Our IVF Laboratory
The planning and construction of our new IVF laboratory and office took about two years and was from the ground up. There are many factors that go into making a good IVF laboratory from a construction and facility standpoint in addition to the people that make it all work. We think we excelled at all of these.
In the past, many IVF labs were retrofitted into hospital operating rooms or other office rooms that were not compatible with the strict requirements of an IVF lab. Some programs have their IVF laboratory in a different part of the building from the procedure room for egg retrievals and embryo transfers. These labs use special pediatric mobile incubators called Isolettes to transfer the gametes and embryos. Transfer may introduce potential threats to the oocytes and embryos because of the differing environments the Isolettes must be exposed to. Our procedure room and IVF lab are connected by a door and only a few feet separate the incubators from the procedure table. Thus, the embryos go from the incubators into the patient’s womb in the least amount of time.
Factors like air quality, temperature, and light are know to affect oocytes and embryos. Air quality is crucial for the success of IVF. The ambient environment air quality can be enhanced with decreased light (i.e. bright light can harm embryos), no windows in the lab, no alcohols or perfumes, non-toxic paints, HEPA (i.e. High Efficiency Particulate Air) and charcoal filtrated air, positive pressure and general sterility precautions. HEPA filtration removes 99.97 % of airborne particles at 3 mm. The air must be filtered with charcoal to remove carbon based contaminants and HEPA to remove particulate material before entering the lab space. The best way to do this is to have a dedicated HVAC ( i.e. Heating Ventilation and Air Conditioning) unit on the roof of the building directly above the lab. This separates the IVF lab environment from the rest of the building. This is the way we designed our lab. Additionally, in order to assure maximum air exchanges per hour and maximum air pressure we used a commercial HVAC unit that is twice as powerful as needed. Charcoal filtration of the air occurs when the outside air is brought into the unit and HEPA filtration occurs before the air enters the laboratory space. We designed our building with a flat roof to accommodate this system. If the roof was arched or the lab was not on the top floor of a multi-story building it would be difficult to have such a system.
Our IVF lab consists of a retrieval room, embryology laboratory, cryopreservation room and two accessory laboratories that are all under this clean room umbrella. In order to further isolate the IVF lab from the environment, the walls go all the way up to the roof above the drop ceiling. Additionally, the drop ceiling has solid panels with gaskets and the light boxes are sealed and controlled by rheostats. We are very concerned with the emissions of volatile organic compounds (VOC) from materials associated with the building like paints, floorings, adhesives, and just about everything else. Anesthetic gasses may increase VOCs. We have no anesthetic gasses in the procedure room. Even perfume and cologne may have VOCs, so all staff and patients are requested not to wear these. These compounds could work their way into the incubators and affect the embryos. The paints used in the IVF lab were all expoxy based compounds that emit low VOCs and cure quickly. The flooring is all single sheet which wraps up the wall for 6 inches. This keeps the chance of dust or germs in the crevices between flooring tiles low and makes it easier to clean the flooring. Some labs will have a coving along the floor that could be a potential problem for dust accumulation.
In order to control the lab environment, it is best not to have window or other surface that may not insulate the lab well. Temperature is a factor that must be controlled. Patients are well aware that hospital operating rooms are generally very cold in order to inhibit bacterial growth. Some have experienced this at the time of embryo transfer. Cold temperatures are detrimental to oocytes and embryos. Cooling only 1° C may cause irreversible meiotic spindle damage to the human oocyte that may not recover upon warming. Our lab and procedure room are perfectly controlled.
We have an independent company evaluate all of the rooms associated with the IVF laboratory. We have the pressure gradients measured from the embryology lab to the procedure room to the hallway. We have positive pressure and a gradient forces air from the higher pressure in the embryology laboratory. This pushes out any potential toxin. The HEPA filters are tested to be sure that they are removing particles from the air at the desired level and we calculate the number of complete air changes that occur in each room with the HVAC system per hour. This testing validates the quality, but the most important benchmark is embryo growth and pregnancy rates. Ours are excellent and the attention to detail in the lab pays off.
Our laboratory has been accredited by the College of American Pathology (CAP) and passed all inspections with flying colors since its inception. In fact, our Lab Director, Sandi Malott, ELD, is a CAP inspector. A picture of our certification certificate is in Figure 1.
Figure 1. CAP Certificate.
Additionally, we are members in good standing with the Society of Assisted Reproductive Technology (SART) since 1998. See Figure 2.
Figure 2. SART Membership.
The following pictures show the procedure room where we do egg retrievals and embryos transfers. The Dutch door is between the embryology lab and procedure room. You can see that it is only a couple of steps between each room. When we do embryo transfers, the partner is able to walk into the lab and see the embryo culture dishes the embryos grow in just before we do the transfer.
Figure 3. Procedure room showing patient procedure table, ultrasound machine and door between lab and procedure room.
Figure 4. Procedure room showing anesthesia equipment and supply cabinet.
Figure 5. Procedure room showing opening into Embryology Laboratory.
Figure 6. Ceiling in procedure room showing HEPA filters.
Figure 7. Part of stereo system in procedure room. Patients may bring personal music for retrievals and transfers.
Figure 8. Temperature control for IVF procedure room and lab.
Figure 9. Four of our incubators where embryo culture takes place. These incubators have back-up power in the unlikely event of a power outage. The air inside the incubators is charcoal and HEPA filtered to further purify the air that enters the incubator.
Figure 10. The Sensaphone monitoring system notifies the embryology staff if the incubators change temperature 24 hours a day via telephone.
Figure 11. The laboratory has two work stations with separate stereomicroscopes. These work stations are for single users and face in opposite directions to reduce the risk of human error in the handling of gametes.
Figure 12. Stainless steel cabinetry is in the IVF lab for storage. This is low VOC.
Figure 13. The large Olympus OX 10 Microscope is for micromanipulation (i.e. ICSI, and assisted hatching). The Eppendorf electronic micromanipulators allow us to safely and delicately handle the gametes and embryos. The anti-vibration table eliminates any possibility vibration affecting the gametes during a micromanipulation procedure. We can monitor the process with a video hook up and take pictures of the embryos to give to the patients.
Figure 14. Close up of the micromanipulation stage of the microscope. The stage has a separate warming control device to make sure the embryos are at 37 ° C.
Figure 15. The embryo cryopreservation room is adjacent to the embryology laboratory. Carbon dioxide tanks send gas lines into the IVF incubators that use 5 % CO2. These can be seen in the corner of the room.
Figure 16. Liquid nitrogen tank used for cryopreservation. It weighs over 600 lbs.
Figure 17. The machine that controls the cryopreservation process. This is connected to a laptop computer to record the data from the cryopreservation process.
Figure 18. Embryos and sperm are stored in separate dewars filled with liquid nitrogen.
We hope that the above gives the reader a better understanding of the
actual IVF laboratory.