Study Results
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View full resultsBasic Information
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COMPLETED
NA
661 participants
INTERVENTIONAL
2014-09-30
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
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Group A
Intent to transfer single euploid embryo based on NGS testing (VeriSeq™ PGS) of biopsied blastocysts
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.
Group B
Intent to transfer single embryo based on morphological assessment according to the Gardner scoring system (no PGS)
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 2 blastocysts suitable for biopsy on day 5 or 6 of embryo development
Exclusion Criteria
* 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
25 Years
40 Years
FEMALE
No
Sponsors
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Reprogenetics
INDUSTRY
Genesis Genetics
OTHER
Illumina, Inc.
INDUSTRY
Responsible Party
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Locations
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Fertility Treatment Center
Tempe, Arizona, United States
HRC Fertility
Encino, California, United States
Acacio Fertility Clinic
Laguna Niguel, California, United States
HRC Fertility Pasadena
Pasadena, California, United States
Fertility Specialists Medical Group
San Diego, California, United States
Reproductive Science Center of San Francisco Bay Area
San Ramon, California, United States
Colorado Center for Reproductive Medicine (CCRM)
Lonetree, Colorado, United States
Reproductive Associates of Delaware
Newark, Delaware, United States
CRM Orlando
Orlando, Florida, United States
Georgia Reproductive Specialists
Atlanta, Georgia, United States
Fertility Institute of Hawaii
Honolulu, Hawaii, United States
Fertility Center of Illinois, Highland Park
Highland Park, Illinois, United States
The Advanced IVF Institute
Naperville, Illinois, United States
IVF New England
Lexington, Massachusetts, United States
IVF Michigan
Bloomfield Hills, Michigan, United States
Genesis Genetics (USA) - Genetics Laboratory
Plymouth, Michigan, United States
Reproductive Science Center of New Jersey
Eatontown, New Jersey, United States
Reprogenetics (USA) - Genetics Laboratory
Livingston, New Jersey, United States
IRMS at St. Barnabas
Livingston, New Jersey, United States
Main Line Fertility
Bryn Mawr, Pennsylvania, United States
Texas Fertility Center
Austin, Texas, United States
Dallas Fertility Center
Dallas, Texas, United States
Dallas IVF
Frisco, Texas, United States
Houston Fertility Institute
Houston, Texas, United States
CORM Houston
Webster, Texas, United States
Utah Fertility Center
Pleasant Grove, Utah, United States
Reproductive Care Center
Sandy City, Utah, United States
Seattle Reproductive Medicine
Seattle, Washington, United States
Melbourne IVF
Melbourne, Victoria, Australia
Olive Fertility Centre
Vancouver, British Columbia, Canada
Reproductive Care Center
Mississauga, Ontario, Canada
TRIO Fertility Treatment Practice
Toronto, Ontario, Canada
Boston Place Clinic
London, Greater London, United Kingdom
Care Fertility Group London
London, Greater London, United Kingdom
Care Fertility Group Manchester
Manchester, Greater Manchester, United Kingdom
Oxford Fertility Unit
Oxford, Oxfordshire, United Kingdom
Genesis Genetics (UK) - Genetics Laboratory
London, , United Kingdom
Reprogenetics (UK) - Genetics Laboratory
Oxford, , United Kingdom
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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RGH-001
Identifier Type: -
Identifier Source: org_study_id
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