Single Embryo TrAnsfeR of Euploid Embryo

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.

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Key information

Conditions

Infertility Aneuploidy Chromosome Aberrations Genital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases

Age range

25 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Melbourne IVF, Melbourne, Victoria, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preimplantation Genetic Screening by NGS

Other

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.

Other names: Veriseq PGS

Primary outcomes

Ongoing Pregnancy

Time frame: Gestational Age of 20 Weeks

Number of Participants with Ongoing Pregnancy at 20 Weeks Gestation

Sponsors and collaborators

Lead sponsor

Illumina, Inc.

Industry

Collaborators

Genesis Genetics
Reprogenetics

Registry information

Official study 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

Acronym: STAR

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Oct 20, 2014
Registry last updated: May 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed