Single Embryo TrAnsfeR of Euploid Embryo (STAR)

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

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.

Study Overview

• Status: Completed
• Conditions: Infertility; Aneuploidy
• Intervention / Treatment: Other: Preimplantation Genetic Screening by NGS

• Study Type: Interventional
• Enrollment (Actual): 661
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3002
      • Melbourne IVF
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 3X7
      • Olive Fertility Centre
  • Ontario
    • Mississauga, Ontario, Canada, L5N 5S3
      • Reproductive Care Center
    • Toronto, Ontario, Canada, M5G 2K4
      • TRIO Fertility Treatment Practice
• United Kingdom
  • London, United Kingdom
    • Genesis Genetics (UK) - Genetics Laboratory
  • Oxford, United Kingdom
    • Reprogenetics (UK) - Genetics Laboratory
  • Greater London
    • London, Greater London, United Kingdom, NW1 6ER
      • Boston Place Clinic
    • London, Greater London, United Kingdom, NW8 7JL
      • Care Fertility Group London
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M14 SHQ
      • Care Fertility Group Manchester
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX42HW
      • Oxford Fertility Unit
• United States
  • Arizona
    • Tempe, Arizona, United States, 85284
      • Fertility Treatment Center
  • California
    • Encino, California, United States, 91436
      • HRC Fertility
    • Laguna Niguel, California, United States, 92677
      • Acacio Fertility Clinic
    • Pasadena, California, United States, 91105
      • HRC Fertility Pasadena
    • San Diego, California, United States, 92123
      • Fertility Specialists Medical Group
    • San Ramon, California, United States, 94583
      • Reproductive Science Center of San Francisco Bay Area
  • Colorado
    • Lonetree, Colorado, United States, 80125
      • Colorado Center for Reproductive Medicine (CCRM)
  • Delaware
    • Newark, Delaware, United States, 19713
      • Reproductive Associates of Delaware
  • Florida
    • Orlando, Florida, United States, 32804
      • CRM Orlando
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Georgia Reproductive Specialists
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • Fertility Institute of Hawaii
  • Illinois
    • Highland Park, Illinois, United States, 60035
      • Fertility Center of Illinois, Highland Park
    • Naperville, Illinois, United States, 60540
      • The Advanced IVF Institute
  • Massachusetts
    • Lexington, Massachusetts, United States, 02421
      • IVF New England
  • Michigan
    • Bloomfield Hills, Michigan, United States, 48304
      • IVF Michigan
    • Plymouth, Michigan, United States
      • Genesis Genetics (USA) - Genetics Laboratory
  • New Jersey
    • Eatontown, New Jersey, United States, 07724
      • Reproductive Science Center of New Jersey
    • Livingston, New Jersey, United States, 07039
      • Reprogenetics (USA) - Genetics Laboratory
    • Livingston, New Jersey, United States, 07078
      • IRMS at St. Barnabas
  • Pennsylvania
    • Bryn Mawr, Pennsylvania, United States, 19010
      • Main Line Fertility
  • Texas
    • Austin, Texas, United States, 78731
      • Texas Fertility Center
    • Dallas, Texas, United States, 75231
      • Dallas Fertility Center
    • Frisco, Texas, United States, 75034
      • Dallas IVF
    • Houston, Texas, United States, 77063
      • Houston Fertility Institute
    • Webster, Texas, United States, 77598
      • CORM Houston
  • Utah
    • Pleasant Grove, Utah, United States, 84062
      • Utah Fertility Center
    • Sandy, Utah, United States, 84092
      • Reproductive Care Center
  • Washington
    • Seattle, Washington, United States, 98109
      • Seattle Reproductive Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Veriseq PGS
No Intervention: Group B; Intent to transfer single embryo based on morphological assessment according to the Gardner scoring system (no PGS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ongoing Pregnancy	Number of Participants with Ongoing Pregnancy at 20 Weeks Gestation	Gestational Age of 20 Weeks

Collaborators and Investigators

• Sponsor: Illumina, Inc.
• Collaborators: Reprogenetics; Genesis Genetics

Publications and helpful links

General Publications

• Cornelisse S, Zagers M, Kostova E, Fleischer K, van Wely M, Mastenbroek S. Preimplantation genetic testing for aneuploidies (abnormal number of chromosomes) in in vitro fertilisation. Cochrane Database Syst Rev. 2020 Sep 8;9(9):CD005291. doi: 10.1002/14651858.CD005291.pub3.
• Fiorentino F, Biricik A, Bono S, Spizzichino L, Cotroneo E, Cottone G, Kokocinski F, Michel CE. Development and validation of a next-generation sequencing-based protocol for 24-chromosome aneuploidy screening of embryos. Fertil Steril. 2014 May;101(5):1375-82. doi: 10.1016/j.fertnstert.2014.01.051. Epub 2014 Mar 6.
• Handyside AH. 24-chromosome copy number analysis: a comparison of available technologies. Fertil Steril. 2013 Sep;100(3):595-602. doi: 10.1016/j.fertnstert.2013.07.1965.
• Schoolcraft WB, Katz-Jaffe MG. Comprehensive chromosome screening of trophectoderm with vitrification facilitates elective single-embryo transfer for infertile women with advanced maternal age. Fertil Steril. 2013 Sep;100(3):615-9. doi: 10.1016/j.fertnstert.2013.07.1972.
• Yang Z, Liu J, Collins GS, Salem SA, Liu X, Lyle SS, Peck AC, Sills ES, Salem RD. Selection of single blastocysts for fresh transfer via standard morphology assessment alone and with array CGH for good prognosis IVF patients: results from a randomized pilot study. Mol Cytogenet. 2012 May 2;5(1):24. doi: 10.1186/1755-8166-5-24.
• Bianchi DW, Parker RL, Wentworth J, Madankumar R, Saffer C, Das AF, Craig JA, Chudova DI, Devers PL, Jones KW, Oliver K, Rava RP, Sehnert AJ; CARE Study Group. DNA sequencing versus standard prenatal aneuploidy screening. N Engl J Med. 2014 Feb 27;370(9):799-808. doi: 10.1056/NEJMoa1311037.
• Munne S, Kaplan B, Frattarelli JL, Child T, Nakhuda G, Shamma FN, Silverberg K, Kalista T, Handyside AH, Katz-Jaffe M, Wells D, Gordon T, Stock-Myer S, Willman S; STAR Study Group. Preimplantation genetic testing for aneuploidy versus morphology as selection criteria for single frozen-thawed embryo transfer in good-prognosis patients: a multicenter randomized clinical trial. Fertil Steril. 2019 Dec;112(6):1071-1079.e7. doi: 10.1016/j.fertnstert.2019.07.1346. Epub 2019 Sep 21.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: October 15, 2014
• First Submitted That Met QC Criteria: October 15, 2014
• First Posted (Estimate): October 20, 2014

Study Record Updates

• Last Update Posted (Actual): May 13, 2020
• Last Update Submitted That Met QC Criteria: May 1, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Vitrification; In vitro fertilization; next generation sequencing; Blastocyst; Preimplantation Genetic Screening; non-invasive prenatal testing
• Additional Relevant MeSH Terms: Pathologic Processes; Chromosome Aberrations; Infertility; Aneuploidy
• Other Study ID Numbers: RGH-001