Frequently Asked Questions
List of Questions and Answers to address communication around the EmbryoScope
June 2010
A. Technical details relating to culturing conditions
- Can you grow to Blastocyst in this EmbryoScope?
Yes, you can grow the embryos for as long as you would in a standard incubator. All instruments are tested individually with 60 thawed 1-cell mouse embryos before release. At least 80% of the embryos (54 of 60) must develop to expanded blastocysts within 96 hours.
- How often do you need to change media?
You can change media as often as you like but we recommend at day 3 if you culture for 5 days. If you culture for 2 or 3 days you do not have to change media.
- How do you handle media change?
Media change can be performed efficiently without moving embryos to a new slide. Each embryo resides in a central inner well within an outer well containing a media droplet. Media can be changed by using a fine tip pipette and drawing spent media from the outer well, while the embryo remains safely in the inner well. New media can then be added to exchange 80 – 90% of the original media.
- Is pH measurement possible?
Not currently, but we may be able to add a pH measurement device in the future. Maintaining the pCO2 and Temperature constant will result in a stable accurate media pH.
- Why is this a non-humid environment?
The EmbryoSlides are not permeable to water vapor. When working with oil cover it is not necessary to incubate in a humid environment as evaporation is effectively eliminated. The risk of fungal and bacterial contamination is greatly reduced in a non-humid environment. There is no need to replenish water reservoirs and accidental condensation of water vapor within the instrument is eliminated.
- How fast does the temperature drop if you have a power failure?
The temperature drops by 2 degrees in 10 minutes and we therefore require that the EmbryoScope is connected to an uninterrupted power supply (UPS). We can provide an UPS that can power the instrument at least 1 hr in case of power failure.
- Is this tri-gas?
Yes,This is a tri-gas incubator. Oxygen and carbon dioxide concentration is maintained by mixing CO2 and N2 into the internal airstream. The tri gas mixer ensure a stable gas composition and a low consumption.
- What is the light exposure?
The internal optics are very light sensitive and designed to work with illumination from a single red LED providing light at 635nm. The discrete wavelength provided by the LED means that the wide spectral composition of light used in a standard microscope, including damaging light shorter than 550nm is totally eliminated. Exposure time is 0.04-.08 sec per image depending on selected exposure time. The light exposure is comparable to standard total light exposure with routine IVF embryo assessemnt checks. As an example, with a 120 hour incubation, if 7 focal planes are selected, with images every 20 minutes the total low energy light exposure is 99s. The maximum exposure using the highest exposure settings is 237s.
B. Capacity questions
- How many patients can an EmbryoScope handle?
The EmbryoScope™ may hold up to 6 EmbryoSlides with embryos from six different patients. Each slide can hold up to 12 embryos and the embryoScope can thus monitor up to 72 embryos simultaneously.
- How long does it take to load a slide?
Once you have passed the learning stage (as this is a new method, you have to allow for some time in the beginning to learn) the time to load a slide is comparable to the time it takes to prepare a standard culture dish. You can use whatever medium you are using today.
- What is the capacity of this monitoring system ?
Depending on what day the clinic grows to (day 2, 3 or 5) and how efficient you are, we estimate between 400 and 600 cycles per year per EmbryoScope.
C. Reference labs and safety
- Is the EmbryoScope approved (CE mark, FDA)?
We received our ISO13486 and CE-marking as a Class IIa Medical Device on June 29 2009. FDA approval as a device for embryo cultivation (510K) is in progress
and therefore this instrument is not available for sale in the US. - Do you have clinical data/published papers documenting outcome?
We have a list of peer reviewed publications describing correlations between early cleavage, divisional synchrony, fragmentation etc. and pregnancy/fetal heart beat/baby take home rate. In addition, we have 5 abstracts accepted at ESHRE 2010, 3 abstracts (to date) accepted at ASRM 2010. - How safe is it for the embryos compared to a normal incubator?
We have shown using extensive studies with mouse embryos that the EmbryoScope is just as safe as any incubator used in the lab today. These findings have been confirmed by initial trial with human embryos. Each individual EmbryoScope is embryotested with 60 thawed 1-cell mouse embryos. At least 80% of the embryos must develop to expanded blastocysts for the instrument to be released. This is also part of our CE marking approval. Preliminary results using human clinical embryos indicate that incubation in the EmbryoScope Instrument is at least as good, if not better, in terms of implantation rate, however we do not have enough cycles to state this with statistical certainty. See upcoming abstracts at ASRM for the preliminary results presentation.
D. Purchasing conditions
- When can I purchase one?
This instrument is now available for sale in Europe. We are currently expanding our distributor network and will keep you informed regarding other sales areas. - What does it cost (EmbryoScope, trays, service, work station)?
Please contact us at sales@fertilitech.com for a price quotation.
E. Respiration questions
- Is this instrument measuring respiration?
No respiration is not a feature of this instrument.
- Why did you not continue with respiration technology?
We recognized the untapped assessment potential that can be realized with time-lapse observation. The developmental pattern of cell divisions appear to relate embryo viability and we designed the current instrument acknowledging that this was an easier instrument to certify and to use in a clinical setting.
- Will you continue with respiration instruments?
We will likely revisit development of a clinic respiration instrument in the future.
