Single Embryo TrAnsfeR of Euploid Embryo

Not Applicable

Completed

Conditions: Aneuploidy
Infertility

Interventions: Other: Preimplantation Genetic Screening by NGS

Registration Number: NCT02268786

Lead Sponsor: Illumina, Inc.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 661

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Preimplantation Genetic Screening by NGS	Intent to transfer single euploid embryo based on NGS testing (VeriSeq™ PGS) of biopsied blastocysts

Primary Outcome Measures

Name	Time	Method
Ongoing Pregnancy	Gestational Age of 20 Weeks	Number of Participants with Ongoing Pregnancy at 20 Weeks Gestation

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (37): Acacio Fertility Clinic
🇺🇸
Laguna Niguel, California, United States
HRC Fertility
🇺🇸
Encino, California, United States
Reproductive Science Center of San Francisco Bay Area
🇺🇸
San Ramon, California, United States
Fertility Specialists Medical Group
🇺🇸
San Diego, California, United States
HRC Fertility Pasadena
🇺🇸
Pasadena, California, United States
Colorado Center for Reproductive Medicine (CCRM)
🇺🇸
Lonetree, Colorado, United States
CRM Orlando
🇺🇸
Orlando, Florida, United States
Georgia Reproductive Specialists
🇺🇸
Atlanta, Georgia, United States
Fertility Institute of Hawaii
🇺🇸
Honolulu, Hawaii, United States
The Advanced IVF Institute
🇺🇸
Naperville, Illinois, United States
Fertility Center of Illinois, Highland Park
🇺🇸
Highland Park, Illinois, United States
IVF Michigan
🇺🇸
Bloomfield Hills, Michigan, United States
Genesis Genetics (USA) - Genetics Laboratory
🇺🇸
Plymouth, Michigan, United States
IVF New England
🇺🇸
Lexington, Massachusetts, United States
IRMS at St. Barnabas
🇺🇸
Livingston, New Jersey, United States
Main Line Fertility
🇺🇸
Bryn Mawr, Pennsylvania, 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
🇨🇦
Mississauga, Ontario, Canada
Melbourne IVF
🇦🇺
Melbourne, Victoria, Australia
Seattle Reproductive Medicine
🇺🇸
Seattle, Washington, United States
TRIO Fertility Treatment Practice
🇨🇦
Toronto, Ontario, Canada
Boston Place Clinic
🇬🇧
London, Greater London, United Kingdom
Olive Fertility Centre
🇨🇦
Vancouver, British Columbia, Canada
Care Fertility Group London
🇬🇧
London, Greater London, United Kingdom
Care Fertility Group Manchester
🇬🇧
Manchester, Greater Manchester, United Kingdom
Genesis Genetics (UK) - Genetics Laboratory
🇬🇧
London, United Kingdom
Reprogenetics (UK) - Genetics Laboratory
🇬🇧
Oxford, United Kingdom
Reprogenetics (USA) - Genetics Laboratory
🇺🇸
Livingston, New Jersey, United States
Fertility Treatment Center
🇺🇸
Tempe, Arizona, United States
Reproductive Science Center of New Jersey
🇺🇸
Eatontown, New Jersey, United States
Oxford Fertility Unit
🇬🇧
Oxford, Oxfordshire, United Kingdom
Reproductive Associates of Delaware
🇺🇸
Newark, Delaware, United States
Texas Fertility Center
🇺🇸
Austin, Texas, United States