Criteria for Selecting an Infertility or IVF Clinic
Criteria for Selecting a High-Tech Infertility Clinic
Reproductive Endocrinologist (May also be Reproductive Surgeon):
It is recommended that a board-approved M.D. who has completed a fellowship in Reproductive Endocrinology direct the follicular recruitment phase of any ART cycle. The American Society for Reproductive Medicine (ASRM) recommends that each physician supervise a minimum of 20 follicular recruitment cycles per year. Additionally, it is critical that there be access to a Reproductive Surgeonspecializing in treating obstructions, endometriosis, uterine abnormalities and other reproductive organ disorders which require surgical repair and use of laporoscopic microsurgery techniques.
|Critical for female diagnosis & surgical repair of reproductive organ disorders||Critical for female diagnosis and surgical repair of reproductive organ disorders.||Critical||Critical||Critical||Critical|
Clinics should have access to the services of a Reproductive Immunologist for patients who have suspected immunological barriers to achieving pregnancy. Autoimmune factors include lupus-like anticoagulant antibodies, antiphospholipid antibodies, antithyroid antibodies and low levels of leukocyte antibodies. Alloimmune factors include elevated levels of natural killer cells, embryotoxity and low levels of leukocyte antibodies. Much of the testing for these diagnoses is not available in standard labs, hence the importance of affiliation with a facility which has both an RI and testing capabilities.
|Critical in diagnosing immunological barriers to pregnancy, especially for patients with recurrent losses.||Critical during treatment cycle for those with diagnosed immune problems.||Critical during treatment cycle for those with diagnosed immune problems.||Critical during treatment cycle for those with diagnosed immune problems.||: Critical during treatment cycle for those with diagnosed immune problems.||Critical during treatment cycle for those with diagnosed immune problems.|
The embryo laboratory director should be an M.D. or have a doctorate in a chemical, physical or biological science. He or she should have a minimum of two years documented experience in a program performing at least 100 IVF-related procedures per year and a minimum annual live-birth rate of 10 percent retrieval cycle. Each staff embryologist should perform at least 20 complete ART procedures annually. Among the embryology staff there should be one person with experience in each of these fields: preimplantation embryology, andrology and pre- and post-fertilization events. Before attempting human freezing, at least one member of the embryo laboratory staff should have demonstrated the ability to freeze-thaw embryos with a survival/developmental rate of more than 50 percent. Embryo lab technologists should have bachelor’s or master’s degrees and documented experience in tissue culture, sperm-egg interaction and sterile technique, and have completed at least 30 IVF procedures.
Reproductive Urologist (May also be Reproductive Surgeon):
Clinics must have access to a urologist who specializes in diagnosing and treating male factor problems. While it is not critical that the urologist be on the clinic staff, it is important that the urologist work closely with staff to ensure that treatment of the couple is a coordinated effort. A Reproductive urologist is an M.D. with an additional residency in treating urinary tract and male reproductive disorders, two years of general surgical training and specialized, microsurgical reconstructive training in repairing obstructions, varicoceles and other anatomic disorders of the male reproductive tract.
|Critical in diagnosing/treating male factor. Must work closely with clinic staff to coordinate couple’s treatment.||Critical||Critical||Critical||Critical||Critical|
Andrologists are generally laboratory specialists, rather than M.D.s, with doctorates in biochemistry, treatment cycle, endocrinology or physiology. Their focus is hormonal issues and sperm quality rather than anatomical reasons for male factor infertility. They develop and direct procedures for handling sperm in larger clinics, where they work closely with the embryologist to prepare sperm up to the point of fertilization. In some cases, the andrologist is also a urologist.
|N/A||Not Critical||Not Critical||Not Critical||:Not Critical||Not critical for treatment cycles, but valuable in maintaining lab standards and developing procedures for new technologies.|
Geneticist and Genetic Counseling:
A clinic should have access to a geneticist for patients who may have genetic abnormalities which affect patients with chromosomal abnormalities which may affect fertility. Parental screening should include thalassemia, sickle cell anemia and Tay Sachs syndrome. In cases of recurrent miscarriage, parents should be screened for other genetic anomalies. Once a couple achieves pregnancy, genetic screening (CVS, amniocentesis and alpha fetoprotein (AFP) testing), along with appropriate counseling, should be available.
|Critical for diagnosing patients with chromosomal abnormalities which may affect fertility.||Not critical for cycle. Important for fetal evaluation if pregnancy occurs||Not critical for cycle. Important for fetal evaluation if pregnancy occurs||Not critical for cycle. Important for fetal evaluation if pregnancy occurs||:Not critical for cycle. Important for fetal evaluation if pregnancy occurs||Not critical for cycle. Important for fetal evaluation if pregnancy occurs|
Cryopreservation (Embryo and Sperm):
It is imperative 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.
|Not Critical.||Critical if using frozen sperm.||Critical if using frozen sperm.||Critical if using frozen sperm.||:Not critical||Critical if using frozen sperm.|
Micromanipulation (PZD, SUZI, ICSI):
Partial Zona Dissection (PZD) is a procedure in which the shell surrounding the egg is opened to allow sperm to enter more easily. Sub-Zonal Insemination (SUZI) involves injecting a sperm into the area between the zona and the egg once the shell has been opened. 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. The success of any of these procedures depends on the skill of the embryologist or technician performing the micromanipulation technique. If scheduled for one of these procedures, it is imperative to compare stats of several clinics.
|Not Applicable||Not critical||Not critical||Not critical||:Not critical||Critical|
Cycle Monitoring/Staff Availability:
It is imperative that a clinic offer 7-day per week availability for patients in a treatment cycle. This means staff for ultrasound monitoring, blood tests and answering questions. A doctor must be “on call” 24 hours per day during treatment cycles.
|Availability on appropriate days imperative for accurate diagnosis.||Critical||Critical||Critical||Critical||Critical|
Federal legislation passed in 1988, the Clinical Laboratory Improvement Amendment (CLIA), requires accreditation of all laboratories. Additional accreditation by a national organization, such as the Commission on Laboratory Accreditation (COLA) and the American College of Pathologists (CAP) is recommended.
Many clinics require psychological counseling for patients contemplating ART procedures, especially when using donor eggs or donor sperm. Hospital Affiliation: While it is not critical to have on-site hospital facilities, doctors must have affiliation with a hospital for admission when complications or emergencies develop. Patients with insurance considerations should determine if coverage is offered for the affiliated hospital.
Reporting of Success Rates:
The Fertility Clinic Success Rate and Certification Act of 1992 (HR4773) directs the selection of a secretary of Health and Human Services to develop a model program for the certification of embryo laboratories. It also requires ART programs to provide their success rates to the Center for Disease Control (CDC) for annual publication. Though not fully implemented, this law standardizes reporting procedures so that “success” rates reflect the actual number of pregnancies in relation to completed ART cycles. Couples in treatment should ask for success rates (take-home baby rates) representing their particular diagnosis and prospective ART procedure. Additionally, when comparing clinic rates, it is imperative to know whether results include stats for women over 40 and men with male factor.
|Critical in selection of clinic.||Not Applicable.||Not Applicable.||Not Applicable.||Not Applicable.||Not Applicable.|
- In Vitro Fertilization (IVF): Fertilization outside the body in a glass dish. Eggs are aspirated from the woman’s ovaries in a surgical procedure, mixed with sperm and, if fertilization and cell division occur, placed in the uterus two or three days later.
- Gamete Intra-Fallopian Transfer (GIFT): Combining eggs and sperm outside the body and returning them immediately to the fallopian tubes, where fertilization will occur.
- Zygote Intra-Fallopian Transfer (ZIFT): IVF where a zygote (a fertilized egg that has not yet divided) is transferred into the fallopian tube.
- Frozen Embryo Transfer (FET): When too many embryos for implantation result from an ART procedure, they’re frozen for use in a future cycle. FET cycles are usually less expensive because they require only one surgical procedure and do not require superovulation drugs.
- PZD, SUZI, ICSI: See “Micromanipulation ” entry in this chart.