- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02305420
EmbryoGen/ Blastgen for Couples With Implantation Problems or Previous Miscarriage (BlastGen)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
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South Australia
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Adelaide, South Australia, Australia, 5006
- FertilitySA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
women undertaking an IVF or ICSI cycle
- aged between 25 and 41 years
- 2 or more embryos transferred without a positive pregnancy outcome OR a history of at least 1 previous pregnancy loss, OR
- Poor embryo development (<20% of embryo developing on time at Day 3 or no blastocyst above Grade 2 on Day 5)
Exclusion Criteria:
- male partner requiring surgical retrieval of sperm except in cases of previous vasectomy
- the use of another investigational drug within 30 days
- any severe chronic disease that would significantly influence an IVF cycle
- less than 3 follicles>14mm on ultrasound on the day of HCG trigger
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EmbryoGen/BlastGen
EmbryoGen and BlasGen media containing GM-CSF 2ng/ml will be used in the experimental arm The intervention is to use EmbryoGen/BlastGen |
Embryos will be cultured in media containing Gm-CSF (EmbryoGen/ BlastGen media)
Other Names:
|
Active Comparator: Control
Standard Cook sequential media
|
Standard Cook IVF media will be used in the control arm
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Livebirth >20 weeks
Time Frame: 9 months after closure of trial (18 +9 months)
|
Any delivery >20 resulting in a livebirth
|
9 months after closure of trial (18 +9 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Congenital Anomaly Rate
Time Frame: 9 months after closure of trial (18 +9 months)
|
number of liveborns with a congenital anomaly
|
9 months after closure of trial (18 +9 months)
|
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
|
18 months
|
Number of embryos reaching blastocyst stage
Time Frame: 18 months
|
Number of blastocysts per cycle
|
18 months
|
Day 3 and day 5 embryo scores
Time Frame: 18 months
|
grade of day 3 and day 5 embryos
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18 months
|
Cryopreservation outcomes
Time Frame: 18 months
|
Number of Frozen blastocysts
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18 months
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8114
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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