The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02305420




Registration number
NCT02305420
Ethics application status
Date submitted
27/11/2014
Date registered
2/12/2014
Date last updated
19/02/2018

Titles & IDs
Public title
EmbryoGen/ Blastgen for Couples With Implantation Problems or Previous Miscarriage
Scientific title
EmbryoGen/ Blastgen for Couples With Implantation Problems or Previous Miscarriage
Secondary ID [1] 0 0
8114
Universal Trial Number (UTN)
Trial acronym
BlastGen
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent Miscarriage 0 0
Infertility 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy
Reproductive Health and Childbirth 0 0 0 0
Abortion

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - EmbryoGen/ BlastGen media
Treatment: Devices - Standard Cook sequential media

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

Active Comparator: Control - Standard Cook sequential media


Treatment: Devices: EmbryoGen/ BlastGen media
Embryos will be cultured in media containing Gm-CSF (EmbryoGen/ BlastGen media)

Treatment: Devices: Standard Cook sequential media
Standard Cook IVF media will be used in the control arm

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Livebirth >20 weeks - Any delivery >20 resulting in a livebirth
Timepoint [1] 0 0
9 months after closure of trial (18 +9 months)
Secondary outcome [1] 0 0
Congenital Anomaly Rate - number of liveborns with a congenital anomaly
Timepoint [1] 0 0
9 months after closure of trial (18 +9 months)
Secondary outcome [2] 0 0
Clinical pregnancy rates at 7 and 12 weeks gestation - Fetal Heart Beat seen on Ultrasound scan at 7 and 12 weeks
Timepoint [2] 0 0
18 months
Secondary outcome [3] 0 0
Number of embryos reaching blastocyst stage - Number of blastocysts per cycle
Timepoint [3] 0 0
18 months
Secondary outcome [4] 0 0
Day 3 and day 5 embryo scores - grade of day 3 and day 5 embryos
Timepoint [4] 0 0
18 months
Secondary outcome [5] 0 0
Cryopreservation outcomes - Number of Frozen blastocysts
Timepoint [5] 0 0
18 months

Eligibility
Key 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)
Minimum age
25 Years
Maximum age
41 Years
Gender
Females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
FertilitySA - Adelaide
Recruitment postcode(s) [1] 0 0
5006 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
FertilitySA
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Adelaide
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 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.
Trial website
https://clinicaltrials.gov/show/NCT02305420
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications