The Components of a Reliable Laboratory

Quality of Embryologists

Laboratory interventions are often manual and so you want to be sure your laboratory’s embryologists are seasoned. Here is one example of how fertilization rates (and pregnancy rates) are impacted by embryologists’ experience in the first year of training:

Many clinics show you the biography of their head embryologist, but most likely someone else will be handling your case. We find going to LinkedIn and searching for that laboratory’s embryologists is a good way to learn who is in the lab. To do this, type in the clinic’s name, and then click “Filter By People” and under “Title” type in “Embryologist.” Below is an example of outputs for Colorado Center for Reproductive Medicine.

CCRM Embryologists on LinkedIn

Here is what to look for: a master’s (or higher) degree in hard sciences, many years of laboratory experience and plenty of time in your clinic’s laboratory (see an example below). Many laboratories have high employee turnover, which is disruptive to the system and can impact your results.

Embryologist Bio

Many clinics track the performance of each embryologist and if you are fearful procedures like ICSI or PGS biopsy will be handled by of the poorer performers, you may consider asking if the work be divided amongst two embryologists.

Always On When You Need Them

When your clinic is doing cycles with patients, the lab should be open and working seven days a week. To do this reliably a clinic must have multiple embryologists available on any given day. This matters because you need to have your embryos transferred when the endometrium is most susceptible to implantation, not when the embryologists happen to be in town. In this Danish laboratory study below, Sundays are taken off and therefore good Day 5 embryos must wait to be transferred on Day 6. This led to far worse outcomes for patients.

That said, laboratories do need time to recalibrate their equipment and it is hard to know how much disruption this causes. We suggest ensuring your cycle does not occur while the laboratory is doing any routine maintenance.

Many believe if the laboratory is open, it’s best to have at least two embryologists working. That’s because many labs’ procedures require that identification checks on patient material is always double checked by a second embryologist.

Additionally, you want your eggs, sperm, and embryos to be at a laboratory that is “busy” but not “overloaded.” We generally hear that a good “yearly cycles-to-embryologist ratio” lies somewhere between 150-to-1 to 200-to-1. Less and the embryologists are not in practice. More and they are likely overwhelmed.

Disaster Recovery

By our estimation over 30% of US clinics are in zones threatened by natural disaster. Post-hurricane in 2005, flooding in one major NYC laboratory required other clinics to help rescue samples. Ensure your clinic has a disaster recovery plan that includes real-time monitoring systems to indicate when equipment begins to fail, and an uninterrupted power supply if power gets severed.

Accreditation & Does It Really Matter?

Laboratories can be easily started, and are loosely regulated, so do not expect the government or any governing body to help you ascertain if your clinic’s laboratory is good. Below is a run-down of the more popularly mentioned accreditations.

The College of American Pathology (CAP) runs a peer-inspection program that ensures laboratories have methods for record-keeping and improvement. 96% of laboratories have CAP accreditation (find yours here) and if yours doesn’t, that is a red flag.

The State of New York has its own system of licensure, which is significantly more stringent than CAP’s, and any fertility clinic’s laboratory in the state should be certified. If a non-New York laboratory has New York accreditation that should be considered an encouraging sign.

The FDA does regulate laboratories if those laboratories work with donor eggs or donor sperm, which nearly all do (see if yours is registered here). Inspections are infrequent and they look to ensure standards are being met so diseases are not transmitted through sperm and egg donation. We view this similarly to CAP: it’s only noteworthy if your lab is not registered.

Accreditation and Regulatory

When Your Clinic Doesn’t Have a Lab

The cost for a clinic to start its own laboratory is a minimum of $500,000 to $1 million. A lot of doctors don’t have that kind of capital, so there’s a reasonable chance you will go to a clinic that uses another clinic’s laboratory.

According to our data, roughly 17% of U.S. clinics have this sort of arrangement. This happens more often in smaller clinics, but it’s also true of the fourth largest clinic in the country.

So, are outsourced laboratories anywhere near as effective as in-house laboratories? That is difficult to ascertain. Below we compare the IVF success rates for a clinic that uses its own in-house laboratory and an outsourced laboratory (this clinic drives most of the volume seen in the outsourced lab).

Since these labs are in the same region, they presumably have a similar patient mix, and since they receive patients from the same clinic, their patients were presumably treated similarly: protocols, rates of ICSI, PGS et al. Overall, their performance rates are identical. As to whether all outsourced labs are as skilled as this outsourced laboratory is hard for us to say.

Pro Tips

  • Make sure the laboratory is open 7 days a week while you’ll be cycling and try to avoid periods when the laboratory is undergoing any sort of major period of maintenance

  • Use LinkedIn to get a sense for who works in your clinic’s laboratory ensure they are experienced and the laboratory team has worked together for years

  • Ensure the embryologist working on your embryos is experienced and you can request multiple embryologists oversee steps like fertilization if you have concerns with one embryologist

  • Look for between a 150-to-1 and 200-to-1 cycles-to-embryologist ratio to ensure the laboratory is in practice but not overwhelmed

  • Ensure your clinic has a disaster recovery plan in place with real-time equipment monitoring and backup power generation

  • Ask or look up to see if your laboratory is CAP accredited and FDA registered. In the State of NY, they should have NY state licensure

  • Request to receive all of the same data and information from the outsourced laboratory as from an in-house laboratory
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