Reproductive Health Science (ASX:RHS) and Monash IVF Group have partnered to develop a new and potentially more accurate way to test for chromosome number in embryos without biopsy.
The companies are now conducting a prospective pilot clinical trial of non-invasive Preimplantation Genetic Screening (PGS) using embryo culture media.
RHS managing director, Dr Michelle Fraser, said “success in the clinical trial has the potential to change global practice”.
IVF embryos are generally grown in culture media that is typically disposed. However, through protocols developed by Repromed, part of the Monash IVF Group, in conjunction with the Robinson Research Institute, the quality and quantity of DNA has been shown to be a viable template for PGS without the need for embryo biopsy.
PGS is used to identify embryos with the correct number of chromosomes, avoiding the transfer of non-viable embryos with the incorrect number of chromosomes. Embryos with the incorrect number of chromosomes typically lead to failed IVF transfers.
PGS says it can make IVF more efficient and successful by finding embryos with the correct number of chromosomes and selecting them for transfer.
Repromed has been developing their method for how and when to collect the culture media over the past 18 months under the leadership of Professor Michelle Lane.
It says it chose to work with RHS on the final protocol due to “the performance of RHS product DOPlify, its ease of use, the ready protocol automation as well as the opportunity to work locally.”
The clinical trial follows joint validation between RHS and Repromed comparing used culture media to results from matched embryo biopsy samples. Patient recruitment has been finalised and the trial end point is a comparison of pregnancy rates between non-invasive PGS and standard embryo biopsy-based PGS. Results will be available later in the year.
“By shifting away from embryo biopsy to using the spent culture media, PGS becomes non-invasive and the embryo that is transferred remains intact. The clinical trial is expected to show a positive impact on IVF success rates," said Dr Fraser. "This is a great example of two South Australian globally competitive companies combining expertise to make a revolutionary change to the IVF industry.”