Time-lapse embryo selection for single blastocyst transfer – results of a multicenter, prospective, randomized clinical trial

The results encourage the hypothesis that in each azoospermic individual there is still chance to find cells belonging to the spermatogenic epithelia, which may assist in future therapeutic strategies for male infertility. Supported by: The Israel Ministry of Scienc and Technology. ASSISTED REPRODUCTIVE TECHNOLOGIES - CLINICAL II O-293 Tuesday, October 15, 2013 04:00 PM THE IMPACT OF SINGLE VS DOUBLE BLASTOCYST TRANSFER ON PREGNANCY OUTCOMES AND THE MULTIPLE BIRTH RATE: A PROSPECTIVE, RANDOMIZED CONTROL TRIAL. M. I. Abuzeid,a S. Joseph,b Y. Abuzeid,b W. Salem,c b a a M. G. Corrado, M. Ashraf. Division of Reproductive Endocrinology and Infertility, Dept of OB/GYN, Hurley Medical Center / IVF Michigan, PC, Flint, MI; bResearch, IVF Michigan, PC, Rochester Hills, MI; cObsetrics and Gynecology, UCSF Medical Center, Women’s Health, San Francisco, CA. OBJECTIVE: To determine if single blastocyst transfer (SBT) compromises pregnancy outcomes compared to traditional double blastocyst transfer (DBT) in patients with favorable reproductive potential. DESIGN: Randomized Control Trial ISRCTN69937179. MATERIALS AND METHODS: The study (2009-13) consists of 41 patients with SBT (group 1) and 39 patients with DBT (group 2). All women were <35 years, had day 3 FSH levels <10 mIU/ml, had no history of poor ovarian response, and no more than one previous IVF failure. Randomization criterion was two good quality Day 5 blastocysts. ICSI was performed on mature oocytes and luteal phase was Supported by vaginal progesterone. Some women who did not get pregnant or who miscarried underwent subsequent frozen-thawed cycles. RESULTS: No significant difference was observed in the demographic data or infertility etiology between the groups except for mean female age and incidence of endometriosis (both significantly lower in group 1). There was no significant difference in the ovarian stimulation or embryology data between the groups. There was a significant difference in clinical pregnancy (59% vs 80%, P<0.05), and delivery/ongoing pregnancy (44% vs 67%, P<0.05) rates, but no difference in implantation (49% vs 54%), miscarriage, or ectopic rates between group 1 and group 2, respectively. There was a significantly higher multiple pregnancy rate in group 2 (33%) compared to 0% in group 1 (P<0.05). When fresh and frozen cycles were combined, there was a significant difference (P<0.05) in clinical pregnancy (71% vs 90%) and delivery/ongoing pregnancy (56% vs 77%) between group 1 and group 2 respectively. CONCLUSION: In patients with favorable reproductive potential, although SBT appears to reduce clinical pregnancy and live-birth rates, excellent pregnancy outcomes are achieved. Clinicians must weigh the benefits of DBT against the risk associated with multiple pregnancy in each specific patient before determining the number of blastocysts to be transferred. Supported by: Partial grant by Ferring Pharmaceutical. O-294 Tuesday, October 15, 2013 04:15 PM EMBRYOS EXHIBITING ABNORMAL FIRST CYTOKINESIS PHENOTYPES ARE ASSOCIATED WITH POORER EMBRYO DEVELOPMENT AND LOWER IMPLANTATION POTENTIAL. J. Conaghan,a K. Athayde Wirka,b M. Gvakharia,c K. Ivani,d S. Shen,b A. A. Chen.b aPacific Fertility Center, San Francisco, CA; bAuxogyn, Inc, Menlo Park, CA; cFertility Physicians of Northern California, San Jose, CA; dReproductive Science Center of the SF Bay Area, San Ramon, CA. OBJECTIVE: Combined with timing of the 2nd and 3rd cytokinesis, a prolonged 1st cytokinesis duration has been reported to correlate with low blastocyst formation and reduced expression of cytokinesis genes (Wong et al, 2010). This study determined the incidence of a novel abnormal 1st cytokinesis phenotype, evaluated the duration of 1st cytokinesis, and assessed clinical relevance. DESIGN: Multisite retrospective cohort study. MATERIALS AND METHODS: Patients from 3 clinics consented to have embryos imaged using the EevaÔ Test (Auxogyn), which performs timelapse analysis of key cell division timings (Jun2011-Oct 2012). Embryo videos were reviewed for 1st cytokinesis phenotype and duration (P1). Abnormal phenotype was defined as oolema ruffling and/or formation of

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pseudo cleavage furrows. P1 duration was defined as the time from appearance of the 1st cleavage furrow to completion of the 1st division. Clinical pregnancy was confirmed by ultrasound at 6 wks. Fisher’s Exact test was used to assess statistical significance. RESULTS: A total of 638 embryos from 67 patients were categorized into groups: (1) with normal phenotype (442/638¼69%) and (2) with abnormal phenotype (196/638¼31%). Both groups had good morphology embryos on D3 (53% and 34% with 6-10 cells, %10% frag, p<0.001). Group 2 had a lower blastocyst formation rate (131/305¼43% vs. 26/126¼20%, p<0.0001) and trended to lower implantation rate (15/91¼17% vs. 2/ 32¼6%, p¼0.2). Group 2 also exhibited prolonged P1 (0.5 0.8 vs. 1.83.3 hrs, p<0.0001). Within Group 2, a subgroup of embryos with P1R0.5 hrs had even lower blastocyst formation (6/70¼9%; p<0.0001 vs. Group 1, p<0.05 vs. Group 2), and none (0/14) implanted. CONCLUSION: Embryos exhibiting abnormal 1st cytokinesis phenotypes represent 31% of the embryo population and have significantly lower developmental potential. Since many of these embryos have good morphology at the cleavage stage, using time-lapse to detect abnormal and prolonged 1st cytokinesis phenotypes may improve the success of embryo selection. Supported by: Auxogyn. O-295 Tuesday, October 15, 2013 04:30 PM TIME-LAPSE EMBRYO SELECTION FOR SINGLE BLASTOCYST TRANSFER – RESULTS OF A MULTICENTER, PROSPECTIVE, S. Matyas,a RANDOMIZED CLINICAL TRIAL. P. Kovacs,a V. Forgacs,b A. Sajgo,a F. Rarosi,c C. Pribenszky.d aKaali Institute IVF Center, Budapest, Hungary; bForgacs Intezet, Budapest, Hungary; cDept. Medical Physics and Informatics, Bolyai Inst., Univ. of Szeged, Szeged, Hungary; d Dept. of Animal Breeding and Genetics, St. Istvan Univ. Faculty of Veterinary Science, Budapest, Hungary. OBJECTIVE: A multiple pregnancy is an undesired outcome of assisted reproduction. Current selection methods are inefficient at identifying the embryo with the highest implantation potential. Time lapse (TL) embryo monitoring provides additional information about embryo development and therefore may aid embryo selection. Our aim is to study whether TL monitoring combined with morphological scoring is superior to traditional embryo observation when a single blastocyst (BC) is selected for transfer (ET). DESIGN: Prospective, randomized, multicenter trial. MATERIALS AND METHODS: Patients eligible for single ET (SET) were randomized to TL monitoring (automated time-lapse device inside traditional incubators, Primo Vision, Vitrolife Kft., Hungary) vs. standard daily embryo monitoring. Stimulation / retrieval/ laboratory procedures followed standard methods. Embryos were cultured in multi-well dishes until the BC stage when there were R3 good morphology day-3 embryos. The embryo for ET was selected based on day 5 morphology (control group) or on TL observations (composite score based on cleavage kinetics, fragmentation, BC formation). Demographic, stimulation and outcome parameters were compared. RESULTS: 62 patients were randomized so far (30 TL vs 32 standard monitoring), 13 dropped out. Patient and stimulation parameters were comparable between the two groups. The clinical and ongoing pregnancy rates were not statistically different: 15/24 (62.5% TL) vs 12/25 (48% control) and 14/24 (58.3% TL) vs 11/25 (44% control), respectively. CONCLUSION: TL observation of embryos may assist embryo selection for SET. This non-invasive method could prove to be a useful tool in minimizing the risk of multiple gestations. Although statistical difference was not reached with the current patient number, if the trend continues during this study it is anticipated that TL embryo selection will be demonstrated to significantly improve clinical and ongoing pregnancy rates. O-296 Tuesday, October 15, 2013 04:45 PM THE STATE OF INSURANCE MANDATES AND INTRACYTOPLASMIC SPERM INJECTION (ICSI) USE IN THE UNITED STATES. N. K. Banks,a J. M. Norian,b M. B. Henne.c aNational Human Genome Research Institute, National Institutes of Health, Bethesda, MD; b HRC Fertility, Pasadena, CA; cDepartment of Defense Pharmacoeconomic Center, Fort Sam Houston, TX. OBJECTIVE: ICSI is an effective and accepted treatment for male factor infertility; however, the evidence does not currently support widespread use of ICSI to address non-male-factor infertility. Despite this, use of ICSI has

Vol. 100, No. 3, Supplement, September 2013