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 Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Illumina, Inc.
- Enrollment
- 661
- Locations
- 38
- Primary Endpoint
- Ongoing Pregnancy
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 25 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Group A
Intent to transfer single euploid embryo based on NGS testing (VeriSeq™ PGS) of biopsied blastocysts
Intervention: Preimplantation Genetic Screening by NGS (Other)
Group B
Intent to transfer single embryo based on morphological assessment according to the Gardner scoring system (no PGS)
Outcomes
Primary Outcomes
Ongoing Pregnancy
Time Frame: Gestational Age of 20 Weeks
Number of Participants with Ongoing Pregnancy at 20 Weeks Gestation
Secondary Outcomes
No secondary outcomes reported