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Single Embryo TrAnsfeR of Euploid Embryo (STAR)

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ClinicalTrials.gov Identifier: NCT02268786
Recruitment Status : Active, not recruiting
First Posted : October 20, 2014
Last Update Posted : March 1, 2017
Sponsor:
Collaborators:
Reprogenetics (USA)
Genesis Genetics
Reprogenetics (UK)
Information provided by (Responsible Party):
Illumina, Inc.

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.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
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

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   25 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient undergoing IVF
  • At least 2 blastocysts suitable for biopsy on day 5 or 6 of embryo development

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

Information from the National Library of Medicine

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


  Show 36 Study Locations
Sponsors and Collaborators
Illumina, Inc.
Reprogenetics (USA)
Genesis Genetics
Reprogenetics (UK)
Investigators
Study Director: Amy Mueller, MD Sponsor GmbH

Publications of Results:
Responsible Party: Illumina, Inc.
ClinicalTrials.gov Identifier: NCT02268786     History of Changes
Other Study ID Numbers: RGH-001
First Posted: October 20, 2014    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017

Keywords provided by Illumina, Inc.:
Preimplantation Genetic Screening
Blastocyst
Vitrification
In vitro fertilization
non-invasive prenatal testing
next generation sequencing

Additional relevant MeSH terms:
Infertility
Aneuploidy
Genital Diseases, Male
Genital Diseases, Female
Chromosome Aberrations
Pathologic Processes