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Single Embryo TrAnsfeR of Euploid Embryo (STAR)

Primary Purpose

Infertility, Aneuploidy

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Preimplantation Genetic Screening by NGS
Sponsored by
Illumina, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Infertility focused on measuring Preimplantation Genetic Screening, Blastocyst, Vitrification, In vitro fertilization, non-invasive prenatal testing, next generation sequencing

Eligibility Criteria

25 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Fertility Treatment Center
  • HRC Fertility
  • Acacio Fertility Clinic
  • HRC Fertility Pasadena
  • Fertility Specialists Medical Group
  • Reproductive Science Center of San Francisco Bay Area
  • Colorado Center for Reproductive Medicine (CCRM)
  • Reproductive Associates of Delaware
  • CRM Orlando
  • Georgia Reproductive Specialists
  • Fertility Institute of Hawaii
  • Fertility Center of Illinois, Highland Park
  • The Advanced IVF Institute
  • IVF New England
  • IVF Michigan
  • Genesis Genetics (USA) - Genetics Laboratory
  • Reproductive Science Center of New Jersey
  • Reprogenetics (USA) - Genetics Laboratory
  • IRMS at St. Barnabas
  • Main Line Fertility
  • Texas Fertility Center
  • Dallas Fertility Center
  • Dallas IVF
  • Houston Fertility Institute
  • CORM Houston
  • Utah Fertility Center
  • Reproductive Care Center
  • Seattle Reproductive Medicine
  • Melbourne IVF
  • Olive Fertility Centre
  • Reproductive Care Center
  • TRIO Fertility Treatment Practice
  • Boston Place Clinic
  • Care Fertility Group London
  • Care Fertility Group Manchester
  • Oxford Fertility Unit
  • Genesis Genetics (UK) - Genetics Laboratory
  • Reprogenetics (UK) - Genetics Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group A

Group B

Arm Description

Intent to transfer single euploid embryo based on NGS testing (VeriSeq™ PGS) of biopsied blastocysts

Intent to transfer single embryo based on morphological assessment according to the Gardner scoring system (no PGS)

Outcomes

Primary Outcome Measures

Ongoing Pregnancy
Number of Participants with Ongoing Pregnancy at 20 Weeks Gestation

Secondary Outcome Measures

Full Information

First Posted
October 15, 2014
Last Updated
May 1, 2020
Sponsor
Illumina, Inc.
Collaborators
Reprogenetics, Genesis Genetics
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1. Study Identification

Unique Protocol Identification Number
NCT02268786
Brief Title
Single Embryo TrAnsfeR of Euploid Embryo
Acronym
STAR
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 Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Illumina, Inc.
Collaborators
Reprogenetics, Genesis Genetics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Aneuploidy
Keywords
Preimplantation Genetic Screening, Blastocyst, Vitrification, In vitro fertilization, non-invasive prenatal testing, next generation sequencing

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
661 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Intent to transfer single euploid embryo based on NGS testing (VeriSeq™ PGS) of biopsied blastocysts
Arm Title
Group B
Arm Type
No Intervention
Arm Description
Intent to transfer single embryo based on morphological assessment according to the Gardner scoring system (no PGS)
Intervention Type
Other
Intervention Name(s)
Preimplantation Genetic Screening by NGS
Other Intervention Name(s)
Veriseq PGS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ongoing Pregnancy
Description
Number of Participants with Ongoing Pregnancy at 20 Weeks Gestation
Time Frame
Gestational Age of 20 Weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Fertility Treatment Center
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85284
Country
United States
Facility Name
HRC Fertility
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Acacio Fertility Clinic
City
Laguna Niguel
State/Province
California
ZIP/Postal Code
92677
Country
United States
Facility Name
HRC Fertility Pasadena
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Fertility Specialists Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Reproductive Science Center of San Francisco Bay Area
City
San Ramon
State/Province
California
ZIP/Postal Code
94583
Country
United States
Facility Name
Colorado Center for Reproductive Medicine (CCRM)
City
Lonetree
State/Province
Colorado
ZIP/Postal Code
80125
Country
United States
Facility Name
Reproductive Associates of Delaware
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
CRM Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Georgia Reproductive Specialists
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Fertility Institute of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Fertility Center of Illinois, Highland Park
City
Highland Park
State/Province
Illinois
ZIP/Postal Code
60035
Country
United States
Facility Name
The Advanced IVF Institute
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
Facility Name
IVF New England
City
Lexington
State/Province
Massachusetts
ZIP/Postal Code
02421
Country
United States
Facility Name
IVF Michigan
City
Bloomfield Hills
State/Province
Michigan
ZIP/Postal Code
48304
Country
United States
Facility Name
Genesis Genetics (USA) - Genetics Laboratory
City
Plymouth
State/Province
Michigan
Country
United States
Facility Name
Reproductive Science Center of New Jersey
City
Eatontown
State/Province
New Jersey
ZIP/Postal Code
07724
Country
United States
Facility Name
Reprogenetics (USA) - Genetics Laboratory
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
IRMS at St. Barnabas
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07078
Country
United States
Facility Name
Main Line Fertility
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
Texas Fertility Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Dallas Fertility Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Dallas IVF
City
Frisco
State/Province
Texas
ZIP/Postal Code
75034
Country
United States
Facility Name
Houston Fertility Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77063
Country
United States
Facility Name
CORM Houston
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Utah Fertility Center
City
Pleasant Grove
State/Province
Utah
ZIP/Postal Code
84062
Country
United States
Facility Name
Reproductive Care Center
City
Sandy
State/Province
Utah
ZIP/Postal Code
84092
Country
United States
Facility Name
Seattle Reproductive Medicine
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Melbourne IVF
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Olive Fertility Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3X7
Country
Canada
Facility Name
Reproductive Care Center
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5N 5S3
Country
Canada
Facility Name
TRIO Fertility Treatment Practice
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2K4
Country
Canada
Facility Name
Boston Place Clinic
City
London
State/Province
Greater London
ZIP/Postal Code
NW1 6ER
Country
United Kingdom
Facility Name
Care Fertility Group London
City
London
State/Province
Greater London
ZIP/Postal Code
NW8 7JL
Country
United Kingdom
Facility Name
Care Fertility Group Manchester
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M14 SHQ
Country
United Kingdom
Facility Name
Oxford Fertility Unit
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX42HW
Country
United Kingdom
Facility Name
Genesis Genetics (UK) - Genetics Laboratory
City
London
Country
United Kingdom
Facility Name
Reprogenetics (UK) - Genetics Laboratory
City
Oxford
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23993662
Citation
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.
Results Reference
result
PubMed Identifier
23993664
Citation
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.
Results Reference
result
PubMed Identifier
22551456
Citation
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.
Results Reference
result
PubMed Identifier
24613537
Citation
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.
Results Reference
result
PubMed Identifier
24571752
Citation
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.
Results Reference
result
PubMed Identifier
31551155
Citation
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.
Results Reference
result
PubMed Identifier
32898291
Citation
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.
Results Reference
derived

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Single Embryo TrAnsfeR of Euploid Embryo

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