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The field of assisted reproductive technologies (ART) continues to evolve from its first successful birth in 1978 in England, and then in 1981 in the United States. Over the last 6 years, the total number of cycles in the U.S. has increased by 44% to nearly 370,000.
SART membership consists of more than 350 clinics throughout the United States, representing 80% of ART clinics. Over 95% of ART cycles in 2021 in the United States were performed in SART-member clinics.
SART is an invaluable resource for both patients and physicians. Their website includes a “Predict My Success” calculator that allows patients and physicians to enter individualized data to calculate the chance of having a baby over one or more complete cycles of IVF. To help us understand the pregnancy outcome data from ART – cycles per clinic along with national results – I posed the questions below to Amy Sparks, PhD, HCLD, director of the IVF and Andrology Laboratories and the Center for Advanced Reproductive Care at University of Iowa Hospitals and Clinics, Iowa City. Dr. Sparks is past president of SART and former chairperson of the SART Registry committee when the current Clinic Summary Report format was initially released.
Question: The Fertility Clinic Success Rate and Certification Act (FCSRCA) of 1992 mandated that all ART clinics report success rate data to the federal government, through the Centers for Disease Control and Prevention, in a standardized manner. As ART is the only field in medicine to be required to annually report their patient outcomes, that is, all initiated cycles and live births, why do you believe this law was enacted and is limited to reproductive medicine?
Answer: The FCSRCA of 1992 was enacted in response to the lack of open and reliable pregnancy success rate information for patients seeking infertility care using assisted reproductive technologies. Success rates of 25%-50% were being advertised by independent clinics when, nationally, fewer than 15% of ART procedures led to live births. The Federal Trade Commission said such claims were deceptive and filed charges against five clinics, saying they misrepresented their success in helping women become pregnant. The government won one case by court order and the other four cases were settled out of court.
This field of medicine was in the spotlight as the majority of patients lacked insurance coverage for their ART cycles, and there was a strong desire to protect consumers paying out of pocket for relatively low success. Recognizing that the FTC’s mission is to ensure truth in advertising and not regulate medical care, Congress passed the FCSRCA, mandating that all centers providing ART services report all initiated cycles and their outcomes. The CDC was appointed as the agency responsible for collecting cycle data and reporting outcomes. Centers not reporting their cycles are listed as nonreporting centers.
This act also established standards for accreditation of embryology laboratories including personnel and traditional clinical laboratory management requirements. These standards serve as the foundation for embryology laboratory accrediting agencies.
Q: Why have live-birth rates on SART appeared to be focused on “per IVF cycle” as opposed to the CDC reporting of live births “per embryo transfer?”
A: An ART cycle “start” is defined as the initiation of ovarian stimulation with medication that may or may not include administration of exogenous gonadotropins, followed by oocyte retrieval and embryo transfer. Not every patient beginning a cycle will undergo an oocyte retrieval and not all patients who undergo oocyte retrieval have an embryo transfer. The live-birth rates (LBR) for each of these steps of progression in the ART process are available in the SART and CDC reports.
In 2016, SART recognized that practices were foregoing fresh embryo transfer after oocyte retrieval, opting to cryopreserve all embryos to either accommodate genetic testing of the embryos prior to transfer or to avoid embryo transfer to an unfavorable uterine environment. In response to changes in practice and in an effort to deemphasize live birth per transfer, thereby alleviating a potential motivator or pressure for practitioners to transfer multiple embryos, SART moved to a report that displays the cumulative live-birth rate per cycle start for oocyte retrieval. The cumulative live-birth rate per cycle start for oocyte retrieval is the chance of live birth from transfers of embryos derived from the oocyte retrieval and performed within 1 year of the oocyte retrieval.
This change in reporting further reduced the pressure to transfer multiple embryos and encouraged elective, single-embryo transfer. The outcome per transfer is no longer the report’s primary focus.
Q: The latest pregnancy outcomes statistics are from the year 2020 and are finalized by the CDC. Why does the SART website have this same year labeled “preliminary” outcomes?
A: Shortly after the 2016 SART report change, the CDC made similar changes to their report. The difference is that SART provides a “preliminary” report of outcomes within the year of the cycle start for oocyte retrieval. The cumulative outcome is not “finalized” until the following year as transfers may be performed as late as 12 months after the oocyte retrieval.
SART has opted to report both the “preliminary” or interim outcome and the “final” outcome a year later. The CDC has opted to limit their report to “final” outcomes. I’m happy to report that SART recently released the final report for 2021 cycles.
Q: Have national success rates in the United States continued to rise or have they plateaued?
A: It appears that success rates have plateaued; however, we find ourselves at another point where practice patterns and patients’ approach to using ART for family building have changed.
Recognizing the impact of maternal aging on reproductive potential, patients are opting to undergo multiple ART cycles to cryopreserve embryos for family building before they attempt to get pregnant. This family-building path reduces the value of measuring the LBR per cycle start as we may not know the outcome for many years. SART leaders are deliberating intently as to how to best represent this growing patient population in outcome reporting.
Q: Can you comment on the reduction of multiple gestations with the increasing use of single-embryo transfer?
A: The reduction in emphasis on live births per transfer, emphasis on singleton live-birth rates in both the SART and CDC reports, and American Society for Reproductive Medicine practice committee guidelines strongly supporting single embryo transfer have significantly reduced the rate of multiple gestations.
A decade ago, only a third of the transfers were single-embryo transfers and over 25% of live births resulted in a multiple birth. Today, the majority of embryo transfers are elective, single-embryo transfers, and the multiple birth rate has been reduced by nearly 80%. In 2020, 93% of live births from IVF were singletons.
Q: SART offers an online IVF calculator so both patients and physicians can plug in data for an approximate cumulative success rate for up to three IVF cycles. The calculator pools data from all U.S.-reporting IVF centers. Can you explain what an “IVF cycle” is and what patient information is required? Why do success rates increase over time?
A: Each “IVF cycle” is a cycle start for an oocyte retrieval and all transfers of embryos from that cycle within a year of the oocyte retrieval. If the first cycle and subsequent transfers do not lead to a live birth, patients still have a chance to achieve a live birth with a second or third cycle. The success rate increases over time as it reflects the chance of success for a population of patients, with some achieving a live birth after the first cycle and additional patients who achieve success following their third cycle.
Q: The SART IVF calculator can be used with no prior IVF cycles or following an unsuccessful cycle. Are there data to support an estimation of outcome following two or even more unsuccessful cycles?
A: The variables in the SART IVF calculator are based upon the cycle-specific data from patients seeking care at SART member clinics. The current predictor was built with data from cycles performed in 2015-2016. SART is adjusting the predictor and developing a calculator that will be routinely updated, accordingly.
Q: Only approximately 40% of states have some form of infertility coverage law in place; however the number of IVF cycles in the United States continues to increase on an annual basis. What do you think are the driving factors behind this?
A: Advocacy efforts to improve patients’ access to infertility care have included giving patients tools to encourage their employers to include infertility care in their health care benefits package. More recently, the “Great Resignation” has led to the “Great Recruitment” and employers are recognizing that the addition of infertility care to health care benefits is a powerful recruitment tool.
Dr. Trolice is director of The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando.
The field of assisted reproductive technologies (ART) continues to evolve from its first successful birth in 1978 in England, and then in 1981 in the United States. Over the last 6 years, the total number of cycles in the U.S. has increased by 44% to nearly 370,000.
SART membership consists of more than 350 clinics throughout the United States, representing 80% of ART clinics. Over 95% of ART cycles in 2021 in the United States were performed in SART-member clinics.
SART is an invaluable resource for both patients and physicians. Their website includes a “Predict My Success” calculator that allows patients and physicians to enter individualized data to calculate the chance of having a baby over one or more complete cycles of IVF. To help us understand the pregnancy outcome data from ART – cycles per clinic along with national results – I posed the questions below to Amy Sparks, PhD, HCLD, director of the IVF and Andrology Laboratories and the Center for Advanced Reproductive Care at University of Iowa Hospitals and Clinics, Iowa City. Dr. Sparks is past president of SART and former chairperson of the SART Registry committee when the current Clinic Summary Report format was initially released.
Question: The Fertility Clinic Success Rate and Certification Act (FCSRCA) of 1992 mandated that all ART clinics report success rate data to the federal government, through the Centers for Disease Control and Prevention, in a standardized manner. As ART is the only field in medicine to be required to annually report their patient outcomes, that is, all initiated cycles and live births, why do you believe this law was enacted and is limited to reproductive medicine?
Answer: The FCSRCA of 1992 was enacted in response to the lack of open and reliable pregnancy success rate information for patients seeking infertility care using assisted reproductive technologies. Success rates of 25%-50% were being advertised by independent clinics when, nationally, fewer than 15% of ART procedures led to live births. The Federal Trade Commission said such claims were deceptive and filed charges against five clinics, saying they misrepresented their success in helping women become pregnant. The government won one case by court order and the other four cases were settled out of court.
This field of medicine was in the spotlight as the majority of patients lacked insurance coverage for their ART cycles, and there was a strong desire to protect consumers paying out of pocket for relatively low success. Recognizing that the FTC’s mission is to ensure truth in advertising and not regulate medical care, Congress passed the FCSRCA, mandating that all centers providing ART services report all initiated cycles and their outcomes. The CDC was appointed as the agency responsible for collecting cycle data and reporting outcomes. Centers not reporting their cycles are listed as nonreporting centers.
This act also established standards for accreditation of embryology laboratories including personnel and traditional clinical laboratory management requirements. These standards serve as the foundation for embryology laboratory accrediting agencies.
Q: Why have live-birth rates on SART appeared to be focused on “per IVF cycle” as opposed to the CDC reporting of live births “per embryo transfer?”
A: An ART cycle “start” is defined as the initiation of ovarian stimulation with medication that may or may not include administration of exogenous gonadotropins, followed by oocyte retrieval and embryo transfer. Not every patient beginning a cycle will undergo an oocyte retrieval and not all patients who undergo oocyte retrieval have an embryo transfer. The live-birth rates (LBR) for each of these steps of progression in the ART process are available in the SART and CDC reports.
In 2016, SART recognized that practices were foregoing fresh embryo transfer after oocyte retrieval, opting to cryopreserve all embryos to either accommodate genetic testing of the embryos prior to transfer or to avoid embryo transfer to an unfavorable uterine environment. In response to changes in practice and in an effort to deemphasize live birth per transfer, thereby alleviating a potential motivator or pressure for practitioners to transfer multiple embryos, SART moved to a report that displays the cumulative live-birth rate per cycle start for oocyte retrieval. The cumulative live-birth rate per cycle start for oocyte retrieval is the chance of live birth from transfers of embryos derived from the oocyte retrieval and performed within 1 year of the oocyte retrieval.
This change in reporting further reduced the pressure to transfer multiple embryos and encouraged elective, single-embryo transfer. The outcome per transfer is no longer the report’s primary focus.
Q: The latest pregnancy outcomes statistics are from the year 2020 and are finalized by the CDC. Why does the SART website have this same year labeled “preliminary” outcomes?
A: Shortly after the 2016 SART report change, the CDC made similar changes to their report. The difference is that SART provides a “preliminary” report of outcomes within the year of the cycle start for oocyte retrieval. The cumulative outcome is not “finalized” until the following year as transfers may be performed as late as 12 months after the oocyte retrieval.
SART has opted to report both the “preliminary” or interim outcome and the “final” outcome a year later. The CDC has opted to limit their report to “final” outcomes. I’m happy to report that SART recently released the final report for 2021 cycles.
Q: Have national success rates in the United States continued to rise or have they plateaued?
A: It appears that success rates have plateaued; however, we find ourselves at another point where practice patterns and patients’ approach to using ART for family building have changed.
Recognizing the impact of maternal aging on reproductive potential, patients are opting to undergo multiple ART cycles to cryopreserve embryos for family building before they attempt to get pregnant. This family-building path reduces the value of measuring the LBR per cycle start as we may not know the outcome for many years. SART leaders are deliberating intently as to how to best represent this growing patient population in outcome reporting.
Q: Can you comment on the reduction of multiple gestations with the increasing use of single-embryo transfer?
A: The reduction in emphasis on live births per transfer, emphasis on singleton live-birth rates in both the SART and CDC reports, and American Society for Reproductive Medicine practice committee guidelines strongly supporting single embryo transfer have significantly reduced the rate of multiple gestations.
A decade ago, only a third of the transfers were single-embryo transfers and over 25% of live births resulted in a multiple birth. Today, the majority of embryo transfers are elective, single-embryo transfers, and the multiple birth rate has been reduced by nearly 80%. In 2020, 93% of live births from IVF were singletons.
Q: SART offers an online IVF calculator so both patients and physicians can plug in data for an approximate cumulative success rate for up to three IVF cycles. The calculator pools data from all U.S.-reporting IVF centers. Can you explain what an “IVF cycle” is and what patient information is required? Why do success rates increase over time?
A: Each “IVF cycle” is a cycle start for an oocyte retrieval and all transfers of embryos from that cycle within a year of the oocyte retrieval. If the first cycle and subsequent transfers do not lead to a live birth, patients still have a chance to achieve a live birth with a second or third cycle. The success rate increases over time as it reflects the chance of success for a population of patients, with some achieving a live birth after the first cycle and additional patients who achieve success following their third cycle.
Q: The SART IVF calculator can be used with no prior IVF cycles or following an unsuccessful cycle. Are there data to support an estimation of outcome following two or even more unsuccessful cycles?
A: The variables in the SART IVF calculator are based upon the cycle-specific data from patients seeking care at SART member clinics. The current predictor was built with data from cycles performed in 2015-2016. SART is adjusting the predictor and developing a calculator that will be routinely updated, accordingly.
Q: Only approximately 40% of states have some form of infertility coverage law in place; however the number of IVF cycles in the United States continues to increase on an annual basis. What do you think are the driving factors behind this?
A: Advocacy efforts to improve patients’ access to infertility care have included giving patients tools to encourage their employers to include infertility care in their health care benefits package. More recently, the “Great Resignation” has led to the “Great Recruitment” and employers are recognizing that the addition of infertility care to health care benefits is a powerful recruitment tool.
Dr. Trolice is director of The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando.
The field of assisted reproductive technologies (ART) continues to evolve from its first successful birth in 1978 in England, and then in 1981 in the United States. Over the last 6 years, the total number of cycles in the U.S. has increased by 44% to nearly 370,000.
SART membership consists of more than 350 clinics throughout the United States, representing 80% of ART clinics. Over 95% of ART cycles in 2021 in the United States were performed in SART-member clinics.
SART is an invaluable resource for both patients and physicians. Their website includes a “Predict My Success” calculator that allows patients and physicians to enter individualized data to calculate the chance of having a baby over one or more complete cycles of IVF. To help us understand the pregnancy outcome data from ART – cycles per clinic along with national results – I posed the questions below to Amy Sparks, PhD, HCLD, director of the IVF and Andrology Laboratories and the Center for Advanced Reproductive Care at University of Iowa Hospitals and Clinics, Iowa City. Dr. Sparks is past president of SART and former chairperson of the SART Registry committee when the current Clinic Summary Report format was initially released.
Question: The Fertility Clinic Success Rate and Certification Act (FCSRCA) of 1992 mandated that all ART clinics report success rate data to the federal government, through the Centers for Disease Control and Prevention, in a standardized manner. As ART is the only field in medicine to be required to annually report their patient outcomes, that is, all initiated cycles and live births, why do you believe this law was enacted and is limited to reproductive medicine?
Answer: The FCSRCA of 1992 was enacted in response to the lack of open and reliable pregnancy success rate information for patients seeking infertility care using assisted reproductive technologies. Success rates of 25%-50% were being advertised by independent clinics when, nationally, fewer than 15% of ART procedures led to live births. The Federal Trade Commission said such claims were deceptive and filed charges against five clinics, saying they misrepresented their success in helping women become pregnant. The government won one case by court order and the other four cases were settled out of court.
This field of medicine was in the spotlight as the majority of patients lacked insurance coverage for their ART cycles, and there was a strong desire to protect consumers paying out of pocket for relatively low success. Recognizing that the FTC’s mission is to ensure truth in advertising and not regulate medical care, Congress passed the FCSRCA, mandating that all centers providing ART services report all initiated cycles and their outcomes. The CDC was appointed as the agency responsible for collecting cycle data and reporting outcomes. Centers not reporting their cycles are listed as nonreporting centers.
This act also established standards for accreditation of embryology laboratories including personnel and traditional clinical laboratory management requirements. These standards serve as the foundation for embryology laboratory accrediting agencies.
Q: Why have live-birth rates on SART appeared to be focused on “per IVF cycle” as opposed to the CDC reporting of live births “per embryo transfer?”
A: An ART cycle “start” is defined as the initiation of ovarian stimulation with medication that may or may not include administration of exogenous gonadotropins, followed by oocyte retrieval and embryo transfer. Not every patient beginning a cycle will undergo an oocyte retrieval and not all patients who undergo oocyte retrieval have an embryo transfer. The live-birth rates (LBR) for each of these steps of progression in the ART process are available in the SART and CDC reports.
In 2016, SART recognized that practices were foregoing fresh embryo transfer after oocyte retrieval, opting to cryopreserve all embryos to either accommodate genetic testing of the embryos prior to transfer or to avoid embryo transfer to an unfavorable uterine environment. In response to changes in practice and in an effort to deemphasize live birth per transfer, thereby alleviating a potential motivator or pressure for practitioners to transfer multiple embryos, SART moved to a report that displays the cumulative live-birth rate per cycle start for oocyte retrieval. The cumulative live-birth rate per cycle start for oocyte retrieval is the chance of live birth from transfers of embryos derived from the oocyte retrieval and performed within 1 year of the oocyte retrieval.
This change in reporting further reduced the pressure to transfer multiple embryos and encouraged elective, single-embryo transfer. The outcome per transfer is no longer the report’s primary focus.
Q: The latest pregnancy outcomes statistics are from the year 2020 and are finalized by the CDC. Why does the SART website have this same year labeled “preliminary” outcomes?
A: Shortly after the 2016 SART report change, the CDC made similar changes to their report. The difference is that SART provides a “preliminary” report of outcomes within the year of the cycle start for oocyte retrieval. The cumulative outcome is not “finalized” until the following year as transfers may be performed as late as 12 months after the oocyte retrieval.
SART has opted to report both the “preliminary” or interim outcome and the “final” outcome a year later. The CDC has opted to limit their report to “final” outcomes. I’m happy to report that SART recently released the final report for 2021 cycles.
Q: Have national success rates in the United States continued to rise or have they plateaued?
A: It appears that success rates have plateaued; however, we find ourselves at another point where practice patterns and patients’ approach to using ART for family building have changed.
Recognizing the impact of maternal aging on reproductive potential, patients are opting to undergo multiple ART cycles to cryopreserve embryos for family building before they attempt to get pregnant. This family-building path reduces the value of measuring the LBR per cycle start as we may not know the outcome for many years. SART leaders are deliberating intently as to how to best represent this growing patient population in outcome reporting.
Q: Can you comment on the reduction of multiple gestations with the increasing use of single-embryo transfer?
A: The reduction in emphasis on live births per transfer, emphasis on singleton live-birth rates in both the SART and CDC reports, and American Society for Reproductive Medicine practice committee guidelines strongly supporting single embryo transfer have significantly reduced the rate of multiple gestations.
A decade ago, only a third of the transfers were single-embryo transfers and over 25% of live births resulted in a multiple birth. Today, the majority of embryo transfers are elective, single-embryo transfers, and the multiple birth rate has been reduced by nearly 80%. In 2020, 93% of live births from IVF were singletons.
Q: SART offers an online IVF calculator so both patients and physicians can plug in data for an approximate cumulative success rate for up to three IVF cycles. The calculator pools data from all U.S.-reporting IVF centers. Can you explain what an “IVF cycle” is and what patient information is required? Why do success rates increase over time?
A: Each “IVF cycle” is a cycle start for an oocyte retrieval and all transfers of embryos from that cycle within a year of the oocyte retrieval. If the first cycle and subsequent transfers do not lead to a live birth, patients still have a chance to achieve a live birth with a second or third cycle. The success rate increases over time as it reflects the chance of success for a population of patients, with some achieving a live birth after the first cycle and additional patients who achieve success following their third cycle.
Q: The SART IVF calculator can be used with no prior IVF cycles or following an unsuccessful cycle. Are there data to support an estimation of outcome following two or even more unsuccessful cycles?
A: The variables in the SART IVF calculator are based upon the cycle-specific data from patients seeking care at SART member clinics. The current predictor was built with data from cycles performed in 2015-2016. SART is adjusting the predictor and developing a calculator that will be routinely updated, accordingly.
Q: Only approximately 40% of states have some form of infertility coverage law in place; however the number of IVF cycles in the United States continues to increase on an annual basis. What do you think are the driving factors behind this?
A: Advocacy efforts to improve patients’ access to infertility care have included giving patients tools to encourage their employers to include infertility care in their health care benefits package. More recently, the “Great Resignation” has led to the “Great Recruitment” and employers are recognizing that the addition of infertility care to health care benefits is a powerful recruitment tool.
Dr. Trolice is director of The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando.
