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Single Embryo TrAnsfeR of Euploid Embryo (STAR)

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ClinicalTrials.gov Identifier: NCT02268786
Recruitment Status : Completed
First Posted : October 20, 2014
Results First Posted : May 4, 2020
Last Update Posted : May 13, 2020
Sponsor:
Collaborators:
Reprogenetics
Genesis Genetics
Information provided by (Responsible Party):
Illumina, Inc.

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 661 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
Actual Study Start Date : September 2014
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. Ongoing Pregnancy [ Time Frame: Gestational Age of 20 Weeks ]
    Number of Participants with Ongoing Pregnancy at 20 Weeks Gestation


Eligibility Criteria
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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
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Illumina, Inc.
Reprogenetics
Genesis Genetics
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Illumina, Inc.
ClinicalTrials.gov Identifier: NCT02268786    
Other Study ID Numbers: RGH-001
First Posted: October 20, 2014    Key Record Dates
Results First Posted: May 4, 2020
Last Update Posted: May 13, 2020
Last Verified: May 2020
Keywords provided by Illumina, Inc.:
Preimplantation Genetic Screening
Blastocyst
Vitrification
 In vitro fertilization
non-invasive prenatal testing
next generation sequencing
Additional relevant MeSH terms:
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Infertility
Aneuploidy
Chromosome Aberrations
Pathologic Processes