The BlastGen study: a randomized controlled trial of blastocyst media supplemented with granulocyte-macrophage colony-stimulating factor

Ryan D Rose; Michael F Barry; Emma V Dunstan; Siu Man Yuen; Lyndal P Cameron; Emma J Knight; Robert J Norman; M Louise Hull

doi:10.1016/j.rbmo.2020.01.011

The BlastGen study: a randomized controlled trial of blastocyst media supplemented with granulocyte-macrophage colony-stimulating factor

Reprod Biomed Online. 2020 May;40(5):645-652. doi: 10.1016/j.rbmo.2020.01.011. Epub 2020 Jan 23.

Authors

Ryan D Rose¹, Michael F Barry², Emma V Dunstan³, Siu Man Yuen⁴, Lyndal P Cameron³, Emma J Knight⁵, Robert J Norman², M Louise Hull²

Affiliations

¹ Fertility SA, St Andrews Hospital, 350 South Terrace, Adelaide SA 5000, Australia; Adelaide Health and Medical Sciences, Robinson Research Institute, The University of Adelaide, AHMS Building, North Terrace, Adelaide SA 5005, Australia. Electronic address: ryan.rose@adelaide.edu.au.
² Fertility SA, St Andrews Hospital, 350 South Terrace, Adelaide SA 5000, Australia; Adelaide Health and Medical Sciences, Robinson Research Institute, The University of Adelaide, AHMS Building, North Terrace, Adelaide SA 5005, Australia.
³ Fertility SA, St Andrews Hospital, 350 South Terrace, Adelaide SA 5000, Australia.
⁴ Adelaide Health and Medical Sciences, Robinson Research Institute, The University of Adelaide, AHMS Building, North Terrace, Adelaide SA 5005, Australia.
⁵ School of Public Health, Robinson Research Institute, AHMS Building, The University of Adelaide, North Terrace, Adelaide5005 SA, Australia.

PMID: 32220517
DOI: 10.1016/j.rbmo.2020.01.011

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.

Keywords: ART; Blastocyst; Embryo; Embryo quality; GM-CSF; IVF.

Publication types

Randomized Controlled Trial

MeSH terms

Adult
Culture Media / chemistry*
Embryo Culture Techniques / methods*
Embryo Transfer / methods
Embryonic Development / physiology*
Female
Fertilization in Vitro / methods
Granulocyte-Macrophage Colony-Stimulating Factor / analysis*
Humans
Male
Pregnancy
Pregnancy Outcome
Pregnancy Rate
Sperm Injections, Intracytoplasmic / methods
Treatment Outcome

Substances

Culture Media
Granulocyte-Macrophage Colony-Stimulating Factor

Associated data

ClinicalTrials.gov/NCT02305420