Clinical trial NCT02268786: Single Embryo TrAnsfeR of Euploid Embryo
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
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Aneuploidy
Keywords: Preimplantation Genetic Screening
Blastocyst
Vitrification
In vitro fertilization
non-invasive prenatal testing
next generation sequencing
Lead sponsor: Illumina, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Reprogenetics
name: Genesis Genetics
First posted: 2014-10-20
Enrollment: 661
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


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

Primary outcomes:
measure: Ongoing Pregnancy
timeFrame: Gestational Age of 20 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Fertility Treatment Center
state: Arizona
city: Encino
country: United States
facility: HRC Fertility
state: California
city: Laguna Niguel
country: United States
facility: Acacio Fertility Clinic
state: California
city: Pasadena
country: United States
facility: HRC Fertility Pasadena
state: California
city: San Diego
country: United States
facility: Fertility Specialists Medical Group
state: California
city: San Ramon
country: United States
facility: Reproductive Science Center of San Francisco Bay Area
state: California
city: Lonetree
country: United States
facility: Colorado Center for Reproductive Medicine (CCRM)
state: Colorado
city: Newark
country: United States
facility: Reproductive Associates of Delaware
state: Delaware
city: Orlando
country: United States
facility: CRM Orlando
state: Florida
city: Atlanta
country: United States
facility: Georgia Reproductive Specialists
state: Georgia
city: Honolulu
country: United States
facility: Fertility Institute of Hawaii
state: Hawaii
city: Highland Park
country: United States
facility: Fertility Center of Illinois, Highland Park
state: Illinois
city: Naperville
country: United States
facility: The Advanced IVF Institute
state: Illinois
city: Lexington
country: United States
facility: IVF New England
state: Massachusetts
city: Bloomfield Hills
country: United States
facility: IVF Michigan
state: Michigan
city: Plymouth
country: United States
facility: Genesis Genetics (USA) - Genetics Laboratory
state: Michigan
city: Eatontown
country: United States
facility: Reproductive Science Center of New Jersey
state: New Jersey
city: Livingston
country: United States
facility: Reprogenetics (USA) - Genetics Laboratory
state: New Jersey
city: Livingston
country: United States
facility: IRMS at St. Barnabas
state: New Jersey
city: Bryn Mawr
country: United States
facility: Main Line Fertility
state: Pennsylvania
city: Austin
country: United States
facility: Texas Fertility Center
state: Texas
city: Dallas
country: United States
facility: Dallas Fertility Center
state: Texas
city: Frisco
country: United States
facility: Dallas IVF
state: Texas
city: Houston
country: United States
facility: Houston Fertility Institute
state: Texas
city: Webster
country: United States
facility: CORM Houston
state: Texas
city: Pleasant Grove
country: United States
facility: Utah Fertility Center
state: Utah
city: Sandy
country: United States
facility: Reproductive Care Center
state: Utah
city: Seattle
country: United States
facility: Seattle Reproductive Medicine
state: Washington
city: Melbourne
country: Australia
facility: Melbourne IVF
state: Victoria
city: Vancouver
country: Canada
facility: Olive Fertility Centre
state: British Columbia
city: Mississauga
country: Canada
facility: Reproductive Care Center
state: Ontario
city: Toronto
country: Canada
facility: TRIO Fertility Treatment Practice
state: Ontario
city: London
country: United Kingdom
facility: Boston Place Clinic
state: Greater London
city: London
country: United Kingdom
facility: Care Fertility Group London
state: Greater London
city: Manchester
country: United Kingdom
facility: Care Fertility Group Manchester
state: Greater Manchester
city: Oxford
country: United Kingdom
facility: Oxford Fertility Unit
state: Oxfordshire
city: London
country: United Kingdom
facility: Genesis Genetics (UK) - Genetics Laboratory
city: Oxford
country: United Kingdom
facility: Reprogenetics (UK) - Genetics Laboratory
Study officials:
References:
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.
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.
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.
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.
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.
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.
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.