Setting up a new IVF lab can be both daunting and confusing. There is a buffet of options available. After selecting the space and narrowing down on a budget, when one thinks they are finally there, comes the time to take some of the most difficult decisions (1) How much equipment to procure, (2) How many lab personnel are required to run a lab without any glitches. Going overboard with the setup and expenses needs to be avoided, but one must be careful to not cut too many corners either. Less equipment and personnel will put a strain on the quality and success, whereas, going overboard with setup and equipment will lead to underutilization. Therefore, creating the right balance is key in maintaining cost effectiveness and increasing efficiency.
The embryology laboratory should be in an area immediately adjacent to the operating room, where the follicular aspirations and ETs are to be performed. During a follicular aspiration, it is vital that the clinician is able to communicate directly with the laboratory scientist(s) and discuss the source of the aspirate, i.e., the size and appearance of the follicles, the character of the aspirate and whether to aspirate.(1)
Let’s start with equipment first, we have tried to compile a list of equipment needed for functioning of a good quality lab, without breaking your budget.
Laminar Flow Hood
All manipulations of human oocytes and embryos as well as the final preparation of the culture media must be accomplished under a horizontal laminar flow hood. The horizontal laminar flow hood surrounds the items in the hood with filtered air, thus decreasing the chances of microbiologic contamination. Laminar is probably one of the most important and most used equipment in an IVF laboratory. One of the most critical aspects that you should look at in an LAH is temperature stability. The working surface should have stable temperature, with minimal or no fluctuation. Stability in temperature Is key in preventing the spindle fiber of the oocyte from getting damaged. It seems that human oocytes are more sensitive to temperature fluctuations than are oocytes from other animals, and the spindle structure is disrupted even when oocytes are exposed briefly to temperature even slightly less than 37°C. This spindle damage is directly proportional to low fertilization rate and poor embryo development.
Picking the right Laminar: Practically speaking, the price jump from a locally manufactured laminar to an international one is very steep. To give you a perspective of a local 4X2 laminar will be under 8 lakhs INR, whereas, an international make will be an upward of 15 lakhs INR. The decision between the two would revolve mostly around cost.
If you are starting afresh with a clinic it would be easier to invest in a local made brand like Shivani, Intermedics, Stech and so on. They comparatively provide better stability in temperature. We have worked on them and they do the job well. Eventually, once your centre picks up and you have some spare cash, do invest in equipment. You can then upgrade to an international brand, like IVF Tech or Origio, to name a few.
Size of Laminar: We would recommend your main laminar to be 6 feet by 2 feet in size. (Be it local or international make) 6X2 laminar has provision for two stereo zooms to be installed, making it easier for two people to work simultaneously on it. You would not believe how much difference this will make. You might have to pay a little extra now but in the long run when your cycles and team expand, you will be grateful for that little extra space as with just an additional stereozoom you will be able to accommodate more in less.
Smaller Laminar: This can be 4 feet by 2 feet or 2 feet by 2 feet (depending on the space you have allocated for your laboratory). This small laminar should be used for vitrification and dish preparation. Both these procedures need to be done at room temperature and we don’t need any temperature control in the laminar. Therefore, for the small laminar you should invest only in a locally made brand, as the cost difference would be huge, without compromising on the quality as such. We strongly recommend that you invest in this laminar because making dishes on a heated surface causes irreversible osmolality change, which can affect the PH of the media. Also, vitrification media is sensitive to heat. Hence, both these procedures need to be done at room temperature.
Number of Laminar: In our experience, with one main laminar and one smaller one, your lab is equipped to go from 5 cycles per month to up to 60-70 cycles a month.
We like to call this the “womb” of any IVF Laboratory. The primary function of an incubator within the IVF laboratory is to provide a stable environment to optimize gamete function and embryo development in vitro. To achieve this goal, an incubator must regulate several environmental variables, including gas concentrations, temperature and humidity. There are two types of incubators – box and bench top. It would be best to use a mix of both. For incubators, we highly recommend using only internationally approved brands, as this can make or break your “Laboratory Health”.
Box Incubators: These, as the name suggests, are box-shaped, with a hinged door and three levels to keep the media and dishes. These incubators provide carbon dioxide and heat, which help in monitoring PH and provide a holistic approach to culturing. There are many available in the market; we have used Hera Cell by Thermoscientific extensively and swear by it. It is fuss free and has a great sterilization and stabilisation mechanism.
Use: We recommend using the box incubator as your “working incubator”, as this incubator will inevitably be opened several times during the procedure, e.g. to keep the eggs after OPU, between denudation and injection and so on. Also, this incubator is quite spacious and is used for storing dishes for calibration. You require only one of these, for up to 60-70 cycles.
Benchtop Incubators: These, as the name suggests, are flat incubators and have a very stable culturing environment. They use trigas mixture, which reduces the oxygen concentration (5%). Some examples of benchtop incubators are Minc and Miri. The reason we love to use them as culturing incubator are:
(i) Low oxygen concentration (5%), which gives more optimal embryos on Day 3 and significantly higher blastocyst formation rate on Day 5 and Day 6.(2)
(ii) Oocytes after ICSI go to this incubator until blastocyst stage, which ensures that the embryos develop here without much disturbance.
(iii) Many studies have proved that opening/closing of the doors of the incubator multiple times leads to deterioration of culture conditions, impacting embryo development.
For this reason, benchtop incubators are the preferred choice for culturing embryos. You can store limited dishes per incubator, but in turn, the opening of the incubator will be much lesser, making it a win-win situation.
How many: One benchtop incubator is good for upto 15 cycles, so you can keep adding more, as and when your cycles increase. The good part is that these incubators can be stacked one on top of the other, so you end up saving space as well.
ICSI Micromanipulator: For most clinics that offer ICSI to patients, it is imperative to have an ICSI station. There are two most widely used brands – RI and Narishige.
Similarities: They both have heated stage, and offer the same precision of micromanipulation. They come attached with an inverted microscope, which could either be Nikon or Olympus.
Difference: RI has an added feature that makes aligning of pipettes very simple. In RI, the movements are manual, whereas, Narishige has motorized movement.
They both do the job well, preference of one over the other is just a matter of what one has been using and what one is used to. For instance, I had started my career using a RI, so I used to like it more but now I have been using Narishige since the last 7 years and I love it. NO Favourites here!
Heat Blocks: Small but essential. These heat blocks are used to warm media in test tubes. They are extremely useful during egg collection and we would recommend having one of these in the OT, in order to keep the tubes warm, so that when the doctor aspirates the follicular fluid, the tubes don’t undergo a shock, due to change of temperature. Remember stable temperature is crucial for a good cycle outcome.
The other heat block should be kept in the pass box or the table between the OT and the laboratory. The tubes with follicular fluid should be kept in this heat block until the embryologist is ready to screen them. We must keep in mind that the time needed to screen the follicular fluid by an embryologist increases as the number of follicles increase or if there is too much blood in the follicular fluid. During this time, the tubes waiting to be screened should be in the heat block. This little change will make a huge difference in the quality of your cycle.
Refrigerator: A simple refrigerator is required to store media. Media, unless kept for equilibration, should always be kept in a cool environment away from light.
Cryotanks: Cryotanks are a must for any freezing program be it semen, oocyte or embryo. A separate cryotank is preferred for semen and embryos. It is also recommended to have a separate small tank for storage of infectious samples. Some clinics undertake cases involving patients infected with Hbsag and HCV and it is imperative that the semen or embryos from such patients be stored separately.
Semen can be stored in cryovials or straws and embryos/oocytes can be stored in aluminium canes or daisy goblet. We personally prefer daisy goblet because (1) Easy to store (2) Saving space in cryotanks
Lab personnel/ Embryologist/ Lab Scientists
Embryologist is one of the most crucial roles in an IVF lab. The number of people in the lab will depend at the stage of your lab in terms of workload:
- You are just starting your clinic: If you are just starting off with your clinic and are unsure about the number of cases, it would be best to start with one fully trained embryologist and an andrologist. We have seen a lot of clinics make the mistake of inducting an embryologist after the cases are enrolled to save on the salary of the embryologist. But, we can’t stress enough on the importance of embryologists when the lab is being set up. There are many technical challenges while setting up a lab, and if your embryologist is already on board they can help in guiding on where to place the equipment, positioning of gas lines and even to check whether the equipment is working fine during installation. So, invest a little more but have the embryologist on board from the lab set up phase.
Suggested Team: Embryologist + Andrologist
- Clinic is doing 20 – 35cases: It would be best to have a senior embryologist/ lab manager, who does all procedures including ICSI and a junior embryologist who can do procedures from egg screening to denudation, but needs more practise. This junior embryologist should be trained by the lab manager gradually for ICSI. It is very important to ensure that there’s a healthy atmosphere and the team is motivated at all times. It’s the duty of the lab manager to ensure that the team is on the right track.
Suggested team: Lab Manager + junior embryologist + Andrologist
- Clinic doing 35 – 60 cases: This would be a busy clinic and you will need to have at least two people who are proficient at doing ICSI, because you need to factor in for the reality – that people fall ill or take leaves. Apart from that, a junior embryologist and an andrologist should be on board. The lab manager should be the most experienced, and the team members will have to run through him or her for any lab related decisions.
Suggested Team : Lab Manager + Embryologist + Junior Lab manager + Andrologist
After 60 cases, you need to evaluate the requirements of your lab and add people as and when required. Three things should be kept in mind for running a successful team.
- Always keep the juniors motivated by training them and validating them, you will realise that it goes a long way.
- At any time in a busy lab, have two people who can do all procedures. e.g. lab manager and embryologist. This will ensure that your system is not dependent on one person and doesn’t collapse very easily.
- A good lab environment and a healthy relationship between the team members, ensuring a smooth flow of work within the clinic and minimal troubleshoot related to personnel.
- Laboratory setup for human in invitro fertilization (fertility and sterility,
VoL 42, No.1, July 1984 )
- Int J Clin Exp Pathol. 2014; 7(9): 6191–6198. Published online 2014 Aug