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Single Embryo TrAnsfeR of Euploid Embryo

Information source: Illumina, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infertility; Aneuploidy

Intervention: Preimplantation Genetic Screening by NGS (Other)

Phase: Phase 3

Status: Recruiting

Sponsored by: Illumina, Inc.

Official(s) and/or principal investigator(s):
Kate Kurtzman, MD, Study Director, Affiliation: Sponsor GmbH

Overall contact:
Theraysa Gapasin, Email: tgapasin@illumina.com


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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Screening

Primary outcome: Ongoing Pregnancy

Secondary outcome: Fetal Aneuploidy Status


Minimum age: 25 Years. Maximum age: 40 Years. Gender(s): Female.


Inclusion Criteria:

- Patient undergoing IVF

- At least 2 blastocysts suitable for biopsy on day 5 or 6 of embryo development

Exclusion Criteria:

- More than two implantation failures

- More than one miscarriage

- Parental chromosome abnormalities or single gene disorder

- Non study related pre implantation genetic testing

- Use of donor oocytes or gestational carriers

- Male Factor (< 1,000,000 sperm)

- FSH >10

- AMH < 7. 5 pmol/L or 1 ng/mL

- Gender selection cycles

- Concurrent participation in another clinical trial

Locations and Contacts

Theraysa Gapasin, Email: tgapasin@illumina.com

Genesis Genetics (UK) - Genetics Laboratory, London, United Kingdom; Recruiting
Tony Gordon

Reprogenetics (UK) - Genetics Laboratory, Oxford, United Kingdom; Recruiting
Dagan Wells

Olive Fertility Centre, Vancouver, British Columbia V5Z 3X7, Canada; Not yet recruiting
Kelly Gray, Phone: 604-559-9950, Email: kgray@olivefertility.com
Gary Nakhuda, MD, Principal Investigator

HRC Fertility, Encino, California 91436, United States; Recruiting
Gavin Henriques, Phone: 818-788-7288, Ext: 243, Email: gavin@californiareproductiveservices.com
Robert Boostanfar, MD, FACOG, Principal Investigator

Acacio Fertility Clinic, Laguna Niguel, California 92677, United States; Recruiting
Sylvia Parrett, Phone: 949-249-9200, Email: sparrett@acaciofertility.com
Brian Acacio, MD, Principal Investigator

HRC Fertility Pasadena, Pasadena, California 91105, United States; Recruiting
Gladdys Caspellan, Phone: 626-440-9161, Email: gladdysd@havingbabies.com
John Wilcox, MD,FACOG, Principal Investigator

Fertility Specialists Medical Group, San Diego, California 92123, United States; Recruiting
Carol Mills, Phone: 858-505-5500, Email: cmills@ivfspecialists.com
Arlene Morales, MD, Principal Investigator

Reproductive Science Center of San Francisco Bay Area, San Ramon, California 94583, United States; Recruiting
Jennifer Woltz-Nurani, Phone: 650-485-9904, Email: jennifer.woltz-nurani@integramed.com
Susan Willman, MD, Principal Investigator

Colorado Center for Reproductive Medicine (CCRM), LoneTree, Colorado 80125, United States; Recruiting
Lindsey Munkwitz, Phone: 303-788-8310, Email: LindseyM@colocrm.com
William Schoolcraft, MD, Sub-Investigator
Mandy Katz-Jaffe, Ph.D., Principal Investigator

Boston Place Clinic, London, Greater London NW1 6ER, United Kingdom; Recruiting
Carl Batilo, Phone: +44 (0) 207 993 0870, Email: Carl.Batilo@bostonplaceclinic.co.uk
Stuart Lavery, MD, Principal Investigator

Care Fertility Group London, London, Greater London NW8 7JL, United Kingdom; Recruiting
Francesca Steyn, Phone: +44 207 61 66 767, Email: Francesca.Steyn@carefertility.com
Robert Forman, MD, Principal Investigator

Care Fertility Group Manchester, Manchester, Greater Manchester M14 SHQ, United Kingdom; Recruiting
Anthea Jackson, Phone: +44 161 249 3040, Email: anthea.jackson@carefertility.com
Mark Selder, MD, Principal Investigator

Fertility Institute of Hawaii, Honolulu, Hawaii 96814, United States; Recruiting
Joycelyn Chun, Phone: 808-545-2800, Email: joycelyn@armghawaii.com
John Frattarelli, MD, Principal Investigator

Fertility Center of Illinois, Highland Park, Highland Park, Illinois 60035, United States; Recruiting
Ilynne McGovern, Phone: 847-433-9050, Ext: 4, Email: ilynne@aparentivf.com
Brian Kaplan, MD, Principal Investigator

IVF New England, Lexington, Massachusetts 02421, United States; Recruiting
Paige Hoisington, Phone: 781-674-1269, Email: phoisington@ivfne.com
Samuel Pang, MD, Principal Investigator

Genesis Genetics (USA) - Genetics Laboratory, Plymouth, Michigan, United States; Recruiting
Mark Hughes

Reproductive Science Center of New Jersey, Eatontown, New Jersey 07724, United States; Recruiting
Hina Ahmed, MS, PA-C, Phone: 732-918-2500, Email: hinaa@fertilitynj.com
Jessica Mann, MD, Principal Investigator

IRMS at St. Barnabas, Livingston, New Jersey 07078, United States; Recruiting
Olga Spathis, Phone: 201-348-8879, Email: ospathis@gmail.com
Stephanie Thompson, MD, Principal Investigator

Reprogenetics (USA) - Genetics Laboratory, Livingston, New Jersey 07039, United States; Recruiting
Santiago Munne, PhD

ISIS Regional Fertility Centre, Mississauga, Ontario L5N 5S3, Canada; Recruiting
Pauline Saunders, Phone: 905-816-9822, Ext: 2503, Email: lab@isisrfc.com
Mathias Gysler, MD, Principal Investigator

Oxford Fertility Unit, Oxford, Oxfordshire OX42HW, United Kingdom; Recruiting
Ginny Mounce, Phone: +44 1865 782800, Email: Ginny.mounce@obs-gyn.ox.ac.uk
Tim Child, MD, Principal Investigator

Main Line Fertility, Bryn Mawr, Pennsylvania 19010, United States; Recruiting
Eileen Davies, Phone: 484-380-4861, Email: daviese@mainlinefertility.com
Michael Glassner, MD, Principal Investigator

Dallas Fertility Center, Dallas, Texas 75231, United States; Recruiting
Ruth Still, Phone: 214-363-5965, Email: ruth.still@dallasfertility.com
Samuel Chantilis, MD, Principal Investigator

Dallas IVF, Frisco, Texas 75034, United States; Recruiting
Lisa Wegener, Phone: 214-297-0020, Email: lisa@dallasivf.com
Lowell Ku, MD, Principal Investigator

Utah Fertility Center, Pleasant Grove, Utah 84062, United States; Recruiting
Tonya Canaday, Phone: 801-785-5100, Email: tonya.canaday@integramed.com
Dierdre Conway, MD, Principal Investigator

Reproductive Care Center, Sandy, Utah 84092, United States; Recruiting
Rachel Rhinehart, Phone: 801-878-8888, Email: rhinehartr@fertilitydr.com
Keith Blauer, MD, Principal Investigator

Melbourne IVF, Melbourne, Victoria 3002, Australia; Recruiting
Franca HaleAgresta, Phone: +61 3 94734570, Email: franca.agresta@mivf.com.au
Leeanda Wilton, PhD, Principal Investigator
Lyndon Hale, MD, Sub-Investigator

Seattle Reproductive Medicine, Seattle, Washington 98109, United States; Recruiting
Liz Farouki, Phone: 206-301-2570, Email: liz.farouki@integramed.com
Angela Thyer, MD, Principal Investigator
David Ball, PhD, Sub-Investigator

Additional Information

Starting date: September 2014
Last updated: June 19, 2015

Page last updated: August 23, 2015

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