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
1 other identifier
interventional
661
4 countries
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2014
Typical duration for not_applicable
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 15, 2014
CompletedFirst Posted
Study publicly available on registry
October 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2016
CompletedResults Posted
Study results publicly available
May 4, 2020
CompletedMay 13, 2020
May 1, 2020
2.3 years
October 15, 2014
April 22, 2020
May 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ongoing Pregnancy
Number of Participants with Ongoing Pregnancy at 20 Weeks Gestation
Gestational Age of 20 Weeks
Study Arms (2)
Group A
EXPERIMENTALIntent to transfer single euploid embryo based on NGS testing (VeriSeq™ PGS) of biopsied blastocysts
Group B
NO INTERVENTIONIntent to transfer single embryo based on morphological assessment according to the Gardner scoring system (no PGS)
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patient undergoing IVF
- At least 2 blastocysts suitable for biopsy on day 5 or 6 of embryo development
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Illumina, Inc.lead
- Reprogeneticscollaborator
- Genesis Geneticscollaborator
Study Sites (38)
Fertility Treatment Center
Tempe, Arizona, 85284, United States
HRC Fertility
Encino, California, 91436, United States
Acacio Fertility Clinic
Laguna Niguel, California, 92677, United States
HRC Fertility Pasadena
Pasadena, California, 91105, United States
Fertility Specialists Medical Group
San Diego, California, 92123, United States
Reproductive Science Center of San Francisco Bay Area
San Ramon, California, 94583, United States
Colorado Center for Reproductive Medicine (CCRM)
Lonetree, Colorado, 80125, United States
Reproductive Associates of Delaware
Newark, Delaware, 19713, United States
CRM Orlando
Orlando, Florida, 32804, United States
Georgia Reproductive Specialists
Atlanta, Georgia, 30342, United States
Fertility Institute of Hawaii
Honolulu, Hawaii, 96814, United States
Fertility Center of Illinois, Highland Park
Highland Park, Illinois, 60035, United States
The Advanced IVF Institute
Naperville, Illinois, 60540, United States
IVF New England
Lexington, Massachusetts, 02421, United States
IVF Michigan
Bloomfield Hills, Michigan, 48304, United States
Genesis Genetics (USA) - Genetics Laboratory
Plymouth, Michigan, United States
Reproductive Science Center of New Jersey
Eatontown, New Jersey, 07724, United States
Reprogenetics (USA) - Genetics Laboratory
Livingston, New Jersey, 07039, United States
IRMS at St. Barnabas
Livingston, New Jersey, 07078, United States
Main Line Fertility
Bryn Mawr, Pennsylvania, 19010, United States
Texas Fertility Center
Austin, Texas, 78731, United States
Dallas Fertility Center
Dallas, Texas, 75231, United States
Dallas IVF
Frisco, Texas, 75034, United States
Houston Fertility Institute
Houston, Texas, 77063, United States
CORM Houston
Webster, Texas, 77598, United States
Utah Fertility Center
Pleasant Grove, Utah, 84062, United States
Reproductive Care Center
Sandy City, Utah, 84092, United States
Seattle Reproductive Medicine
Seattle, Washington, 98109, United States
Melbourne IVF
Melbourne, Victoria, 3002, Australia
Olive Fertility Centre
Vancouver, British Columbia, V5Z 3X7, Canada
Reproductive Care Center
Mississauga, Ontario, L5N 5S3, Canada
TRIO Fertility Treatment Practice
Toronto, Ontario, M5G 2K4, Canada
Boston Place Clinic
London, Greater London, NW1 6ER, United Kingdom
Care Fertility Group London
London, Greater London, NW8 7JL, United Kingdom
Care Fertility Group Manchester
Manchester, Greater Manchester, M14 SHQ, United Kingdom
Oxford Fertility Unit
Oxford, Oxfordshire, OX42HW, United Kingdom
Genesis Genetics (UK) - Genetics Laboratory
London, United Kingdom
Reprogenetics (UK) - Genetics Laboratory
Oxford, United Kingdom
Related Publications (7)
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.
PMID: 23993662RESULTSchoolcraft 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.
PMID: 23993664RESULTYang 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.
PMID: 22551456RESULTFiorentino 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.
PMID: 24613537RESULTBianchi 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.
PMID: 24571752RESULTMunne 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.
PMID: 31551155RESULTCornelisse 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.
PMID: 32898291DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Tasha Kalista
- Organization
- Illumina
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2014
First Posted
October 20, 2014
Study Start
September 1, 2014
Primary Completion
December 31, 2016
Study Completion
December 31, 2016
Last Updated
May 13, 2020
Results First Posted
May 4, 2020
Record last verified: 2020-05