Key IVF scientific insights from our workshop in Paris

Gloria Martinez, MSc, Global Product Manager-CASA and Laser

Traditionally, semen analysis has always been performed manually according to established standards, as described in the World Health Organization (WHO) manual. However, this process has several limitations, including subjectivity, inter- and intra-operator variability, higher likelihood of errors, and limited traceability.

To overcome these limitations, CASA systems (Computer-Aided Semen Analysis) were developed. These systems typically consist of a microscope, camera, and computer. Initially, they functioned as a “black box,” providing results without visibility into how the analysis was performed. Today, they are fully automated systems offering multiple advantages – standardisation, reliability, objectivity, traceability, time efficiency, and comprehensive reporting.

Among the parameters that can be analysed are motility, concentration, vitality, morphology, DNA fragmentation, round cells, and leukocytes, among others.

At the same time, it is essential to emphasize that proper training, regular calibration, and correct sample preparation for each kit are indispensable when using a CASA system.

In addition, a basic semen analysis sometimes fails to explain cases of idiopathic infertility. In such cases, functional sperm tests may be performed. One example is the Catsper test, which can detect abnormalities in the Catsper ion channel in normozoospermic samples. This channel plays a key role in sperm hyperactivation and fertilization.

In summary, performing an appropriate semen analysis enables a correct and precise diagnosis, which has a direct clinical impact – particularly by improving the accuracy of insemination technique selection.

Irene Cuevas Sàiz, Senior Clinical Embryologist, responsable de laboratoire, Hospital General Universitario de Valencia 

The first successful pregnancy after the use of frozen human embryos took place in 1983. Since then, embryo and gamete cryopreservation has earned interest among the IVF community, as the availability of frozen samples increases the possibilities of success in IVF. The change into vitrification against slow freezing, was a game changing for the improvement of cryopreservation. IVF cycle segmentation is a reliable technique as embryo survival is above 90% and more single embryo transfers are performed. That contributes to the increase of clinical pregnancy rates and cumulative delivery rates. We can see data from Europe (EIM reports) and over the world (ICMART reports) that confirm it. With respect to gamete, oocyte, cryopreservation, there is more flexibility for the use of donor oocytes. And many other advantages that have overcome vitrification an essential part of an IVF treatment. But there are still some concerns about this technique, and one of the most challenging issues is the use of potentially toxic cryoprotectant substances at high concentrations that allow high survival rates, but in the other hand, would have potential side effects to the gametes or embryos, including epigenetic changes. That is one of the reasons why it is essential research in continuous improvement in vitrification and warming of the samples.

Oocytes are very sensitive cells to cryopreservation because of their size, the amount of water content and intracellular structure. The reduction in time of exposure to the equilibration solution during vitrification and dilution after warming are showing better survival rates, maturation restore after GV warming, preserved genetic integrity and normal embryo developmental potential. Although further prospective research studies are needed, fast vitrification and warming protocols look promising in the improvement of oocyte cryopreservation.

With respect to embryo vitrification, mainly at the blastocyst stage, several publications are highlighting similar results: higher survival rates, higher implantation rates and healthy infants.

Those shorten protocols are not only improving the results, but contributing to better laboratory workflow, shortening the time spent by embryologist for the vitrifications and warmings. This is of special importance for oocyte warming, as there is a reduction in the difference of time after warming for sibling oocytes that need to be injected.

In addition to the new protocols, two studies conducted at Hospital General Universitario were presented. One of them showing that embryos that loose more volume during vitrification had higher implantation potential. That lead us to “help” blastocysts loosing volume by artificially collapsing them by means of a laser shot prior starting the equilibration. The second study presented showed a new variable employed to predict embryo implantation: the velocity of re-expansion after warming. Using time-lapse imaging after warming, we were able to calculate the velocity of re-expansion that was directly correlated with implantation and further development of the embryos, helping us in the decision of transferring the embryo or warming another frozen one. Moreover, to increase the velocity of the warmed ones, we “help” them by doing laser assisted hatching to around ¼ of the zona just after warming, while the blastocyst is still collapsed.

To summarize, continuous research on gamete and embryo vitrification and warming will help us going on improving the clinical results in an IVF treatment. So, the answer to the title of the presentation was YES, there´s still room for improvement.

Stefanie De Gheselle, Senior Embryologist, UZ Gent Belgium 

The presentation emphasized that quality management in the IVF laboratory is not an administrative formality, but the backbone of safe, consistent, and patient-centered care. Every step in the IVF process directly influences outcomes, making validation, traceability, and risk-based decision-making essential for embryologists. A structured three-phase approach was outlined, moving from initial risk analysis, through pre-clinical validation, to controlled clinical implementation and continuous performance monitoring. The guiding principle is that quality is ongoing: built on documentation, SOPs, training, and systematic review of key performance indicators to maintain excellence.

A major focus was the importance of systematic risk assessment at the earliest stage, where the EuroGTP II interactive web tool was highlighted as practical and structured framework to identify novelty, score risks (probability × severity × detectability), and determine proportional validation steps before clinical use. It brings clarity, traceability, and consistency to change control. EuroGTP II is freely accessible online via EDQM: https://soho-guides.edqm.eu/home.

Terminology was clarified according to EDQM quality concepts used in IVF laboratories:

• Qualification – confirming equipment performs correctly in the lab (e.g., IQ-OQ-PQ).
• Validation – assessing a new procedure, device, medium, or consumable before clinical use to ensure safety, reproducibility, and intended performance.
• Verification – evaluating an existing method, product, or system in your own laboratory setting to confirm it performs as expected.
• Quality Control (QC) – routine ongoing checks after implementation to ensure continued stability and detect deviations early.

Illustrative cases from laboratory practice, including single-step blastocyst warming and introduction of a new time-lapse incubation system, showed that structured risk analysis, proportional validation, and post-implementation verification via KPI monitoring lead to safe and efficient clinical practice. Ultimately, validation is not paperwork – it is proof that what we do truly works, safeguarding patients and supporting continuous quality improvement in IVF.

Bénédicte Weiss, Clinical Science and Education Manager, Nexpring Health 

• A barcode-based system for control, traceability, labeling, and quality management. All barcodes are readable (API, etc.).
• Specifically designed for IVF clinics to eliminate any risk of mix-up between patients’ gametes and embryos.
• Enables both electronic and visual documentation (barcode labels + patient identification) of every step, answering the key questions who, what, when, and where, including image capture of procedures.
• Offers high mobility and flexibility thanks to the Pocket Reader (barcode and photo scanner), which requires no fixed device and does not restrict workspace or heating areas.

This identity verification system ensures complete and reliable traceability throughout all stages – from oocyte retrieval to embryo transfer – including freezing, inventory management, and consumables and media lot traceability.

The cycle-based package allows broad flexibility in the number of labels used, with no additional cost. The system requires no annual maintenance, and updates are provided free of charge.