Infertility Clinical Trial
Official title:
EmbryoGen/ Blastgen for Couples With Implantation Problems or Previous Miscarriage
EmbryoGen and BlastGen contain the cytokine growth factor Granulocyte-Macrophage
Colony-Stimulating Factor (GM-CSF), which has been documented to give significant benefit to
this difficult group of patients.
Results showed a highly significant effect of 44% relative improvement in ongoing
implantation rate (p=0.001) in women who have previously miscarried (Ziebe et al 2013).
We wish to undertake a randomised Controlled trial to determine if EmbryoGen/BlastGen media
improves pregnancy outcomes in women with recurrent implantation failure, recurrent
miscarriage and poor embryo development when compared to standard media.
A randomised control pilot study will be undertaken for 100 women who have implantation
failure (≥ 2 embryo transfers without a pregnancy) or at least 1 previous miscarriage and are
having a further IVF cycle.
At oocyte retrieval each couple will be randomised using numbered envelopes containing pre
randomised group allocations by a person uninvolved in the trial to:
1. BlastGen Group (n=50): culturing their embryos in ORIGIO standard, sequential culture
mediums for 3 days (EmbryoGen included) then BlastGen media (GM-CSF containing media)
for remaining 2 days or
2. Standard Media Group (n=50): culturing their embryos in Cook standard sequential medium
for 5 days.
The best single embryo will be transferred on day 5.
The clinical staff and participating couple will be blinded as to whether BlastGen or
standard media was used in culture to day 5. Fertility SA embryologists will not be blind as
to which study group a couple is in and which media is being used. The embryos will be
cultured using the usual methods and lab facilities by Fertility SA's current embryology
staff members who will not be blind to the media being used.
Records on the outcome of the oocyte fertilisation, blastocyst development, implantation rate
and pregnancy rates will be recorded, as is standard practice. Pregnancy scans will be
carried out at 7 and 12 weeks. Live birth outcomes and any congenital anomalies will be
recorded.
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