Infertility Clinical Trial
— BlastGenOfficial title:
EmbryoGen/ Blastgen for Couples With Implantation Problems or Previous Miscarriage
Verified date | February 2018 |
Source | FertilitySA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | June 14, 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 25 Years to 41 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Australia | FertilitySA | Adelaide | South Australia |
Lead Sponsor | Collaborator |
---|---|
FertilitySA | University of Adelaide |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Livebirth >20 weeks | Any delivery >20 resulting in a livebirth | 9 months after closure of trial (18 +9 months) | |
Secondary | Congenital Anomaly Rate | number of liveborns with a congenital anomaly | 9 months after closure of trial (18 +9 months) | |
Secondary | Clinical pregnancy rates at 7 and 12 weeks gestation | Fetal Heart Beat seen on Ultrasound scan at 7 and 12 weeks | 18 months | |
Secondary | Number of embryos reaching blastocyst stage | Number of blastocysts per cycle | 18 months | |
Secondary | Day 3 and day 5 embryo scores | grade of day 3 and day 5 embryos | 18 months | |
Secondary | Cryopreservation outcomes | Number of Frozen blastocysts | 18 months |
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