The BlastGen pilot study: A prospective, pilot, randomised controlled trial of GM-CSF supplemented blastocyst media
Date
2020
Authors
Rose, R.D.
Barry, M.F.
Dunstan, E.V.
Yuen, S.M.
Cameron, L.P.
Knight, E.J.
Norman, R.J.
Hull, M.L.
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Journal article
Citation
Reproductive BioMedicine Online, 2020; 40(5):645-652
Statement of Responsibility
Ryan D. Rose, Michael F. Barry, Emma V. Dunstan, Siu Man Yuen, Lyndal P. Cameron, Emma J. Knight, Robert J. Norman, M. Louise Hull
Conference Name
Abstract
Research question: Does Embryogen®/BlastGen™ culture medium improve live birth rates compared with standard culture medium for women undergoing IVF and intracytoplasmic sperm injection (ICSI) with poor prognosis. Design: Randomized clinical trial. A total of 100 couples undergoing IVF/ICSI were randomly allocated to having their inseminated oocytes incubated in either Embryogen®/BlastGen™ sequential culture media or standard Cleavage/Blastocyst sequential culture media for 5 days (ClinicalTrials.gov Identifier: NCT02305420). Results: No statistically significant difference in live birth rate was found between the control group and the Embryogen®/ BlastGen™ group (17 [34%] versus 11 [22%], respectively) (OR 0.55; 95% CI 0.22 to 1.32; P = 0.18). After adjustment for maternal age, body mass index and fertilization procedure, the blastulation rate reduced (40.6 ± 26.5 versus 24.6 ± 26.7; RR 0.70, CI 0.52 to 0.95; P < 0.05), and grade of the embryo transferred (OR 0.35, CI 0.16 to 0.77; P < 0.01) when Embryogen®/BlastGen™ medium was used. Conclusion: A significant reduction in day-5 embryo outcome parameters was found using Embryogen®/BlastGen™ compared with standard medium, and insufficient evidence of a difference in pregnancy outcomes. Taking into consideration the small samples size, study limitations and strict inclusion criteria of this single-centre study, further research is needed to determine the efficacy of Embryogen®/BlastGen™ medium in couples undergoing IVF/ICSI.
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© 2020 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.