IVF could receive a boost with the development of a new fertility culture medium. The medium can substantially improve embryo plantation, it has been found.
Professor Sarah Robertson, a reproductive biologist with the University of Adelaide, partnered with a Danish company to develop the product that improves IVF embryo implantation rates for some women by up to 40 per cent. The medium is formulated with Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF).
The GM-CSF study is a multi centre, randomized, parallel group, double-blinded, placebo-controlled, efficacy trial conducted at 11 Danish and 3 Swedish centres. A total of 1,332 patients were enrolled in the study of which 1,319 patients were included, and 1,151 received an embryo transfer. This makes it the world's largest fertility media study to date.
According to the study protocol, embryos were cultured until day 3, either in EmbryoGen® or in EmbryoAssistTM (one of ORIGIO's current commercially available fertility culture media which was used as the control medium in the study). During the course of the study, the concentration of human serum albumin (HSA) was increased in EmbryoGen® as well as in EmbryoAssist™. This was done to improve the overall performance and robustness of the media.
The GM-CSF study showed an ongoing implantation rate of 22.8% in week 7 for the overall study group which is an increase of 15.7% of EmbryoGen® compared to the control group. A higher effect was seen in week 12. which more accurately reflects the
performance of the media in relation to the "baby-take-home-rate."
Exposure to EmbryoGen® showed a statistically significant improvement in the ongoing implantation rate in the commercially relevant subgroup comprising women who have previously experienced miscarriage. As expected, the control was lower in this subgroup, as these patients generally have lower ongoing implantation rates.
However, the study documented that EmbryoGen® statistically significantly increased the overall ongoing implantation rate for this subgroup. This improvement correlates well with the scientific hypothesis that GM-CSF positively influences the embryo implantation potential.
"This is a wonderful advance for couples undertaking IVF, particularly those who have previously lost babies in the first trimester," Professor Robertson says.
It is also the culmination of more than two decades' work for Professor Robertson, who based her PhD on the role of growth factors in healthy pregnancies and then worked with Swedish colleagues to explore applications in IVF embryos.
"This breakthrough has been 20 years in the making," Professor Robertson says. "It's enormously rewarding to see one's basic research translate into practical outcomes that will benefit so many families".
"From day one we went right back to the fundamental biology to see what makes an embryo healthy in its normal environment in the reproductive tract. We discovered that embryo is exposed to growth factor signals from the mother's tissues, which is critical to its optimal development.
"This is a major paradigm shift for reproductive medicine. All of the other ART companies around the world, along with biologists and clinicians in this area, have thought that embryos don't need growth factors.
"We have demonstrated through extensive animal and human clinical trials that the reality is just the opposite. EmbryoGen is not only completely safe and natural - it contains signalling molecules that the embryo expects to find in the mother's body - but our data from animal studies shows that it may also result in IVF babies that are larger and healthier at birth."
Professor Robertson says IVF children are often smaller at birth, sometimes leading to long term effects in later life.
"By adding back this growth factor and protecting the embryo from stress, the result should be babies that are of a similar size to those naturally conceived." The data on the perinatal outcomes will be available later this year.
EmbryoGen will be launched in Europe and the Middle East by mid 2011 and in the USA in late 2012.