EmbryoGen/ Blastgen for Couples With Implantation Problems or Previous Miscarriage

About this trial

Last updated 8 years ago

Study ID

8114

Status

Completed

Type

Interventional

Phase

Phase 4

Placebo

Accepting

25 to 41 Years

Female

Trial Timing

Ended 9 years ago

What is this trial about?

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.

What are the participation requirements?

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