Special contribution FERTILITY AND STERILITY® Copyright
~
Vol. 66, No.5 , November 1996
1996 American Society for Reproductive Medicine
Printed on acid-free paper in U.
s. A.
Assisted reproductive technology in the United States and Canada: 1994 results generated from the American Society for Reproductive Medicine/Society for Assisted Reproductive Technology Registry
Society for Assisted Reproductive Technology and The American Society for Reproductive Medicine Birmingham, Alabama
Objective: To summarize the procedures and outcomes of assisted reproductive technology (ART) initiated in the United States in 1994. Design: Data were collected on the Society for Assisted Reproductive Technology (SART) Database program and submitted to KMPG Peat Marwick, who served as the 1994 collection center for the American Society for Reproductive Medicine/Society for Assisted Reproductive Technology Registry. Participant(s): Two hundred forty-nine programs submitted data on procedures performed in 1994. Data were collected after October 1995 so that outcome of all pregnancies established would be known. Main Outcome Measure(s): The outcomes measured included clinical pregnancy, ectopic pregnancy, abortion, stillbirth, delivery, and congenital abnormality. Result(s): Programs reported initiations of 39,390 cycles of ART treatment, excluding frozen embryo and donor oocyte cycles. Of these, 33,700 cycles initiated were IVF (standard, with micromanipulation, and for host uterus transfer) with 20.7% deliveries per retrieval; 4,214 were cycles of GIFT with 28.4% deliveries per retrieval; 926 were cycles of zygote intrafallopian transfer with 29.1% deliveries per retrieval; and 550 were combination cycles, combining IVF and one of the tubal transfer techniques, resulting in 29.7% deliveries per retrieval. In addition to these cycles initiated in 1994, 7,046 frozen ET procedures were reported, either as separate procedures or in combination with another ART procedure with 15.4% deliveries per procedure, and 3,119 donor oocyte cycles were initiated with an overall success of 46.8% deliveries per retrieval. As a result of all procedures, a total of 9,573 deliveries were reported. Conclusion(s): In 1994, there were fewer programs reporting a similar number of treatment cycles of ART as in 1993. Overall average success rates (deliveries per procedures) exhibited only a small increase compared with previously reported summaries. Fertil Steril® 1996; 66:697 -705 Key Words: Assisted reproductive technology, in vitro fertilization, gamete intrafallopian transfer, zygote intrafallopian transfer, cryopreserved embryos, donor oocytes
This report of assisted reproductive technology (ART) activities for the year 1994 has been prepared by the Society for Assisted Reproductive Technology (SART) and The American Society for Reproductive Medicine (ASRM). It represents voluntary reporting
by 249 programs offering ART. All members of SART agree to submit their data for publication; all such data are potentially subject to validation by a separate SART committee. MATERIALS AND METHODS
Received July 31, 1996. Reprint requests: Society for Assisted Reproductive Technology, The American Society for Reproductive Medicine, 1209 Montgomery Highway, Birmingham, Alabama 35216-2809 (FAX: 205978-5005). Vol. 66, No.5, November 1996
Cycle-specific data (with each patient initiation registered prospectively) was collected retrospectively for cycles and transfers performed from J anuary 1,1994 to December 31,1994 and form the basis for this report. The final data were submitted by
Society for Assisted Reproductive Technology ART Registry results: 1994
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the ART programs after October of 1995 to permit reporting of outcomes of all pregnancies established and analysis was completed in July 1996. The year 1994 was the first year that a centralized collection center was used with the SART Database Program. Some member programs did not submit the data in a timely fashion to allow inclusion in this report. It is estimated that the number of programs not submitting data was 28. The ART procedures were divided for reporting purposes into several categories. These were IVF, GIFT, zygote intrafallopian transfer (ZIFT), cryopreserved ETs, and other combinations or procedures (additional ART). Programs also submitted information on IVF cycles in which oocyte micromanipulation was performed. Donor oocyte and IVF cycles for host uterus transfer also were reported. For IVF, GIFT, and ZIFT, data were compiled in two categories by age of the woman at the time of retrieval: :539 years or ;:::40 years. These age groups then were separated further into male factor and no male factor diagnoses, using World Health Organization classification of semen parameters «20 X 106/mL or motility < 40%) as determined in the ART laboratory (1). In vitro fertilization, GIFT, and ZIFT procedures were analyzed for cycles during which ovulation induction medications were used (stimulated cycles) or not used (unstimulated) in each of the categories described above. A clinical pregnancy was defined as an ultrasound-confirmed gestational sac within the uterus (which excludes ectopic and biochemical pregnancies). Ectopic pregnancies (EPs) were reported separately. Clinic-specific data compilation of patient and cycle-specific information was used for this summary report. RESULTS AJIAJlTProcedures
In 1994, 249 programs reported initiation of a total of 42,509 cycles of ART treatment. Of these cycles, 26,961 cycles initiated were standard IVF, 6,520 IVF with oocyte micromanipulation, 4,214 were cycles of GIFT, 926 were cycles of ZIFT, with 550 initiated combinations ofIVF and tubal transfer. There were 3,119 donor oocyte and 219 cycles of IVF for host uterus reported. Additionally, 7,046 frozen ET procedures were listed, either separate or in combination with another ART procedure. As a result of all these procedures (ART and cryopreserved ETs), a total of 9,573 deliveries were reported. Summary data are shown in Table 1 and compared with the annual 1992 and 1993 reports in Table 2 (2, 3). 698
In Vitro Fertilization
All Cycles
Of the 26,961 initiated cycles of standard IVF, 23,254 or 86.2% led to a retrieval, for an overall cancellation rate of 13.8%. Of the 23,254 retrievals, 20,979 or 90.2% led to a transfer. For all reporting programs, 6,114 clinical pregnancies resulted. The overall success rates, in terms of clinical pregnancies were 22.7% per initiated cycle, 26.3% pregnancies per retrieval, and 29.1% pregnancy per transfer. A total of 4,912 deliveries were reported or 18.2% deliveries per initiated cycle, 21.1% deliveries per retrieval, and 23.4% deliveries per transfer. Nineteen percent of the clinical pregnancies were lost, with the majority of losses reported as spontaneous first trimester losses. A total of 246 EPs were reported or 3.9% ofpregnancies established and 1.2% of IVF transfers. Overall, 63.7% of deliveries were singletons, 28.3% were twins, 5.9% were triplets, and 0.6% were higher order multiple deliveries. Sixty-eight deliveries resulting in stillbirths (1.4%) were reported. Outcome of delivery was not known in 100 cases (2.0%). A total of 6,339 IVF babies were reported as normal neonates, with 82 structural and 92 functional defects, or 2.7 defects per 100 neonates reported. Unstimulated Cycles
Of the 26,961 reported cycles, 410 were unstimulated cycles reported by 62 programs, with 204 or 49.8% of these cycles resulting in retrievals, or a 50.2% cancellation rate. Of those progressing to retrieval, 157 or 77.0% of retrievals resulted in transfer. For the unstimulated cycles, 22 clinical pregnancies were reported, with 16 deliveries or 7.8% deliveries per retrieval. A total of 81 of the unstimulated cycles were initiated in women who were ;:::40 years at the time of retrieval, with 45 retrievals (55.5% of cycles) done, and two pregnancies (2.5% of cycles initiated) but no deliveries reported. In women < 40 years with no male factor diagnosed, the overall success rate for 286 unstimulated cycles initiated was 13 deliveries (4.5% per initiated cycle) and 10.2% deliveries per retrieval in 128 retrievals. Stimulated Cycles by Age and Male Factor
Stimulated cycles (26,551) were analyzed by age of the woman at the time of retrieval and diagnosis of male factor (Table 2). The group defined by the woman being <40 years of age and with no male factor diagnosis had a 12.1% cycle cancellation rate in 17,061 stimulations initiated. The 14,990 retrievals done resulted in 4,506 clinical pregnancies and 3,671 deliveries, for an overall success rate of 21.5% deliveries per initiated cycle, 24.5% deliveries per
Society for Assisted Reproductive Technology ART Registry results: 1994
Fertility and Sterility®
Table 1 Comparison of Reported Outcomes for All ART Procedures
Cycles a procedures:j: Cancellation (%) Retrievals Transfers Transfers per retrieval (%) Pregnancies Pregnancy loss (%) Deliveries Deliveries per retrieval (%) Singleton (%) EPs EP per transfer (%) Birth defects per neonates delivered
(%)~
IVF
GIFT
ZIFT
Donor*
Cryopreserved ETst
26,961 13.8 23,254 20,979 90.2 6,114 19 4,912 21.1 63.7 246 1.2 2.7
4,214 12.4 3,692 3,658 99.1 1,342 22.5 1,054 28.5 63.2 45 1.2 1.8
962 13.6 800 696 87.0 278 16.2 233 29.1 65.1 9 1.3 2.4
3,119 14.4 1,983 2,758 139.111 1,139 17.4 929 46.8 60.3 17 0.6 2.1
7,193 NA§ NA 6,901 NA 1,329 21.1 1,076 NA 76.2 44 0.6 2.6
* Donor includes known or anonymous, but not surrogate. t Cryopreserved ET cycles not done in combination with fresh ETs and not with donor egg-embryo :j: Includes all cycles, regardless of age or diagnosis.
§ NA, not available. II Some donors' oocytes used for transfer into more than one recipient. ~ Birth defect reporting did not account for all neonatal outcomes.
retrieval, and 26.2% deliveries per transfer. When the age of the woman was ~40 years and there was no male factor, 3,517 stimulations were initiated; the cancellation rate was 23.0%, and success was 6.9% deliveries per initiated cycle, 9.0% deliveries per retrieval, and 10.2% deliveries per transfer with 2,709 retrievals done resulting in 243 deliveries. For women < 40 years and no male factor, the abortion (spontaneous and induced) rate was 18.5% of pregnancies, with 5.3% induced abortions. For women ~ 40 years and no male factor, 35.2% of pregnancies were lost, with 5.1% of these induced. If the woman was <40 years, but there was a male factor diagnosed, only 10.0% of 4,929 stimulated cycles initiated were canceled. In this category of male factor stimulated cycles, 4,485 retrievals were done, and only 82.7% of these progressed to transfer (3,708 transfers). In the same age group but with no male factor, 93.4% of the 14,990 retrievals went to transfer (14,001 transfers). In the women < 40 years old and with male factor, the clinical pregnancy rate
(PR) for stimulated cycles was 21.9% per initiated cycle, 24.1% per retrieval, and 29.1% per transfer, and the delivery rate was 18.4% per initiated cycle, 20.2% per retrieval, and 24.5% per transfer. In women < 40 years and with no male factor, the clinical PR for stimulated cycle was 26.4% per initiated cycle, 30.1% per retrieval, and 32.2% per transfer, and the delivery rate was 21.5% per initiated cycle, 24.5% per retrieval, and 26.2% per transfer. In the women> 40 years old for the male factor stimulated cycles, the clinical PR was 11.4% per initiated cycle, 13.7% per retrieval, and 16.5% per transfer, and the delivery rate was 7.1% per initiated cycle, 8.5% per retrieval, and 10.3% per transfer. In comparison, in stimulated cycles with no male factor diagnosis in women > 40 years old, the clinical PR was 11. 0% per initiated cycle, 14.2% per retrieval, and 16.1% per transfer, and the delivery rate was 6.9% per initiated cycle, 9.0% per retrieval, and 10.2% per transfer. For all reported stimulation cycles, 17.2% were in women> 40 years (with and without male factor),
Table 2 Effect of Age and Diagnosis of Male Factor on Outcome for Stimulated 1994 IVF Cycles* Patient category
Women <40 Women ;;;,:40 Women <40 Women ;;;,:40 1994 totals 1993 totals 1992 totals
years years years years
with with with with
no male factor no male factor male factor male factor
No. of retrievals
14,990 2,709 4,485 866 23,050 27,117 24,717
Cancellationst
Transfers per retrieval
%
%
12.1 23.0 9.0 17.1 13.2 13.7 14.7
93.4 88.3 82.7 83.3 90.3 89.3 87.7
* This table denotes information only on stimulated IVF cycles and excludes unstimulated cycles.
Vol. 66, No.5, November 1996
No. of pregnancies
No. of deliveries:j:
Deliveries per retrieval %
4,506 383 1,081 119 6,089 6,305 5,261
3,671 243 908 74 4,896 5,089 4,188
24.5 9.0 20.2 8.5 21.2 18.8 16.9
t Percent of stimulated cycles initiated that did not proceed to retrieval. :j: Deliveries with at least one liveborn infant.
Society for Assisted Reproductive Technology ART Registry results: 1994
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and 22.5% of cycles regardless of age included a male factor diagnosis. Analysis by Number of Cycles Done
Data were analyzed according to the number of cycles reported by each clinic doing IVF. Sixty-six percent of programs initiated :5100 cycles per year and 39% initiated :550 cycles per year. There were no significant· differences in outcome from groups of programs with different volumes of activity. When programs reporting <30 initiated cycles are excluded, the mean (±SD) success rate for cycles in women < 40 years and without male factor was 21.3% ± 8.0% deliveries per initiated cycle, including both stimulated and unstimulated cycles. The median success rate in the same subgroup of patients was 20.2% deliveries per all initiated cycles. Sixteen programs reported success rates, as deliveries per initiated cycle, of 30% or higher and only one program reported a delivery per initiated cycle of 2!:40% in this same category of IVF patient. Oocyte Micromanipulation
Programs submitted information on the number of retrievals and ETs in which oocyte micromanipulation for assisted fertilization as well as assisted hatching on embryos (micro-operative techniques) was used. The specific technique of micromanipulation was not recorded in these data; and undoubtedly both subzonal sperm insertion and intracytoplasmic sperm injection (ICSI) were being used during 1994. Additionally, the database program, in its 1994 version, did not differentiate as to whether assisted fertilization and/or assisted hatching were performed. There were 6,525 initiated cycles, 6,311 retrievals, and 5,773 ETs that involved microperative techniques reported by 135 programs. Of the ETs, 3,250 were "mixed" transfers, that is, these included both embryos generated after micromanipulation as well as embryos generated by standard IVF insemination resulting from 3,530 initiated cycles and 3,414 retrievals. These "mixed" transfers resulted in 791 clinical pregnancies and 607 deliveries for a clinical PR of 22.4% per initiated cycle, 23.2% per retrieval, and 24.3% per transfer. The pregnancy loss rate was 21.2% and 24 EPs occurred. As a result of these pregnancies originating from "mixed" transfers, 809 liveborn infants were delivered (65.4% singleton, 29.0% twin, 3.9% triplet) with 784 reported as normal infants and 19 with structural or functional defects. There were nine infants with unknown outcome. Six hundred seventy-one clinical pregnancies were established with embryos exclusively generated after oocyte and/or embryo micromanipulation. Five 700
hundred forty-five deliveries resulted (67.0% singleton, 28.1% twin, and 4.8% triplet gestations) from the 2,990 cycles initiated, the 2,897 retrievals, and the 2,523 transfers of embryos all generated after oocyte-gamete micromanipulation. The pregnancy loss rate was 18.8%. There were 702 normal infants delivered and 22 infants with structural or functional abnormalities; outcomes were unknown in 5 infants. Eleven EPs occurred. The clinical PR was 22.4% per initiated cycle, 23.2% per retrieval, and 26.6% per ET whereas the delivery rate was 18.0% per initiated cycle, 18.6% per retrieval, and 21.4% per ET where all embryos resulted from microperative technique(s). Gamete Intrafallopian Transfer
All Cycles
There were 155 programs that reported GIFT procedures, not in conjunction with an IVF procedure. Of the total of 4,214 cycles of GIFT alone reported, 3,692 retrievals (87.6% of cycles) resulted. A total of 3,658 transfers were done, or 99.1% of retrievals resulted in a transfer of gametes. There were 1,342 clinical pregnancies established, for a clinical PR of 31.8% per initiated cycle, 36.3% per retrieval, and 36.7% per gamete transfer. Of these pregnancies, 1,054 were reported as deliveries or 25.0% deliveries per initiated cycle, 28.5% per retrieval, and 28.8% per gamete transfer. Of the clinical pregnancies identified, 78.5% overall went to delivery. A total of 45 EPs were reported or 1.2% of transfers done and 3.2% of pregnancies. Thirteen stillbirths were reported. Gamete intrafallopian transfer cycles are summarized and compared with other ART procedures in Table 1. Of the delivered pregnancies, 63.6% were singletons, 29.2% were twins, 6.5% were triplets, and 0.6% were higher order multiples, for a total of 1,358 infants born. Ten deliveries (0.9%) had unknown outcomes. The number of normal neonates reported was 1,333 with 25 or 1.8% of reported neonates having functional or structural defects. Information was not provided for outcomes of 10 infants. Age and Male Factor
Cycles of GIFT were stratified according to age of the woman at retrieval and according to male factor diagnoses. Results in each category are shown in Table 3. Women who were <40 years with no male factor diagnosis had 2,759 cycles initiated, 2,459 retrievals (11.0% cancellation rate), and 2,441 gamete transfers; 998 clinical pregnancies and 825 deliveries resulted. Therefore, the clinical PR in this younger group with no male factor was 36.2% per
Society for Assisted Reproductive Technology ART Registry results: 1994
Fertility and Sterility®
Table 3 Effect of Age and Diagnosis of Male Factor on Outcome for 1994 GIFT Cycles* Patient category
Women <40 Women ;;;,:40 Women <40 Women ;;;,:40 1994 totals 1993 totals 1992 totals
years years years years
with with with with
no male factor no male factor male factor male factor
No. of retrievals
2,459 594 533 131 3,717 4,202 4,837
Cancellationst
Transfers per retrieval
%
%
10.9 19.1 6.0 14.9 11.8 15.8 16.1
99.3 99.2 98.7 96.2 99.1 98.5 97.4
No. of pregnancies
No. of deliveries:j:
Deliveries per retrievals %
998 145 177 22 1,342 1,472 1,621
825 73 143 13 1,054 1,182 1,274
33.5 12.3 26.8 9.9 28.4 28.1 26.3
* This table denotes information on both stimulated and unstimulated (n = 23) cycles initiated for GIFT.
t Percent of cycles initiated that did not proceed to retrieval. :j: Deliveries with at least one liveborn infant.
initiated cycle, 40.6% per retrieval, and 40.9% per gamete transfer. The delivery rate in this same subgroup was 29.9% per initiated cycle, 33.5% per retrieval, and 33.8% per gamete transfer. The abortion rate (spontaneous and induced) was 19.0% with 1.3% induced. Women ~ 40 years with no male factor had 734 cycles initiated, 594 retrievals (19.1% cancellation rate), and 589 gamete transfers; 145 clinical pregnancies and 73 deliveries resulted. Therefore, the clinical PR in this older group with no male factor was 19.7% per initiated cycle, 24.4% per retrieval, and 24.6% per gamete transfer. The delivery rate in this same subgroup was 9.9% per initiated cycle, 12.3% per retrieval, and 12.4% per gamete transfer. The abortion rate (spontaneous and induced) was 49.6% with 15.3% induced. In 567 initiated cycles in which the woman was <40 years but a male factor diagnosis was made, 533 retrievals (6% cancellation rate), and 526 gamete transfers occurred. There were 177 clinical pregnancies and 143 resulting deliveries reported. Therefore, the clinical PR in this younger group with male factor was 31.2% per initiated cycle, 33.2% per retrieval, and 33.6% per gamete transfer. The delivery rate in this same subgroup was 25.2% per initiated cycle, 26.8% per retrieval, and 27.2% per gamete transfer. The abortion rate was 18.6% (3% induced). In 154 initiated cycles in which the woman was ~40 years but a male factor diagnosis was made, 131 retrievals (14.9% cancellation rate) and 126 gamete transfers occurred. There were 22 clinical pregnancies and 13 resulting deliveries reported. Therefore, the clinical PR in this older group with male factor was 14.3% per initiated cycle, 16.8% per retrieval, and 17.5% per gamete transfer. The delivery rate in this same subgroup was 8.4% per initiated cycle, 9.9% per retrieval, and 10.3% per gamete transfer. The abortion rate was 36.4% (all spontaneous). Overall, 21.1% of GIFT cycles were initiated in
women > 40 years and 17.1% of cycles regardless of age had an identified male factor diagnosis.
Vol. 66, No.5, November 1996
Additional ART
Zygote Intrafallopian Transfer
Additional ART included ZIFT and either ZIFT or GIFT combined with IVF and was reported by 62 and 71 programs, respectively. The total number of ZIFT only procedures initiated was 926, with 800 retrievals (13.6% of cycles cancelled) and 696 transfers resulting, or 87% transfers per retrieval. As a result, 278 clinical pregnancies were established, and 233 delivered, for an overall success rate of 25.2% deliveries per initiated cycle, 29.1% per retrieval, and 33.5% per zygote transfer. In addition, nine EPs were reported, or 1.3% of transfers and 3.1 % of clinical pregnancies. There were a total of 296 liveborn infants reported. Of the 232 deliveries with reported outcome, 67.5% were singletons, 27.7% were twins, 4.8% were triplets, and none were quadruplets. The number of normal neonates was 289, with 7 or 2.4 per 100 neonates having functional or structural defects. Combination Procedures
Combinations ofZIFT or GIFT with an IVF (uterine) transfer was reported in 550 initiated cycles, 523 retrievals, and 522 transfers. Clinical pregnancies were reported in 183 cycles, for a rate of 33.3% per initiated cycle, 35.0% per retrieval, and 35.1% per ET. Ofthese clinical pregnancies, 155 delivered at least one liveborn infant or 28.2% deliveries per initiated cycle, 29.7% per retrieval, and 29.6% per ET. In addition, five EPs were reported or 1.0% of transfers and 2.7% of clinical pregnancies. Donor Oocytes
There were 163 programs reporting the use of donor oocytes. A total of 3,119 cycles were initiated,
Society for Assisted Reproductive Technology ART Registry results: 1994
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2,587 with anonymous donors and 532 with known or designated donors. Of the overall total, 1,983 went to retrieval. After these retrievals, 2,758 transfers were done. In some unknown number of cases, one donor's oocytes were used for multiple recipients. Clinical pregnancies were reported in 1,139 cycles. The 2,587 cycles initiated on anonymous donor resulted in 1,662 retrievals, and 2,305 transfers. As a result, 963 clinical pregnancies were established, for an overall clinical PR of 57.8% per retrieval and 41.8% per ET. There were 794 deliveries, making the delivery rate 47.8% per retrieval, and 34.4% per transfer. There were 60.8% singleton pregnancies, 33.1 % twin gestations, 5.7% triplet, and 0.4% quadruplet. Of deliveries with at least one liveborn infant, 1,039 normal infants, 12 infants with structural defects, and 8 with functional defects were reported. One infant had an unknown outcome. Sixteen EPs were reported, or 0.7% of transfers and 1.6% of pregnancies. The total number of cycles initiated using known donors resulted in 321 retrievals and 453 transfers. As a result, 176 clinical pregnancies were established (54.8% per retrieval and 38.8% per transfer) and 135 delivered, for an overall success rate of 42.1 % deliveries per retrieval and 29.8% per transfer. In addition, one ectopic pregnancy was reported, or 0.2% of transfers and 0.6% of pregnancies. There were a total of 180 liveborn infants reported. Of the delivered pregnancies, 67.9% were singletons, 27.5% were twins, and 3.8% were triplets. The number of normal neonates was 174, with 6 having structural or functional defects. In Vitro Fertilization for Host Uterus Transfer
Sixty-four programs reported performing host uterus cycles. A total of 219 cycles were initiated with 188, or 85.8% progressing to retrieval, and 184 resulting in transfers, or 97.9% transfers per retrieval. Clinical pregnancies were reported in 61 cycles, for a rate 27.8% per initiated cycle, 32.4% per retrieval, and 33.1% per ET. Of these clinical pregnancies, 56 delivered, or 91.8% of pregnancies. The multiple birth rate was 27.3% twins and 5.5% triplets, no quadruplets, and 67.2% singletons. No EPs were reported. The success rate in terms of delivered pregnancies was 25.6% per initiated cycle, 29.8% per retrieval, and 30.4% per transfer. The number of normal neonates reported was 67; there were 2 with structural or functional defects, and 1 delivery with outcome unknown. Transfer of Cryopreserved Embryos
A total of221 programs (88.7%) reported transfer of cryopreserved embryos as a separate procedure 702
using eggs obtained from the intended recipient, for a total of 7,193 thaw and 6,901 transfer procedures (96.0% of thaws resulting in transfer). Clinical pregnancies resulted in 1,329 or 18.5% of thaw and 19.2% of transfer procedures, with 1,076 deliveries, for a success rate of 15.0% deliveries per thaw and 15.6% per transfer procedure. A total of 1,294 liveborn infants resulted from 1,075 deliveries with known outcome (1 delivery with unknown outcome). There were 1,259 normal infants, 34 with structural or functional defects, and 1 with unknown neonatal outcome. Cryopreserved ETs were done as a combination procedure with 145 IVF, GIFT, or ZIFT cycles. The success rates reported for these cycles were 25 deliveries with cryopreserved embryos and other ART (17.2% deliveries per transfer procedure). DISCUSSION
It is estimated that at present, because of compelling public and governmental concerns surrounding ART, the majority of programs doing ART are reporting their data. Data reporting is mandatory for SART membership and, therefore, the ASRMlSART Registry is capturing data from active SART programs. The year 1994 was the initial year for data reporting using the SART Database program with prospective registering of patient cycles to a centralized data collection facility. As with any new database program and particularly in a dynamic field like ART, new techniques and procedures were not anticipated, leading to some recording difficulties experienced by a number of programs. In 1994, there was only a 6.7% decrease in the number of programs reporting data to the new reporting system of the ASRMlSART registry and a 4.4% decrease in number of procedures performed. The cancellation rate for IVF procedures (13.8%) was similar to the 14.0% reported for 1993 cycles (3). Success rates increased for standard IVF procedures, reported in 1993 as 18.6% deliveries per retrieval and 21.1% in the 1994 reporting year. Success rates for GIFT also increased minimally to 28.5% in 1994, from that reported in 1993 as 28.1% deliveries per retrieval. Success rates for ZIFT also increased slightly from 24.4% in 1993 to 29.1% in 1994, again expressed as deliveries per retrieval. However, the number of cycles initiated in 1994 for GIFT and ZIFT decreased by 15.6% and 46.3%, respectively, from the number initiated in 1993. No consensus exists as to the explanation for a possible increase in overall success with tubal transfer techniques compared with IVF. The patient profiles encompass different age distributions, different diagnostic categories, and possibly differences in
Society for Assisted Reproductive Technology ART Registry results: 1994
Fertility and Sterility®
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numbers of gametes-embryos transferred per patient. This report did not request data on the method of tubal transfer, so the number of transcervical procedures is unknown. The low cancellation rate for GIFT transfers reflects the fact that fertilization is not a prerequisite for transfer, whereas the IVF and ZIFT procedures include a 10% to 13% cancellation of transfers after attempted retrieval. Because the 0.9% GIFT cancellation of transfers most probably reflects the low probability of failure to retrieve 00cytes, the IVF and ZIFT cancellations mostly likely include approximately 9% to 12% of patients who may have experienced a failure to fertilize. As expected, the absence of transfers after attempted retrieval are higher for IVF and ZIFT cycles with an identified male factor component; however, even in women < 40 years with no male factor, 6.6% of attempted retrievals failed to progress to transfer in IVF cycles. In addition to the consequences of not using exogenous ovarian stimulation (the obvious ones being a lower yield of oocytes-embryos), the markedly lower success rate in unstimulated cycles likely reflects a selection bias, as some programs offer natural or unstimulated cycles primarily to women who have demonstrated a poor response to prior stimulation attempts. Therefore, the increased failure rate at each step of the process that might be expected as a result of lack of suppression of premature ovulation, reliance on a single follicle, single oocyte, and possibly a single embryo for transfer may be compounded in some programs and some cycles by a decreased quality of oocyte and embryo secondary to selection of patients demonstrated to be poor responders. The dominant effect of age and male factor diagnosis was again verified, suggesting that the couple with a younger woman and a man who has no identified problem with sperm parameters has a much greater probability of success. The age of 40 years at the time of retrieval was selected arbitrarily as the division point, but efforts to analyze data by age of each patient in the future will enable more precise determination of probabilities for populations of women at each age. Data were not collected regarding the ability of sperm function assays, morphology assessments, or antibodies to influence ART outcomes. None of these characteristics were included in the definition of male factor for this reporting interval. Data on the use of oocyte micromanipulation for assisted fertilization showed that it was used in approximately 21.3% of IVF retrievals (this number was 4.8% in 1993). These data precede the widespread use of the apparently more successful technique of ICSI, but also include the use of assisted hatching. It will be interesting to compare this 1994 Vol. 66, No.5, November 1996
data with the use of microoperative techniques in subsequent years. Again, no details on the indications for oocyte micromanipulation or assisted hatching was requested for the 1994 submission. No separate data were collected on the use of micro manipulation for assisted hatching. Cycle-specific reporting as started with 1994 cycles will allow greater analysis of these subgroups of ART patients. The incidence ofEPs for both IVF and tubal transfer procedures has remained in the range of 0.6% to 1.3% of transfers done. The overall incidence of poor outcomes, including stillbirths and birth defects, remains low, but more stringent requirements for follow-up and reporting are in progress to define better these critical data. The incidence of birth defects from these data can be estimated at between 1.8% and 2.7% of all neonates, but not all neonatal outcomes were reported. The incidence of prematurity was not requested for these neonates. The incidence of multiple gestations also was determined; the percentage of singleton deliveries was similar for most ART procedures, with 60.3% to 65.1% singletons for IVF, GIFT, ZIFT, or donor oocytes cycles, but it was slightly higher (67%) for IVF with micromanipulation, likely reflecting smaller numbers of embryos per transfer. Of the multiple births reported, most, or 28.8% of all, births were twin gestations. In summary, there was a decrease in the number of programs reporting more cycles of ART, with only a small increased overall probability of success than described previously (2, 3). This decrease in reporting is in part explained by the known difficulties with the new 1994 data reporting system. The dominant adverse effects of age and male factor diagnosis on outcomes was corroborated. An increase in the number of families benefiting from oocyte donation and embryo cryopreservation continues to be recorded.
Acknowledgments. The generous donation of time and effort by the members of the SART Registry Committee and of Ms. Joyce Zeitz, SART Administrator, who have and continue to contribute significantly to this present and ongoing data collection-reporting effort is hereby recognized. The data for each reporting program were published separately, in the annual Clinic Specific Report for 1994. Programs submitting data were: Alabama: ART Program at Birmingham, Birmingham; University of Alabama-Birmingham, Birmingham; University of South Alabama, Mobile. Arizona: Fertility Treatment Center, Chandler; IVF Phoenix, Phoenix; Arizona Institute of Reproductive Medicine, Phoenix; Southwest Fertility Center, Phoenix; Arizona Center for Fertility Studies, Scottsdale. Arkansas: University of Arkansas for Medical Sciences, Little Rock. California: West Coast Fertility Centers, Anaheim; Alta Bates In Vitro, Berkeley; West Coast Infertility and Reproductive Associates, Beverly Hills; Central California IVF, Fresno; Lorna Linda University, Lorna Linda; Long Beach Memorial Medical Center, Long Beach; Center for Reproductive
Society for Assisted Reproductive Technology ART Registry results: 1994
703
g
Medicine, Los Angeles; FGE Medical Clinic, Los Angeles; University of Southern California, Los Angeles; Tyler Medical Clinic, Los Angeles; University of California-Los Angeles Fertility Center, Los Angeles; Hoag Fertility Services, Newport Beach; Newport Beach Surgery Center, Newport Beach; Northridge Hospital, Northridge; NOVA In Vitro Fertilization, Palo Alto; Huntington Reproductive Center, Pasadena; Pomerado Hospital, Poway; Center for Advanced Reproductive Care, Redondo Beach; Pacific Fertility Center-Sacramento, Sacramento; University of CaliforniaDavis, Sacramento; Alvarado Hospital Center, San Diego; IGO Medical Group, San Diego; Sharp Fertility Center, San Diego; Astarte Fertility, San Francisco; San Francisco Center for Reproductive Medicine, San Francisco; University of California-San Francisco, San Francisco; Fertility and Reproductive Health Institute, San Jose; Center for ART, Santa Monica; San Ramon Regional Medical Center, San Ramon; Stanford IVF, Stanford; San Antonio Fertility and Endocrinology, Upland. Colorado: Colorado Springs Center for Reproductive Health, Colorado Springs; Reproductive Genetics In Vitro Center, Denver; University of Colorado Health Sciences, Denver; The Center for Reproductive Medicine, Englewood; Conceptions Reproductive Associates, Littleton. Connecticut: University of Connecticut, Farmington; Reproductive Endocrinology and Infertility Associates, Hartford; Yale University In Vitro, New Haven; New England Fertility Institute, Stamford. Delaware: Reproductive Endocrine and Fertility Center of Delaware, Newark. District of Columbia: The George Washington University, Washington, D.C.; Columbia Hospital for Women, Washington, D.C. Florida: Fertility Institute of Boca Raton, Boca Raton; Fertility Institute of West Florida, Clearwater; Florida Institute of Fertility, Fort Lauderdale; Womens Health Care, Fort Myers; Shands Hospital/University of Florida, Gainesville; Fertility Institute of Northwest Florida, Gulf Breeze; Memorial's Assisted Fertility Program, Jacksonville; Northwest Center for Infertility, Margate; Fertility and IVF Center of Miami, Miami; University of Miami, Miami; Center for Infertility, Orlando; Reproductive Medicine and Fertility Center, Orlando; Arnold Palmer Hospital Fertility Center, Orlando; Center for Advanced Reproductive Endocrinology, Plantation; South Florida Institute, South Miami; HumanaiSt. Joseph's Women's Hospital, Tampa. Georgia: Reproductive Biology Associates, Atlanta; Center for Advanced Reproductive Technology, Atlanta; Medical College of Georgia, Augusta; Augusta Reproductive Biology, Augusta. Hawaii: Pacific In Vitro Fertilization, Honolulu. lllinois: Michael Reese Fertility Center, Chicago; Northwestern University, Chicago; IVF Illinois, Chicago; Center for Human Reproduction, Chicago; Rush-Presbyterian-St. Luke's, Chicago; University of Chicago Hospitals, Chicago; Midwest IVF/Andrology Laboratory, Downers Grove; Hinsdale Center for Reproduction, Hinsdale; Oak Brook Fertility Center, Oak Brook; Center for Advanced Reproduction, Park Ridge; Rockford Health Systems, Rockford; Reproductive Endocrinology Associates, Springfield. Indiana: Associated Fertility and Gynecology, Fort Wayne; Advanced Fertility Institute, Indianapolis; Indianapolis Fertility Center, Indianapolis. Iowa: McFarland Clinic, Ames; University of Iowa Hospitals and Clinics, Iowa City. Kansas: Reproductive Resource Center of Greater Kansas City, Overland Park; The Center for Reproductive Medicine, Wichita. Kentucky: Central Baptist Hospital, Lexington; University of Kentucky, Lexington; Women's Pavilion Health and Resource Center, Louisville. Louisiana: Fertility and Laser Center, Metairie; Fertility Institute of New Orleans, New Orleans. Maryland: ART Program at Sinai Hospital, Baltimore; Union Memorial Hospital, Baltimore; The Johns Hopkins Medical Institute, Baltimore; University of Maryland, Baltimore; Montgomery Infertility Institute, Bethesda; Shady Grove Fertility Center, Rockville; Fertility Center of Maryland, Towson; The Women's Fertility Center, Towson. Massachusetts: Brigham and Women's Hospital, Boston; Tufts-New England Medical
704
Center, Boston; Faulkner Center, Boston; Boston IVF, Brookline; The Malden Hospital, Malden; Fertility Center of New England, Reading; Baystate IVF, Springfield; Boston Regional Center, Stoneham; IVF America-Boston, Waltham. Michigan: University of Michigan, Ann Arbor; Center for Reproductive Medicine, Dearborn; Hutzel Hospital, Detroit; Hurley Medical Center, Flint; West Michigan Reproductive Institute, Grand Rapids; Blodgett Memorial ART Program, Grand Rapids; Sparrow Hospital Fertility Center, Lansing; F.I.R.S.T., Inc., Saginaw; Henry Ford Reproductive Medicine, Troy; Ann Arbor Reproductive Medicine, Ypsilanti. Minnesota: University Women's Health Clinic, Minneapolis; IVF Minnesota, Minneapolis; Mayo Clinic ART Program, Rochester; Midwest Center for Reproductive Health, St. Louis Park; Reproductive Health Associates, St. Paul. Mississippi: University of Mississippi, Jackson. Missouri: St. Luke's Hospital Advanced Reproduction, Chesterfield; University of Missouri, Columbia; Infertility and IVF Center, St. Louis; St. Luke's GIFT and IVF Program, St. Louis; Jewish Hospital, St Louis. Nebraska: University of Nebraska, Omaha; Nevada: Shapiro Reproductive Health, Las Vegas; University Institute for Fertility, Las Vegas; Northern Nevada Fertility Center, Reno. New Hampshire: Dartmouth-Hitchcock Medical Center, Lebanon. New Jersey: Diamond Institute for Infertility, Irvington; East Coast Infertility and IVF, Little Silver; Cooper Center for IVF, Marlton; South Jersey Fertility Center, Marlton; University of Medicine and Dentistry of New Jersey, R. W. Johnson Medical School, New Brunswick; Center for Fertility and Reproductive Medicine, Newark; IVF New Jersey, Somerset. New Mexico: Presbyterian Hospital, Albuquerque; Southwest Fertility Lab Services, Albuquerque. New York: Albany Medical Center, Albany; The Fertility Institute at Brooklyn Hospital, Brooklyn; Brooklyn Fertility Center, Brooklyn; IVF Program Children's Hospital, Buffalo; Montefiore Medical Center, Dobbs Ferry; North Shore University Hospital, Manhasset; IVF America Long Island, Mineola; New York Fertility Institute, New York; Advanced Fertility Services, New York; New York University Medical Center, New York; The Mount Sinai Medical Center, New York; Center for Reproductive Medicine-Cornell, New York; Columbia Prysterian Medical Center, New York; IVF America-Westchester, Port Chester; Long Island IVF, Port Jefferson; Institute for Reproductive Health, Rochester; Strong Infertility and IVF Center, Rochester. North Carolina: North Carolina Center for Reproductive Medicine, Raleigh; University of North Carolina, Chapel Hill; Chapel Hill Fertility Center, Chapel Hill; Reproductive Diagnostics, Charlotte; Institute for Assisted Reproduction, Charlotte; Duke University Medical Center, Durham; Wake Forest University, Winston-Salem. Ohio: Akron City Hospital, Akron; Fertility Unlimited, Akron; University of Cincinnati Hospital, Cincinnati; Greater Cincinnati Institute/Christ Hospital, Cincinnati; Bethesda Center for Reproductive Health and Fertility, Cincinnati; University Hospitals of Cleveland, Cleveland; Riverside Reproductive Services, Columbus; Genetics and IVF Institute of Ohio, Dayton; Miami Valley Hospital, Dayton. Oklahoma: Bennett Fertility Institute, Oklahoma City; University of Oklahoma ART Program, Oklahoma City; Tulsa Center for Fertility, Tulsa. Oregon: Northwest Fertility Center, Portland; University Fertility Consultants, Portland. Pennsylvania: Toll Center for Reproductive Sciences, Abington; Fertility and Reproductive Health Services, Allentown; Chong S. Lee, Bethlehem; Geisinger Medical Center, Danville; Family Fertility Center, Easton; Milton S. Hershey Medical Center, Hershey; Fertility Associates, Inc., Monroeville; Hospital University of Pennsylvania Medical Center, Philadelphia; Thomas Jefferson IVF Program, Philadelphia; Pennsylvania Reproductive Associates, Philadelphia; MageeWomens Hospital, Pittsburgh; Allegheny General Hospital, Pittsburgh; Reproductive Endocrinology and Fertility, Upland; Main Line Reproductive Science Center, Wayne; Women's Clinic Ltd.,
Society for Assisted Reproductive Technology ART Registry results: 1994
Fertility and Sterility®
West Reading. Puerto Rico: Centro de Fertilidad del Caribe, Santurce. Rhode Island: Women and Infants Hospital, Providence. South Carolina: Reproductive Endocrinology Associates, Greenville; Southeastern Fertility Center, Mt. Pleasant. Tennessee: East Tennessee State University, Johnson City; Appalachian Fertility, Kingsport; University of Tennessee, Knoxville; University of Tennessee Medical Group, Inc., Memphis; Center for Assisted Reproduction, Nashville; Vanderbilt Center for Fertility, Nashville. Texas: St. David's Hospital IVF, Austin; Trinity In Vitro Program, Carrollton; Presbyterian Hospital, Dallas; Baylor Center for Reproductive Health, Dallas; National Fertility Center, Dallas; Center for Assisted Reproduction, Fort Worth; OB & GYN Associates, Houston; Southwest Fertility Center, Hurst; Center for Reproductive Medicine, Lubbock; Texas Tech University, Lubbock; South Texas Fertility Center, San Antonio; Fertility Center of San Antonio, San Antonio. Utah: University of Utah, Salt Lake City. Vermont: University of Vermont, Burlington. Virginia: Dominion Fertility, Arlington; University of Virginia ART Program, Charlottesville; The Jones Institute for Reproductive Medicine, Norfolk; Johnston-Willis Hospital ART Program, Richmond; Medical College of Virginia, Richmond; Richmond Center for Fertility and Endocrinology, Richmond. Washington: Laboratory for Reproductive Health, Bellevue; Olympia Women's Health, Olympia; Seattle Fertility and Gynecology Clinic, Seattle; University of Washington, Seattle; First Hill Women's Clinic, Seattle; Fertility Clinic of Puget Sound, Tacoma. West Virginia: Center for Reproductive Medicine, Charleston. Wisconsin: Appleton Medical Center, Appleton; GundersenlLutheran Endocrine Center, La Crosse; University of Wisconsin, Madison; Marshfield Clinic, Marshfield; Advanced Institute of Fertility, Milwaukee; Reproductive Specialty Center, Milwaukee; WomenCare, Waukesha; Women's Health Care, Waukesha. Canada: Regional Fertility Programme, Calgary, Alberta; The Goal Program, Ottawa, Ontario. REFERENCES 1. World Health Organization. Laboratory manual of human semen and semen-cervical mucus interaction. 2nd ed. Cambridge: The Press Syndicate of the University of Cambridge, 1987. 2. The American Fertility Society. Society for Assisted Repro-
Vol. 66, No.5, November 1996
ductive Technology, Assisted reproductive technology in the United States and Canada: 1992 results generated from The American Fertility Society/Society for Assisted Reproductive Technology Registry. Fertil Steril 1994;62:1121-8. 3. Society for Assisted Reproductive Technology, American Society for Reproductive Medicine. Assisted reproductive technology in the United States and Canada: 1993 results generated from the American Society for Reproductive Medicine/Society for Assisted Reproductive Technology Registry. Fertil Steril 1995;64:13-21.
Editorial Comment
This activity report for the year 1994 is the first report in which ART outcome reporting is compiled from patient and cycle-specific data submitted by member programs to a central depository using the SART Data Collection System. The functions of data collection and future validation will continue to be carried out under the auspices of the SART Executive Council as well as the Centers for Disease Control and Prevention (CDC) with input from the SART Registry, Validation, and Research Committees. The actual mechanisms for the implementation of the Fertility Clinic Success Rate and Certification Act of 1992 are being developed actively at the Federallevel with the agency assigned that responsibility being the CDC. Both ASRM and SART believe that the efforts of the SART Executive Council and SART committees in both the data reporting and laboratory accreditation arenas will facilitate compliance by ART programs with this federal law. Maria Bustillo, M.D. SART President, 1993-1994 Paul Zarutskie, M.D. SART President, 1995-1996
Society for Assisted Reproductive Technology ART Registry results: 1994
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