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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02305420
Other study ID # 8114
Secondary ID
Status Completed
Phase Phase 4
First received November 27, 2014
Last updated February 14, 2018
Start date November 2014
Est. completion date June 14, 2017

Study information

Verified date February 2018
Source FertilitySA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.


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:

1. 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

2. 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.


Recruitment information / eligibility

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

Study Design


Intervention

Device:
EmbryoGen/ BlastGen media
Embryos will be cultured in media containing Gm-CSF (EmbryoGen/ BlastGen media)
Standard Cook sequential media
Standard Cook IVF media will be used in the control arm

Locations

Country Name City State
Australia FertilitySA Adelaide South Australia

Sponsors (2)

Lead Sponsor Collaborator
FertilitySA University of Adelaide

Country where clinical trial is conducted

Australia, 

Outcome

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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