The first live human birth using a novel technology that uses induced pluripotent stem cells (iPSCs) to support egg maturation outside the body has been reported.
During in vitro maturation (IVM), immature eggs are removed from a woman's ovaries and cultured in vitro until they mature and can be fertilised and implanted. This technique is not new (see BioNews 431), but so far it has been less efficient, with lower pregnancy and implantation rates than IVF. Now, biotechnology start-up, Gameto, based in New York, has developed a novel technique, Fertilo, to overcome the main limitations of IVM.
'We are delighted to celebrate the world's first live birth conceived using Fertilo,' said Dr Dina Radenkovic, CEO and co-founder of Gameto. 'This milestone marks a turning point in reproductive health and highlights the first application of iPSC technology in IVF and the immense potential of our technology.'
Current IVM methods mainly rely on supplementing cell culture media with growth factors, small molecules and hormones known to influence egg maturation. However, poor egg quality and reduced embryo formation rates remain a problem.
The Fertilo technique aids immature egg maturation in vitro by supplementing the traditional culture media with human stem cell-derived ovarian support cells (OSC), thus mimicking egg development in vivo.
Publishing their findings as a preprint in bioRxiv that has not yet been peer-reviewed, the scientists show that eggs grown using OSC-IVM display gene expression similar to that seen during in vivo egg development, with improved embryo formation rates.
Prior to the use of Fertilo in human fertility treatment, the researchers conducted a multigenerational study in mice, publishing their results in Reproduction Biomedicine Online. Here they demonstrated the safety of supplementing human OSCs to the IVM medium, with no adverse effects on embryo development or offspring health and fertility across generations.
IVF relies on ten to 14 days of high dose hormonal stimulation to mature eggs. Fertilo reduces the need for hormone injections to just three days, and minimises the risk of ovarian hyperstimulation syndrome, associated with high hormone doses.
'Fertilo is a major advancement for women who cannot tolerate or do not want to undergo the burden of the traditional IVF protocol, bringing hope and new possibilities to a broader patient population,' said Dr Luis Guzmán, lead at Pranor Labs, Peru, who oversaw the Fertilo-enabled IVF cycle that led to the first live birth.
Gameto has secured regulatory clearance for Fertilo in Australia, Japan, Argentina, Paraguay, Mexico, and Peru and is preparing for Phase 3 clinical trials in the USA.
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