Single Embryo TrAnsfeR of Euploid Embryo (STAR)
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|ClinicalTrials.gov Identifier: NCT02268786|
Recruitment Status : Unknown
Verified February 2017 by Illumina, Inc..
Recruitment status was: Active, not recruiting
First Posted : October 20, 2014
Last Update Posted : March 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Infertility Aneuploidy||Other: Preimplantation Genetic Screening by NGS||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Official 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|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||April 2017|
|Estimated Study Completion Date :||June 2017|
Experimental: Group A
Intent to transfer single euploid embryo based on NGS testing (VeriSeq™ PGS) of biopsied blastocysts
Other: 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.
Other Name: Veriseq PGS
No Intervention: Group B
Intent to transfer single embryo based on morphological assessment according to the Gardner scoring system (no PGS)
- Ongoing Pregnancy [ Time Frame: Gestational Age of 20 Weeks ]Rate of ongoing pregnancy at 20 weeks gestation between patients who received an embryo transfer in Groups A and and B.
- Fetal Aneuploidy Status [ Time Frame: Gestational Age of at least 10 Weeks ]Fetal aneuploidy status by maternal cell-free DNA (cfDNA) testing using verifi® prenatal test compared to PGS result and/or fetal karyotype if available.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02268786
|Study Director:||Amy Mueller, MD||Sponsor GmbH|