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Single Embryo TrAnsfeR of Euploid Embryo (STAR)

I

Illumina

Status

Completed

Conditions

Aneuploidy
Infertility

Treatments

Other: Preimplantation Genetic Screening by NGS

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02268786
RGH-001

Details and patient eligibility

About

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.

Enrollment

661 patients

Sex

Female

Ages

25 to 40 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

661 participants in 2 patient groups

Group A
Experimental group
Description:
Intent to transfer single euploid embryo based on NGS testing (VeriSeq™ PGS) of biopsied blastocysts
Treatment:
Other: Preimplantation Genetic Screening by NGS
Group B
No Intervention group
Description:
Intent to transfer single embryo based on morphological assessment according to the Gardner scoring system (no PGS)

Trial contacts and locations

38

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Data sourced from clinicaltrials.gov

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