Overview

This trial is active, not recruiting.

Conditions infertility, aneuploidy
Treatment preimplantation genetic screening by ngs
Phase phase 3
Sponsor Illumina, Inc.
Collaborator Reprogenetics (USA)
Start date September 2014
End date January 2017
Trial size 600 participants
Trial identifier NCT02268786, RGH-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose screening
Arm
(Experimental)
Intent to transfer single euploid embryo based on NGS testing (VeriSeq™ PGS) of biopsied blastocysts
preimplantation genetic screening by ngs Veriseq PGS
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.
(No Intervention)
Intent to transfer single embryo based on morphological assessment according to the Gardner scoring system (no PGS)

Primary Outcomes

Measure
Ongoing Pregnancy
time frame: Gestational Age of 20 Weeks

Secondary Outcomes

Measure
Fetal Aneuploidy Status
time frame: Gestational Age of at least 10 Weeks

Eligibility Criteria

Female participants from 25 years up to 40 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Illumina, Inc..