The Right Stuff
First and foremost, an IVF laboratory works because of its people. They are the most critical and essential element to success. A typical lab hosts a director, embryologists, and andrologists (the specialists that work primarily with male reproductive issues). In addition, there are clinical chemistry technicians for hormonal and other diagnostic assays. At RMI, each member of the lab team holds an advanced academic degree in biology and they are either board certified or eligible for board certification within their specialty areas. Board certification ensures that the biologists have completed apprenticeships under professional supervision within their disciplines and that they have passed lengthy written exams on the biology that underlies what occurs during the natural reproductive cycle as well as during an IVF cycle.
They also are certified in terms of the experience required to run the laboratory equipment needed to do IVF and ART and in all the specific procedures such as IVF, ICSI (Intracytoplasmic Sperm Injection), cryopreservation, and andrology. It takes years to achieve this level of competency and the lab staff who receive these certifications are the best of the best in the United States. Above all though, they are first and foremost dedicated to getting the very best results for the patient during their IVF/ART procedure.
From the Ground Up
Building and running an IVF/ART laboratory is complex. Much like surgical or procedure rooms in a hospital setting, an IVF/ART laboratory has special air handling requirements to ensure clean and fresh air, lighting requirements to protect the embryos during procedures, and a source of uninterrupted power. The sperm and eggs must be handled in a “clean room” like environment to prevent unwanted contamination and the lights are kept low to avoid any possibility of photo damage to the eggs or embryos.
The lab contains multiple incubators which serve as “hotel rooms” for the sperm and eggs to unite, and later for up to five days of “culture” during which the resulting embryos grow and thrive “in vitro” until they are transferred to the mother’s uterus. “In Vitro” is Latin for “in glass” as opposed to “In Vivo” which means “in the body”. This is how In Vitro Fertilization gets its name…fertilization takes place in a culture dish outside the body. The irony of this original definition is that IVF babies are no longer Test Tube Babies nor are they cultured “in glass”. They are maintained in plastic culture dishes that have been specifically tested and approved for use in IVF! The environment of the incubators have been set to mimic the warmth, humidity and low oxygen conditions found in the oviduct and uterus of the mother. These incubators are monitored continuously by the lab staff and have electronic alarm systems in place to ensure all environmental parameters are kept within normal limits 24/7/365.
Embryos grow in “culture medium” which has also been developed specifically for human embryos to meet their nutritional needs.
Another great piece of lab equipment is the ICSI machine. This is a large microscope fitted with mechanical arms and controls which allow the lab staff to physically manipulate both sperm and eggs!! Imagine working on an egg which is the diameter of a human hair and injecting it with a sperm that is one tenth the size of the egg!! Using very fine glass needles that are hollow, a single sperm can be picked up and injected directly into an egg without damaging it. This bypasses potential problems with fertilization by the sperm alone and usually ensures an embryo will result. The procedure is called Intracytoplasmic Sperm Injection ( ICSI).
The same “micromanipulators” can be used to remove cells from the early embryo in order to send them out for genetic testing. This is called embryo biopsy and the technique is commonly used to either screen for potential genetic disorders that might be carried by an embryo or to determine the presence of a known disorder that must be eliminated from consideration for uterine replacement. The first is called Preimplantation Genetic Screening and the second, is Preimplantation Genetic Diagnosis. So as you would imagine the lab staff who do this work are very highly skilled individuals!
Keeping it Cool
And finally, there is the cell freezer! The ability to “freeze” gametes and embryos is hugely important. We actually use the term cryopreservation instead of freezing because technically we are not freezing the specimens. Freezing does not require that the specimen be alive after it is thawed ( imagine thawing out a frozen hamburger for example) , whereas “ cryopreservation” means that we are using super low temperatures to slow down the metabolism of the gametes and embryos to preserve their viability in order to thaw them later and completely restore them to normal function.
Cryopreservation used to be done utilizing a computer-controlled cell freezer that slowly dropped the temperature of the embryo to levels where it could be stored in liquid nitrogen indefinitely. More recently, IVF/ART labs have begun to shift to a new faster method called “Vitrification”, which is similar to “flash freezing” an object directly in supercold liquid nitrogen. The results reported so far are very good for vitrification and embryonic survival and pregnancy rates from vitrified embryos are surpassing those of the older “slow freeze” method. Vitrification also appears to hold promise for successful cryopreservation of human eggs as well. These are just a few of the complex pieces of equipment and procedures you will find in an IVF /ART lab. They are essential for doing IVF/ART cases and for safely storing any extra embryos that a patient might have from a procedure so she can use them in the future. It takes a lot of training, skill and patience to be an IVF lab person, that is for sure.
The Rules of the ‘Road’
The final element of creating an IVF/ART laboratory is ensuring that the lab and staff meet the regulatory requirements of the Federal and State governments within which the facility and staff reside. In 1988 and again in 1992, the Federal government enacted laboratory standards under which all medical laboratories, regardless of specialty, must operate. Compliance with standards for diagnostic laboratories, such as an andrology lab, is reviewed annually and surveyed biannually in order for the program to retain its license to operate. In addition, as a result of the Wyden Act of 1992, all IVF clinics must report their success rates for IVF/ART annually to the Centers for Disease Control in Atlanta, GA.
The data on IVF programs in the USA is summarized by state and available online for review. These regulations, along with a host of other requirements, are what helps protect the patient safety and ensures a good outcome from the diagnostic testing and the clinical procedures for IVF/ART. To pass the annual and biannual reviews, a lab and its staff actually must provide daily monitoring and documentation in writing of all that goes on within. That is a lot of work, but again, a certified IVF lab provides safety and assurance to the patients that all is in order. At RMI, we meet all the State and Federal requirements and we are licensed by CLIA, IDPH, and certified by the Joint Commission (JCAHO). RMI is also a longstanding member of the Society of Assisted Reproductive Technology and abides by its guidelines for professional conduct and honest reporting of IVF/ART results.
In the end, a lab, just like an embryo, relies on the combination of the best ‘elements’ and, of course the right people. After 29 years of directing IVF laboratories and training many M.D. fellows and lab technicians, I am extremely proud of Team RMI. I know how hard they work and it shows in our outstanding results that complement and result from the excellent care provided by our physicians, nurses and support staff.
All of this, along with your embryos, creates ‘the right stuff’.
Richard G. Rawlins, Ph.D., HCLD, ELD (ABB) is the Lab Director for Reproductive Medicine Institute. Dr. Rawlins is a Professor of Obstetrics and Gynecology and a Professor of Anatomy & Cell Biology at Rush Medical College. He received his Ph.D. from Michigan State University in 1984. He joined Rush University Medical Center in Chicago that same year and began the development of the Centers In Vitro Fertilization Program. Dr. Rawlins also built out and directed the reproductive laboratories at Centro de Fertilidad del Caribe in San Juan, Puerto Rico, and the Clarian North Fertility Center in Carmel, Indiana.
In conjunction with clinical responsibilities, Dr. Rawlins is an active academic. He lectures on reproductive anatomy and histology to medical students, has participated in the Division of Cell Biology in the Rush Graduate College, trained clinical fellows in the ABOG approved clinical Fellowship Program for Reproductive Endocrinology and Infertility at Rush and lectured to the residents on reproductive endocrinology and statistics. Dr. Rawlins has also trained 68 clinicians and biologists in IVF/ART and he has established more than 15 IVF/ART programs globally, including sites in Germany, Poland, Brasil, Chile, Paraguay, Puerto Rico, Taiwan, Indonesia and the Philippines.