- Email: [email protected]
Cetrorelix acetate vs leuprolide acetate offers patients under 40 similar pregnancy rates in cycles using assisted reproductive technologies (ART)
plicates staff scheduling, forces physicians to adjust protocols to avoid weekend retrievals, and/or increase labor costs. Assuming average stimulation of ten days, our program launches patients on Fridays, to land retrievals midweek. In repeat cycles we adjust protocols based on previous cycle, but do not cancel IVF patients only to avoid weekend retrievals. To identify when this modified Friday start approach breaks down, and to improve the predictability of ovarian stimulation, we sought to determine what factors contribute to unpredicted weekend retrievals in women undergoing IVF. DESIGN: Retrospective review of cycles characterized by unpredictable ovarian stimulation leading to weekend retrievals in a large IVF program, which employs routine Friday launches. MATERIALS AND METHODS: Review of all cycles whose retrievals fell on weekends, and comparison of clinical characteristics of patients having unpredicted weekend retrievals vs. the general IVF population, between January 1, 2004 to April 15, 2004, identified from our IVF database. RESULTS: 19 out of 258 (7%) cycles were at risk for weekend retrievals during the study period. 3 of 19 cycles (16%) were converted to intrauterine inseminations because of poor ovarian response. Six weekend retrievals were for preimplantation genetic diagnosis, to ensure availability of the genetics laboratory after a weekday biopsy, leaving 10 unplanned weekend retrievals. Two weekend retrievals were performed on young women with exceptionally long ovarian stimulations (15 days). Two weekend retrievals resulted from patient requests. 4/10 (40%) patients with unpredicted weekend retrievals were first time cyclers. 5/6 (83%) repeat cycles with unexpected weekend retrievals had different ovarian stimulation regimens from previous cycle(s). Patients undergoing unpredicted weekend retrievals had significantly higher basal FSH levels (9.54⫾3.53 vs. 6.7⫾2.79; P⬍0.05) (T-test) compared to the general IVF population. They also tended to be older (37.0⫾3.77 vs. 34.92⫾4.79; P⫽.147), though this difference did not reach statistical significance at the sample size studied. CONCLUSION: Launching patients on Fridays for IVF does not completely avoid weekend retrievals. Patients undergoing unpredicted weekend retrievals have decreased ovarian reserve compared to the general IVF population, consistent with observations that decreased ovarian reserve not only decreases the level of ovarian stimulation, but also increases its variability. Age also likely influences the risk of unpredictable ovarian stimulation. Nurses determining launch dates for patients undergoing controlled ovarian stimulation for IVF should factor in basal FSH, age, previous stimulation protocols, and changes in stimulation protocols. We now are incorporating the above factors into a mathematical model, using multiple regressions, to better predict duration of ovarian stimulation, to avoid patient and staff inconvenience, as well as increased labor cost associated with unpredictable ovarian stimulation. Supported by: WIH Research Fund
P-560 Does catheter type utilized for intrauterine insemination affect pregnancy rates? K. Dorsey, C. Foley, J. Jones, A. Konowal, D. Kelk, D. Smith. University of Colorado Health Sciences Center, Aurora, CO. OBJECTIVE: To determine if the insemination catheter used for intrauterine insemination cycles affects pregnancy rates. DESIGN: Retrospective analysis. MATERIALS AND METHODS: 369 insemination cycles utilizing the most common insemination catheters were reviewed. The catheter utilized, patient age, pre- and post-wash sperm counts, total motile sperm count (TOTM), and pregnancy rates were compared among 3 catheter types. The catheters utilized included the Tomcat, Roseff Double Lumen and Wallace catheters. All semen samples were prepared utilizing Enhance-S ⫹ Cell Isolation Media™ (Conceptions Technology) using a density gradient technique. RESULTS: There was no significant difference in pregnancy rates among the 3 catheters utilized. The pregnancy rate for the Tomcat catheter was 22.8% (N⫽280 inseminations), Roseff Double Lumen 23.7% (N⫽38) and the Wallace catheter 18.6% (N⫽ 51). There were no significant differences in patient age, sperm counts or TOTM among the groups. There was a significant difference in cost among the catheters with the Tomcat priced at $0.65 (65 cents) per catheter, the Roseff Double Lumen at $6.80 per catheter and the Wallace at $6.30 per catheter. CONCLUSION: When comparing the Tomcat, Roseff Double Lumen
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and Wallace catheters utilized for insemination, there appears to be no significant difference in pregnancy rates. There is, however, a marked difference in cost between catheters and utilizing the Tomcat catheter would be the most cost effective choice. Supported by: None
P-561 Hormonal response to ovarian stimulation as a predictor of IVF success. K. R. Hammond, M. Manning, M. P. Steinkampf. University of Alabama at Birmingham, Birmingham, AL. OBJECTIVE: Over 100,000 in vitro fertilization (IVF) cycles are performed in the United States annually. The costs can be extremely prohibitive, limiting the treatment options of some couples and the number of IVF attempts of others. If reliable predictors could be found to determine the likelihood of success of a given IVF cycle before egg retrieval, the financial burden would be substantially reduced. The purposes of this study were to determine whether there is a “cut-off” value of estradiol (E2) either on stimulation day 6 or on the day of hCG administration, above or below which the likelihood of pregnancy is minimal, and whether the increase in E2 level or its rate of rise is predictive of IVF success. DESIGN: Retrospective study. MATERIALS AND METHODS: The medical records of all patients undergoing IVF at a single university program between January, 2000 and February, 2003 were reviewed. Cycles using donor oocytes or that were canceled prior to oocyte retrieval were excluded from the analysis. Variables examined included E2 level on stimulation day 6, E2 level on the day of hCG administration, the number of days of ovarian stimulation, the absolute E2 rise, and the rate of E2 rise. The principal outcome measure was a live birth or a pregnancy that had continued beyond the first trimester at the time of the study. Statistical analyses were performed using t-tests and univariate analysis, as appropriate. RESULTS: A total of 220 IVF cycles were included in the study. There were no significant differences between successful (S) and unsuccessful (NS) IVF cycles with respect to the E2 levels after 6 days of ovarian stimulation (NS: 552 pg/mL, S: 539 pg/mL; P⫽0.84) or on the day of hCG (NS: 2,307 pg/mL, S: 2,330 pg/mL; P⫽0.92). Similarly, there were no significant differences with respect to the absolute rise in E2 (NS: 1726 pg/mL, S: 1801 pg/mL; P⫽0.71), the rate of E2 rise (NS: 694 pg/mL-day, S: 579 pg/mL-day; P⫽0.15), or the duration of ovarian stimulation. However, in women over 37 years of age, the absolute E2 rise was substantially higher in cycles in which a continuing pregnancy was achieved (NS: 1,377 pg/mL, S: 2,318 pg/mL; P⫽0.012). Nevertheless, because of the significant overlap between values in the two groups, the absolute E2 rise was not clinically useful to predict cycle outcome. CONCLUSION: The hormonal response to ovarian stimulation does not appear to be a clinically useful predictor of success in an IVF cycle. Supported by: None
P-562 Cetrorelix acetate vs leuprolide acetate offers patients under 40 similar pregnancy rates in cycles using assisted reproductive technologies (ART). G. Cameron, M. Sanchez, E. Zbella. Florida Fertility Institute, Clearwater, FL. OBJECTIVE: In clinical practice, antagonist protocols are often reserved for older patients or known poor responders. The onset of action for GnRH antagonists occurs within 2 hours of administration, yet the effects are immediately reversible with discontinuation. These features make GnRH antagonists an attractive alternative for these patients. The original clinical trials with GnRH antagonists were done in normal patients with a mean age of 32 yearsa,b. The objective of this study was to determine if younger patients in our practice benefit from the other known benefits of an antagonist protocol, such as fewer days of stimulation and less total gonadotropin dose, while also achieving the same pregnancy rates obtained with traditional protocols. DESIGN: Retrospective analysis MATERIALS AND METHODS: All patients under 40 years old who underwent IVF and ICSI from February 2002 to November 2003 were included in this analysis. Patients who received hMG were excluded. In the
Vol. 82, Suppl. 2, September 2004
antagonist arm (CET), 16 patients received follitropin alfa and cetrorelix. Cetrorelix 0.25 mg was administered when the lead follicle was 12 to 14 mm. Twenty-three patients were treated with mid-luteal leuprolide acetate (LUP) and received either follitropin alfa or beta. All patients had OPU from 34 –36 hours after u-hCG 10,000 U was administered. A statistical analysis was completed using Statpro and Jump software with a Student t-test and a Chi-square for independence. Determination of baseline parameters such as age, number of previous cycles, total r-FSH dose, and stimulation days were compared. A comparison of number of follicles ⬎ 15 mm, the peak estradiol (E2) level, number of oocytes, and the number metaphase II (MII) oocytes was completed. Pregnancy rates were compared using Chi square test (p⬍0.05). RESULTS: Patients in both groups were similar in age. The CET patients had a significantly higher number of ART attempts but significantly fewer days of stimulation and total r-hFSH dose. No difference was noted for outcomes in terms of peak E2, follicles ⬎ 15 mm, number of oocytes retrieved, number of MII oocytes, or clinical pregnancy rates. CONCLUSION: Regardless of the protocol utilized, cetrorelix or midluteal leuprolide, patients had similar clinical outcomes. However, due to shorter treatment cycles and the use of less medication, cetrorelix cycles may ultimately be more cost-effective. Prospective, randomized studies are needed to confirm the findings of this analysis. aAlbano, et al., Human Reprod 2000:15;526. bFelberbaum, et al., Human Reprod 2000:15;1015. Supported by: Serono, Inc.
P-564 Incorporating surgical sperm extractions into an in vitro fertilization (IVF) operating room ⴚ A multidisciplinary approach. M. Baracewicz, E. Ginsburg. Brigham and Women’s Hospital, Boston, MA. OBJECTIVE: To evaluate the efficacy of a multidisciplinary approach to incorporate surgical sperm retrieval procedures, i.e., testicular sperm extraction (TESA), and percutaneous epididymal sperm aspiration (PESA), into the existing operations of an IVF surgical suite. DESIGN: Retrospective chart review of cases done April 1, 2003 through April 30, 2004 MATERIALS AND METHODS: Interviews were conducted with members of the IVF team including embryologists, nurses, anesthesiologists, and urologists. A plan for communication among IVF team members was established. Nurses and surgical technicians were trained about preoperative, intraoperative, and postoperative care of men undergoing these procedures. A written procedure was developed for nurses circulating in the operating room (OR). Preoperative and postoperative orders were developed for surgical sperm retrieval procedures undertaken in the IVF suite. Institutional Review Board approval was obtained for using medical records for the purpose of analyzing sperm extractions done between April 2003 and April 2004. The number of procedures, type of anesthesia used, and length of preoperative, operating room, and recovery times were noted for cases with located records. RESULTS: Table 1: Data Collection for Surgical Sperm Extraction
P-563 Predicting pregnancy outcome from early obstetrical ultrasound in patients undergoing intrauterine insemination (IUI). G. Saphier, G. Paoletti-Falcone. Reproductive Science Center of Boston, Waltham, MA. OBJECTIVE: In our practice, one of the most common questions posed by patients at the time of their early obstetrical ultrasound is, “What is my chance of miscarriage now?” Though there are national statistics on the likelihood of miscarriage we were interested to look at the infertility population and specifically at our own population. DESIGN: Retrospective analysis. MATERIALS AND METHODS: We retrospectively analyzed 287 pregnant patients who had undergone IUI cycles using either clomiphene citrate or human menopausal gonadotropins (hMG) stimulation between August 1, 2001 and July 31, 2003. Patients were evaluated based on 5 variables: number of sacs, heart rate, crown-rump length (CRL), average gestational size and yolk sac. Only patients whose pregnancy outcome data was available were included in the sample. Binary logistic regression using Fisher’s scoring optimization technique was performed using JMP 5.01 software. Each variable was evaluated independently by keeping all the other variables constant. This methodology allowed each variable to be compared independently to the study population. RESULTS: The probabilities of having a live birth for every unit increase in the measurements of each variable analyzed, increases1.03 times for age, 2.00 for number of sacs, 1.08 for heart rate, 1.21 for size of gestational sac, and decreases 0.61 for crown-rump length, and 0.22 for size of yolk sac respectively. Thus, as the CRL and yolk measurements increase, the odds of having a live birth decreases. Inversely as, number of sacs, heart rate and size of gestational sac increases the odds of having a live birth also increases. CONCLUSION: There is an increased likelihood of delivering live babies for patients undergoing IUI when a greater number and size of gestational sacs are present, and when the baby’s heart rate is faster than for patients whose fetuses have a larger crown-rump and yolk sac measurement. Supported by: None
FERTILITY & STERILITY威
* IVGA ⫽ Intravenous General Anesthesia LMA ⫽ Laryngeal Mask Airway GETA ⫽ General Endotracheal Anesthesia Table 2: Mean ⫾ SD time of Surgical Sperm Extraction in the IVF OR vs the Main OR (mins).
There was no statistically significant difference of operative variables between cases performed in the main OR verses the IVF suite. (P⬎0.05 for each analysis.) CONCLUSION: Incorporating surgical sperm extractions into an IVF OR has several practical advantages. The proximity of the embryology lab to the IVF operating room was a benefit for embryology staff and the surgeon, who could be informed about epididymal sample quality within minutes. Ability to schedule cases as needed, without relying on the availability of the main hospital OR was a major benefit for the IVF and urology physicians. Coordination of discharge between a woman undergoing an egg retrieval, and her male partner undergoing sperm retrieval, was more efficient because they were both recovering in the same area. Supported by: None
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P-560 Does catheter type utilized for intrauterine insemination affect pregnancy rates? K. Dorsey, C. Foley, J. Jones, A. Konowal, D. Kelk, D. Smith. University of Colorado Health Sciences Center, Aurora, CO. OBJECTIVE: To determine if the insemination catheter used for intrauterine insemination cycles affects pregnancy rates. DESIGN: Retrospective analysis. MATERIALS AND METHODS: 369 insemination cycles utilizing the most common insemination catheters were reviewed. The catheter utilized, patient age, pre- and post-wash sperm counts, total motile sperm count (TOTM), and pregnancy rates were compared among 3 catheter types. The catheters utilized included the Tomcat, Roseff Double Lumen and Wallace catheters. All semen samples were prepared utilizing Enhance-S ⫹ Cell Isolation Media™ (Conceptions Technology) using a density gradient technique. RESULTS: There was no significant difference in pregnancy rates among the 3 catheters utilized. The pregnancy rate for the Tomcat catheter was 22.8% (N⫽280 inseminations), Roseff Double Lumen 23.7% (N⫽38) and the Wallace catheter 18.6% (N⫽ 51). There were no significant differences in patient age, sperm counts or TOTM among the groups. There was a significant difference in cost among the catheters with the Tomcat priced at $0.65 (65 cents) per catheter, the Roseff Double Lumen at $6.80 per catheter and the Wallace at $6.30 per catheter. CONCLUSION: When comparing the Tomcat, Roseff Double Lumen
S334
and Wallace catheters utilized for insemination, there appears to be no significant difference in pregnancy rates. There is, however, a marked difference in cost between catheters and utilizing the Tomcat catheter would be the most cost effective choice. Supported by: None
P-561 Hormonal response to ovarian stimulation as a predictor of IVF success. K. R. Hammond, M. Manning, M. P. Steinkampf. University of Alabama at Birmingham, Birmingham, AL. OBJECTIVE: Over 100,000 in vitro fertilization (IVF) cycles are performed in the United States annually. The costs can be extremely prohibitive, limiting the treatment options of some couples and the number of IVF attempts of others. If reliable predictors could be found to determine the likelihood of success of a given IVF cycle before egg retrieval, the financial burden would be substantially reduced. The purposes of this study were to determine whether there is a “cut-off” value of estradiol (E2) either on stimulation day 6 or on the day of hCG administration, above or below which the likelihood of pregnancy is minimal, and whether the increase in E2 level or its rate of rise is predictive of IVF success. DESIGN: Retrospective study. MATERIALS AND METHODS: The medical records of all patients undergoing IVF at a single university program between January, 2000 and February, 2003 were reviewed. Cycles using donor oocytes or that were canceled prior to oocyte retrieval were excluded from the analysis. Variables examined included E2 level on stimulation day 6, E2 level on the day of hCG administration, the number of days of ovarian stimulation, the absolute E2 rise, and the rate of E2 rise. The principal outcome measure was a live birth or a pregnancy that had continued beyond the first trimester at the time of the study. Statistical analyses were performed using t-tests and univariate analysis, as appropriate. RESULTS: A total of 220 IVF cycles were included in the study. There were no significant differences between successful (S) and unsuccessful (NS) IVF cycles with respect to the E2 levels after 6 days of ovarian stimulation (NS: 552 pg/mL, S: 539 pg/mL; P⫽0.84) or on the day of hCG (NS: 2,307 pg/mL, S: 2,330 pg/mL; P⫽0.92). Similarly, there were no significant differences with respect to the absolute rise in E2 (NS: 1726 pg/mL, S: 1801 pg/mL; P⫽0.71), the rate of E2 rise (NS: 694 pg/mL-day, S: 579 pg/mL-day; P⫽0.15), or the duration of ovarian stimulation. However, in women over 37 years of age, the absolute E2 rise was substantially higher in cycles in which a continuing pregnancy was achieved (NS: 1,377 pg/mL, S: 2,318 pg/mL; P⫽0.012). Nevertheless, because of the significant overlap between values in the two groups, the absolute E2 rise was not clinically useful to predict cycle outcome. CONCLUSION: The hormonal response to ovarian stimulation does not appear to be a clinically useful predictor of success in an IVF cycle. Supported by: None
P-562 Cetrorelix acetate vs leuprolide acetate offers patients under 40 similar pregnancy rates in cycles using assisted reproductive technologies (ART). G. Cameron, M. Sanchez, E. Zbella. Florida Fertility Institute, Clearwater, FL. OBJECTIVE: In clinical practice, antagonist protocols are often reserved for older patients or known poor responders. The onset of action for GnRH antagonists occurs within 2 hours of administration, yet the effects are immediately reversible with discontinuation. These features make GnRH antagonists an attractive alternative for these patients. The original clinical trials with GnRH antagonists were done in normal patients with a mean age of 32 yearsa,b. The objective of this study was to determine if younger patients in our practice benefit from the other known benefits of an antagonist protocol, such as fewer days of stimulation and less total gonadotropin dose, while also achieving the same pregnancy rates obtained with traditional protocols. DESIGN: Retrospective analysis MATERIALS AND METHODS: All patients under 40 years old who underwent IVF and ICSI from February 2002 to November 2003 were included in this analysis. Patients who received hMG were excluded. In the
Vol. 82, Suppl. 2, September 2004
antagonist arm (CET), 16 patients received follitropin alfa and cetrorelix. Cetrorelix 0.25 mg was administered when the lead follicle was 12 to 14 mm. Twenty-three patients were treated with mid-luteal leuprolide acetate (LUP) and received either follitropin alfa or beta. All patients had OPU from 34 –36 hours after u-hCG 10,000 U was administered. A statistical analysis was completed using Statpro and Jump software with a Student t-test and a Chi-square for independence. Determination of baseline parameters such as age, number of previous cycles, total r-FSH dose, and stimulation days were compared. A comparison of number of follicles ⬎ 15 mm, the peak estradiol (E2) level, number of oocytes, and the number metaphase II (MII) oocytes was completed. Pregnancy rates were compared using Chi square test (p⬍0.05). RESULTS: Patients in both groups were similar in age. The CET patients had a significantly higher number of ART attempts but significantly fewer days of stimulation and total r-hFSH dose. No difference was noted for outcomes in terms of peak E2, follicles ⬎ 15 mm, number of oocytes retrieved, number of MII oocytes, or clinical pregnancy rates. CONCLUSION: Regardless of the protocol utilized, cetrorelix or midluteal leuprolide, patients had similar clinical outcomes. However, due to shorter treatment cycles and the use of less medication, cetrorelix cycles may ultimately be more cost-effective. Prospective, randomized studies are needed to confirm the findings of this analysis. aAlbano, et al., Human Reprod 2000:15;526. bFelberbaum, et al., Human Reprod 2000:15;1015. Supported by: Serono, Inc.
P-564 Incorporating surgical sperm extractions into an in vitro fertilization (IVF) operating room ⴚ A multidisciplinary approach. M. Baracewicz, E. Ginsburg. Brigham and Women’s Hospital, Boston, MA. OBJECTIVE: To evaluate the efficacy of a multidisciplinary approach to incorporate surgical sperm retrieval procedures, i.e., testicular sperm extraction (TESA), and percutaneous epididymal sperm aspiration (PESA), into the existing operations of an IVF surgical suite. DESIGN: Retrospective chart review of cases done April 1, 2003 through April 30, 2004 MATERIALS AND METHODS: Interviews were conducted with members of the IVF team including embryologists, nurses, anesthesiologists, and urologists. A plan for communication among IVF team members was established. Nurses and surgical technicians were trained about preoperative, intraoperative, and postoperative care of men undergoing these procedures. A written procedure was developed for nurses circulating in the operating room (OR). Preoperative and postoperative orders were developed for surgical sperm retrieval procedures undertaken in the IVF suite. Institutional Review Board approval was obtained for using medical records for the purpose of analyzing sperm extractions done between April 2003 and April 2004. The number of procedures, type of anesthesia used, and length of preoperative, operating room, and recovery times were noted for cases with located records. RESULTS: Table 1: Data Collection for Surgical Sperm Extraction
P-563 Predicting pregnancy outcome from early obstetrical ultrasound in patients undergoing intrauterine insemination (IUI). G. Saphier, G. Paoletti-Falcone. Reproductive Science Center of Boston, Waltham, MA. OBJECTIVE: In our practice, one of the most common questions posed by patients at the time of their early obstetrical ultrasound is, “What is my chance of miscarriage now?” Though there are national statistics on the likelihood of miscarriage we were interested to look at the infertility population and specifically at our own population. DESIGN: Retrospective analysis. MATERIALS AND METHODS: We retrospectively analyzed 287 pregnant patients who had undergone IUI cycles using either clomiphene citrate or human menopausal gonadotropins (hMG) stimulation between August 1, 2001 and July 31, 2003. Patients were evaluated based on 5 variables: number of sacs, heart rate, crown-rump length (CRL), average gestational size and yolk sac. Only patients whose pregnancy outcome data was available were included in the sample. Binary logistic regression using Fisher’s scoring optimization technique was performed using JMP 5.01 software. Each variable was evaluated independently by keeping all the other variables constant. This methodology allowed each variable to be compared independently to the study population. RESULTS: The probabilities of having a live birth for every unit increase in the measurements of each variable analyzed, increases1.03 times for age, 2.00 for number of sacs, 1.08 for heart rate, 1.21 for size of gestational sac, and decreases 0.61 for crown-rump length, and 0.22 for size of yolk sac respectively. Thus, as the CRL and yolk measurements increase, the odds of having a live birth decreases. Inversely as, number of sacs, heart rate and size of gestational sac increases the odds of having a live birth also increases. CONCLUSION: There is an increased likelihood of delivering live babies for patients undergoing IUI when a greater number and size of gestational sacs are present, and when the baby’s heart rate is faster than for patients whose fetuses have a larger crown-rump and yolk sac measurement. Supported by: None
FERTILITY & STERILITY威
* IVGA ⫽ Intravenous General Anesthesia LMA ⫽ Laryngeal Mask Airway GETA ⫽ General Endotracheal Anesthesia Table 2: Mean ⫾ SD time of Surgical Sperm Extraction in the IVF OR vs the Main OR (mins).
There was no statistically significant difference of operative variables between cases performed in the main OR verses the IVF suite. (P⬎0.05 for each analysis.) CONCLUSION: Incorporating surgical sperm extractions into an IVF OR has several practical advantages. The proximity of the embryology lab to the IVF operating room was a benefit for embryology staff and the surgeon, who could be informed about epididymal sample quality within minutes. Ability to schedule cases as needed, without relying on the availability of the main hospital OR was a major benefit for the IVF and urology physicians. Coordination of discharge between a woman undergoing an egg retrieval, and her male partner undergoing sperm retrieval, was more efficient because they were both recovering in the same area. Supported by: None
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