Fertility clinics are facing demands to restrict the most popular form of IVF after a shocking new report linked it to an increased risk of birth defects. The study created a major alert after revealing the ICSI treatment, used by 23,000 women in the UK every year, creates a ‘sky high’ chance of having a baby with serious abnormalities.
The procedure, which involves injecting a single sperm into an egg, is used in both the NHS and the private sector, and now represents more than half of all IVF treatments. But it is more expensive than standard IVF, raising fears some clinics may be promoting it to increase profits. Scientists behind the latest survey of 300,000 births found that one child in ten born following ICSIhas a defect – twice the level of the general population – but that standard IVF has no extra risks compared with natural births.
Following the report, other experts called for clinics to use ICSI only when there was no medical alternative, and demanded a national database of children born from IVF be set up urgently. Women who undergo the most popular IVF treatment in Britain are twice as likely to have babies with birth defects as the rest of the population, the shocking new survey revealed.
Women who undergo the ICSI process, in which a single sperm is injected into an egg, are more likely to have a baby with problems including cleft palate, heart and lung conditions, cerebral palsy and blood disorders. The extensive research found that ten in every 100 births from ICSI had a defect, compared with five in 100 natural births. But other forms of IVF are no more risky than natural conception. When other factors such as the mother’s age, smoking habits and underlying health problems are taken into account, the ICSI treatment is linked to a 57 per cent increase in birth defects, compared to natural conception.
The treatment was designed to help infertile men become fathers, but has become the dominant IVF process, accounting for 52 per cent of all such treatments carried out in this country. More than 23,000 women were treated using the technique in 2010, when 6,500 babies were born as a result. Previous studies have raised concerns over birth defects from all forms of IVF, but the new research, published yesterday in the prestigious New England Journal of Medicine, concludes that the abnormalities stem specifically from using the ICSI method. The study’s author, Professor Michael Davies from the University of Adelaide, said: ‘We know from the study that standard IVF is safe. But we also now know that with ICSI, the risk is sky high.’
Last night, British doctors said ICSI was too widely used and said it should only be offered if there is no alternative. They also suggested its popularity was caused by clinics promoting the treatment for commercial profit, as it costs an additional £1,000 on top of the £2,500 fee for standard IVF. Scientists also called for a national register of births for all IVF treatments to be established to allow research into long-term effects. Prof Davies said ICSI – intracytoplasmic sperm injection – effectively creates children from single sperm that Nature might have weeded out as unsuitable.
By contrast, in standard IVF, eggs are placed in a dish with a sperm sample and allowed to be fertilise naturally which means it is still the strongest sperm which reaches the egg. Infertility consultant Gedis Grudzinskas said: ‘The use of ICSI has increased in the UK over recent years and in some centres it is used universally. That’s irresponsible and this study should cause those centres to rethink their policy. ‘Some of these ICSI decisions could be commercially driven, although I would hope not.’
Dr Alastair Sutcliffe, an expert on the effects of IVF in children, added: ‘I’m against the widespread increasing unrestricted use of ICSI because it’s hardly a Darwinian way of reproducing. Now this paper’s come out, those who are close to the wind on this issue might think twice.’ Part of the popularity of ICSI is because it has a conception rate of just under 30 per cent, compared to around 25 per cent for standard IVF. Figures from regulators, the Human Fertilisation and Embryology Authority (HFEA), show that fewer than half of couples using ICSI do so because of male infertility.
In one large unit, the London Women’s Clinic, 83 per cent of IVFs were ICSIs. But medical director Peter Bowen-Simpkins denied it was offered to generate profit. He said: ‘That’s an inevitable criticism, but many of our patients are single women and same sex couples using frozen donor sperm which means ICSI will be more successful.’ The new research paper, one of the most comprehensive ever, looked at 300,000 births in South Australia over 16 years, including 6,100 from fertility treatment. It found 8.3 per cent of babies born from any fertility treatment had some defect, compared with 5.8 per cent of those conceived naturally.
But when they took into account other factors, standard IVF was no more risky than naturally conception. In contrast, ICSI babies did have a high risk of defects, even after these factors were taken into account. Out of 939 single babies born from ICSI, 91 were found later to have a birth defect – a rate of 9.9 per cent. The researchers said in general ICSI babies were therefore 57 per cent more likely to have an abnormality than those born after standard IVF or conceived naturally. But that figure could be as much as 90 per cent in a worst-case scenario. The risk of cerebral palsy also doubled following ICSI treatment, although it was still rare (0.4 per cent compared to 0.2 per cent conceived naturally).
Prof Davies, who did not call for the technique to be abandoned, said it was unclear whether the increased birth defects following ICSI was down to a problem inherent in the technique, or because of the quality of sperm used, which could carry damaged DNA. He said: ‘There are some seriously defective sperm that can be selected and there are many occasions when that sperm could never naturally fertilise an egg. But we can’t jump to that conclusion straight away. ‘This is a technology that’s operating at the absolutely limits of available knowledge, which does open up a debate about how fast should some of these things be implemented.’
Advice on the HFEA website has not been updated since March 2009. It says: ‘Although some research suggests that fertility treatment may be associated with an increased incidence of birth defects, this risk remains low. ‘Research to date does not show with absolute certainty that any increased risk is due to fertility treatment. Other causes cannot be discounted, including underlying sub-fertility in the parents, their age and unexplored factors.’
Last night the regulator said it has ‘no plans’ to update its guidance as a result of the latest research. A spokeswoman said: ‘Research into the area is ongoing and, to make sure patients understand the risks of fertility treatment, we keep research of this kind under review.’ The question all couples must now ask: Do you REALLY need this procedure? Researchers said children born via ICSI were 57 per cent more likely to have an abnormality than those born by standard IVF.
Unless you’ve had personal experience of infertility, it isn’t easy to understand how devastating it can be to find that you’re not able to become pregnant naturally or the lengths to which you would go in order to have a much-longed-for baby. Couples who are trying unsuccessfully to conceive are faced with an ever-expanding fertility industry offering everything from the latest high-tech treatments to the wackiest complementary therapies.
ICSI, the focus of the new research, was developed in the early Nineties and has been a huge step forward in the treatment of male infertility. It has allowed men who once would never have been able to have their own genetic children to become fathers. ICSI has been so successful that some clinics now use it widely, and may offer it even when there isn’t a male fertility problem. Cynics might suggest that this is because ICSI is a more expensive treatment and makes the specialists more money, but it’s also true that some clinics believe they get better success rates when they use ICSI.
So what should couples do if they’re about to embark on fertility treatment in the light of this new research? The message for anyone having standard IVF is extremely positive and reassuring, but there may be more concerns for those who have been recommended ICSI. Talking it through with your fertility specialist is a good idea, and if you’re considering ICSI as an optional add-on to your treatment, you may want to think about whether you really need it. For couples where there is a male factor fertility problem and ICSI is the only possibility, the real risks are still small, and ICSI has produced many thousands of healthy babies.
What’s more, one interesting result from the research was that when embryos created using ICSI were frozen, the risks were reduced. It has been suggested that only the most robust embryos will survive the freezing and thawing process. The researchers themselves haven’t concluded that couples who need ICSI for male fertility problems should not go ahead with the treatment, but have shown that considering freezing embryos before having them transferred is something couples may want to think about. This particular research paper is actually a good news story for fertility patients, as it has found that babies born after standard IVF treatment have no greater risk of problems than those conceived naturally.
Infertility is tough, and one of the best ways to help yourself get through it is to ensure that you are well-informed. If you’ve got concerns about any aspect of infertility or treatment, it’s always advisable to raise them with a doctor or fertility specialist who will be able to offer the best advice for your individual situation.
Article: 5th May 2012 www.dailymail.co.uk
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