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

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

Research output: Contribution to journal › Article › peer-review

7 Citations (Scopus)

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.

Original language	English
Pages (from-to)	645-652
Number of pages	8
Journal	Reproductive BioMedicine Online
Volume	40
Issue number	5
DOIs	https://doi.org/10.1016/j.rbmo.2020.01.011
Publication status	Published or Issued - May 2020

Keywords

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

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10.1016/j.rbmo.2020.01.011

Cite this

@article{df0d386de14b4bdcb1813fb9f5d903d7,

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

abstract = "RESEARCH QUESTION: Does Embryogen{\textregistered}/BlastGen{\texttrademark} 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{\textregistered}/BlastGen{\texttrademark} 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{\textregistered}/BlastGen{\texttrademark} 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{\textregistered}/BlastGen{\texttrademark} medium was used.CONCLUSION: A significant reduction in day-5 embryo outcome parameters was found using Embryogen{\textregistered}/BlastGen{\texttrademark} 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{\textregistered}/BlastGen{\texttrademark} medium in couples undergoing IVF/ICSI.",

keywords = "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",

author = "Rose, {Ryan D} and Barry, {Michael F} and Dunstan, {Emma V} and Yuen, {Siu Man} and Cameron, {Lyndal P} and Knight, {Emma J} and Norman, {Robert J} and Hull, {M Louise}",

year = "2020",

month = may,

doi = "10.1016/j.rbmo.2020.01.011",

language = "English",

volume = "40",

pages = "645--652",

journal = "Reproductive BioMedicine Online",

issn = "1472-6483",

publisher = "Elsevier",

number = "5",

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TY - JOUR

T1 - The BlastGen study

T2 - a randomized controlled trial of blastocyst media supplemented with granulocyte-macrophage colony-stimulating factor

AU - Rose, Ryan D

AU - Barry, Michael F

AU - Dunstan, Emma V

AU - Yuen, Siu Man

AU - Cameron, Lyndal P

AU - Knight, Emma J

AU - Norman, Robert J

AU - Hull, M Louise

PY - 2020/5

Y1 - 2020/5

N2 - 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.

AB - 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.

KW - Adult

KW - Culture Media/chemistry

KW - Embryo Culture Techniques/methods

KW - Embryo Transfer/methods

KW - Embryonic Development/physiology

KW - Female

KW - Fertilization in Vitro/methods

KW - Granulocyte-Macrophage Colony-Stimulating Factor/analysis

KW - Humans

KW - Male

KW - Pregnancy

KW - Pregnancy Outcome

KW - Pregnancy Rate

KW - Sperm Injections, Intracytoplasmic/methods

KW - Treatment Outcome

U2 - 10.1016/j.rbmo.2020.01.011

DO - 10.1016/j.rbmo.2020.01.011

M3 - Article

C2 - 32220517

SN - 1472-6483

VL - 40

SP - 645

EP - 652

JO - Reproductive BioMedicine Online

JF - Reproductive BioMedicine Online

IS - 5

ER -