Fellowship training and board certification in reproductive endocrinology and infertility Joseph C. Gambone, D.O., M.P.H.,a James H. Segars, M.D.,b Marcelle Cedars, M.D.,c and William D. Schlaff, M.D.d a Department of Obstetrics and Gynecology, David Geffen School of Medicine, University of California, Los Angeles, California; b Department of Gynecology and Obstetrics, Johns Hopkins University, Baltimore, Maryland; c Department of Obstetrics and Gynecology, University of California, San Francisco, California; and d Department of Obstetrics and Gynecology, Thomas Jefferson University, Philadelphia, Pennsylvania
Reproductive endocrinology and infertility (REI) is one of the original officially recognized subspecialties in obstetrics and gynecology and among the earlier subspecialties in medicine. Recognized by the American Board of Obstetrics and Gynecology in 1972, fellowship programs are now 3 years in length following an obstetrics and gynecology residency. Originally focused on endocrine problems related to reproductive function, the assisted reproductive technologies (ART) have recently become the larger part of training during REI fellowships. It is likely that the subspecialty of REI strengthens the specialty of obstetrics and gynecology and enhances the educational experience of residents in the field. The value of training and certification in REI is most evident in the remarkable and consistent improvement in the success of ART procedures, particularly in vitro fertilization. The requirement for documented research activity during REI fellowships is likely to stimulate a more rapid adoption (translation) of newer research findings into clinical care after training. Although mandatory reporting of outcomes has been proposed as a reason for this improvement the rapid translation of reproductive research into clinical practice is likely to be a major cause. Looking forward, REI training should emphasize and strengthen education and research into the endocrine, environmental, and genetic aspects of female and male reproUse your smartphone duction to improve the reproductive health and fertility of all women. (Fertil SterilÒ 2015;104: to scan this QR code 3–7. Ó2015 by American Society for Reproductive Medicine.) and connect to the Key Words: REI, certification, training, subspecialty, infertility, endocrinology Discuss: You can discuss this article with its authors and with other ASRM members at http:// fertstertforum.com/gambonej-training-certification-rei/
A
s of May 2014 there were 1,269 American Board of Obstetrics and Gynecology (ABOG)–certified reproductive endocrinologists in the United States. Over a fairly short time period of about 35 years the clinical subspecialty of reproductive endocrinology and infertility (REI) that was initially formed in the early 1970s has matured and continues to evolve. The process for training and certifying obstetricians and gynecologists in REI is relatively old compared with other certified clinical subspecialties
in medicine, with most subspecialties recognized by the American Board of Medical Specialties in the past 15– 20 years. Interest and training activity in the endocrinology of reproduction actually began much earlier, even before the specialty of obstetrics and gynecology was formed. In 1916 a small group of physicians in the United States met at the American Medical Association annual meeting to formalize an association for endocrinology. The Association for the Study of Internal Secretions was
Received March 13, 2015; revised April 6, 2015; accepted April 9, 2015; published online June 3, 2015. J.C.G. has nothing to disclose. J.H.S. is on the American Board of Obstetrics and Gynecology. M.C. has nothing to disclose. W.D.S. has nothing to disclose. Reprint requests: Joseph C. Gambone, D.O., M.P.H., Departments of Obstetrics and Gynecology, David Geffen School of Medicine, University of California, Los Angeles, California (E-mail: jgambone@ ucla.edu). Fertility and Sterility® Vol. 104, No. 1, July 2015 0015-0282/$36.00 Copyright ©2015 American Society for Reproductive Medicine, Published by Elsevier Inc. http://dx.doi.org/10.1016/j.fertnstert.2015.04.039 VOL. 104 NO. 1 / JULY 2015
discussion forum for this article now.*
* Download a free QR code scanner by searching for “QR scanner” in your smartphone’s app store or app marketplace.
incorporated in Delaware in January 1918 (1). This group met annually, except for 2 years during World War II, eventually changing their name to The Endocrine Society in 1952. The journal Endocrinology was published starting in 1917 and a second journal, Journal of Clinical Endocrinology, began in 1941, later adding Metabolism to the journal title to become JCEM. Research and opinion articles relating to the endocrinology of reproduction have been published in both of those journals over the years. The subspecialty of reproductive endocrinology in obstetrics and gynecology was fortunate to have had very gifted early leaders such as Howard and Georgeanna Seegar Jones at Johns Hopkins, Leon Speroff and Nathan Kase at Yale, and Samuel Yen and Robert Jaffe at the University of California, 3
VIEWS AND REVIEWS who along with others conducted research and began teaching and writing about the physiology and endocrinology of reproduction. The now classic textbooks by Yen and Jaffe as well as Speroff, Kase, and Glass introduced the topics of reproductive endocrinology and infertility into the mainstream of medical practice, including obstetrics and gynecology. These leaders were among the first to establish REI fellowship programs in the United States. An interesting historical note is that because there were initially no boardcertified REI subspecialists in obstetrics and gynecology, and an exam was required, early candidates for certification were also examined by internists with special research and scholarly training in the endocrinology of reproduction. The subspecialty of REI was officially recognized by ABOG in 1972. Fellowship programs in reproductive endocrinology lasted for 2 years and the focus was largely on reproductive disorders that had an endocrine basis for their pathophysiology. These disorders included abnormal pubertal development, recurrent miscarriage, polycystic ovary syndrome (PCOS), menopause, and, in some centers, contraceptive care and research. Laparoscopy and reconstructive surgery were also an important aspect of REI training when formal training programs began. The clinical involvement of reproductive endocrinologists in advanced assisted reproductive technologies (ART) came soon after the report of the first successful in vitro fertilization (IVF) birth in 1978 in the United Kingdom (U.K.) by Robert G. Edwards and Patrick C. Steptoe. Research that led up to this achievement included successful IVF in the rabbit by Chang (2) in 1959 and in the human in 1965 by Edwards and Jones. The work done at Johns Hopkins in 1965 by Edwards and Jones was initially reported to be unsuccessful, but a later review of photographs revealed that human fertilization in the laboratory had actually been achieved that year (3). In the United States, translating these successes in the laboratory into clinical practice was complicated and delayed by political debate about the appropriateness of government funding for this type of research. After the first live birth from IVF in 1978 in the U.K., however, couples in the United States with infertility resistant to traditional treatments applied political pressure and helped to propel the science and clinical activity of IVF into the mainstream. In 2010 the Nobel Prize for Medicine was awarded to Robert G. Edwards for his seminal work in IVF. (According to Nobel Committee rules, a Nobel prize can not be awarded posthumously, thus eliminating Patrick Steptoe from consideration. Dr. Steptoe died in 1988.) The development and expansion of IVF capabilities has had a profound effect on human reproduction, with more than 5 million births worldwide, as well as a big impact on the field of REI.
CURRENT REGULATION OF FELLOWSHIP TRAINING AND THE CERTIFICATION PROCESS FOR REI There are currently 43 ABOG-certified REI training programs in the United States, and each year 45 candidates are certified. Today, fellowship programs have increased 4
to 3 years in duration and the curriculum for fellowship training consists of surgical skills, ART, clinical training, and didactic education, including biostatistics and epidemiology. In addition, fellows in the subspecialty were always required to pursue a structured research project as a requisite for certification. Currently the requirements and criteria for training in the subspecialty are determined by the Division of Reproductive Endocrinology and Infertility at ABOG. After satisfactory completion of an accredited fellowship, graduates may sit for the written exam in the subspecialty. Candidates who pass the written exam and certification in obstetrics and gynecology (basic specialty boards) are eligible to apply for the oral subspecialty exam. ABOG has now adopted a continuous certification process. That is, REI-certified physicians must annually complete several maintenance of certification (MOC) assignments to maintain their certified status. Training in REI in the United States is rigorous, and high standards are required for acceptance into certified programs and for eventual subspecialty board certification by ABOG. Fellows must master a broad range of information and may choose to become proficient in advanced surgical procedures such as minimally invasive surgery, microscopic tubal anastomosis, and reconstructive surgery. This training is in addition to ART-related skills which consume most of the clinical time in many programs. Recently some REI fellowships have incorporated simulation into fellowship training, becoming one of the first to do so in the obstetrical subspecialties. This aspect of fellowship training, which involves the use of nonhuman models to teach and practice clinical skills, is beneficial and is expected to increase in the future. Whether simulation will substitute for diminished operative experience in fellowships is unclear. The American College of Obstetricians and Gynecologists (ACOG) supports, first and foremost, the concept of one unified medical specialty for the health care of women, particularly for their reproductive needs. The specialty training and ongoing medical education materials and programs provided by ACOG make obstetricians and gynecologists uniquely qualified to provide this care. The role of advanced fellowship training and certification in one of the subspecialties, such as REI, is seen as enhancing this overall concept as long as it does not detract from the clinical experience of residents in the basic specialty or inappropriately limit the scope of practice for those who are certified only in obstetrics and gynecology. Members of all of the subspecialty groups in obstetrics and gynecology can remain active fellows of the College and participate in ongoing education programs as well as the formulation of ACOG practice and policy statements. This is viewed as strengthening and unifying the overall specialty of obstetrics and gynecology rather than fragmenting or dividing it. When clinical outcomes are improved by advanced training and certification in women's health care, our patients benefit. Currently in obstetrics and gynecology there are three ‘‘boarded’’ subspecialties in addition to REI, i.e., maternal-fetal medicine, gynecologic oncology, and female pelvic medicine and reconstructive surgery. VOL. 104 NO. 1 / JULY 2015
Fertility and Sterility® Accreditation of Fellowship Training for REI Most residencies in obstetrics and gynecology in the United States are certified and approved by the Accreditation Council for Graduate Medical Education (ACGME). Residencies not accredited by the ACGME are accredited by the American Osteopathic Association (AOA) and the American Association of Colleges of Osteopathic Medicine (AACOM). By the year 2020 all osteopathic programs, including osteopathic fellowships, will also come under the ACGME, which now has representatives from the AOA and the AACOM on its governing board. Currently three of the four fellowship programs for the subspecialties in obstetrics and gynecology are certified by ABOG. Female pelvic medicine and reconstructive surgery, the fourth and newest subspecialty in obstetrics and gynecology, has their fellowship accredited by the ACGME. ABOG is currently exploring the possibility of moving accreditation of REI programs to the ACGME. If the discussions prove to be fruitful, the transfer may occur within the next 5 years.
Evolving Training in REI Fellowships Training during the 36 months of fellowship in REI must include R12 months of direct clinical exposure and R18 months of exposure to research activities. There are specific didactic requirements that must be met, including demonstrated ability to apply biostatistics for the analysis of research data. As part of the oral exam, after completion of the fellowship, a candidate for certification by the ABOG must submit and defend a research project thesis. There has been a dramatic increase in the exposure of fellows to ART, such as IVF, and a concomitant decrease in surgical cases. This is due in part to improved success rates of ART, making surgical treatment of infertility less pervasive, and increased training in laparoscopy and other minimally invasive techniques during the basic obstetrics and gynecology residency. Additionally, the development of advanced training programs that focus specifically on minimally invasive surgical procedures have further eroded the surgical volumes for REI programs. Finally, increased focus by medical endocrinology on reproductive topics (PCOS and menopause/osteoporosis) and the growth and development of family planning training programs (contraception) have limited the exposure that REI fellows have to clinical endocrinology. Some have been concerned that the endocrine disorders, which were at the core when the subspecialty was founded, are receiving less attention. Recommendations for future emphasis in REI fellowships might include more research and clinical studies of the environment of early reproductive events, immunology, genetics, and epigenetics. REI provides a unique research opportunity for the study of early embryonic development and even the impact that the health of women before conception may have on fetal development and the occurrence of chronic diseases later in life (4). Programs in REI have been particularly vulnerable to limitations on National Institutes of Health and other government funding owing to legislative prohibitions on certain areas of research, including research on human embryos. At VOL. 104 NO. 1 / JULY 2015
a time when there is an urgent need for translational research, and REI provides a rich environment to study early human development, prohibitions on this research activity are counterproductive to improving the reproductive health of women and perhaps even the long-term health of their children. Translational medicine, however, requires clinicians to be aware of and even better be part of the efforts that move basic research efficiently into clinical practice. The history of medicine is full of examples of potential clinical breakthroughs that remained unnoticed for far too long because of a gap between basic research and clinical recognition. By making research activity an integral part of fellowship training in REI, reproductive research is more likely to have a timely and positive effect on patient care. The practice of REI is unique for its integration of sophisticated laboratory techniques into daily clinical activities.
IMPACT OF REI FELLOWSHIPS ON OBSTETRICS AND GYNECOLOGY RESIDENCIES AND COMMUNITY PRACTICE A probable benefit of subspecialty training in REI and other subspecialties is to ‘‘raise the bar’’ of clinical practice in departments where obstetrics and gynecology residents are educated. The impact that subspecialty training in REI has on residencies is thought to be positive overall. Initially, residents may be fearful that their experience (particularly surgical experience) will be diminished by fellows eager to perform procedures that they would otherwise perform. When fellowship training is carried out in a way that includes residents, and when REI fellows are readily available for teaching residents, their presence is appreciated. Fellows, for example, are thought to enhance a resident's experience of doing endovaginal ultrasound and diagnostic laparoscopies. It is currently not known how long residents spend on an REI rotation, but it is likely 8–12 weeks on average. Residents typically do not perform, nor do they expect to perform, oocyte retrievals and embryo transfers, but they benefit from learning the proper indications for advanced ART procedures, and by closely observing them they are in a better position to refer patients later in their practices. Additionally, exposure of obstetrics and gynecology residents to REI increases their exposure to the endocrinology of the menstrual cycle and all of its ramifications for office-based gynecology, including evaluation and management of amenorrhea, anovulation, ovarian failure, and basic ovulation induction.
VALUE OF SUBSPECIALTY TRAINING AND CERTIFICATION IN REI One way to judge the success of any health care activity, including subspecialty training and certification, is to base it on the value that it eventually provides to patients in terms of improved clinical outcomes (5). One measure of the value of fellowship training in REI is the improvement in clinical outcomes that occur as a direct result of the research that is stimulated as part of the educational process leading to certification. Improvements in clinical outcomes 5
VIEWS AND REVIEWS for embryo transfer, sonohysterography, and oocyte retrieval have all been documented based on research performed in fellowship programs (6–8). It is likely that the establishment of a culture of improving clinical care based through research learned during training will carry over into clinical practice. Several important organizations have had a great influence on the subspecialty of REI and have helped to establish the value of fellowship training. The American Society for Reproductive Medicine (ASRM), which was known in 1972 as the American Fertility Society had, and continues to have, a positive impact on the field of REI. Recently, ASRM has partnered with Virtamed to produce a training simulator for embryo transfer and intrauterine insemination (IUI). One of the affiliates of ASRM, the Society for Assisted Reproductive Technology (SART), has been collecting and analyzing outcomes from member IVF cycles since soon after it was organized. IVF is one of only a very few clinical activities in all of U.S. health care that is currently required by law to report results in a verifiable way. Reporting is now mandatory for SART members and mandatory for all programs whether they belong to SART or not. In addition to SART, outcomes are reported to the Centers for Disease Control and Prevention for surveillance, in accordance with the law. Consumers have ready access to these results. Because IVF programs in the U.S. are predominantly led and managed by fellowship-trained and board-certified REI subspecialists, the remarkable improvement in IVF success rates in the U.S. from 1997 to 2011 (Fig. 1) may be interpreted as a measure of the value of training in ART that occurs during fellowships. Some have stated that the improvement in IVF outcomes is due primarily to publically published results that may stimulate competition and increase performance (9). Not all of the effects of public reporting may be positive, however, with
FIGURE 1
concern about the possibility of unintended consequences. These include misinterpretation of results by consumers and gaming of results by providers by refusing to treat more difficult patients (10). Another explanation for the improvement seen in IVF outcomes could be the close collaboration between andrology and embryology laboratories and clinical practice during IVF cycles. The ability to ‘‘translate’’ improvements in the laboratory more quickly and directly to patient care, along with improvements in the use of available pharmacologic agents for ovarian stimulation, are also possible explanations for the improvement in IVF success.
FUTURE CHALLENGES AND ESTABLISHING VALUE There is very good evidence suggesting that fellowship training and certification in REI has improved clinical outcomes in IVF. One challenge for the subspecialty in the future is to identify the clinical, research, and financial trends that will define the specialty as well as the subspecialty. Fellowship curricula are typically defined well in advance of implementation, but only after deliberations that are often protracted. The pace of change in medicine seems to be accelerating, and that will require a similarly open-minded and responsive evolution of all subspecialty fellowship programs in obstetrics and gynecology, including REI. To best serve our patients, and our field, we should broaden our fellowships and not constrict them. Rather than having shorter fellowships that focus on the technical aspects of IVF, fellowships should include more information on environment and health, immunology, cellular aging, genetics, and epigenetics. The core basic training in endocrinology that is critical to our understanding of both female and male reproductive health, embryology, and early pregnancy should be maintained and strengthened. The RE in REI provides an essential foundation for the understanding and treatment of infertility. Additionally, research experience could be expanded so that fellows can find their passion. This passion may be found in the more classic bench-top research so critical to REI, or in the more clinically focused research initiated by those physicians who work with our patients on a daily basis and see the critical questions that remain unanswered. Our field is maturing and, with that, starting to differentiate. This is a good thing and should be acknowledged and rewarded by finding ways to utilize this diversity to further the field, drive the research agenda, and improve reproductive health for all women. Acknowledgments: The authors thank Drs. Kenneth Noller, ABOG, Hal Lawrence, and Sandra Carson, ACOG.
Average percent live-births in women < 38 years of age resulting from non-donor, fresh embryo transfers from 1997 through 2011 (15 years). Some attribute most of this improvement to competition inspired by public disclosure of results. Others feel that a major cause is the efficient translation of research into clinical care. Data: Centers for Disease Control and Prevention (CDC), 1997-2012 (www.cdc.gov/art/artreports). Gambone. Training and certification for REI. Fertil Steril 2015.
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REFERENCES 1. 2. 3. 4.
The Endocrine Society. History of the Endocrine Society. Available at: www.endo-society.org/about/history.cfm. Accessed February 22, 2015. Chang MC. Fertilization of rabbit ova in vitro. Nature 1959;184:466–7. Jones HW. IVF: Past and future. Reprod Biomed Online 2003;6:375–81. Bateson P, Barker D, Clutton-Brock T, Deb D, D'Udine B, Foley RA, et al. Developmental plasticity and human health. Nature 2004;430:419–21. VOL. 104 NO. 1 / JULY 2015
Fertility and Sterility® 5. 6.
7.
Porter ME. What is value in health care? N Engl J Med 2010;363: 2477–81. Neithardt AB, Seagers JH, Hennessy S, James AN, McKeeby JL. Embryo afterloading: a refinement in embryo transfer technique that may increase clinical pregnancy. Fertil Steril 2005;83:710–4. Parker JD, Alvero RJ, Luterzo J, Segars JH, Armstrong AY. Assessment of resident competency in the performance of sonohysterography: does the level of training impact the accuracy? Am J Obstet Gynecol 2004;191:582–6.
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8.
Goldman KN, Moon KS, Yauger BJ, Payson MD, Segars JH, Stegmann BJ. Proficiency in oocyte retrieval: how many procedures are necessary for training? Fertil Steril 2011;95:2279–82. 9. Porter M, Rahim S, Tsai B. In vitro fertilization: outcomes measurement. Boston: Harvard Business School Press; 2008. 10. Health Affairs. Public reporting on quality and costs. Health policy briefs, causes for concern. Available at: www.healthaffairs.org/healthpolicybriefs/ brief.php?brief_id¼65. Accessed March 11, 2015.
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Reproductive endocrinology and infertility (REI) is one of the original officially recognized subspecialties in obstetrics and gynecology and among the earlier subspecialties in medicine. Recognized by the American Board of Obstetrics and Gynecology in 1972, fellowship programs are now 3 years in length following an obstetrics and gynecology residency. Originally focused on endocrine problems related to reproductive function, the assisted reproductive technologies (ART) have recently become the larger part of training during REI fellowships. It is likely that the subspecialty of REI strengthens the specialty of obstetrics and gynecology and enhances the educational experience of residents in the field. The value of training and certification in REI is most evident in the remarkable and consistent improvement in the success of ART procedures, particularly in vitro fertilization. The requirement for documented research activity during REI fellowships is likely to stimulate a more rapid adoption (translation) of newer research findings into clinical care after training. Although mandatory reporting of outcomes has been proposed as a reason for this improvement the rapid translation of reproductive research into clinical practice is likely to be a major cause. Looking forward, REI training should emphasize and strengthen education and research into the endocrine, environmental, and genetic aspects of female and male reproUse your smartphone duction to improve the reproductive health and fertility of all women. (Fertil SterilÒ 2015;104: to scan this QR code 3–7. Ó2015 by American Society for Reproductive Medicine.) and connect to the Key Words: REI, certification, training, subspecialty, infertility, endocrinology Discuss: You can discuss this article with its authors and with other ASRM members at http:// fertstertforum.com/gambonej-training-certification-rei/
A
s of May 2014 there were 1,269 American Board of Obstetrics and Gynecology (ABOG)–certified reproductive endocrinologists in the United States. Over a fairly short time period of about 35 years the clinical subspecialty of reproductive endocrinology and infertility (REI) that was initially formed in the early 1970s has matured and continues to evolve. The process for training and certifying obstetricians and gynecologists in REI is relatively old compared with other certified clinical subspecialties
in medicine, with most subspecialties recognized by the American Board of Medical Specialties in the past 15– 20 years. Interest and training activity in the endocrinology of reproduction actually began much earlier, even before the specialty of obstetrics and gynecology was formed. In 1916 a small group of physicians in the United States met at the American Medical Association annual meeting to formalize an association for endocrinology. The Association for the Study of Internal Secretions was
Received March 13, 2015; revised April 6, 2015; accepted April 9, 2015; published online June 3, 2015. J.C.G. has nothing to disclose. J.H.S. is on the American Board of Obstetrics and Gynecology. M.C. has nothing to disclose. W.D.S. has nothing to disclose. Reprint requests: Joseph C. Gambone, D.O., M.P.H., Departments of Obstetrics and Gynecology, David Geffen School of Medicine, University of California, Los Angeles, California (E-mail: jgambone@ ucla.edu). Fertility and Sterility® Vol. 104, No. 1, July 2015 0015-0282/$36.00 Copyright ©2015 American Society for Reproductive Medicine, Published by Elsevier Inc. http://dx.doi.org/10.1016/j.fertnstert.2015.04.039 VOL. 104 NO. 1 / JULY 2015
discussion forum for this article now.*
* Download a free QR code scanner by searching for “QR scanner” in your smartphone’s app store or app marketplace.
incorporated in Delaware in January 1918 (1). This group met annually, except for 2 years during World War II, eventually changing their name to The Endocrine Society in 1952. The journal Endocrinology was published starting in 1917 and a second journal, Journal of Clinical Endocrinology, began in 1941, later adding Metabolism to the journal title to become JCEM. Research and opinion articles relating to the endocrinology of reproduction have been published in both of those journals over the years. The subspecialty of reproductive endocrinology in obstetrics and gynecology was fortunate to have had very gifted early leaders such as Howard and Georgeanna Seegar Jones at Johns Hopkins, Leon Speroff and Nathan Kase at Yale, and Samuel Yen and Robert Jaffe at the University of California, 3
VIEWS AND REVIEWS who along with others conducted research and began teaching and writing about the physiology and endocrinology of reproduction. The now classic textbooks by Yen and Jaffe as well as Speroff, Kase, and Glass introduced the topics of reproductive endocrinology and infertility into the mainstream of medical practice, including obstetrics and gynecology. These leaders were among the first to establish REI fellowship programs in the United States. An interesting historical note is that because there were initially no boardcertified REI subspecialists in obstetrics and gynecology, and an exam was required, early candidates for certification were also examined by internists with special research and scholarly training in the endocrinology of reproduction. The subspecialty of REI was officially recognized by ABOG in 1972. Fellowship programs in reproductive endocrinology lasted for 2 years and the focus was largely on reproductive disorders that had an endocrine basis for their pathophysiology. These disorders included abnormal pubertal development, recurrent miscarriage, polycystic ovary syndrome (PCOS), menopause, and, in some centers, contraceptive care and research. Laparoscopy and reconstructive surgery were also an important aspect of REI training when formal training programs began. The clinical involvement of reproductive endocrinologists in advanced assisted reproductive technologies (ART) came soon after the report of the first successful in vitro fertilization (IVF) birth in 1978 in the United Kingdom (U.K.) by Robert G. Edwards and Patrick C. Steptoe. Research that led up to this achievement included successful IVF in the rabbit by Chang (2) in 1959 and in the human in 1965 by Edwards and Jones. The work done at Johns Hopkins in 1965 by Edwards and Jones was initially reported to be unsuccessful, but a later review of photographs revealed that human fertilization in the laboratory had actually been achieved that year (3). In the United States, translating these successes in the laboratory into clinical practice was complicated and delayed by political debate about the appropriateness of government funding for this type of research. After the first live birth from IVF in 1978 in the U.K., however, couples in the United States with infertility resistant to traditional treatments applied political pressure and helped to propel the science and clinical activity of IVF into the mainstream. In 2010 the Nobel Prize for Medicine was awarded to Robert G. Edwards for his seminal work in IVF. (According to Nobel Committee rules, a Nobel prize can not be awarded posthumously, thus eliminating Patrick Steptoe from consideration. Dr. Steptoe died in 1988.) The development and expansion of IVF capabilities has had a profound effect on human reproduction, with more than 5 million births worldwide, as well as a big impact on the field of REI.
CURRENT REGULATION OF FELLOWSHIP TRAINING AND THE CERTIFICATION PROCESS FOR REI There are currently 43 ABOG-certified REI training programs in the United States, and each year 45 candidates are certified. Today, fellowship programs have increased 4
to 3 years in duration and the curriculum for fellowship training consists of surgical skills, ART, clinical training, and didactic education, including biostatistics and epidemiology. In addition, fellows in the subspecialty were always required to pursue a structured research project as a requisite for certification. Currently the requirements and criteria for training in the subspecialty are determined by the Division of Reproductive Endocrinology and Infertility at ABOG. After satisfactory completion of an accredited fellowship, graduates may sit for the written exam in the subspecialty. Candidates who pass the written exam and certification in obstetrics and gynecology (basic specialty boards) are eligible to apply for the oral subspecialty exam. ABOG has now adopted a continuous certification process. That is, REI-certified physicians must annually complete several maintenance of certification (MOC) assignments to maintain their certified status. Training in REI in the United States is rigorous, and high standards are required for acceptance into certified programs and for eventual subspecialty board certification by ABOG. Fellows must master a broad range of information and may choose to become proficient in advanced surgical procedures such as minimally invasive surgery, microscopic tubal anastomosis, and reconstructive surgery. This training is in addition to ART-related skills which consume most of the clinical time in many programs. Recently some REI fellowships have incorporated simulation into fellowship training, becoming one of the first to do so in the obstetrical subspecialties. This aspect of fellowship training, which involves the use of nonhuman models to teach and practice clinical skills, is beneficial and is expected to increase in the future. Whether simulation will substitute for diminished operative experience in fellowships is unclear. The American College of Obstetricians and Gynecologists (ACOG) supports, first and foremost, the concept of one unified medical specialty for the health care of women, particularly for their reproductive needs. The specialty training and ongoing medical education materials and programs provided by ACOG make obstetricians and gynecologists uniquely qualified to provide this care. The role of advanced fellowship training and certification in one of the subspecialties, such as REI, is seen as enhancing this overall concept as long as it does not detract from the clinical experience of residents in the basic specialty or inappropriately limit the scope of practice for those who are certified only in obstetrics and gynecology. Members of all of the subspecialty groups in obstetrics and gynecology can remain active fellows of the College and participate in ongoing education programs as well as the formulation of ACOG practice and policy statements. This is viewed as strengthening and unifying the overall specialty of obstetrics and gynecology rather than fragmenting or dividing it. When clinical outcomes are improved by advanced training and certification in women's health care, our patients benefit. Currently in obstetrics and gynecology there are three ‘‘boarded’’ subspecialties in addition to REI, i.e., maternal-fetal medicine, gynecologic oncology, and female pelvic medicine and reconstructive surgery. VOL. 104 NO. 1 / JULY 2015
Fertility and Sterility® Accreditation of Fellowship Training for REI Most residencies in obstetrics and gynecology in the United States are certified and approved by the Accreditation Council for Graduate Medical Education (ACGME). Residencies not accredited by the ACGME are accredited by the American Osteopathic Association (AOA) and the American Association of Colleges of Osteopathic Medicine (AACOM). By the year 2020 all osteopathic programs, including osteopathic fellowships, will also come under the ACGME, which now has representatives from the AOA and the AACOM on its governing board. Currently three of the four fellowship programs for the subspecialties in obstetrics and gynecology are certified by ABOG. Female pelvic medicine and reconstructive surgery, the fourth and newest subspecialty in obstetrics and gynecology, has their fellowship accredited by the ACGME. ABOG is currently exploring the possibility of moving accreditation of REI programs to the ACGME. If the discussions prove to be fruitful, the transfer may occur within the next 5 years.
Evolving Training in REI Fellowships Training during the 36 months of fellowship in REI must include R12 months of direct clinical exposure and R18 months of exposure to research activities. There are specific didactic requirements that must be met, including demonstrated ability to apply biostatistics for the analysis of research data. As part of the oral exam, after completion of the fellowship, a candidate for certification by the ABOG must submit and defend a research project thesis. There has been a dramatic increase in the exposure of fellows to ART, such as IVF, and a concomitant decrease in surgical cases. This is due in part to improved success rates of ART, making surgical treatment of infertility less pervasive, and increased training in laparoscopy and other minimally invasive techniques during the basic obstetrics and gynecology residency. Additionally, the development of advanced training programs that focus specifically on minimally invasive surgical procedures have further eroded the surgical volumes for REI programs. Finally, increased focus by medical endocrinology on reproductive topics (PCOS and menopause/osteoporosis) and the growth and development of family planning training programs (contraception) have limited the exposure that REI fellows have to clinical endocrinology. Some have been concerned that the endocrine disorders, which were at the core when the subspecialty was founded, are receiving less attention. Recommendations for future emphasis in REI fellowships might include more research and clinical studies of the environment of early reproductive events, immunology, genetics, and epigenetics. REI provides a unique research opportunity for the study of early embryonic development and even the impact that the health of women before conception may have on fetal development and the occurrence of chronic diseases later in life (4). Programs in REI have been particularly vulnerable to limitations on National Institutes of Health and other government funding owing to legislative prohibitions on certain areas of research, including research on human embryos. At VOL. 104 NO. 1 / JULY 2015
a time when there is an urgent need for translational research, and REI provides a rich environment to study early human development, prohibitions on this research activity are counterproductive to improving the reproductive health of women and perhaps even the long-term health of their children. Translational medicine, however, requires clinicians to be aware of and even better be part of the efforts that move basic research efficiently into clinical practice. The history of medicine is full of examples of potential clinical breakthroughs that remained unnoticed for far too long because of a gap between basic research and clinical recognition. By making research activity an integral part of fellowship training in REI, reproductive research is more likely to have a timely and positive effect on patient care. The practice of REI is unique for its integration of sophisticated laboratory techniques into daily clinical activities.
IMPACT OF REI FELLOWSHIPS ON OBSTETRICS AND GYNECOLOGY RESIDENCIES AND COMMUNITY PRACTICE A probable benefit of subspecialty training in REI and other subspecialties is to ‘‘raise the bar’’ of clinical practice in departments where obstetrics and gynecology residents are educated. The impact that subspecialty training in REI has on residencies is thought to be positive overall. Initially, residents may be fearful that their experience (particularly surgical experience) will be diminished by fellows eager to perform procedures that they would otherwise perform. When fellowship training is carried out in a way that includes residents, and when REI fellows are readily available for teaching residents, their presence is appreciated. Fellows, for example, are thought to enhance a resident's experience of doing endovaginal ultrasound and diagnostic laparoscopies. It is currently not known how long residents spend on an REI rotation, but it is likely 8–12 weeks on average. Residents typically do not perform, nor do they expect to perform, oocyte retrievals and embryo transfers, but they benefit from learning the proper indications for advanced ART procedures, and by closely observing them they are in a better position to refer patients later in their practices. Additionally, exposure of obstetrics and gynecology residents to REI increases their exposure to the endocrinology of the menstrual cycle and all of its ramifications for office-based gynecology, including evaluation and management of amenorrhea, anovulation, ovarian failure, and basic ovulation induction.
VALUE OF SUBSPECIALTY TRAINING AND CERTIFICATION IN REI One way to judge the success of any health care activity, including subspecialty training and certification, is to base it on the value that it eventually provides to patients in terms of improved clinical outcomes (5). One measure of the value of fellowship training in REI is the improvement in clinical outcomes that occur as a direct result of the research that is stimulated as part of the educational process leading to certification. Improvements in clinical outcomes 5
VIEWS AND REVIEWS for embryo transfer, sonohysterography, and oocyte retrieval have all been documented based on research performed in fellowship programs (6–8). It is likely that the establishment of a culture of improving clinical care based through research learned during training will carry over into clinical practice. Several important organizations have had a great influence on the subspecialty of REI and have helped to establish the value of fellowship training. The American Society for Reproductive Medicine (ASRM), which was known in 1972 as the American Fertility Society had, and continues to have, a positive impact on the field of REI. Recently, ASRM has partnered with Virtamed to produce a training simulator for embryo transfer and intrauterine insemination (IUI). One of the affiliates of ASRM, the Society for Assisted Reproductive Technology (SART), has been collecting and analyzing outcomes from member IVF cycles since soon after it was organized. IVF is one of only a very few clinical activities in all of U.S. health care that is currently required by law to report results in a verifiable way. Reporting is now mandatory for SART members and mandatory for all programs whether they belong to SART or not. In addition to SART, outcomes are reported to the Centers for Disease Control and Prevention for surveillance, in accordance with the law. Consumers have ready access to these results. Because IVF programs in the U.S. are predominantly led and managed by fellowship-trained and board-certified REI subspecialists, the remarkable improvement in IVF success rates in the U.S. from 1997 to 2011 (Fig. 1) may be interpreted as a measure of the value of training in ART that occurs during fellowships. Some have stated that the improvement in IVF outcomes is due primarily to publically published results that may stimulate competition and increase performance (9). Not all of the effects of public reporting may be positive, however, with
FIGURE 1
concern about the possibility of unintended consequences. These include misinterpretation of results by consumers and gaming of results by providers by refusing to treat more difficult patients (10). Another explanation for the improvement seen in IVF outcomes could be the close collaboration between andrology and embryology laboratories and clinical practice during IVF cycles. The ability to ‘‘translate’’ improvements in the laboratory more quickly and directly to patient care, along with improvements in the use of available pharmacologic agents for ovarian stimulation, are also possible explanations for the improvement in IVF success.
FUTURE CHALLENGES AND ESTABLISHING VALUE There is very good evidence suggesting that fellowship training and certification in REI has improved clinical outcomes in IVF. One challenge for the subspecialty in the future is to identify the clinical, research, and financial trends that will define the specialty as well as the subspecialty. Fellowship curricula are typically defined well in advance of implementation, but only after deliberations that are often protracted. The pace of change in medicine seems to be accelerating, and that will require a similarly open-minded and responsive evolution of all subspecialty fellowship programs in obstetrics and gynecology, including REI. To best serve our patients, and our field, we should broaden our fellowships and not constrict them. Rather than having shorter fellowships that focus on the technical aspects of IVF, fellowships should include more information on environment and health, immunology, cellular aging, genetics, and epigenetics. The core basic training in endocrinology that is critical to our understanding of both female and male reproductive health, embryology, and early pregnancy should be maintained and strengthened. The RE in REI provides an essential foundation for the understanding and treatment of infertility. Additionally, research experience could be expanded so that fellows can find their passion. This passion may be found in the more classic bench-top research so critical to REI, or in the more clinically focused research initiated by those physicians who work with our patients on a daily basis and see the critical questions that remain unanswered. Our field is maturing and, with that, starting to differentiate. This is a good thing and should be acknowledged and rewarded by finding ways to utilize this diversity to further the field, drive the research agenda, and improve reproductive health for all women. Acknowledgments: The authors thank Drs. Kenneth Noller, ABOG, Hal Lawrence, and Sandra Carson, ACOG.
Average percent live-births in women < 38 years of age resulting from non-donor, fresh embryo transfers from 1997 through 2011 (15 years). Some attribute most of this improvement to competition inspired by public disclosure of results. Others feel that a major cause is the efficient translation of research into clinical care. Data: Centers for Disease Control and Prevention (CDC), 1997-2012 (www.cdc.gov/art/artreports). Gambone. Training and certification for REI. Fertil Steril 2015.
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Goldman KN, Moon KS, Yauger BJ, Payson MD, Segars JH, Stegmann BJ. Proficiency in oocyte retrieval: how many procedures are necessary for training? Fertil Steril 2011;95:2279–82. 9. Porter M, Rahim S, Tsai B. In vitro fertilization: outcomes measurement. Boston: Harvard Business School Press; 2008. 10. Health Affairs. Public reporting on quality and costs. Health policy briefs, causes for concern. Available at: www.healthaffairs.org/healthpolicybriefs/ brief.php?brief_id¼65. Accessed March 11, 2015.
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