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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Timepoint [1] 0 0
9 months after closure of trial (18 +9 months)
Secondary outcome [1] 0 0
Congenital Anomaly Rate
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
Timepoint [2] 0 0
18 months
Secondary outcome [3] 0 0
Number of embryos reaching blastocyst stage
Timepoint [3] 0 0
18 months
Secondary outcome [4] 0 0
Day 3 and day 5 embryo scores
Timepoint [4] 0 0
18 months
Secondary outcome [5] 0 0
Cryopreservation outcomes
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
Sex
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
1/11/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/06/2017
Sample size
Target
Accrual to date
Final
100
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/study/NCT02305420
Trial related presentations / publications
Rose RD, Barry MF, Dunstan EV, Yuen SM, Cameron LP, Knight EJ, Norman RJ, Hull ML. The BlastGen study: a randomized controlled trial of blastocyst media supplemented with granulocyte-macrophage colony-stimulating factor. Reprod Biomed Online. 2020 May;40(5):645-652. doi: 10.1016/j.rbmo.2020.01.011. Epub 2020 Jan 23.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02305420