Status:
COMPLETED
EmbryoGen/ Blastgen for Couples With Implantation Problems or Previous Miscarriage
Lead Sponsor:
FertilitySA
Collaborating Sponsors:
University of Adelaide
Conditions:
Recurrent Miscarriage
Infertility
Eligibility:
FEMALE
25-41 years
Phase:
PHASE4
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 pa...
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 I...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2017
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02305420
Start Date
November 1 2014
End Date
June 14 2017
Last Update
February 19 2018
Active Locations (1)
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1
FertilitySA
Adelaide, South Australia, Australia, 5006