When patients select a reproductive endocrinologist (RE) and fertility clinic, they are by default selecting an IVF lab. Having healthy embryos to transfer to a uterus is arguably the most important factor in the whole IVF process, and while there are many factors that contribute to this, the skills and policies of the lab are important.
Once a clinical treatment plan has been set by a doctor, it becomes the responsibility of the IVF lab to execute the plan according. The scientists who supervise embryo growth are called embryologists. The field of embryology is complicated and culturing and growing delicate cells is a relatively new science. This means that new information is being discovered and there isn't always a single, standardized approach.
If you are not familiar with what makes a good IVF lab or what you need to know about the lab at the clinic you select, you are not alone. It can be hard for a patient to navigate all of their options when it comes to treatment. It's good to know from the outset that no lab can improve the quality of eggs, sperm, or embryos. The technology simply isn't there. The best an IVF Lab can do is identify, process, culture, document the growth and development of your gametes and do no harm.
Here are a series of questions about the IVF lab that you may want to investigate before considering treatment with a clinic.
1. Is the IVF laboratory accredited?
The College of American Pathologists (CAP) and The Joint Commission (JCAHO), along with state agencies regularly inspect laboratories to make sure that labs are staffed appropriately and that they maintain patient safety and quality standards. This is a requirement of the CDC. The FDA also regulates clinics that create donor gametes.
Do the laboratory and clinic advertise their accreditation and professional affiliations on their website or in their office?
2. Is the laboratory directed and staffed with qualified and appropriate staff?
Check out their website. Do they list their employees? Do they boast their experience and education? How many cycles per year do they perform and does the ratio of staffing seem reasonable? The ASRM has established the following guidelines for staffing an embryology facility:
|Number of Laboratory Cycles||Minimum Number of Embryologists|
|>600||1 additional embryologist for each additional 200 cycles|
The CDC now requires a 4-year science degree for embryologists, but a grandfather clause exists. The American Association of Bioanalysts (AAB) certifies embryologists, but it is not required.
Laboratory directors should have a High Complexity Lab Director (HCLD) or MD and should have specific experience in a reproductive laboratory. Recent research or publications may mean the director is staying current in the field and committee or board membership and participation shows they have been or are a leader in the field of their practice.
3. How are the facilities maintained?
IVF labs grow and process very sensitive cells that are vulnerable to exposure of environmental contaminants. There is a debate that light, fragrances, chemicals and air quality affect embryo growth. Most laboratories have specialized ventilation systems and filters to ensure elimination of outside contamination. Many regulate personal protective equipment such as scrubs, masks, hair and shoe covers to protect their employees and patient specimens from exposure. You don’t want someone with gasoline on their shoes from filling their car up on the way to work in the IVF lab.
At my clinic, we control the cleaning products used throughout the clinic, construction and renovation timing, and all materials used in the IVF Lab. Even wind patterns can be important to avoid contamination from air pollution.
4. Are treatment protocols customized for you or are you part of their “system”?
If you are selecting a warranty for financial risk-sharing program, you may be entering a treatment structure that is predetermined and not focused on your specific needs. For example, decisions that might be mandated by such an agreement include the use of intracytoplasmic sperm injection (ICSI), frozen embryo transfers (FET) only, or even what medications are to be used.
5. Do they perform testing or procedures because the can or because they should?
Testing and micromanipulation procedures serve a purpose, but that doesn't mean they provide benefits for everyone or should necessarily have a blanket application. Questions to consider may include asking if the clinic performs:
- ICSI on 100% of their patients,
- Freeze all embryos before transfer
- Preimplantation genetic screening (PGS) on all embryos for non-medical reasons
These procedures are all potentially damaging and come with risks and benefits. Are they recommended specifically for you based on their experience and your testing results in order to increase your chance of success?
6. What are the clinic’s success rates?
Success rates are not 100% indicative of quality care. Some IVF Labs accept more challenging patient demographics and cases. If the clinic is a member of SART you can look at their success rates or go to the CDC’s website to look at how they perform.
7. What are their cryopreservation policies?
Not every embryo is destined to create a pregnancy. A consistent and normal growth pattern that generates a morphologically high-quality blastocyst is indicative of a high chance of implantation. Embryo quality and thaw survival are correlated. This means that healthy embryos are more likely to survive the thaw and the best way to know if an embryo is healthy is to see if it will grow into a healthy blastocyst. If an embryo is frozen before this stage of blastocyst culture, the chances of surviving the thaw are reduced.
Most embryo thaws occur after a patient has paid for cryopreservation, storage, preparation and hormonal stimulation for a frozen embryo transfer. If the embryo/s don’t survive, the money (and your emotional investment) are spent. Respectfully ask what the IVF lab freezing policy is:
- Does the clinic or IVF Lab freeze all embryos?
- What stage do they cryopreserve at?
- Do they store cryopreserved eggs, sperm and embryos onsite and if so, how do they ensure their security and safety?
- What are their survival rates of frozen embryos?
Some clinics are more conservative than others when it comes to freezing embryos. Consider if their policy aligns with what you and your partner are comfortable with.
Navigating your fertility journey can be challenging. Finding a clinic and IVF Lab that is a good fit can make the journey easier. Each IVF Lab and clinic have different approaches to a similar process and it is to your advantage to do your research. Investigate the clinic's website, ask for referrals, and respectfully ask any questions that you have to help you decide if a particular clinic's approach is a fit for you.