N/A N=661 Randomized Single-blind Screening

Single Embryo TrAnsfeR of Euploid Embryo

Infertility · Aneuploidy

Bottom Line

View on ClinicalTrials.gov: NCT02268786 ↗

Enrolled (actual)

661

Serious AEs

0.0%

Results posted

May 2020

Primary outcome: Primary: Ongoing Pregnancy — 137; 143 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Preimplantation Genetic Screening by NGS (Other)
Age: Adult · 25+ yrs
Sex: Female
Sponsor: Illumina, Inc.
Primary completion: Dec 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Ongoing Pregnancy	137; 143	—

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.

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 ( 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02268786). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.