First randomised trial shows IVF culture media affect the outcomes of embryos and babies
Fertility experts are calling on the companies who make the solutions in which embryos are cultured during in vitro fertilisation (IVF) to give a clear list of ingredients following publication of a trial that shows that the composition of these laboratory cultures affects the outcomes of the resulting embryos and babies.
The first randomised controlled trial (RCT) to look at the effect on perinatal outcomes of different IVF culture media found that they affected the numbers of viable embryos created, the rates of successful implantation in the womb, the pregnancy rates and the babies’ birthweights.
The research is published today (Wednesday) in Human Reproduction [1], one of the world’s leading reproductive medicine journals, together with a second paper [2] that reviews what is currently known about embryo culture media and which concludes “there is a strong case for demanding full transparency concerning the compositions of and scientific rationale behind the composition of embryo culture media”. In an accompanying editorial [3], the journal’s editor-in-chief, Professor Hans Evers, calls for urgent action by industry and regulators in the wake of these findings, saying that, just as with foods such as peanut butter, the exact composition of the culture media should be listed.
Read press release in full.
In the second paper, a working group of the European Society of Human Reproduction and Embryology, including Professor Daniel Brison Scientific Director of the Department of Reproductive Medicine and Consultant Clinical Scientist, Central Manchester University Hospitals NHS Foundation Trust (CMFT), led by Professor Arne Sunde, head of obstetrics and gynaecology at the University Hospital in Trondheim, Norway, made the same recommendations. Their research showed that culture media vary widely, their composition is usually unknown by the end users (the embryologists, clinicians and patients), and data about the influence of the media on outcomes are conflicting.
Professor Daniel Brison explains:
“Our position paper from ESHRE (Sunde et al) brings together a number of scientists with an interest in the impact of ART and culture medium in particular on long term health of children, and will carry great weight in the profession as it includes the current and former Chairs of ESHRE. The paper calls for complete disclosure of culture medium composition so that embryologist and clinicians can provide full information to the patients who are giving consent to for their embryos and future children to be grown in these media. The paper also calls for European bodies to increase oversight of embryo culture medium and for national regulators such as MHRA and HFEA in the UK to at least record the type of culture medium each embryo is grown in on the national registry. At the moment this is not being done.
“The paper from Dumoulin’s group (Kleijeckers et al 2016) is highly significant as it is the first properly randomised clinical trial to show that culture medium alone can alter the birthweight of the resulting baby. Up until now we have not known whether the medium, or other things to do with the patients or the ART treatment, were responsible. Now we know that it is the medium, at least in this particular comparison.
“This new research helps us develop a better understanding of what can affect the IVF process in the very early stages. By continuing research into culture medium, we aim to identify the very best mediums to give those undergoing IVF treatment the very best start, with the end goal of improving success rates and long term health outcomes.
“Now that we have good evidence connecting culture medium with birthweight, it is time to take action. We need culture medium companies to provide full information on the medium, regulatory bodies to provide more transparent oversight over new media compositions, and national regulators like the HFEA to collect the information allowing culture medium to be linked to long term future health outcomes.”
[1] “Influence of embryo culture medium (G5 and HTF) on pregnancy and perinatal outcome after IVF: a multicenter RCT,” by Sander H.M. Kleijkers et al. Human Reproductionjournal. doi:10.1093/humrep/dew156.
[2] “Time to take human embryo culture seriously”, by Arne Sunde et al. Human Reproduction journal. doi:10.1093/humrep/dew157.
[3] “Peanut butter”, by Hans Evers. Human Reproduction journal. doi:10.1093/humrep/dew129.
