Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2026-01-29 @ 2:08 PM
Study NCT ID:
NCT02305420
Status:
COMPLETED
Last Update Posted:
2018-02-19
First Post:
2014-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EmbryoGen/ Blastgen for Couples With Implantation Problems or Previous Miscarriage
Sponsor:
FertilitySA
Organization:
Study Overview
Official Title:
EmbryoGen/ Blastgen for Couples With Implantation Problems or Previous Miscarriage
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BlastGen
Brief Summary:
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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: