EmbryoGen/ Blastgen for Couples With Implantation Problems or Previous Miscarriage (BlastGen)
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|ClinicalTrials.gov Identifier: NCT02305420|
Recruitment Status : Completed
First Posted : December 2, 2014
Last Update Posted : February 16, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Miscarriage Infertility||Device: EmbryoGen/ BlastGen media Device: Standard Cook sequential media||Phase 4|
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:
- 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
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Randomised control trial comparing EmbryoGen/ BlastGen media use with standard media in IVF|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||EmbryoGen/ Blastgen for Couples With Implantation Problems or Previous Miscarriage|
|Actual Study Start Date :||November 2014|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||June 14, 2017|
EmbryoGen and BlasGen media containing GM-CSF 2ng/ml will be used in the experimental arm
The intervention is to use EmbryoGen/BlastGen
Device: EmbryoGen/ BlastGen media
Embryos will be cultured in media containing Gm-CSF (EmbryoGen/ BlastGen media)
Other Name: GM-CSF containing media
Active Comparator: Control
Standard Cook sequential media
Device: Standard Cook sequential media
Standard Cook IVF media will be used in the control arm
- Livebirth >20 weeks [ Time Frame: 9 months after closure of trial (18 +9 months) ]Any delivery >20 resulting in a livebirth
- Congenital Anomaly Rate [ Time Frame: 9 months after closure of trial (18 +9 months) ]number of liveborns with a congenital anomaly
- Clinical pregnancy rates at 7 and 12 weeks gestation [ Time Frame: 18 months ]Fetal Heart Beat seen on Ultrasound scan at 7 and 12 weeks
- Number of embryos reaching blastocyst stage [ Time Frame: 18 months ]Number of blastocysts per cycle
- Day 3 and day 5 embryo scores [ Time Frame: 18 months ]grade of day 3 and day 5 embryos
- Cryopreservation outcomes [ Time Frame: 18 months ]Number of Frozen blastocysts
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02305420
|Australia, South Australia|
|Adelaide, South Australia, Australia, 5006|