Preimplantation Genetic Screening in IVF treatment
Research type
Research Study
Full title
Preimplantation Genetic Testing for Aneuploidy (PGT-A) in in vitro fertilisation (IVF) treatment: pilot phase of a randomised controlled trial
IRAS ID
236067
Contact name
Sesh K Sunkara
Contact email
Sponsor organisation
King's College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
One in seven couples in the UK experience difficulty conceiving. Many of them require in vitro fertilisation (IVF) treatment which the National Institute for Health and Clinical Excellence (NICE) recommends as effective treatment for prolonged unresolved infertility.
IVF success rates remain low (26% live birth/ treatment cycle in the UK in 2016). The lower success rate is attributed mainly to poor quality of the embryos and increased embryo aneuploidy (embryos with wrong number of chromosomes) encountered more with increasing female age. Embryo aneuploidy is also the main reason for the higher miscarriage rates among older women. Chromosomes are small structures within cells containing genetic material.
IVF treatment involves hormonal stimulation of ovaries, followed by a minor surgical procedure for retrieval of eggs which are then mixed with sperm in the laboratory to create embryos. Embryos are incubated for a few days before selection for transfer into the womb. Embryo selection for replacement into the womb is routinely performed using morphological assessment (appearance). However, many embryos do not implant and fail to result in a pregnancy despite apparently normal morphologic development suggesting inadequacy of morphological assessment for selecting the best embryos.
It has been suggested that additional genetic screening of embryos by removing few cells (biopsy) and performing genetic analysis to determine number of chromosomes termed preimplantation genetic screening (PGS) thereby transferring only euploid embryos (with correct number of chromosomes) into the uterus leads to improved embryo implantation, fewer miscarriages, higher live births.
We propose to undertake an initial pilot study towards a larger randomised controlled trial (RCT) for evaluating the clinical effectiveness and cost consequences of PGS in women aged ≥35 years undergoing IVF treatment.
Study sites will be IVF clinics. Hundred women will be randomised during the pilot phase to having IVF treatment with or without PGS. The study will last for 18 months.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
20/EM/0290
Date of REC Opinion
17 Jan 2021
REC opinion
Further Information Favourable Opinion