Eeva™ pregnancy pilot study: a randomized controlled trial of single embryo transfer (SET) on day 3 or day 5 with or without time-lapse imaging (TLI) selection

P-545 Wednesday, October 19, 2016 UTILIZATION OF INTRACYTOPLASMIC SPERM INJECTION (ICSI) AMONG FERTILITY CENTERS IN THE UNITED STATES 2000-2013. T. A. Chang,a E. S. Jacoby,a Y. T. Su,b J. F. Knudtson,a R. D. Robinson,a R. S. Schenken.a aObstetrics and Gynecology, University of Texas Health Science Center, San Antonio, TX; bResearch Consultant, Helotes, TX. OBJECTIVE: To investigate trends and factors in ICSI utilization among fertility clinics in the United States. DESIGN: Retrospective data analysis of CDC annual ART report 20002013 (latest published data) MATERIALS AND METHODS: Fresh non-donor cycles were analyzed. Longitudinal trends of ICSI practice, and effects of patient volume, geographic region, male factor diagnosis, and insurance coverage mandates on utilization, were compared. T-tests and Pearson’s correlation coefficients were used to analyze all trends and differences in proportions between categories. RESULTS: The number of fresh non-donor ICSI cycles continued to increase from 33,378 in 2000 to 67,693 in 2012, followed by a slight decrease to 64,425 in 2013. The percent of cycles using ICSI in all fertility centers increased from average 44.8% in 2000 to average 72.3% in 2013 despite the fluctuation of total cycles and no significant change in the prevalence of male factor related infertility (35.0-38.2%). Nationwide inter-clinic data showed no significant correlation between ICSI utilization and male factor related diagnosis in general. In recent years, programs with smaller patient volume consistently showed a higher percentage of ICSI compared to larger clinics (p < .05). This is in contrast to 2000 data which showed larger clinics performing a higher percentage of ICSI cycles (p < .05). Overall pregnancy, implantation, and live birth rates were similar between programs with low and high ICSI utilization rates. Differences among geographic regions were found with local trends of utilization gradually shifting throughout the years, without change in the incidence of male factor diagnosis rates. Many programs in states with insurance mandates showed higher ICSI rates, but generally a lower incidence of male factor infertility diagnosis. CONCLUSIONS: ICSI utilization rates in the United States have continued to increase, with significant variability based on factors including male factor diagnosis, clinic sizes and geographic regions. However, the increase in ICSI use did not correlate to clinical outcomes. These findings warrant further investigations regarding the appropriate use of ICSI for non-male factor infertility.

OBJECTIVE: TLI is increasingly used for embryo selection, despite relatively sparse high-quality evidence supporting its utility. This study was designed to assess the value of the EevaTM test [times in the 2-cell (P2) and 3-cell (P3) stages] for embryo selection when used as an adjunct to conventional morphology (CM) for day 3 or day 5 transfer. DESIGN: Randomized controlled trial. MATERIALS AND METHODS: Patients with a planned fresh SET, < 3 prior retrievals, and > 4 zygotes were blocked on age (<35, 35-37, 38-40 y) and randomized by closed envelope immediately after the fertilization check to one of 3 arms: Arm 1: Day 3 with EevaTM+CM; Arm 2: Day 5 with EevaTM+CM; Arm 3: Day 5 with CM alone. Other TLI parameters used for selection included abnormal and direct cleavage. Exclusion criteria were use of donor egg, gestational carrier or PGD/PGS, and presence of an uninterrupted hydrosalpinx or history of intrauterine adhesions. Embryos in all 3 arms were imaged continuously by EevaTM version 2.2 in the same type of incubator. Intention-to-treat and as-treated analyses of the primary endpoint (clinical pregnancy rate [CPR] at 7 weeks) and secondary endpoint (ongoing pregnancy rate [OPR] at 12 weeks) were performed. Multivariate regression adjusted for age, body mass index (BMI), and number of embryos on day 1. Sensitivity, specificity, PPV, and NPV of the EevaÔ test (High/Medium vs. Low) for predicting ongoing pregnancy at 12 weeks were calculated. RESULTS: Of 217 patients consented, 163 were randomized. Demographic and cycle characteristics were similar among the three study arms. Neither CPR nor OPR differed significantly between randomization arms in both intention-to-treat and as-treated analyses; notably, selection of a day 5 embryo with only CM resulted in the highest pregnancy rates (Table). While the sensitivity of EevaTM High/Medium was the same on day 3 vs. day 5 (95.2% vs. 95.4%), the specificity (5.9% vs. 17.0%), PPV (38.5% vs. 46.6%) and NPV (66.7% vs. 83.3%) were all lower for day 3. CONCLUSIONS: Addition of the EevaÔ test to CM did not improve clinical outcomes compared with CM alone, despite a 95% sensitivity of a High/ Medium embryo resulting in ongoing pregnancy. This study was not powered to detect statistical difference, though the observed trend favoring selection on day 5 with CM alone challenges the use of P2 and P3 for time-lapse selection. These findings do not preclude the utility of P2 and P3 for embryo selection when used in conjunction with other time-lapse markers. Supported by: Progyny, Inc.

P-547 Wednesday, October 19, 2016

P-546 Wednesday, October 19, 2016

METABOLOMIC PROFILE OF FOLLICULAR FLUID AS A PREDICTIVE TOOL FOR PREGNANCY a a OUTCOMES. D. A. Montani, J. Camillo, A. Rodrigues-Oliveira,b D. Oliveira-Silva,b E. G. Lo Turco,c R. Fraietta.c aDepartment of Surgery, Division of Urology, Human Reproduction Sector, Sao Paulo Federal University, Sao Paulo, Brazil; bSao Paulo Federal University, Diadema, Brazil; cDepartment of Surgery, Division of Urology, Human, Sao Paulo Federal University, Sao Paulo, Brazil.

EEVAÔ PREGNANCY PILOT STUDY: A RANDOMIZED CONTROLLED TRIAL OF SINGLE EMBRYO TRANSFER (SET) ON DAY 3 OR DAY 5 WITH OR WITHOUT TIME-LAPSE IMAGING (TLI) SELECTION. D. J. Kaser,a C. L. Bormann,a S. A. Missmer,a,b L. V. Farland,a,b E. S. Ginsburg,a C. Racowsky.a aObstetrics, Gynecology & Reproductive Biology, Brigham & Women’s Hospital, Harvard Medical School, Boston, MA; bEpidemiology, Harvard Chan School, Boston, MA.

OBJECTIVE: This study evaluated the metabolic profile of follicular fluid from women who underwent in vitro fertilization treatments as a potential predictive approach for pregnancy. DESIGN: Prospective study including follicular fluid samples from 91 women. MATERIALS AND METHODS: According to the b-hCG levels measured 14 days after the embryo transfer the samples were divided

ART OUTCOME PREDICTORS - LABORATORY

Table. Ongoing pregnancy rate at 12 weeks according to day of transfer and method of selection

N (%) Intention-to-treat Day 3 EevaÔ+CM 21/56 (37.5) Day 5 EevaÔ+CM 18/54 (33.3) Day 5 CM alone 25/53 (47.2) As-treated Day 3 EevaÔ+CM 19/49 (38.8) Day 5 EevaÔ+CM 18/52 (34.6) Day 5 CM alone 26/53 (49.1) a Adjusted for patient age, BMI and number of embryos on day 1

e312

ASRM Abstracts

Crude OR (95% CI)

Adjusted OR (95% CI)a

0.67 (0.31-1.44) 0.56 (0.26-1.22) 1.00 (referent)

0.69 (0.32-1.50) 0.53 (0.24-1.18) 1.00 (referent)

0.66 (0.30-1.45) 0.55 (0.25-1.20) 1.00 (referent)

0.67 (0.30-1.49) 0.53 (0.24-1.18) 1.00 (referent)

Vol. 106, No. 3, Supplement, September 2016