What Is a Good ART Program, and How To Find It

David Adamson, MD, FVCSC, FACOG, FACS©
Director, Fertility Physicians Of Northern California
Palo Alto & San Jose, California
http://www.fpnc.com

Adjunct Clinical Professor, Stanford University School Of Medicine
Associate Clinical Professor, University Of California San Francisco

Introduction

It was 30 years ago that Louise Brown was born in England. Very few people could appreciate what impact the assisted reproductive technologies (ART) would have on our specialty. Today there are many ART programs all around the world, so many that it is often difficult for patients to know which program is the best for them. This article will review the attributes of a good ART program, and suggests ways how patients can go about finding a good ART program.

WHAT IS A GOOD ART PROGRAM?

Most infertility specialists would consider the following attributes to be important for a good ART program. Patients should try to determine whether a program in which they are interested does well while considering the following factors.

1. High-Quality Laboratory

First, the ART laboratory must be of high quality. In the final analysis, this means that the laboratory can obtain maximum fertilization, maturation, implantation, development, and live birth rates. This, however, is dependent on a large number of factors, including physical facilities, equipment, and supplies. Physical plant requirements include adequate space, clean air, security systems, and proximity to operating rooms for gamete intrafallopian transfer (GIFT). Most important, a sufficient number of well-trained and experienced laboratory personnel need to be available. They also need to be able to communicate clearly with each other, with the medical team, and with the patient. A good laboratory also needs to have systems and protocols in place for all aspects of their operation, and need to have these organized in procedures manuals that are easily available and understood by all who work in the laboratory.

The Society for Assisted Reproductive Technology (SART) in the United States, and other professional organizations in other countries, have developed detailed manuals and inspection lists, and on-site inspection and certification systems that help to ensure that laboratories are following commonly-accepted standards. While such certification cannot guarantee laboratory quality, it does promote standards and practices which should improve laboratory quality overall. With few exceptions, patients should utilize ART programs that have met all the certification requirements for their professional organizations and governmental bodies. It is appropriate for patients to ask programs if they have met such standards.

2. High-Quality Clinical Care

Second, good ART programs must have high quality clinical care. This requires physicians who not only have had sufficient training and experience to provide state-of-the-art ART care, but also are capable of providing non-ART care, such as controlled ovarian stimulation, intrauterine insemination, surgical procedures such as hysteroscopy and laparoscopy, and treatment for the male. It is important to have the best possible ambience that includes adequate facilities, congenial surroundings, an efficient and pleasant staff, and an ability to avoid stress-promoting situations. This requires the ability to see the man and woman separately or together and to provide adequate time for consultation, and to have special areas for infertility patients away from obstetrical patients. The whole team should be involved in the support effort, but it is the physicians’ responsibility to set the tone. It is reasonable for patients to ask their physicians what type of specialty training and credentials they have to provide not only ART services but also other medical infertility services.

An especially important component of high quality clinical care is the ART program’s policy on multiple births. This includes the number of embryos that program recommends for replacement in the uterus, the availability of cryopreservation of embryos, the use of blastocyst culture, the potential to use induced reduction if triplets or a higher order pregnancy occurs and their adherence to professional or governmental guidelines regarding number of embryos to replace. It is important to establish the role patients play in making decisions regarding the number of embryos to replace or have cryopreserved. In some programs this might be left entirely up to patients, but most programs have guidelines they follow to reduce high order multiple births, and some countries have laws limiting the number of embryos to transfer. SART has guidelines that help patients and clinics determine the appropriate number of embryos to transfer.

3. Comprehensive Services

Third, ART programs should provide comprehensive services. These include laboratory services such as intracytoplasmic sperm injection (ICSI), embryo hatching, cryopreservation, blastocyst culture, and preimplantation genetic diagnosis (PGD). Clinical services that should be available include donor oocytes, donor sperm, and gestational carrier. Easy access to endocrinology, andrology, and genetics laboratories should be available. The provision of comprehensive services includes the concept of teamwork among the physicians, nurses, embryologists, mental health professionals, business staff, health plans, attorneys, and agencies providing care. Patients should ask their ART programs how they provide and coordinate these services.

4. Patient Choice

Fourth, good IVF programs must provide consultation services that explain all possible options so that patients can make the most appropriate choice for themselves. This includes discussion of the advantages and disadvantages of no treatment, standard treatment such as controlled ovarian stimulation and operative procedures, standard IVF and ICSI, use of donor gametes, gestational carriers, adoption, and childfree living. The relative benefit or utility of these different options, including an understanding of what is involved with the different choices and the chance of them occurring over what time interval, need to be reviewed. The financial, physical, and emotional costs must be discussed and made specific for patients’ financial and insurance situation, age, physical condition, and psychological status. Complications that especially need to be discussed include the risks of ovarian hyperstimulation, multiple births, problems of prematurity, congenital anomalies, induced reduction, and the relationship between the number of embryos replaced, pregnancy rates, and multiple pregnancy rates. The best choice is the one the patient makes for herself after she has been fully informed and consented regarding the possible options. Good choices must also optimize the chances for a healthy baby and mother. Good ART programs ensure that patients choose their treatment based on an optimal understanding of their situation, and do not choose for the patient. Referrals for second opinions to other reproductive endocrinologists or health care professionals are freely offered. In addition, they provide patients with consent forms that meet the legal requirements and are detailed and comprehensive enough to ensure that the patient can choose wisely. Furthermore, consent forms need to be signed, witnessed and dated at the appropriate times.

5. Excellent Documentation

Fifth, good IVF programs have excellent documentation of their clinical and laboratory care. Accurate and detailed documentation is essential to decrease the risk of error, understand prior care, benchmark outcomes and do clinical research. Careful documentation can be enhanced by standardized protocols and forms, as well as by information systems, but the most essential ingredient is commitment by the clinical and laboratory staff. Patients can ask how their care will be documented and about access to their medical records.

6. Research

Sixth, good IVF programs usually do some clinical and/or laboratory research. Research is important not only because it can create new knowledge, but also because those participating in research learn much more about specific aspects of their program and become better clinicians and embryologists in the process. Patients can ask their physicians about research In which they are involved.

7. Professional Management

Seventh, good IVF programs provide skilled professionals to manage their business. This includes providing advice to patients to maximize insurance reimbursement and to help patients understand the financial implications of their care. If additional financial services are provided, such as financing or “money back” plans, these good programs ensure that their patients are well educated about them before agreeing to them. Patients can ask about the professionals involved in the ART program.

8. Cost-Effective Care

Eighth, good ART programs are aware of and practice cost-effective medicine. This requires that programs only provide services that are clinically appropriate and charge reasonable amounts for their services. It also means that programs constantly strive to reduce their costs and provide better services for their patients. Patients should compare costs among programs, but be careful that they are comparing the cost of similar services when they do so.

9. Psychological Support

Ninth, good ART programs recognize that infertile patients require emotional support as they pursue infertility care. Infertility is a life crisis for many patients, and represents a loss of self-esteem, loss of security, and loss of self as a woman/man, wife/husband, and mother/father. The infertile patient’s overall quality of life is often adversely affected with work schedules, vacations, sex life, and ability to socialize with friends all being negatively impacted. Serious stresses are put on the marital relationship. It is important that ART programs recognize this aspect of infertility and help patients deal with it. Interventions include giving the patient an accurate prognosis, discussing ways to increase control for the patient, reviewing stress-relieving activities, identifying alternative forms of affection and sexual communication, and facilitating access to information and emotional support, such as that provided by RESOLVE, American Fertility Association and other patient support groups, and also on the Internet. Physicians need to counsel couples about problems associated with having children, including the dramatic changes in lifestyle that occur with parenting, and the need not to have unrealistic expectations for themselves or their child.

10. Ethical Care

The tenth attribute of a good ART program is that it practices medicine ethically. ART procedures today are at the center of several of the major ethical dilemmas. These include the use of ART in couples for whom there are religious proscriptions, abortion, induced reduction of high order pregnancies, lifesaving medical treatment of seriously ill babies, appropriate age for parenting, donor sperm, donor oocytes, splitting of donor oocytes, gestational carriers, surrogates, single parenting, sexual orientation’s role in parenting, insurance funding of infertility, limitation of services under managed care, sex selection, preimplantation genetic diagnosis, chorionic villus sampling, amniocentesis, genetic therapy, twinning, embryo research, cloning, and others. There are almost no “correct” or “right” answers to most of these issues. Some of what seemed “wrong” thirty years ago is accepted today (e.g. IVF), some of what was accepted 15 years ago is seriously questioned today (e.g. daughter to mother egg donation), and some of what is questioned today may become commonplace in the future (e.g. preimplantation genetic diagnosis for advanced age). It is important for reproductive physicians to familiarize themselves with the role ethics play in the development and application of the assisted reproductive technologies if they are to counsel their patients wisely.

HOW TO FIND A GOOD ART PROGRAM

Not so long ago most patients found their doctors either by a referral from another physician or by a referral from a patient. Patients and physicians felt they knew who the “good” doctors were, even though there are few, if any, objective measurements to determine what a “good” doctor is. However, the old maxim that the three A’s of a successful practice were availability, affability, and ability is still true since the absence of these attributes generally result in lower quality care. The reason practices that focused on the three A’s were successful is that they were providing what patients wanted, that is, delivering value.

Patients considering ART should ask their physicians and friends about ART programs with which they are familiar. They can also look on the Internet. Professional organizations such as the American Society for Reproductive Medicine (ASRM) and governmental organizations have lists of ART programs, usually with information about their certification and accreditation status, sometimes also with programs’ success rates. Consumer organizations such as RESOLVE and American Fertility Association have information about ART programs. Patients can begin to evaluate programs based on printed information, attendance at seminars put on by the program, by telephone and on the Internet. Patients can use the 3 A’s to get an immediate impression of the ART program and narrow their choices down. They can then get more information about the ten attributes of a good ART program outlined above for these two or three programs so that they can choose the best program for them.

Quality service is the most important requirement for any good practice. This involves, first of all, being available. This is not as simple as it once seemed. Availability now means having sufficient staff to answer telephones so that patients are not left for long periods of time on hold, or do not have to speak to an answering machine every time they call. It may also involve the judicious use of answering machines both for receiving incoming messages and for leaving messages with patients. In ART, availability frequently means the ability to provide seven day a week, 52 weeks per year service. While it is possible to program some aspects of infertility care, much of it remains tied to patients’ biological rhythms. It is therefore important that patients be able to obtain office visits on short notice, frequently the same day or the next day, at times which are convenient to them, and be seen on time and for as much time as they need. Clearly all of these requirements create many more demands on the ART program than on the vast majority of other medical offices. The utilization of flexible schedules, as well as ancillary health care personnel such as nurse practitioners, can be instrumental in ensuring that such access to the practice is available most of the time. Patients should ask about the availability of different ART and fertility services, and the physical location and scheduling of appointments for these services.

The second major component of quality service is affability, not just from the physician but from all the staff. It is essential that individuals working in all positions are capable of a very high level of interpersonal skills and commitment to quality patient care. This is especially true in ART programs where anxieties, frustrations, disappointments, and depressions occur frequently. Such care and attention need to be provided consistently, even to patients who may have very difficult clinical situations and/or who can place major time and psychological demands on a practice. Patients should be able to tell from their interaction with the ART program if this commitment to meet their clinical needs is present. They should also be able to determine the ART program’s commitment to providing non-clinical services that are important, such as financial counseling and psychological support.

Ability is the third A important for a good ART program. This requires well trained, experienced, and highly motivated reproductive clinical and laboratory specialists who are consistently undertaking continuing medical education through reading, meetings, and the acquisition of new skills. There should also be a commitment to matching or exceeding professional standards that can be determined from asking the ART program about their utilization of professional standards and guidelines. Other attributes of a high quality program include the performance of research and teaching that help maintain current state-of-the-art knowledge and skills. It is appropriate for patients to ask their physicians about these aspects of their program.

EVALUATION OF ART PREGNANCY RATES

All patients want to know what the chances are that they will have a baby if they undergo ART cycles. In many countries the “success rates” of individual ART programs are published or are available on the Internet. In other countries the results are published but not for individual programs. It is only natural that patients will want to use these results to determine which program they should choose. Indeed, the original intended purpose of publishing these results in many countries has been to assist patients in selecting an ART program. And these numbers can be helpful in choosing between a program with very high pregnancy rates compared with one that has very low pregnancy rates. However, often the published success rates are over-interpreted by patients who give them an accuracy and meaning greater than they actually have. There are many difficulties and problems in measuring pregnancy rates from ART treatment.

An excellent example of this is the SART Registry report of results in the United States. Despite the best efforts of clinicians, biologists, statisticians, computer programmers, the American Society for Reproductive Medicine (ASRM), the Society for Assisted Reproductive Technology (SART), and the Centers for Disease Control (CDC), the report is not perfect . Some of the outstanding issues with reporting outcomes are:

• The definition of pregnancy rate is now live birth per ovarian stimulation. All cancelled cycles need to be included in the denominator. Some clinicians think this is not an accurate way to represent ART outcomes.
• Some argue that pregnancies achieved from cryopreserved-thawed oocytes in subsequent cycles should be included in the fresh cycle pregnancy rate. No satisfactory way to do this has been identified.
• Results vary from program to program each year and within programs from year to year based on random variation alone.
• Patient populations vary greatly from program to program. Some of these differences, such as age, are known to affect pregnancy rates while the impact of others, such as type of prior treatment, are not yet known. Data to identify variables which predict outcomes are now being collected, but much is still to be learned before program-to-program comparisons can be considered valid.
• Patient selection varies greatly among programs. For example, some programs encourage more patients to use donor oocytes than other programs; this affects the reported pregnancy rates.
• The delay in reporting means that by the time clinic-specific results are reported, many programs have changed personnel and/or protocols, and/or begun utilizing new technology (e.g. intracytoplasmic sperm injection).
• Different programs use different protocols with some encouraging many patients to undergo standard infertility treatment before pursuing ART, while other programs recommend ART immediately to almost all of their patients.
• Some programs have focused their advertising on categories of patients in which they have the best results, or may cryopreserve embryos more frequently than other programs.
• Some programs replace larger numbers of embryos, thereby obtaining higher pregnancy rates, but also higher multiple birth rates, which is not a desired outcome but to which less attention has been given in the past.
• Individual patient values and preferences vary in different areas of the country. For example, the acceptability of multifetal reduction (MFR) varies greatly, thereby influencing patients’ decisions regarding the use of ovarian stimulation drugs, IVF, and/or blastocyst culture, the number of embryos to be replaced, as well as other treatments.

There are other difficulties which makes it very complicated and difficult to directly compare one program with another based on published pregnancy rates. In fact, in the SART/CDC report, there is a statement on every clinic report page that states, “A comparison of clinic success rates may not be meaningful because patient medical characteristics and treatment approaches may vary from clinic to clinic.”

SUMMARY

Many factors affect the quality of an ART program. These include the quality of the laboratory and clinical services, the availability of comprehensive services, documentation of care, patient choice, research and teaching commitment, cost-effectiveness of care, psychological support, professional management and ethics. Patients should review clinic-specific reports of pregnancy rates, but recognize their limitations. In the final analysis, the availability of the care and the rapport with the physician are important considerations in deciding where to undergo treatment.

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