- Email: [email protected]
Cost effectiveness modeling comparing recombinant FSH with urinary FSH for ovarian stimulation: a multinational evaluation
Design: A randomized, prospective comparison of the pregnancy rates with the currently-used catheter (Tomcat) and with another commercially available transfer catheter (SIVF 6019 catheter, Cook, Australia) in the period September to December 2001. Materials/Methods: Included in the evaluation were patients who met the following criteria: female partner ⬍40 years of age, ⱕ2 previous IVF attempts, and with sufficient Day 3 embryos to meet the standard number to be transferred for each age group (irrespective of quality). All eligible patients were included, regardless of the etiology of their infertility or the treatment (i.e. IVF, ICSI or MESA). Pregnancy and implantation results (# sacs/total # embryos transferred) were compared using Fisher’s exact test. Results: A total of 118 Day 3 embryo transfers were included, 58 using the original catheter and 60 using the Cook catheter. The patients’ ages in each group were similar (33.6 vs 33.4 years, respectively), the average number of embryos transferred per patient was 2.7 and 2.8, and overall embryo quality was similar in both groups (31/58 vs 30/60 patients had only good quality embryos transferred). The pregnancy rates per embryo transfer were 16/58 (28%) and 31/60 (52%) (p ⬍0.01), with implantation rates of 23 sacs/154 embryos (15%) and 52 sacs/170 embryos (31%), respectively (P ⬍0.001). When only the younger patients (⬍35 years) were considered, the pregnancy rates were 7/32 and 17/35 (22% vs 49%; p ⬍0.05) and the implantation rates were 11 sacs/68 embryos (16%) and 25 sacs/78 embryos (32%), respectively; p ⬍0.05. Considering only patients who had exclusively 8-cell embryos transferred (40/58 and 41/60 patients, respectively), the pregnancy rates were 10/40 (25%) and 25/41 (61%; p ⬍0.01). In this group, the mean numbers of embryos transferred were 2.0 and 2.1 per patient, giving implantation rates of 14 sacs/94 embryos (15%) and 40 sacs/101 embryos (40%; p ⬍0.0001). Conclusions: The embryo transfer catheter was found to exert a significant effect upon the success of IVF treatment. The quality of the Day 3 embryos transferred during this study was high, as demonstrated by the high pregnancy and implantation rates achieved with the Cook catheter. These results serve to illustrate (a) the vital importance of controlling all aspects of embryo culture and transfer; and (b) the effect that a single adverse factor can have on the achievement of pregnancy.
Monday, October 14, 2002 4:15 P.M. O-46 Cost effectiveness modeling comparing recombinant FSH with urinary FSH for ovarian stimulation: A multinational evaluation. Jean-Paul Auray, Ge´ rard Duru, Salim Daya, Ariel Beresniak. Ctr National de Research Scientific, Lyon, France; McMaster Univ, Hamilton, ON, Canada; Serono Intl, Geneva, Switzerland. Objective: The focus on cost containment imposed by shrinking national health care budgets is increasingly putting pressure on investigators to demonstrate that newer interventions are not only effective but also cost effective. In the area of assisted reproductive technology (ART) a shift in usage is occurring from urinary derived to biotechnology derived (recombinant) gonadotropins for ovarian stimulation. Provision of treatment with ART often involves several cycles of treatment, each associated with multiple steps with varying outcomes at each step. To take into account all the situations that are possible during the repeated cycles of treatment when trying to evaluate different ovarian stimulation regimens is a complex task that requires large numbers of subjects to adequately address the cost effectiveness of these therapies. A more efficient approach is to employ modeling techniques that can easily be applied to the different national health care systems. The objective of this study was to compare the cost-effectiveness of recombinant(r) FSH with urinary(u) FSH in the UK, USA, Germany and Spain. Design: The analyses used the Markov model and Montecarlo simulations taking into account the different health care environments in the four countries. For each nation, costs were provided by their national formulary and clinic tariff, and probabilities for outcomes were obtained from randomized controlled trials, the medical literature and national registries. Materials/Methods: The data were then validated by a panel of national experts and, because estimates for key clinical data vary depending on the source, the estimation of variability in the transition probabilities was also ratified by the panel. This approach provided a range of transitional probabilities from which a precise standard deviation could be obtained for each
S18
Abstracts
outcome. The final Markov matrix included 300/600 health states that represented the complete ART process over multiple cycles involving the transfer of fresh or cryopreserved embryos. Results: In the UK, the mean cost per pregnancy was Pd. St. 6060 for uFSH and Pd. St. 5906 for rFSH In USA, the mean cost per pregnancy was USD 47,096 for rFSH and USD 40,688 for rFSH. In Germany, the mean cost per pregnancy was Euro 23269 for uFSH and Euro 22144 for rFSH. In Spain, the mean cost per pregnancy was Euro 20565 for uFSH and Euro 19834 for rFSH. Conclusions: The studies confirmed that rFSH (GonalF) is more cost effective than uFSH for ovarian stimulation. The lower average cost per pregnancy was observed consistently in each country. Supported by: Serono International SA.
Monday, October 14, 2002 4:30 P.M. O-47 A multicenter prospective randomized controlled trial of in-vitro fertilization alone (IVF) versus combined in-vitro fertilization and intracytoplasmic sperm injection (IVF/ICSI) in unexplained infertility. Shu C. Foong, Calvin A. Greene, Seang L. Tan, Suzanne C. Tough. Univ of Calgary, Calgary, AB, Canada; Regional Fertility Program, Calgary, AB, Canada; McGill Univ, Montreal, QC, Canada. Objective: To compare conventional IVF versus combined IVF/ICSI in improving outcome in patients diagnosed with unexplained infertility. Design: A prospective randomized controlled trial of 96 women with unexplained infertility was conducted in two major Canadian centers. Materials/Methods: All patients underwent down-regulation with a Gonadotropin Releasing Hormone (GnRH) agonist prior to starting recombinant human Follicle Stimulating Hormone (Gonal-F). Patients were randomized to conventional IVF or IVF/ICSI on the day of final follicular maturation induced by administration of human chorionic gonadotropin (hCG). All embryos were then assigned a score based on embryo quality. The best quality embryos, to a maximum of four, were used in the embryo transfer process. Patients were then monitored for cycle outcome culminating in pregnancy or menstruation. Outcome data collected include fertilization rate, implantation rate, clinical pregnancy rate and live birth rate. Results: A total of 96 patients were recruited, 60 from center 1 and 36 from center 2. Forty-seven patients were randomized to IVF and 49 were randomized to ICSI. Patient characteristics were similar between the two groups. There was no statistically significant difference in embryo quality between the IVF and IVF/ICSI groups. There was also no statistically significant difference in fertilization rate (77.27% IVF vs. 80.24% IVF/ ICSI, p ⫽ 0.43) or implantation rate (29.14% IVF vs. 30.41% IVF/ICSI, p ⫽ 0.88). The difference in clinical pregnancy rate (40.43% IVF vs. 38.78% IVF/ICSI, p ⫽ 0.87) and live birth rate (36.17% IVF vs. 34.69% IVF/ICSI, p ⫽ 0.88) between IVF and IVF/ICSI were not statistically significant. Conclusions: There is no added advantage of combined IVF/ICSI over conventional IVF in the treatment of unexplained infertility. Supported by: research grant from Serono Canada.
Monday, October 14, 2002 4:45 P.M. O-48 Sharing oocyte donors makes more sense scientifically, clinically, and financially. Frederick Licciardi, Lisa Kump, Alan Berkeley, Nicole Noyes, Jamie Grifo, Lewis Krey. NYU Program for In Vitro Fertilization, Reproductive Surg and Infertility, New York, NY. Objective: To evaluate whether there are any benefits to distributing the oocytes retrieved during an anonymous oocyte donation cycle to a single recipient rather than sharing among two recipients. Design: Retrospective review of oocyte donation cycles conducted at a large, university- based oocyte donation program. Materials/Methods: All anonymous oocyte donation cycles (n ⫽ 221) during 2000 and 2001 were evaluated. There were 100 exclusive (1 recip-
Vol. 78, No. 3, Suppl. 1, September 2002
Monday, October 14, 2002 4:15 P.M. O-46 Cost effectiveness modeling comparing recombinant FSH with urinary FSH for ovarian stimulation: A multinational evaluation. Jean-Paul Auray, Ge´ rard Duru, Salim Daya, Ariel Beresniak. Ctr National de Research Scientific, Lyon, France; McMaster Univ, Hamilton, ON, Canada; Serono Intl, Geneva, Switzerland. Objective: The focus on cost containment imposed by shrinking national health care budgets is increasingly putting pressure on investigators to demonstrate that newer interventions are not only effective but also cost effective. In the area of assisted reproductive technology (ART) a shift in usage is occurring from urinary derived to biotechnology derived (recombinant) gonadotropins for ovarian stimulation. Provision of treatment with ART often involves several cycles of treatment, each associated with multiple steps with varying outcomes at each step. To take into account all the situations that are possible during the repeated cycles of treatment when trying to evaluate different ovarian stimulation regimens is a complex task that requires large numbers of subjects to adequately address the cost effectiveness of these therapies. A more efficient approach is to employ modeling techniques that can easily be applied to the different national health care systems. The objective of this study was to compare the cost-effectiveness of recombinant(r) FSH with urinary(u) FSH in the UK, USA, Germany and Spain. Design: The analyses used the Markov model and Montecarlo simulations taking into account the different health care environments in the four countries. For each nation, costs were provided by their national formulary and clinic tariff, and probabilities for outcomes were obtained from randomized controlled trials, the medical literature and national registries. Materials/Methods: The data were then validated by a panel of national experts and, because estimates for key clinical data vary depending on the source, the estimation of variability in the transition probabilities was also ratified by the panel. This approach provided a range of transitional probabilities from which a precise standard deviation could be obtained for each
S18
Abstracts
outcome. The final Markov matrix included 300/600 health states that represented the complete ART process over multiple cycles involving the transfer of fresh or cryopreserved embryos. Results: In the UK, the mean cost per pregnancy was Pd. St. 6060 for uFSH and Pd. St. 5906 for rFSH In USA, the mean cost per pregnancy was USD 47,096 for rFSH and USD 40,688 for rFSH. In Germany, the mean cost per pregnancy was Euro 23269 for uFSH and Euro 22144 for rFSH. In Spain, the mean cost per pregnancy was Euro 20565 for uFSH and Euro 19834 for rFSH. Conclusions: The studies confirmed that rFSH (GonalF) is more cost effective than uFSH for ovarian stimulation. The lower average cost per pregnancy was observed consistently in each country. Supported by: Serono International SA.
Monday, October 14, 2002 4:30 P.M. O-47 A multicenter prospective randomized controlled trial of in-vitro fertilization alone (IVF) versus combined in-vitro fertilization and intracytoplasmic sperm injection (IVF/ICSI) in unexplained infertility. Shu C. Foong, Calvin A. Greene, Seang L. Tan, Suzanne C. Tough. Univ of Calgary, Calgary, AB, Canada; Regional Fertility Program, Calgary, AB, Canada; McGill Univ, Montreal, QC, Canada. Objective: To compare conventional IVF versus combined IVF/ICSI in improving outcome in patients diagnosed with unexplained infertility. Design: A prospective randomized controlled trial of 96 women with unexplained infertility was conducted in two major Canadian centers. Materials/Methods: All patients underwent down-regulation with a Gonadotropin Releasing Hormone (GnRH) agonist prior to starting recombinant human Follicle Stimulating Hormone (Gonal-F). Patients were randomized to conventional IVF or IVF/ICSI on the day of final follicular maturation induced by administration of human chorionic gonadotropin (hCG). All embryos were then assigned a score based on embryo quality. The best quality embryos, to a maximum of four, were used in the embryo transfer process. Patients were then monitored for cycle outcome culminating in pregnancy or menstruation. Outcome data collected include fertilization rate, implantation rate, clinical pregnancy rate and live birth rate. Results: A total of 96 patients were recruited, 60 from center 1 and 36 from center 2. Forty-seven patients were randomized to IVF and 49 were randomized to ICSI. Patient characteristics were similar between the two groups. There was no statistically significant difference in embryo quality between the IVF and IVF/ICSI groups. There was also no statistically significant difference in fertilization rate (77.27% IVF vs. 80.24% IVF/ ICSI, p ⫽ 0.43) or implantation rate (29.14% IVF vs. 30.41% IVF/ICSI, p ⫽ 0.88). The difference in clinical pregnancy rate (40.43% IVF vs. 38.78% IVF/ICSI, p ⫽ 0.87) and live birth rate (36.17% IVF vs. 34.69% IVF/ICSI, p ⫽ 0.88) between IVF and IVF/ICSI were not statistically significant. Conclusions: There is no added advantage of combined IVF/ICSI over conventional IVF in the treatment of unexplained infertility. Supported by: research grant from Serono Canada.
Monday, October 14, 2002 4:45 P.M. O-48 Sharing oocyte donors makes more sense scientifically, clinically, and financially. Frederick Licciardi, Lisa Kump, Alan Berkeley, Nicole Noyes, Jamie Grifo, Lewis Krey. NYU Program for In Vitro Fertilization, Reproductive Surg and Infertility, New York, NY. Objective: To evaluate whether there are any benefits to distributing the oocytes retrieved during an anonymous oocyte donation cycle to a single recipient rather than sharing among two recipients. Design: Retrospective review of oocyte donation cycles conducted at a large, university- based oocyte donation program. Materials/Methods: All anonymous oocyte donation cycles (n ⫽ 221) during 2000 and 2001 were evaluated. There were 100 exclusive (1 recip-
Vol. 78, No. 3, Suppl. 1, September 2002