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

Illumina, Inc.37 sites in 4 countries661 target enrollmentSeptember 2014

ConditionsInfertility Aneuploidy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Infertility
Sponsor: Illumina, Inc.
Enrollment: 661
Locations: 37
Primary Endpoint: Ongoing Pregnancy
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2014

End Date

December 31, 2016

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Illumina, Inc.

Responsible Party

Sponsor

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