Embryo selection using time-lapse analysis (Early Embryo Viability Assessment) in conjunction with standard morphology: a prospective two-center pilot study.
Does prospective embryo selection using the results from the Eava Test (Early Embryo Viability Assessment) in combination with standard morphology increase the pregnancy rate of IVF and ICSI patients compared to embryo selection based on morphology only?



Embryo selection using the Eeva Test plus standard morphology on Day 3 results in comparable pregnancy rates as conventional morphological embryo selection.



Time-lapse monitoring of embryo development may represent a superior way to culture and select embryos in vitro. The Eeva Test records the development of each embryo with a cell-tracking system and predicts the likelihood (High, Medium or Low) that an embryo will form a blastocyst based on an automated analysis of early cell division timings.



This trial was designed as a prospective, observational, two-center pilot study with a propensity matched control group. The analysis involved 280 of 302 enrolled patients who were included in the Eeva Test group in 2013 and 560 control patients who were treated in the years 2011-2013. The majority of transfers (98%) were single embryo transfers.



Two academic hospitals (VUmc Amsterdam and UZ Gent) enrolled patients <41 years old, with <3 previous attempts and ≥5 normally fertilized eggs. Propensity matching was used to identify a propensity matched control group from a cohort of 1777 patients based on age, cycle number, oocyte number and number of fertilized oocytes.



There was no difference in patient baseline characteristics between the two groups. The ongoing pregnancy rate (OPR) of patients enrolled in the Eeva Test group (34.3%; 96/280) did not differ significantly from the OPR in the propensity matched control group (34.6%, 194/560; P = 0.92). However, significantly less top quality embryos (eight-cell embryos with ≤25% fragmentation) were transferred in the Eeva Test group compared to the propensity matched control group (70.4% vs. 82.3%; P < 0.001). The transfer of Eeva High and Medium embryos resulted in a significantly higher OPR of 36.8% (89/242) compared to 18.4% (7/38) for Eeva Low embryos (P = 0.02).



This pilot study is limited by its nonrandomized design with a concurrent and historical control.



Our pilot data did not reveal significant differences between time-lapse based and conventional embryo selection. Interestingly, the pregnancy rates were comparable in both groups even though the morphological quality of the transferred embryos was significantly lower in the Eeva Test group compared to the propensity matched control group. A sufficiently powered three-armed randomized controlled trial (RCT) with a solid design should be performed to generate decisive evidence in the future.



Progyny Inc., formerly Auxogyn provided the Eeva scopes, software and technical support for this study. The funding sources did neither influence data collection, management, analysis and interpretation of the data, nor the preparation of the manuscript.



ClinicalTrials.gov: NCT01671644.
Department of Obstetrics and Gynecology, IVF Center, VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, The Netherlands d.kieslinger@vumc.nl.
Dorit C
DC
Kieslinger
Department for Reproductive Medicine, University Hospital Ghent, De Pintelaan 185, 9000 Ghent, Belgium.
Stefanie
S
De Gheselle
Department of Obstetrics and Gynecology, IVF Center, VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, The Netherlands.
Cornelis B
CB
Lambalk
Department for Reproductive Medicine, University Hospital Ghent, De Pintelaan 185, 9000 Ghent, Belgium.
Petra
P
De Sutter
Department of Obstetrics and Gynecology, IVF Center, VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, The Netherlands.
E Hanna
EH
Kostelijk
Department of Epidemiology & Biostatistics, VU University Medical Center, De Boelelaan 1118, 1081 HV Amsterdam, The Netherlands.
Jos W R
JW
Twisk
Department of Obstetrics and Gynecology, IVF Center, VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, The Netherlands.
Joukje
J
van Rijswijk
Department for Reproductive Medicine, University Hospital Ghent, De Pintelaan 185, 9000 Ghent, Belgium.
Etienne
E
Van den Abbeel
Department of Obstetrics and Gynecology, IVF Center, VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, The Netherlands.
Carlijn G
CG
Vergouw
D000328:Adult; D046149:Embryo Culture Techniques / Q000379:methods*; D004624:Embryo Transfer / Q000379:methods; D047108:Embryonic Development / Q000502:physiology*; D005260:Female; D005307:Fertilization in Vitro / Q000379:methods*; D006801:Humans; D010865:Pilot Projects; D011247:Pregnancy; D011446:Prospective Studies; D059008:Time-Lapse Imaging
Eeva Test; embryo selection; morphokinetics; morphology; time-lapse