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.
