regulate the acidity of the media. 
• – Osmotic regulators to maintain a stable environment. 
• – Other optional components, such as antioxidants to reduce oxidative stress (included in the formulation of the Gems culture media Genea Biomedx). 

The Role of Culture Media in Embryo Development:

Embryo culture media serves as a surrogate environment that mimics the conditions of the female reproductive tract, providing essential nutrients, energy sources, and optimal pH and osmolality for embryo growth. Since early embryonic development is highly sensitive to external conditions, the composition of the media can influence embryo quality, implantation rates, and live birth outcomes. 

Historically, culture media have evolved from simple salt solutions designed for somatic cell culture to complex formulations that support embryos from fertilisation to the blastocyst stage. Modern culture media aim to balance embryo developmental needs while minimising stress and epigenetic modifications. 

Two primary approaches dominate modern IVF laboratories: sequential and one-step culture media. The choice between these approaches depends on various factors, including laboratory preferences, patient characteristics, and technological advancements. 

Sequential Culture Media: Characteristics and Advantages 

Sequential culture media systems use different formulations tailored to the changing needs of the embryo during its development. Typically, one type of medium supports early cleavage-stage embryos, from fertilisation until day 3, while a separate medium is used from that point onwards for blastocyst development. 

Advantages of Sequential Media: 

• Stage-Specific Nutrient Optimisation: Different media formulations can be optimised to match the specific metabolic needs of embryos at different stages. 
• Minimised Metabolic Stress: By providing fresh media partway through development, waste accumulation is reduced, and essential nutrients are replenished. 

Challenges of Sequential Media: 

• Frequent Handling: Media changes require additional handling, increasing the risk of temperature and pH fluctuations that could stress embryos. 
• Increased Labour and Cost: Sequential culture protocols are more labour-intensive and require additional media products, making them more expensive than one-step systems. 
• Potential for Human Error: Each media exchange introduces an opportunity for errors, contamination, or inconsistencies in embryo culture. 

One-Step Culture Media: Characteristics and Advantages 

One-step culture media, also known as single-step or continuous media, are designed to support embryo development from fertilisation to the blastocyst stage without media changes. These formulations contain all necessary nutrients, amino acids, and energy sources in a stable composition and at optimised concentrations, allowing uninterrupted culture. 

Advantages of One-Step Media: 

Reduced Handling and Stress: Since embryos remain undisturbed in the same medium throughout development, exposure to environmental stressors, such as temperature fluctuations and pH changes, is minimised. 

Stable Culture Conditions: Continuous culture provides a stable environment, which may help reduce stress-related developmental issues. 

Simplification of Laboratory Workflow: Eliminating media changes simplifies protocols, reduces labour intensity, and lowers the risk of contamination or errors. 

Potential for Time-Lapse Monitoring: One-step media are the perfect partner for time-lapse imaging systems, allowing non-invasive embryo assessment without the need for media exchange, providing a totally undisturbed culture. 

Challenges of One-Step Media: 

Accumulation of Metabolic By-Products: As embryos grow, they release waste products that can accumulate in static media, potentially affecting embryo development. 

Scientific Perspectives: Which System is Better? 

The debate over one-step versus sequential media remains active, with studies showing varying results depending on laboratory conditions, patient populations, and specific protocols. 

Evidence Supporting Sequential Media: 

Some research indicates that stage-specific culture conditions in sequential media may better mimic in vivo conditions, leading to higher-quality embryos and improved implantation rates. The ability to tailor nutrients and reduce metabolic waste accumulation can enhance embryo viability in some cases. 

Evidence Supporting One-Step Media: 

Other studies suggest that continuous culture in one-step media leads to comparable, if not improved, blastocyst formation rates and pregnancy outcomes compared to sequential media. The reduced handling and stable environment may benefit embryo development, particularly in automated systems using time-lapse imaging. 

Clinical Considerations and Laboratory Preferences 

The choice between sequential and one-step culture media often depends on: 

Laboratory Workflow: Labs equipped with time-lapse incubators may favour one-step media, while traditional setups may benefit from sequential media. 

Patient-Specific Factors: Some patient populations, such as those with poor embryo quality or advanced maternal age, may respond better to specific media formulations. 

Cost and Resource Availability: Budget constraints and laboratory expertise can influence media selection 

Conclusion: Finding the Best Approach 

Both sequential and one-step culture media have their respective advantages and challenges, and there is no universally superior option, as both can successfully support embryo development to the blastocyst stage. IVF laboratories must carefully evaluate their workflows, technological capabilities, and patient needs when selecting culture media. Ongoing research and advancements in embryo culture technology will continue to refine these choices, ultimately improving IVF success rates and patient outcomes. 

Given the lack of consensus on which is the better strategy, many companies offer both options in their portfolio, allowing customers to choose their preferred approach. For example, the Gems media suite by Genea Biomedx offers the Cleavage and Blastocyst Media for a sequential strategy and Geri Medium for continuous culture—specifically designed to be the perfect partner for the Geri incubator with an integrated embryo monitoring system. 

Regardless of the approach, optimising embryo culture conditions remains a cornerstone of IVF success, helping more families achieve their dreams of parenthood. 

The post Embryo Culture Media for IVF: Sequential vs. One-Step Media  appeared first on Genea Biomedx.

Vitrification plays a crucial role in fertility preservation, offering hope to individuals who may face fertility challenges in the future. For women undergoing cancer treatment, vitrification allows for the preservation of oocytes before chemotherapy or radiation therapy, which can harm reproductive cells. This gives cancer patients the opportunity to have biological children after their treatment. 

Vitrification is also beneficial for women who wish to delay childbearing for personal or medical reasons. By preserving their oocytes at a younger age, women can increase their chances of having a successful pregnancy later in life when their natural fertility may have declined. This option empowers women to take control of their reproductive future. 

Vitrification is a current rapid cryopreservation technique that is routinely used to store Human Oocytes, Cleavage Stage Embryos, and Blastocysts for future use. This procedure supports cell survival by preventing ice crystal formation within cells. The formation of ice crystal is damaging to the cellular ultra-structure by physically breaking the plasma membrane and organelles. The vitrification process removes all of the water within the oocyte, embryos or blastocysts, transforming the cells cytosol into a glass-like state. This method is widely used in IVF laboratories worldwide and has produced high survival rates and minimal cellular damage, successfully preserving human oocytes, cleavage stage embryos, and blastocysts. 

The Science Behind Vitrification 

The term “vitrification” comes from the Latin word “vitreum,” meaning glass. In the context of cryopreservation, vitrification refers to the transformation of a liquid into a solid glass-like state without forming ice crystals. This process involves two critical steps: the use of cryoprotectants and ultra-rapid cooling. 

Cryoprotectants are substances that protect biological tissue from freezing damage. There are two main types of cryoprotectants used in vitrification: permeating and non-permeating. Permeating cryoprotectants, such as imethyl sulfoxide (DMSO) and ethylene glycol, penetrate the cell membrane and replace water inside the cells. Non-permeating cryoprotectants, like sucrose and trehalose, stay outside the cells and help dehydrate them, reducing the amount of water available to form ice crystals. 

Ultra-rapid cooling cools embryos to -196 C temperature at cooling rates exceeding 10,000 C/minute. This is critical to ensure that embryos spend minimum time in the required highest concentration of cryoprotectants, which can be toxic for embryos if their exposure is prolonged beyond a minute. 

Vitrification in Clinical Practice 

Vitrification is widely used in fertility clinics around the world. It is a standard practice for ‘freezing’ or cryopreserving oocytes and embryos in IVF treatments. The technique has also been successfully applied to preserve ovarian tissue, which can be used for fertility preservation in cancer patients. 

The process of vitrification is highly standardised, with strict protocols in place to ensure the highest quality and safety of the preserved cells. Clinical embryologists undergo specialised training to master the technique and achieve consistent results. This standardisation has contributed to the widespread adoption and success of vitrification in ART. 

The vitrification and warming of oocytes and cleavage stage embryos involves several critical steps: 

1. 1) Incubation in Equilibration solution: The oocytes or embryos are first exposed to an equilibration solution containing cryoprotectants, which helps to dehydrate the cells and introduce intracellular protective agents. The equilibration process allows cryoprotectants to replace water inside the cells, preventing ice formation when the cells get to ‘freezing’ temperatures. The cells are typically placed in a series of solutions with increasing concentrations of cryoprotectants to gradually dehydrate them. 

2. 2) Incubation in Vitrification Solution: Once the cells are partially dehydrated, oocytes or embryos are moved to a solution with even higher concentration of cryoprotectants and loaded into cryodevices, for example straws, in a minimum amount of solution.  

3. 3) Rapid Cooling: The cryodevices are then quickly plunged into liquid nitrogen, the resulting ultra-rapid cooling rate ensuring that the cells turn into a glass-like solid without forming ice crystals. The entire process happens in a matter of seconds. 

4. 4) Storage: The vitrified oocytes or embryos are then stored in liquid nitrogen at -196°C. At this temperature, all metabolic processes stop, and the cells can remain viable for years. Specialised storage tanks are used to maintain the ultra-low temperatures and ensure the long-term viability of the cells. 

5. 5) Warming: When the vitrified oocytes or embryos are needed for use, they are rapidly warmed to avoid the formation of ice crystals during warming. In this process cryodevice containing oocytes or embryos is removed from liquid nitrogen, opened and the section containing the oocyte or embryo is plunged into a warm (+37 C) warming solution containing low concentration of non-permeating cryoprotectant. This process happens within seconds. Oocytes or embryos are then moved through one or more wash drops containing reducing amounts of non-permeating cryoprotectants to ensure controlled dilution and removal of cryoprotectants and rehydration of cells. This process takes a few minutes.  

Blastocysts, being more complex due to differentiation of embryonic cells into Inner Cell Mass and Trophectoderm and the presence of blastocoel cavity, may benefit from an additional step: 

1. 1) Artificial Shrinkage: Expanded blastocysts may undergo artificial shrinkage to reduce the risk of insufficient cryoprotectant penetration. This can be achieved by performing a breach either with a laser pulse or by using a micro manipulation tool to ‘nick’ the outer mass of cells, the trophectoderm. This will ensure that fluid within the blastocoel cavity is removed quickly, and the blastocyst shrinks rapidly. It is not always essential to manually shrink the blastocysts, and some embryologists prefer to use simpler methods to shrink the blastocyst using standard embryo handling pipettes  and by pipetting blastocyst in and out of the pipette several times.  

2. 2) Equilibration, exposure to vitrification solutions and rapid cooling: Blastocysts are then vitrified following very similar processes used for cleavage stage embryos. 

Benefits and Success Rates 

Vitrification has shown higher survival rates and better clinical outcomes compared to the previous slow-freezing methods. Studies have also demonstrated that vitrified oocytes and embryos have similar survival and pregnancy rates to ‘fresh’ ones. This is particularly important for patients undergoing in vitro fertilization (IVF), where the quality and viability of oocytes and embryos play a critical role in the success of the procedure. 

Future of Vitrification 

The future of vitrification looks promising with ongoing advancements aimed at improving efficiency, embryo survival and outcomes are being developed. Key areas of focus include: 

Standardisation:

Efforts are being made to standardise protocols to reduce variability and improve reproducibility across different laboratories.

Cryoprotectant Optimization:

Research is ongoing to develop new cryoprotectants that are less toxic and more effective.

Automation:

Automated systems like Genea Gavi® are being developed to streamline the vitrification process, reducing human error and improving consistency.

Fast Vitrification:

Speeding up the process of embryo equilibration during vitrification cooling and whole procedure during the warming process can make the technique easier for scientists to perform. 

Reducing variability of Automatic Vitrification with Genea Gavi® 

Genea Gavi® represents a significant advancement in the field of vitrification. This automated system offers several benefits: 

Consistency and Precision:

Gavi® standardizes the vitrification process, ensuring consistent results by controlling critical parameters such as temperature, cryoprotectant concentration, and exposure time.

Reduced Learning Curve:

The system simplifies the vitrification process, making it accessible to embryologists with varying levels of experience. 

Improved Outcomes:

Studies have shown that Gavi® can achieve high survival rates and improved clinical outcomes, making it a viable option for modern IVF laboratories.

 

Fast vitrification 

Fast vitrification is a is a recent trend in embryo vitrification accelerating vitrification process while conveying overall benefits of vitrification. This method is gaining attention due to its potential to improve efficiencies, clinical outcomes and reduce the time required for cryopreservation processes. 

In published studies these protocols have maintained similar or better survival and development rates compared to standard vitrification methods while significantly reducing execution times. The reduction in execution times was substantial, with time savings of up to 90% in laboratory settings obtained in some cases. 

While fast vitrification shows promise, its clinical efficacy requires further validation. Published studies indicate high potential, but clinical trials or large sets of data may be needed to confirm the reliability and effectiveness of these protocols in large scale clinical applications. Additionally, the development of universal protocols that can be applied across different cell types remains a significant challenge. 

In conclusion, fast vitrification offers a promising alternative to traditional cryopreservation methods by reducing execution times and minimising the negative effects of cryoprotectants.  

The post Current Vitrification Procedures for Human Oocytes, Cleavage Stage Embryos, and Blastocysts  appeared first on Genea Biomedx.

In vitro fertilisation (IVF) is a complex and multi-step process designed to help individuals and couples overcome infertility and achieve pregnancy. This blog post will provide an overview of the different stages of IVF treatment, highlighting key products and technologies offered by Genea Biomedx for each stage, including oocyte collection, fertilisation, embryo culture, cryopreservation and transfer, as well as steps related to managing key aspects of an IVF cycle safety. 

1. Before IVF at the clinic: Hormonal Ovarian Stimulation  

Ovarian stimulation before the steps conducted in the laboratory is a critical component of IVF treatment. Under natural conditions woman’s ovaries usually release one mature egg per menstrual cycle, but to increase the likelihood of successful fertilisation and embryo development, hormonal ovarian stimulation by targeted medication stimulates ovaries to produce several eggs simultaneously. 

The process of stimulation and the overall IVF cycle starts with initial consultation with fertility specialist including baseline testing via blood samples and ultrasounds, to assess patients’ ovarian reserve and overall health. Ovarian stimulation protocols are tailored to the patient’s specific needs by their treating doctor, differing mainly by their use of either Gonadotropin-Releasing Hormone (GnRH) Agonists or Antagonists, resulting in faster or slower suppression of natural hormone production before Follicle-Stimulating Hormone (FSH), Luteinizing Hormone (LH) and human chorionic gonadotropin (hCG) injections. 

GnRH Agonists and Antagonists at the start of the treatment prevent premature ovulation by suppressing body’s natural hormonal signals, FSH stimulates ovaries to produce multiple follicles, each potentially containing an egg, LH supports maturation of growing eggs and hCG induces final maturation of the eggs. All these medications are tightly controlled prescription medications manufactured by specialised pharmaceutical companies rather than medical device companies.  

After an appropriate protocol has been established and natural hormone production suppressed, patients self-administer daily injections of FSH and LH for about 10-14 days. Throughout this phase, follicle development and hormone levels are monitored by blood tests and ultrasounds. Once the follicles reach the desired size, a trigger shot of hCG or GnRH agonist is administered to induce final maturation, followed by the next step in the overall IVF process, oocyte collection. 

Genea Biomedx does not offer hormonal stimulation medications. 

2. Gamete Retrieval: Egg and Sperm Collection 

Once the follicles have matured, a minor surgical procedure for oocyte retrieval (egg collection) is performed. This involves using a thin needle, guided by transvaginal ultrasound, aspirating eggs from follicles. The procedure is typically done under sedation or anaesthesia in a day surgery, lasting usually less than 30 minutes. The aspirated solution is searched for the presence of eggs, which are transferred into the lab in dishes filled with specialised solution. 

On the same day, the male partner or donor procures a semen sample, which is processed in the lab by washing and selecting the most motile sperm for fertilisation. 

Key IVF products used with eggs include specialised oocyte aspiration buffer assisting in follicle flushing and oocyte handling media maintaining the viability of eggs during the subsequent handling. Sperm handling media or buffer as well as sperm wash solutions are used to wash and prepare the sperm for fertilisation. 

Key products by Genea Biomedx that can be used for these steps include oocyte aspiration media (ORB), sperm media (SPM), sperm buffer (SPB) and sperm washing kit (SWG). 

3. Fertilisation 

The collected eggs and prepared sperm are combined in a laboratory setting to facilitate fertilisation. This can be done through conventional insemination, where sperm is added to the eggs on a fertilisation dish and allowed to fertilise naturally, or through intracytoplasmic sperm injection (ICSI), where a single sperm is directly injected into an egg using specialised micropipettes and injection apparatuses set up on an inverted microscope system. 

4. Embryo Culture 

After fertilisation, the embryos are cultured in laboratory in an incubator with controlled temperature (+37°C) and gas environment (5% CO₂ and either ambient 21% or reduced 5% O₂) for up to 3, 5 or 6 days until they have reached cleavage or blastocysts stages. During this time, the embryos are monitored for development either by periodically removing them from a standard incubator and reviewing them under a microscope, or if using a timelapse incubator, by reviewing their development from a continuous live video recording. 

Key products by Genea Biomedx that can be used for these steps include sequential embryo culture solutions cleavage medium (CLM) and blastocysts medium (BLM), continuous culture medium (ONE) and timelapse incubator and software (GERI and GCA). 

5. Embryo Selection, Cryopreservation and Transfer 

Once the embryos have reached the appropriate stage of development, best-quality embryos are selected for transfer into the uterus either immediately, or for cryopreservation to be transferred later. The number of embryos transferred or cryopreserved depends on various factors, including the number and quality of embryos available. 

Final embryo selection is done by experienced embryologists, who however may use various supporting tools that can standardise and categorise embryos based on their appearance and developmental history.  

Embryo transfer is conducted by depositing embryo transvaginally through a fine catheter filled with suitable solution in a minor procedure lasting only minutes.  

Embryo cryopreservation is conducted either by slow freezing, or these days predominantly by vitrification, a rapid freezing technique that prevents ice crystal formation. In vitrification embryos are moved through solutions with increased levels of cryoprotectants over a period of up to 15 minutes, loaded into thin straws and plunged immediately to liquid nitrogen at -196 C, rendering them into a ‘glass-like’ stage. Slow freezing involves likewise moving embryos through cryoprotectant solutions, followed by cooling in a stepwise manner over a period of hours before plunging them into liquid nitrogen for storage. 

Key products by Genea Biomedx that can be used for these steps include a third-party Eeva Test for embryo assessment, vitrification and warming sets (VIT-01 and WRM-01) and vitrification buffer (VBS). Geri system can also be used with several third party embryo assessment programs. 

7. Managing clinic workflow 

Throughout the IVF process, strict protocols are followed to ensure ideal workflows, efficiencies and safety of the procedures. An important aspect of this is the correct identification and handling of gametes and embryos to ensure integrity of the process and to avoid any mix-ups or mistakes. IVF witnessing can be conducted by manual double-checking and verifying the identity of samples and correctness of each step by two different embryologists, or alternatively, with the help of digital witnessing systems.  

Key features and benefits of electronic systems include automated identification of barcode or Radio Frequency Identification (RFID) tags to automatically identify and track labelled samples, container and documents, with each patient assigned a unique identifier. The systems monitor handling and transfer of gametes and embryos continuously, providing real-time alerts if there is a mismatch or if an incorrect procedure is about to occur, helping to prevent errors before they happen. In addition, the systems record every step of the process, providing a detailed log of all actions taken. This helps clinics to comply with regulatory requirements and maintain high standards of quality control, overall improving the accuracy, safety, and efficiency of IVF treatments and providing peace of mind for both patients and clinicians. 

Conclusions:

IVF is a highly intricate process that requires meticulous attention to detail and the use of specialised products and technologies at each stage. From ovarian stimulation to embryo transfer and cryopreservation, each step is crucial for the success of the treatment. By understanding the stages of IVF and the products involved, we can better appreciate the complexity and precision required to achieve a successful outcome. 

The post Understanding the Stages of Human IVF Treatment  appeared first on Genea Biomedx.

This post aims to lift the curtain on the inner workings of a medical device company developing IVF lab equipment in the fertility technology field, providing a glimpse into what happens behind the scenes and a peek beyond the facade of the usual product promotions and sales. Specifically, this post focuses on the very beginning of the process: what drives a development of a new product and how the earliest stages are profoundly critical for the success of the product.

Product Development Process

Product development process, especially in biotechnology and medical device areas, is driven by a combination of innovation, analyses and technology culminating in product manufacturing and launch. Developing new products involves extensive research, design, testing, and iteration, and each stage is crucial to ensure the final product meets the highest standards of quality and safety.

Financial Realities

While companies and product development professionals would love to build innovative products without budget constraints, the reality is that companies have limited funds and must use them wisely. Start-up companies in med technology with big ideas may receive funding from investors willing to gamble on their success. Unfortunately, often these gambles fail when commercial realities hit, and the company and the investors don’t get a return for their investments.

New product development is also a gamble for established biotech companies. Most of their revenue go into running operations such as manufacturing, sales networks and after-sales services to their customers. Therefore, any investment in new product development must eventually recoup its costs and ideally generate income for further investments.

This acknowledgment of commercial realities is particularly harsh in the field of assisted reproduction technologies, which is largely driven by emotions and sincere desires to help people achieve their dreams of starting a family. However, without these financial considerations, no new innovations can be realised or delivered.

Understanding the behind-the-scenes workings of a medical device company highlights the complex balance between innovation, financial constraints, and the ultimate goal of delivering life-changing products. Despite the challenges, the drive to innovate and improve lives remains at the heart of the industry.

Journey Through the Gates: The Product Development Process for Medical Devices

Product development process for medical devices is strictly controlled and must adhere to internationally recognised standards, most notably ISO 13485, which governs the entire life cycle of a medical instrument. Compliance with these standards is essential, but much relies also on common sense and standard good planning.

Stage-Gated Process

The process is best conducted in logical steps, starting from laying the groundwork on which all subsequent steps are built. There are a few different recognised approaches to achieve this, but most adhere to the so-called stage-gated approach. In this, development projects proceed through different stages and are evaluated at the end of each to determine whether the project should continue or if any issues have been identified that make it impossible or impractical to proceed.

The advantage of stage gates is that if the project seems to be on the wrong track, it can be stopped immediately, preventing further investment in a failing project. While it can be frustrating to stop after significant effort has already been invested, it is ultimately better than continuing and ending up with a failed product.

An example stage-gated process can be divided into three main areas: Innovation, Design, and Commercialisation, this post focussing specifically on the earliest phase of the Innovation stage, Analysis.

What to develop?

What triggers the development of a new product? Sometimes all you need is a novel idea. However, the trigger often comes from detecting a product opportunity gap by identifying a need that customers in the field have, for example the recent push and need for early embryo viability assessment, or general improvements to human embryo incubators, whether time-lapse incubators or bench-top incubators. The detected opportunity may not necessarily be what the customers say they need, but originates from a deeper understanding of what can help them to achieve an outcome or solve a problem. This insight can come from experts in the field who know its processes and operations well, or more interestingly, from an outsider who asks questions others may not think to ask.

How to Delve Deeper: Understanding Customer Needs in Product Development

The Importance of Understanding

Understanding customers allows delving into their pain points. What challenges do they face? What outcomes are they seeking? Only by understanding the “why” behind their requests is it possible to create meaningful solutions.

Look Beyond Surface Requests

Customers often express their desires based on what they know or have experienced. However, their stated preferences may not align with what they truly need. Product developers must ask probing questions: Why do you do things this way? Could there be a better approach? What are you truly trying to achieve with that?

Avoid the “Fast Horses” Trap

Henry Ford famously said, “If I had asked people what they wanted, they would have said faster horses.” Customers tend to propose solutions based on their existing frame of reference. A product developer’s job is to dig deeper. What problem are they trying to solve? What unmet needs exist?

Laying the Foundations

After identifying an idea, customer need or product opportunity gap, several key steps must be undertaken. This is a critical part of any project, and how well this foundation is laid may determine the project’s success or failure. It is also the base on which all subsequent project stages are built, fine-tuned and polished as the project progresses.

• Market Analysis: One of the first steps involves identifying who needs the planned solution. For instance, if the need is for something very specialised, such as a product that only 40 clinics or 5% of the end users in the world would require, it raises the question of whether it is feasible to develop it. Would the company recoup its investment with only a limited number of customers? Additionally, market size must be considered. Is this issue or need recognised in every country or only in a few, or only in a very specified user scenario?
• Competitor Analysis: Another critical aspect is examining competitors: How do customers currently meet this need or solve this issue? Is there a gap in the market, or are there existing competitors offering solutions? If so, what is the cost of their solutions to the customers? Any new product must compete either by price or by offering superior features that justify higher prices, or by providing savings in other areas, thereby offering a true value proposition for customers.
• Business Case: A business case is simply an estimate of financial pros and cons: Would the company get returns on its investment or even make its money back? At least a preliminary investigation must be done at this early stage, considering expected revenues (Market Analysis) and anticipated costs of the project including not only the initial product development and launch costs, but also ongoing manufacturing and after-sale costs (Cost Analysis).

At early stages none of these may be known accurately, but there should be at least a reasonable understanding of them. As the project progresses further towards ideation and fine-tuning the product, the accuracy of these analyses and business case projections needs to be revisited many times.

Intellectual Property and Freedom to Operate

Another important aspect is the consideration of freedom to operate (FTO) and intellectual property (IP), the former being more crucial at this early stage. If significant money and effort are invested in developing a product without analysing FTO, the company might find itself in a situation where someone claims ownership of the technology, preventing the company from selling the product, or necessitating costly licensing agreements with the IP holder.

FTO should be conducted by professional patent attorneys who can thoroughly investigate existing patents and technologies related to the idea. If the FTO analysis shows no competing patents and indicates that the planned solution is not already in the public domain, the company might be onto something valuable. At this point, it is essential to consider whether to pursue patenting the innovation or to keep it as a trade secret, protecting the manufacturing know-how in other ways.

Legal, Ethical and Regulatory and Considerations

Addressing legal, ethical and regulatory environment at the start is also important. Is the solution to the problem legal and ethical? What do the regulations and rules in different countries say about it? Before thoroughly scoping the product, it is not possible to delve into specific regulatory requirements, but they should be at least examined to gain a preliminary understanding.

Identifying and Mitigating Risks

The concept of risk also needs to be examined. What are the risks of the project from technological, legal, ethical, market, competitive, and commercial perspectives, as well as from the IP point of view? Additionally, internal risks must be considered: Does the company have internal capabilities to execute the project or will it need to engage external experts? Are there enough resources and funds to execute the project? What are the risks if any of these imagined threats are realised?

Once the risks have been identified, product developers must devise risk mitigation actions to address them. The advantage of being proactive is that as a result, risks may never even materialise due to proactive mitigation strategies and actions.

All these areas must be examined from the start, but it must be understood that they are only rough estimates and all subsequent stages will add more information, depth, breadth, and accuracy to them.

The Product – Developing Proof-of-Principle

Not last and definitely not the least is the product itself. What would it do? What technology it utilises? After gaining an understanding of the needed product functionalities, the product team starts to develop proof-of-principle test beds and test them in the context of the intended use, coming up with results and recommendations for the next iterations. Several of these test beds can be built separately to address different features of the product, for example in the case of timelapse incubator (time lapse machine), addressing separately IVF incubator temperature alarm system, temperature monitoring system, incubator camera and optics, incubator gas mixture and its control and so forth. Often these crude test beds consist of mechanical contraptions with wires and tubes sticking out, looking nothing like the final elegant product – but it is a start.

Outcomes of the Analysis Stage

The final outcomes of this first Analysis stage are twofold: 1) The proof-of-principle technology & product and 2) The project plan, also called a project management plan. This plan defines how all the subsequent stages of the project are intended to be conducted, what inputs are needed, what outputs are expected, as well as the current status and references to the initial findings of different analyses. This plan must be as accurate as possible but also acknowledge that it will likely change in the future as the project progresses and new things are discovered.

Finally, all the stakeholders representing key areas of the business gather for the first stage gate review to determine if the project has enough merit to proceed. The outcome of this meeting is sometimes called a Design Goal – an acknowledgment that the project now has clearly defined goals to aim for and the new product planning and execution can continue.

Large technology companies may execute dozens or even hundreds of these early-stage analyses, with many of them discontinued at this stage for various reasons: the market may be too small to justify the investment, regulatory requirements may prevent the product’s execution, there may be no freedom to operate because someone else already owns the intellectual property, or some other reason preventing continuation.

Analysis stage is extremely important for any project. Its advantage is that it is relatively inexpensive, involving mainly internal resources and their expertise and time and perhaps some external consultant fees, but does not require significant engineering or chemistry work or external support.

Written by Teija Peura.

The post The Start of Medical Device Development Journey appeared first on Genea Biomedx.