The embryology lab is where sperm and egg will fertilize and your embryos nurtured until they are ready to be transferred back into your uterus for implantation and pregnancy. Who oversees the lab and works with the embryos is important in your consideration of an IVF Program.

What About The IVF Lab?

Federal legislation passed in 1988, the Clinical Laboratory Improvement Amendment (CLIA), requires accreditation of all laboratories performing testing, analysis and reporting. This is a professional standard. Ask about this accreditation. The Society for Assisted Reproductive Technology (SART) website has a very simple way to check up on an IVF program's accreditation. On the SART National Summary Page, you can click on the state and all accredited programs in that state will pop up. You can then find the name of the clinic in question and read its statistics.

For an IVF lab, you want to see CAP certification, which comes from the Commission on Laboratory Accreditation of the College of American Pathologists. CAP is widely considered the leader in quality assurance and accreditation is recognized by the federal government as equal to or more stringent than the government's own inspection program. This is because the CAP inspection program is designed to ensure the highest standards of excellence in all areas of the lab. CAP inspectors examine records and quality control indicators, including staff qualifications, equipment, facilities, safety programs and records, and overall lab management.

Additional accreditation by other national organizations, such as the Commission on Laboratory Accreditation (COLA), is recommended but not necessary.

What Can The Lab Do?

In addition to the standard offerings for sperm preparation and basic fertilization of eggs, an IVF lab should be able to take care of additional services in-house rather than send specimens out to another lab.

Cryopreservation (Embryo and Sperm)

It is critical that a clinic have accredited facilities for freezing and storing embryos. For couples selecting donor insemination and those freezing sperm for later use, sperm cryopreservation on site is desirable. While exact timing of a cycle can enable use of sperm stored at another site, it is far more expedient to have storage and thawing protocols handled at the site where the procedure will take place. Also, the clinic needs to be able to freeze embryos for later use if you have an excess number of embryos and want to use them in later IVF attempts.

Micromanipulation Services

Intracytoplasmic Sperm Injection (ICSI), the latest in micromanipulation techniques and the most promising for couples with severe male factor, involves injecting a single sperm into the egg.

Partial Zona Dissection (PZD) is a procedure in which the shell surrounding the egg is opened to allow sperm to enter more easily. With the advent of ICSI this procedure now done rarely. Sub-Zonal Insemination (SUZI) involves injecting a sperm into the area between the zona and the egg once the shell has been opened. Once again, this is becoming almost obsolete with the growing popularity of ICSI.

Assisted Hatching (AH) involves making a tiny slit in the outer covering of an embryo to allow it to more easily squeeze out of its shell (zona) before implanting in the uterus. This procedure is sometimes done for couples with unsuccessful past IVF attempts, or in older women who appear to have thickened zonas around their embryos.

The availability and success of any of these procedures depends on the skill of the embryologist performing the micromanipulation technique. Like any medical procedure, specialists with the most experience, most talent, and best equipment generally do the best work.

Who Is On Staff In The Lab?

An Embryology Lab Director & ART Lab Staff

The head embryologist and lab director should be an MD or have a doctorate (PhD) in a chemical, physical or biological science. He or she should have a minimum of two years documented experience and have performed at least 100 of these procedures. They should have a minimum annual live-birth rate of 10% per retrieval cycle in IVF procedures.

There may also be on staff one or more embryologists who should each, if on staff, perform at minimum 20 complete ART procedures annually.

Among the embryology staff there should be one person with experience in each of these fields, and one person may be experienced in one, two or all of the following:

• preimplantation embryology
• andrology
• pre- and post-fertilization events including cryopreservation

This person or persons should have experience with and competence with freeze-thaw techniques for embryos, and have a demonstrable record with a survival/developmental rate of more than 50 percent. Embryologist should also have experience in tissue culture, sperm-egg interaction and sterile technique.

An Andrologist

Andrologists are generally laboratory specialists, rather than an MD, with college degrees in biochemistry, biology, endocrinology or physiology. They focus on hormonal issues and sperm quality rather than anatomical reasons for male factor infertility. They are responsible to develop and direct the procedures for handling sperm in larger clinics, where they work closely with the embryologist to prepare sperm up to the point of fertilization. In smaller clinics, the andrologist may also be the embryologist.