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Statistical process control p-charts are an effective method to monitor fertilization rates in the IVF laboratory
formation is significantly improved; being equivalent to that of IVF inseminated embryos. Supported by: None. P-356 Cryopreservation of testicular biopsies in men with obstructive azoospermia yields good pregnancy and live birth rates. J. M. Larson, D. E. Battaglia, K. A. Burry, E. K. Fuchs. Oregon Health and Science University, Portland, OR. OBJECTIVE: There continues to be some controversy surrounding the efficacy of frozen versus fresh testicular biopsy (TESE) with ICSI. In addition some practitioners are concerned about the chromosomal integrity of sperm recovered from frozen biopsies after extended culture. Our purpose was to assess the efficacy of frozen TESE by evaluating fertilization, pregnancy, and live birth rates. DESIGN: Retrospective analysis of patients who underwent TESE cryo and ICSI at a university-based center from 2000 –2002. MATERIALS AND METHODS: A total of 35 couples underwent frozen TESE/ ICSI in 48 cycles; 31 biopsies were frozen from men with obstructive azoospermia and 4 from nonobstructive azoospermia. Open testicular biopsies were performed in an outpatient setting and frozen as in-tact tissue blocks in test yolk buffer (TYB) using a slow cool protocol. Prior to the ICSI cycle a “test” block was thawed, the tubules minced, and the cell suspension cultured in modified-HTF in room air at 25–34° C, and assessed at zero, 24-, and 48-hours to determine the appropriate culture interval for optimum motility. At the time of ICSI, motile sperm were harvested from a similarly prepared tissue and rinsed in PVP before injection. RESULTS: Motile sperm were recovered in all thawed biopsies and 46 out of the 48 cycles achieved embryo transfer (one cycle had no fertilization; one had arrested embryos). The overall 2PN fertilization rate was 64%. In the obstructive azoospermia group the clinical pregnancy and live birth rates per embryo transfer using nondonor egg (maternal age ⱕ40, n⫽29 patients) was 52 and 45% respectively. Pregnancy and live birth rates per ET using anonymous donor egg (n⫽6 patients) were both 57%. In the nonobstrutive azoospermia cohort (n⫽4 patients) 3 patients had clinical pregnancies and one resulted in a live birth. All babies were born healthy and without any major malformations. Optimum sperm culture time varied from 1– 4 hours (10% of patients), 24-hour (75%), and 48-hour(17%) and the live birth rate wasn’t dependent on the sperm culture time. CONCLUSION: Sperm motility was optimized by culturing the cell suspension up to 48-hours post-thaw, and the optimum time interval was patient dependent. Up to 48-hr culture didn’t appear to affect the live birth rate. Our data with regard to nonobstructive azoospermia is too limited to draw any conclusions with efficacy. For men with obstructive azoospermia TESE cryopreservation with ICSI is an effective modality showing good pregnancy and live birth rates. Supported by: None.
DESIGN: Prospective study monitoring FR data from July 7, 2003 through March 28, 2004. MATERIALS AND METHODS: Fertilization assessment was performed daily and the total number of mature eggs and normally fertilized eggs was entered into an Excel spreadsheet. Each week, the percent of eggs which fertilized was calculated and added to the p-chart. Concurrently, the oldest value was removed so that the chart always consisted of a 26 week period (see chart for example). Using a purchased statistical product, the average and 1, 2 and 3 standard deviation values were calculated and plotted. On the chart below, the dotted lines above and below the center line average are 1, 2 and 3 standard deviations (sigma). These areas vary in width since the number of eggs was not constant. Each week, the p-chart was examined for special causes (out of range values) according to published statistical rules: 1 point outside the 3 sigma line, 4 of 5 consecutive points above or below the 1 sigma line, 8 consecutive points above or below the average. RESULTS: The squares on the chart represent the weekly FR and the center line represents the average FR (74.2%) for the 6 month period shown (9/29/2003–3/28/2004). Two statistical special causes were identified during this period. The point below the 3 sigma line (11/30/2003) was determined to result from a problem with a bottle of medium. The data points for the weeks from 12/28/03 to 2/15/04 also represent a special cause since 8 consecutive points were above the average. This corresponds to a change in our procedure for recording our FR data and an increased focus on our FR.
CONCLUSION: P-charts are an effective statistical method which can be used to monitor quality parameters such as FR. They are straightforward and simple to use and identify out of range values in a timely manner, providing important feedback on laboratory processes. Since p-charts use established statistical rules, false positive and false negative values are minimized. Supported by: None.
P-357 Statistical Process Control P-charts are an effective method to monitor fertilization rates in the IVF laboratory. C. B. Barrett, R. D. Powers, M. M. Alper. Boston IVF, Waltham, MA. OBJECTIVE: Most IVF laboratories regularly monitor important quality parameters such as fertilization rates (FR) to ensure that optimal outcomes are obtained. Typically, a FR will be calculated for a selected period of time and then, using empirically-derived rules, it will be determined whether it is within an acceptable range. However, these methods often focus only on a single value or a small number of values and consequently lack a graphical component which allows trends in the data to be visualized. In addition, established statistical rules are generally not used to determine when the data is out of range and this can lead to false positives or false negatives. Recognizing these problems, we wanted to find a method that could be applied to IVF, was simple to use and was based on statistical principles. A set of techniques called statistical process control (SPC) was identified which has been widely used in manufacturing for many years and has seen increasing use in healthcare. SPC uses charts and statistical analyses to assess data and to monitor the quality of a process. Our objective was to determine whether an SPC proportion-chart (p-chart) could be applied to IVF to monitor FR results.
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P-358 Does “EmbryoGlue®” help embryos in their implantation? M. Li, A. Kumar, C. Marin Deugarte, M. Surrey, H. Danzer, D. Hill. ART Reproductive Center, Beverly Hills, CA; OBGYN Department, UCLA Medical Center, Los Angeles, CA. OBJECTIVE: EmbryoGlue® (Vitrolife) is a hyaluronan-rich medium resembling uterine fluid. It is reported to facilitate rapid diffusion with viscous uterine fluid, provide nutritional support from embryo transfer to implantation and support biochemical signaling during implantation (Vitrolife Fertility Systems, 2004). The effects of EmbryoGlue® used during in vitro fertilization ⫺ embryo transfer (IVF-ET) in our laboratory is evaluated. DESIGN: Retrospective study. MATERIALS AND METHODS: 1633 IVF-ET cases were included from 01/01/2002 to 3/15/2004 at ART Reproductive Center, Beverly Hills, California. During stage one (S1) modified HTF-hepes (Irvine Scientific, Cat 90126) ⫹ 20%SS (Irvine Scientific, Cat 90193) was used for ET. Stage 2 (S2) used EmbryoGlue® as the transfer medium according to the manufacturer’s suggested guidelines. RESULTS: In comparing the overall clinical pregnancy rates (Day 3--
Vol. 82, Suppl. 2, September 2004
DESIGN: Prospective study monitoring FR data from July 7, 2003 through March 28, 2004. MATERIALS AND METHODS: Fertilization assessment was performed daily and the total number of mature eggs and normally fertilized eggs was entered into an Excel spreadsheet. Each week, the percent of eggs which fertilized was calculated and added to the p-chart. Concurrently, the oldest value was removed so that the chart always consisted of a 26 week period (see chart for example). Using a purchased statistical product, the average and 1, 2 and 3 standard deviation values were calculated and plotted. On the chart below, the dotted lines above and below the center line average are 1, 2 and 3 standard deviations (sigma). These areas vary in width since the number of eggs was not constant. Each week, the p-chart was examined for special causes (out of range values) according to published statistical rules: 1 point outside the 3 sigma line, 4 of 5 consecutive points above or below the 1 sigma line, 8 consecutive points above or below the average. RESULTS: The squares on the chart represent the weekly FR and the center line represents the average FR (74.2%) for the 6 month period shown (9/29/2003–3/28/2004). Two statistical special causes were identified during this period. The point below the 3 sigma line (11/30/2003) was determined to result from a problem with a bottle of medium. The data points for the weeks from 12/28/03 to 2/15/04 also represent a special cause since 8 consecutive points were above the average. This corresponds to a change in our procedure for recording our FR data and an increased focus on our FR.
CONCLUSION: P-charts are an effective statistical method which can be used to monitor quality parameters such as FR. They are straightforward and simple to use and identify out of range values in a timely manner, providing important feedback on laboratory processes. Since p-charts use established statistical rules, false positive and false negative values are minimized. Supported by: None.
P-357 Statistical Process Control P-charts are an effective method to monitor fertilization rates in the IVF laboratory. C. B. Barrett, R. D. Powers, M. M. Alper. Boston IVF, Waltham, MA. OBJECTIVE: Most IVF laboratories regularly monitor important quality parameters such as fertilization rates (FR) to ensure that optimal outcomes are obtained. Typically, a FR will be calculated for a selected period of time and then, using empirically-derived rules, it will be determined whether it is within an acceptable range. However, these methods often focus only on a single value or a small number of values and consequently lack a graphical component which allows trends in the data to be visualized. In addition, established statistical rules are generally not used to determine when the data is out of range and this can lead to false positives or false negatives. Recognizing these problems, we wanted to find a method that could be applied to IVF, was simple to use and was based on statistical principles. A set of techniques called statistical process control (SPC) was identified which has been widely used in manufacturing for many years and has seen increasing use in healthcare. SPC uses charts and statistical analyses to assess data and to monitor the quality of a process. Our objective was to determine whether an SPC proportion-chart (p-chart) could be applied to IVF to monitor FR results.
S262
P-358 Does “EmbryoGlue®” help embryos in their implantation? M. Li, A. Kumar, C. Marin Deugarte, M. Surrey, H. Danzer, D. Hill. ART Reproductive Center, Beverly Hills, CA; OBGYN Department, UCLA Medical Center, Los Angeles, CA. OBJECTIVE: EmbryoGlue® (Vitrolife) is a hyaluronan-rich medium resembling uterine fluid. It is reported to facilitate rapid diffusion with viscous uterine fluid, provide nutritional support from embryo transfer to implantation and support biochemical signaling during implantation (Vitrolife Fertility Systems, 2004). The effects of EmbryoGlue® used during in vitro fertilization ⫺ embryo transfer (IVF-ET) in our laboratory is evaluated. DESIGN: Retrospective study. MATERIALS AND METHODS: 1633 IVF-ET cases were included from 01/01/2002 to 3/15/2004 at ART Reproductive Center, Beverly Hills, California. During stage one (S1) modified HTF-hepes (Irvine Scientific, Cat 90126) ⫹ 20%SS (Irvine Scientific, Cat 90193) was used for ET. Stage 2 (S2) used EmbryoGlue® as the transfer medium according to the manufacturer’s suggested guidelines. RESULTS: In comparing the overall clinical pregnancy rates (Day 3--
Vol. 82, Suppl. 2, September 2004