The PICSI IVF technique does not help to alleviate male infertility, according to the results from a trial published today.
The technique, which is offered in some private clinics, was also found not to increase the likelihood of having a baby, according to researchers at the University of Leeds, England.
In a trial involving more than 2,700 couples across the UK, the scientists looked at the difference that hyaluronan made to the success rate of treatment for male infertility following injection of PICSI-selected sperm into the egg.
Sperm were selected to fertilise eggs based on whether they could bind to hyaluronan, but the researchers found that there was no meaningful difference in full-term live births using the new PICSI technique. The success rate was about one in four couples for both the PICSI and the standard ICSI treatment.
The results of the Leeds-led study – the largest randomised controlled trial assessing whether PICSI would lead to more live births than current techniques – are published in The Lancet and the researchers say their findings provide vital evidence that could guide clinics and couples seeking treatment for male infertility.
However, the research team did discover that PICSI treatment significantly reduced the number of miscarriages by 39% overall, with 4.3% of couples on PICSI experiencing miscarriage compared with 7.0% on ICSI.
Lead author Dr David Miller, andrologist at the University of Leeds, said: "ICSI treatment is currently used by millions of couples around the world and is becoming the dominant treatment for infertility in many places, so any improvements that can be made to the technique have the potential to create a widespread positive impact.
"Our findings, however, suggest that more work is needed to refine and improve PICSI before it can be more widely recommended to treat infertility.
"This trial has paved the way for further research to focus on miscarriage and look into exactly how and why hyaluronan-selected sperm can reduce the incidence of this devastating outcome."
The trial, which was co-ordinated by Queen Mary University of London, involved 16 fertility centres in England and Scotland, the Royal College of Obstetricians and Gynaecologists and Examen Limited.
Co-author Professor Yakoub Khalaf, medical director and consultant gynaecologist at Guy’s and St Thomas’ NHS Foundation Trust, said couples seeking fertility treatment can be put under pressure to consider add-ons and other techniques, but it is important that there is good evidence to support their use.
"We hope these new findings can help couples who are considering IVF to decide which treatments to choose,” he said.
"IVF success rates have remained at roughly 25% of all treatment cycles for the past decade, so it is vital that we keep developing new effective techniques aimed at improving success rates."
The study was funded by the EME Programme – a Medical Research Council (MRC) and National Institute for Health Research (NIHR) partnership – and supported by the NIHR Clinical Research Network Yorkshire and Humber.
A Randomised Clinical Trial of Physiological, hyaluronan-selected Intra-Cytoplasmic Sperm Injection (PICSI) for Infertility Treatment (HABSelect). Lancet 31 January 2019.
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)32989-1/fulltext
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