RCT of pregnancy outcomes followng PGS versus morphological assessment

• Research type

  Research Study

• Full 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

• IRAS ID

  158876

• Contact name

  Tim Child

• Contact email

  tim.child@obs-gyn.ox.ac.uk

• Sponsor organisation

  Verinata

• Research summary

  In Vitro Fertilisation (IVF) is a worldwide treatment to assist couples in having a child/children. It involves the surgical removal of eggs from a woman's ovaries and fertilisation with sperm in a laboratory. The resulting fertilised egg - an embryo - is then transferred to the woman's uterus (womb) to implant and develop. A long term goal of specialists and patients is to improve the success of IVF.
  One major cause of IVF failure, miscarriage or affected babies, is due to embryos which have abnormal chromosomes. In standard IVF practice embryos are selected for transfer by morphological (appearance) assessment, which does not identify this. Diagnosis is possible by analysing the chromosomes before transfer by a technique called Preimplantation Genetic Screening (PGS). A newer version of this is Next Generation Sequencing (NGS). It is thought that combining PGS/NGS with the practice of transferring only a single embryo (to avoid the risk of twins) will improve IVF outcomes.

  This study aims to compare the pregnancy outcomes of women having planned IVF with a single embryo transfer based on PGS/NGS or morphological assessment alone. This is a prospective, multi-center randomised controlled trial which aims to enrol at least 600 participants worldwide at 15 sites over 12 months. Participants meeting study criteria will be randomised 1:1 to a treatment or control group. Both groups will have a single embryo transferred after vitrification. The treatment group will have PGS/NGS to select a normal embryo for transfer and the control group will have an embryo selected for transfer by morphological assessment. Participants will be on the study from enrolment up to 20 weeks pregnancy or study completion, whichever comes first. This is a commercially funded study.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  14/SC/1124

• Date of REC Opinion

  26 Aug 2014

• REC opinion

  Further Information Favourable Opinion