Treating male infertility using a new IVF technique called PICSI, which is already offered in some private clinics, does not increase the likelihood of having a baby, according to the results of a randomised controlled trial.
During the PICSI treatment, sperm were selected to fertilise eggs based on whether they could bind to hyaluronan, a substance normally found surrounding the surface of eggs.
In a trial involving over 2,700 couples across the UK, researchers 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.
Led by the University of Leeds, the study found no meaningful difference in full-term live births using the new PICSI technique, with a success rate of around one in four couples for both the PICSI and the standard ICSI treatment.
Published in The Lancet, the study was the largest randomised controlled trial assessing whether or not PICSI would lead to more live births than current techniques, providing vital evidence to help guide both clinics and couples who are making decisions about treatment for male infertility.
Although PICSI treatment did not significantly increase the number of live births, the researchers found that it significantly reduced the number of miscarriages by 39% overall (4.3% of couples on PICSI experienced miscarriage compared with 7.0% on ICSI).
The couples involved in the trial were randomly assigned to either the standard ICSI treatment, or the new PICSI treatment, which costs more and is already offered in some fertility clinics, despite the lack of evidence that it increases success rates.
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 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.
Co-author Professor Yakoub Khalaf, Medical Director and Consultant Gynaecologist at Guy's and St Thomas' NHS Foundation Trust, said: "Couples can be put under pressure to consider add-ons and other techniques that give them added hope and expectations of successful treatment, 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.
"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."
Led by the University of Leeds, the clinical trial was coordinated by Queen Mary University of London, and involved sixteen fertility centres in England and Scotland, as well as the Royal College of Obstetricians and Gynaecologists, and Examen Limited.
Professor David Crossman, Chair of the EME Funding Committee, said: "We are very pleased to be supporting great research like this, looking at critical medical interventions.
"This study adds authority to decision making in the field of IVF because of the careful way it was conducted, and the authors have shown there is little benefit to the new treatment. Whilst helping patients with their decisions these investigators have also highlighted the pressing need for further work in this important area."
PICSI treatment is different to the commonly offered IVF treatment add-on 'embryo glue', as PICSI involves pre-selecting sperm based on whether or not they bind to hyaluronan. 'Embryo glue' involves the fertilised embryos being coated in hyaluronan to increase their chances of implanting in the womb.
IVF is used to treat both female and male infertility, which each account for around half of referrals to IVF clinics for assisted conception. In treating male infertility, embryologists manually choose the best sperm with which to fertilise an egg, by sight for ICSI and by hyaluronan binding for PICSI, as the sperm would be less able to cause pregnancy naturally.
###
Notes to editors
For interview requests please contact Simon Moore, Press Officer at the University of Leeds, on 0113 34 38059 or s.i.moore@leeds.ac.uk.
The Lancet paper is titled 'A Randomised Clinical Trial of Physiological, hyaluronan-selected Intra-Cytoplasmic Sperm Injection (PICSI) for Infertility Treatment (HABSelect)' and will be available online here: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)32989-1/fulltext
University of Leeds
The University of Leeds is one of the largest higher education institutions in the UK, with more than 38,000 students from more than 150 different countries, and a member of the Russell Group of research-intensive universities. The University plays a significant role in the Turing, Rosalind Franklin and Royce Institutes.
We are a top ten university for research and impact power in the UK, according to the 2014 Research Excellence Framework, and are in the top 100 of the QS World University Rankings 2019. The University was awarded a Gold rating by the Government's Teaching Excellence Framework in 2017, recognising its 'consistently outstanding' teaching and learning provision. Twenty-six of our academics have been awarded National Teaching Fellowships - more than any other institution in England, Northern Ireland and Wales - reflecting the excellence of our teaching. http://www.leeds.ac.uk
Follow University of Leeds or tag us in to coverage: Twitter Facebook LinkedIn Instagram
MRC and NIHR
The study was funded by an MRC and NIHR partnership created to support the evaluation of interventions with potential to make a step-change in the promotion of health, treatment of disease and improvement of rehabilitation or long-term care.
1. The National Institute for Health Research (NIHR): improving the health and wealth of the nation through research. Established by the Department of Health and Social Care, NIHR:
- Funds, supports and delivers high quality research that benefits the NHS, public health and social care
- Engages and involves patients, carers and the public in order to improve the reach, quality and impact of research
- Attracts, trains and supports the best researchers to tackle the complex health and care challenges of the future
- Invests in world-class infrastructure and a skilled delivery workforce to translate discoveries into improved treatments and services
- Partners with other public funders, charities and industry to maximise the value of research to patients and the economy
The NIHR was established in 2006 to improve the health and wealth of the nation through research, and is funded by the Department of Health and Social Care. In addition to its national role, the NIHR commissions applied health research to benefit the poorest people in low- and middle-income countries, using Official Development Assistance funding.
2. The Medical Research Council is at the forefront of scientific discovery to improve human health. Founded in 1913 to tackle tuberculosis, the MRC now invests taxpayers' money in some of the best medical research in the world across every area of health. Thirty-three MRC-funded researchers have won Nobel prizes in a wide range of disciplines, and MRC scientists have been behind such diverse discoveries as vitamins, the structure of DNA and the link between smoking and cancer, as well as achievements such as pioneering the use of randomised controlled trials, the invention of MRI scanning, and the development of a group of antibodies used in the making of some of the most successful drugs ever developed. Today, MRC-funded scientists tackle some of the greatest health problems facing humanity in the 21st century, from the rising tide of chronic diseases associated with ageing to the threats posed by rapidly mutating micro-organisms. The Medical Research Council is part of UK Research and Innovation. https://mrc.ukri.org/
This work uses data provided by patients and collected by the NHS as part of their care and support and would not have been possible without access to this data. The NIHR recognises and values the role of patient data, securely accessed and stored, both in underpinning and leading to improvements in research and care. http://www.nihr.ac.uk/patientdata
Journal
The Lancet