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Are morphokinetic parameters after thawing related to implantation in day 3 cryopreserved embryos?
Group 1: SIS performed during same IVF cycle; Group 2: SIS performed in a previous menstrual cycle. Parameter
Group 1 (n¼152)
Group 2 (n¼7648)
P
Age (years) BMI (kg/m2) Total stimulation days Total gonadotropins (IU) Number of oocytes retrieved Number of embryos transferred Clinical pregnancy rate Biochemical pregnancy rate Spontaneous miscarriage rate Live birth rate
35.7 (4.99) 23.2 (5.99) 9.28 (1.90) 3161.7 (1433.4) 12.1 (7.61) 2.34 (1.16) 64 (42.1%) 12 (7.89%) 8 (5.26%) 55 (36.2%)
35.9 (4.95) 23.1 (5.89) 9.13 (1.54) 3118.6 (1498.1) 11.7 (6.42) 2.41 (1.19) 2967 (38.8%) 578 (7.56%) 275 (3.60%) 2687 (35.1%)
0.62 0.84 0.24 0.72 0.45 0.47 0.41 0.88 0.28 0.79
P-136 Tuesday, October 20, 2015 ARE MORPHOKINETIC PARAMETERS AFTER THAWING RELATED TO IMPLANTATION IN DAY 3 CRYOPRESERVED EMBRYOS?. E. Fernandez Gallardo, C. Spiessens, T. D’Hooghe, S. Debrock. Leuven University Fertility Centre, Leuven University Hospital, Leuven, Belgium. OBJECTIVE: To study, for the first time, the relation between morphokinetic parameters after thawing and implantation in intact and non-intact vitrified/warmed and slow frozen/thawed embryos. DESIGN: Presence of mitosis, presence of compaction, time to mitosis and time to compaction were analyzed retrospectively for 82 embryos (35 slow frozen and 47 vitrified). After survival, embryos were cultured overnight in ASTECÒ time lapse incubator (TLI) and transferred. Implantation was defined as the presence of fetal sac (intra- or extrauterine) at 6-8 weeks pregnancy after transfer. All transfers included in the study had either 0% or 100% embryos implanted. MATERIALS AND METHODS: Embryos were vitrified (EmbryoStore, GynemedÒ) or slow frozen (Vitr Kit Freeze, Irvine ScientificÒ) on day 3 if R6 cells and <25% fragmentation. An embryo was intact when 100% of blastomeres survived the thawing. A non-intact embryo had R50% and <100% of the blastomeres survived. differences between groups were calculated using chi-square and t-test. RESULTS: Mitosis resumption rate was higher in vitrified embryos than in slow frozen embryos (69% vs. 41%, p¼0.04). No difference was found between intact and non-intact embryos (80% vs. 77%) and implanted and non-implanted (93% vs. 76%). Time to mitosis resumption was shorter in intact than in nonintact embryos (7.14.9h vs. 10.76.6h, p¼0.01), but did not differ between vitrified and slow frozen embryos (7.35.0h vs. 10.26.7h) and between implanted and non-implanted (8.05.3h vs. 8.46.0h). Compaction rate was higher in vitrified embryos than in slow frozen mbryos (60% vs. 22%, p¼0.0009) but was equal in intact and non-intact (49% vs. 35%) and in implanted and non-implanted (64% vs.40%) embryos. Time to compaction was not different neither between vitrified and slow frozen (13.96.0h vs. 16.57.2h), nor between intact and non-intact (15.61.2h vs. 14.02.0h), nor between implanted and non-implanted embryos (17.00.4h vs.13.61.3h). When analyzing separately vitrified embryos and slow frozen embryos, implantation rate was neither related to presence of or time to mitosis (90% vs. 86%; 100% vs. 64%; 6.9h vs. 7.4h; 10.6h vs. 10.1h), nor presence of or time to compaction (70% vs. 56%; 50% vs. 19%; 17.11.2h vs. 12.76.6h; 16.41.6h vs. 16.58.5h). CONCLUSIONS: This is the first time that morphokinetic parameters of day 3 cryopreserved embryos have been described. Time to mitosis was shorter in intact embryos compared to non-intact embryos. Despite the fact that vitrified embryos showed a higher mitosis resumption and compaction rate than slow frozen embryos, no difference was found in time to mitosis and time to compaction. Besides, none of the morphokinetic variables were related to implantation. LEIOMYOMA P-137 Tuesday, October 20, 2015 ANALYSIS OF INTERVENTIONAL FIBROID THERAPIES USING A COMPREHENSIVE COHORT. A. M. Abdelmagied,a,b L. E. Vaughan,c A. Weaver,c S. K. Laughlin-Tommaso,a G. Hesley,d D. A. Woodrum,d V. Jacoby,e T. M. Price,f E. A. Stewart.a aObstetrics and Gynecology, Mayo Clinic, Rochester, MN; bObstetrics and Gynecology, Women Health
FERTILITY & STERILITYÒ
Hospital, Assiut University, Assiut, Egypt; cHealth Sciences Research, Mayo Clinic, Rochester, MN; dRadiology, Mayo Clinic, Rochester, MN; e Obstetrics, Gynecology, and Reproductive Sciences, UCSF, San Francisco, CA; fObstetrics and Gynecology, Duke University, Durham, NC. DESIGN: BASELINE RESULTS FROM THE FIRSTT STUDY. OBJECTIVE: Recruitment for a randomized clinical trial (RCT) of interventional treatments for uterine fibroids is difficult. As part of the FIRSTT study (NCT00995878, clinicaltrials.gov), an RCT comparing uterine artery embolization (UAE) and focused ultrasound surgery (FUS), we also contemporaneously recruited women meeting the same enrollment criteria who declined randomization (Parallel Cohort,PC). We hypothesized that this comprehensive cohort design (CCD) would allow greater enrollment for analysis and increased generalizability of results. DESIGN: RCT and non-randomized PC MATERIALS AND METHODS: Premenopausal women with symptomatic fibroids were recruited from three centers. Baseline data included multiple validated measures such as Uterine Fibroid Symptom and Quality of Life Questionnaire (UFS-QOL), RAND 36, McGill Pain Questionnaire (MPQ) and a Visual Analogue Scale (VAS) for pain. Comparisons between groups were evaluated using the t-test, Wilcoxon rank sum test and chi-square test as appropriate. RESULTS: RCT subjects (N¼ 57) had a higher BMI (MeanSD, 28.75.5 vs. 25.36.0 kg/m2, p¼0.01), were more likely to have had a pregnancy (77.2 vs. 47.1%, p¼0.003) and to be current (17.5 vs. 2.9%, p¼0.048) or ever smokers (42.1 vs. 12.1%, p¼0.003) than PC subjects (N¼34). There were no other differences in patient, fibroid or uterine characteristics, symptoms, or scores on validated instruments at baseline. Among RCT subjects, 8 women randomized to UAE did not undergo treatment compared to 1 randomized to FUS.Within the PC, 18 subjects underwent UAE and 16 underwent FUS. When analyzing the combined RCT-PC group by treatment arm the only significant difference was that women in the FUS arm had higher pain scores on the MPQ (Median, 10.5 vs. 6, p¼0.03). A similar trend was observed on VAS (Median, 39 vs. 24, p¼0.06). CONCLUSIONS: RCT and PC women were comparable. Additional power and decreased bias due to differential loss between arms could be achieved when assessing outcomes in the FIRSTT trial using a comprehensive cohort design with adjustment for baseline differences. Supported by: NIH RC1HD063312, R01HD0605 & UL1 RR024150. P-138 Tuesday, October 20, 2015 DISPARITIES IN THE FINANCIAL IMPACT OF UTERINE FIBROIDS: A QUALITATIVE ASSESSMENT. K. Sengoba,a M. Ghant,b G. Mendoza,c E. E. Marsh.c aObstetrics and Gynecology, Northwestern University Feinberg School of Medicine, Chicago, IL; bUniversity of Illinois at Chicago, Chicago, IL; cFeinberg School of Medicine-Northwestern University, Chicago, IL. OBJECTIVE: While several studies have looked at the impact of the cost of fibroids at a national level, very few have looked at the financial impact of fibroids on an individual level. The purpose of this study is to qualitatively assess the financial burden of uterine fibroids and to identify associated racial disparities of this impact. DESIGN: Qualitative, In-depth interviews and demographic surveys MATERIALS AND METHODS: Women with symptomatic uterine fibroids were recruited from an urban medical center and community-based organizations. The women completed in-depth, one-on-one, semi- structured interviews, a demographic survey and a health literacy assessment. These interviews were recorded and transcribed verbatim. Data were analyzed using a grounded theory approach and uploaded to NVivo version 10 for thematic coding. Three coders independently identified major themes and sub-themes from the interviews. RESULTS: Sixty women completed the study. The mean age of participants was 43.0 6.8 years. 61.7% self-identified as African-American, 25.0% as Caucasian, 8.3% as Hispanic and 5.0% as Asian. The kappa amongst coders was 0.94. One of the major themes identified was financial impact, from which several subthemes were derived. All of the subjects who were concerned about the amount of money spent monthly for hygiene-related products to prevent public embarrassment were African-American. The same was true of the women who were frustrated about the cost of tests they underwent before obtaining a diagnosis. Regardless of race, most of the participants had significant concerns regarding their ability to cover medical bills for fibroids due to either being uninsured or underinsured. African-American women, however, disproportionately expressed financial
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Group 1 (n¼152)
Group 2 (n¼7648)
P
Age (years) BMI (kg/m2) Total stimulation days Total gonadotropins (IU) Number of oocytes retrieved Number of embryos transferred Clinical pregnancy rate Biochemical pregnancy rate Spontaneous miscarriage rate Live birth rate
35.7 (4.99) 23.2 (5.99) 9.28 (1.90) 3161.7 (1433.4) 12.1 (7.61) 2.34 (1.16) 64 (42.1%) 12 (7.89%) 8 (5.26%) 55 (36.2%)
35.9 (4.95) 23.1 (5.89) 9.13 (1.54) 3118.6 (1498.1) 11.7 (6.42) 2.41 (1.19) 2967 (38.8%) 578 (7.56%) 275 (3.60%) 2687 (35.1%)
0.62 0.84 0.24 0.72 0.45 0.47 0.41 0.88 0.28 0.79
P-136 Tuesday, October 20, 2015 ARE MORPHOKINETIC PARAMETERS AFTER THAWING RELATED TO IMPLANTATION IN DAY 3 CRYOPRESERVED EMBRYOS?. E. Fernandez Gallardo, C. Spiessens, T. D’Hooghe, S. Debrock. Leuven University Fertility Centre, Leuven University Hospital, Leuven, Belgium. OBJECTIVE: To study, for the first time, the relation between morphokinetic parameters after thawing and implantation in intact and non-intact vitrified/warmed and slow frozen/thawed embryos. DESIGN: Presence of mitosis, presence of compaction, time to mitosis and time to compaction were analyzed retrospectively for 82 embryos (35 slow frozen and 47 vitrified). After survival, embryos were cultured overnight in ASTECÒ time lapse incubator (TLI) and transferred. Implantation was defined as the presence of fetal sac (intra- or extrauterine) at 6-8 weeks pregnancy after transfer. All transfers included in the study had either 0% or 100% embryos implanted. MATERIALS AND METHODS: Embryos were vitrified (EmbryoStore, GynemedÒ) or slow frozen (Vitr Kit Freeze, Irvine ScientificÒ) on day 3 if R6 cells and <25% fragmentation. An embryo was intact when 100% of blastomeres survived the thawing. A non-intact embryo had R50% and <100% of the blastomeres survived. differences between groups were calculated using chi-square and t-test. RESULTS: Mitosis resumption rate was higher in vitrified embryos than in slow frozen embryos (69% vs. 41%, p¼0.04). No difference was found between intact and non-intact embryos (80% vs. 77%) and implanted and non-implanted (93% vs. 76%). Time to mitosis resumption was shorter in intact than in nonintact embryos (7.14.9h vs. 10.76.6h, p¼0.01), but did not differ between vitrified and slow frozen embryos (7.35.0h vs. 10.26.7h) and between implanted and non-implanted (8.05.3h vs. 8.46.0h). Compaction rate was higher in vitrified embryos than in slow frozen mbryos (60% vs. 22%, p¼0.0009) but was equal in intact and non-intact (49% vs. 35%) and in implanted and non-implanted (64% vs.40%) embryos. Time to compaction was not different neither between vitrified and slow frozen (13.96.0h vs. 16.57.2h), nor between intact and non-intact (15.61.2h vs. 14.02.0h), nor between implanted and non-implanted embryos (17.00.4h vs.13.61.3h). When analyzing separately vitrified embryos and slow frozen embryos, implantation rate was neither related to presence of or time to mitosis (90% vs. 86%; 100% vs. 64%; 6.9h vs. 7.4h; 10.6h vs. 10.1h), nor presence of or time to compaction (70% vs. 56%; 50% vs. 19%; 17.11.2h vs. 12.76.6h; 16.41.6h vs. 16.58.5h). CONCLUSIONS: This is the first time that morphokinetic parameters of day 3 cryopreserved embryos have been described. Time to mitosis was shorter in intact embryos compared to non-intact embryos. Despite the fact that vitrified embryos showed a higher mitosis resumption and compaction rate than slow frozen embryos, no difference was found in time to mitosis and time to compaction. Besides, none of the morphokinetic variables were related to implantation. LEIOMYOMA P-137 Tuesday, October 20, 2015 ANALYSIS OF INTERVENTIONAL FIBROID THERAPIES USING A COMPREHENSIVE COHORT. A. M. Abdelmagied,a,b L. E. Vaughan,c A. Weaver,c S. K. Laughlin-Tommaso,a G. Hesley,d D. A. Woodrum,d V. Jacoby,e T. M. Price,f E. A. Stewart.a aObstetrics and Gynecology, Mayo Clinic, Rochester, MN; bObstetrics and Gynecology, Women Health
FERTILITY & STERILITYÒ
Hospital, Assiut University, Assiut, Egypt; cHealth Sciences Research, Mayo Clinic, Rochester, MN; dRadiology, Mayo Clinic, Rochester, MN; e Obstetrics, Gynecology, and Reproductive Sciences, UCSF, San Francisco, CA; fObstetrics and Gynecology, Duke University, Durham, NC. DESIGN: BASELINE RESULTS FROM THE FIRSTT STUDY. OBJECTIVE: Recruitment for a randomized clinical trial (RCT) of interventional treatments for uterine fibroids is difficult. As part of the FIRSTT study (NCT00995878, clinicaltrials.gov), an RCT comparing uterine artery embolization (UAE) and focused ultrasound surgery (FUS), we also contemporaneously recruited women meeting the same enrollment criteria who declined randomization (Parallel Cohort,PC). We hypothesized that this comprehensive cohort design (CCD) would allow greater enrollment for analysis and increased generalizability of results. DESIGN: RCT and non-randomized PC MATERIALS AND METHODS: Premenopausal women with symptomatic fibroids were recruited from three centers. Baseline data included multiple validated measures such as Uterine Fibroid Symptom and Quality of Life Questionnaire (UFS-QOL), RAND 36, McGill Pain Questionnaire (MPQ) and a Visual Analogue Scale (VAS) for pain. Comparisons between groups were evaluated using the t-test, Wilcoxon rank sum test and chi-square test as appropriate. RESULTS: RCT subjects (N¼ 57) had a higher BMI (MeanSD, 28.75.5 vs. 25.36.0 kg/m2, p¼0.01), were more likely to have had a pregnancy (77.2 vs. 47.1%, p¼0.003) and to be current (17.5 vs. 2.9%, p¼0.048) or ever smokers (42.1 vs. 12.1%, p¼0.003) than PC subjects (N¼34). There were no other differences in patient, fibroid or uterine characteristics, symptoms, or scores on validated instruments at baseline. Among RCT subjects, 8 women randomized to UAE did not undergo treatment compared to 1 randomized to FUS.Within the PC, 18 subjects underwent UAE and 16 underwent FUS. When analyzing the combined RCT-PC group by treatment arm the only significant difference was that women in the FUS arm had higher pain scores on the MPQ (Median, 10.5 vs. 6, p¼0.03). A similar trend was observed on VAS (Median, 39 vs. 24, p¼0.06). CONCLUSIONS: RCT and PC women were comparable. Additional power and decreased bias due to differential loss between arms could be achieved when assessing outcomes in the FIRSTT trial using a comprehensive cohort design with adjustment for baseline differences. Supported by: NIH RC1HD063312, R01HD0605 & UL1 RR024150. P-138 Tuesday, October 20, 2015 DISPARITIES IN THE FINANCIAL IMPACT OF UTERINE FIBROIDS: A QUALITATIVE ASSESSMENT. K. Sengoba,a M. Ghant,b G. Mendoza,c E. E. Marsh.c aObstetrics and Gynecology, Northwestern University Feinberg School of Medicine, Chicago, IL; bUniversity of Illinois at Chicago, Chicago, IL; cFeinberg School of Medicine-Northwestern University, Chicago, IL. OBJECTIVE: While several studies have looked at the impact of the cost of fibroids at a national level, very few have looked at the financial impact of fibroids on an individual level. The purpose of this study is to qualitatively assess the financial burden of uterine fibroids and to identify associated racial disparities of this impact. DESIGN: Qualitative, In-depth interviews and demographic surveys MATERIALS AND METHODS: Women with symptomatic uterine fibroids were recruited from an urban medical center and community-based organizations. The women completed in-depth, one-on-one, semi- structured interviews, a demographic survey and a health literacy assessment. These interviews were recorded and transcribed verbatim. Data were analyzed using a grounded theory approach and uploaded to NVivo version 10 for thematic coding. Three coders independently identified major themes and sub-themes from the interviews. RESULTS: Sixty women completed the study. The mean age of participants was 43.0 6.8 years. 61.7% self-identified as African-American, 25.0% as Caucasian, 8.3% as Hispanic and 5.0% as Asian. The kappa amongst coders was 0.94. One of the major themes identified was financial impact, from which several subthemes were derived. All of the subjects who were concerned about the amount of money spent monthly for hygiene-related products to prevent public embarrassment were African-American. The same was true of the women who were frustrated about the cost of tests they underwent before obtaining a diagnosis. Regardless of race, most of the participants had significant concerns regarding their ability to cover medical bills for fibroids due to either being uninsured or underinsured. African-American women, however, disproportionately expressed financial
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