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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02268786
Registration number
NCT02268786
Ethics application status
Date submitted
15/10/2014
Date registered
20/10/2014
Date last updated
13/05/2020
Titles & IDs
Public title
Single Embryo TrAnsfeR of Euploid Embryo
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Scientific title
Prospective, Multi-center, Randomized Controlled Trial Comparing Pregnancy Outcomes Following Selection and Single Embryo Transfer (SET) Based on Preimplantation Genetic Screening (PGS) by Next Generation Sequencing (NGS) Versus Standard Morphological Assessment
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Secondary ID [1]
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RGH-001
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Universal Trial Number (UTN)
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Trial acronym
STAR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Infertility
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Aneuploidy
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Condition category
Condition code
Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Preimplantation Genetic Screening by NGS
Experimental: Group A - Intent to transfer single euploid embryo based on NGS testing (VeriSeqâ„¢ PGS) of biopsied blastocysts
No Intervention: Group B - Intent to transfer single embryo based on morphological assessment according to the Gardner scoring system (no PGS)
Other interventions: Preimplantation Genetic Screening by NGS
The VeriSeq PGS takes advantage of next-generation sequencing (NGS) technology to provide comprehensive, accurate screening of all 24 chromosomes for selection of euploid embryos.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Ongoing Pregnancy
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Assessment method [1]
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Number of Participants with Ongoing Pregnancy at 20 Weeks Gestation
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Timepoint [1]
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Gestational Age of 20 Weeks
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Eligibility
Key inclusion criteria
- Patient undergoing IVF
- At least 2 blastocysts suitable for biopsy on day 5 or 6 of embryo development
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Minimum age
25
Years
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Maximum age
40
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- History of more than two prior implantation failure following IVF
- History of more than one miscarriage of viable pregnancy
- One or both partners known to be carrier(s) of a chromosomal abnormality
- Known genetic carrier couple and/or one or both partners carrier of a known autosomal
dominant disorder
- Any other non-study related preimplantation genetic testing
- Use of donor oocytes
- Use of gestational carrier (surrogate or donor egg recipient).
- Severe oligospermia (<1,000,000 sperm/ml); Surgical Sperm Retrieval for reasons other
than post-vasectomy and CAVD
- Low ovarian reserve with (FSH) >10 IU/L on day 2-4 of a prior menstrual cycle and/or
(AMH) <7 pmol/L (or <1 ng/ml)
- Gender selection cycles
- Concurrent participation in another clinical trial
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Study design
Purpose of the study
Screening
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/12/2016
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Sample size
Target
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Accrual to date
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Final
661
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Melbourne IVF - Melbourne
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Recruitment postcode(s) [1]
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3002 - Melbourne
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Recruitment outside Australia
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United States of America
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Arizona
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Delaware
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Hawaii
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United States of America
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Illinois
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United States of America
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Massachusetts
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United States of America
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Michigan
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New Jersey
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United States of America
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Pennsylvania
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United States of America
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Texas
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United States of America
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Utah
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Country [15]
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United States of America
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Washington
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Canada
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British Columbia
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Country [17]
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Canada
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Ontario
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Country [18]
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United Kingdom
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State/province [18]
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Greater London
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United Kingdom
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Greater Manchester
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United Kingdom
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Oxfordshire
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Country [21]
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United Kingdom
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London
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Country [22]
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United Kingdom
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State/province [22]
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Oxford
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Illumina, Inc.
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Reprogenetics
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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Genesis Genetics
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Address [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of the current study is to evaluate the effect of preimplantation genetic
screening (PGS) by next generation sequencing (NGS) compared to standard morphological
assessment of embryos on pregnancy rates through a randomized controlled trial (RCT). All
embryos will be vitrified and a single embryo transfer (SET) will be performed with either
screened or unscreened embryos depending on randomization.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02268786
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Contact person for public queries
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Address
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02268786
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