What is the truth about IVF?

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ivf pic from reuters REUTERS Lee had needed IVF because she suffered from polycystic ovary syndrome, which made it difficult to get pregnant naturally.

London - When Marie Storey and her husband Mark were offered help in their desperate bid to have a baby, they admit that they didn’t ask too many questions. They knew their options were limited and were willing to grab any chance they could.

The couple, from Lincoln, were offered a form of assisted conception called ICSI - intracytoplasmic sperm injection.

This involves a single sperm being surgically injected directly into an egg - usually the only option for men, like Mark, who aren’t producing enough sperm for traditional IVF treatment (where sperm and an egg are mixed together in a petri dish).

“We didn’t know anything about the procedure when we went for it,” says Marie, 31. “Like many couples, we just thought: ‘That can work? Great, let’s do it.’ “

When they’d met, Mark, a 40-year-old civil engineer, already had three children from his first marriage and had undergone a vasectomy. After a reversal operation failed, the couple were told ICSI was their only hope.

The private fertility treatment, which cost about £6,000, began on March 6, 2007. Excited and hopeful, they had no reason to suspect it might prove risky, and could even be responsible for harming their longed-for baby.

Mark’s sperm were injected into Marie’s eggs, which had been harvested after she took fertility drugs to stimulate her ovaries to produce more eggs. Two embryos were implanted and the couple were thrilled when they discovered Marie was pregnant.

“By mid-April we were told that we were having twins. I cried with excitement,” says Marie. It was a magical moment for the couple. But at 31 weeks, she started to suffer from pre-eclampsia, a potentially life-threatening blood-pressure condition. A fortnight later, the boys were delivered seven weeks early in an emergency Caesarean section.

At 3lb 14oz, Lloyd was the smaller twin, while Mackenzie weighed only 4lb 14oz.

At four days old, Mackenzie started having feeding difficulties and was diagnosed with a twisted bowel, which required an operation.

But his problems continued. “He wouldn’t take enough milk, so he was tube-fed through his nose until he was eight months old,” says Marie.

And still little Mackenzie failed to thrive. “Though he was a really lively baby, crawling and doing everything his brother did, he just wasn’t growing as fast.

“We tried to wean him at eight months, but he’d take a few mouthfuls of food before giving up. He couldn’t manage any more.”

In short, Mackenzie was a very sick little boy. When he was about 12 months old, he underwent yet more surgery, this time to insert a tube so he could be fed directly into his stomach, and also to correct a hiatus hernia, where the stomach bulges into the chest wall.

The tube stayed in for three years and it is only now he’s five that Mackenzie’s parents feel he’s out of the woods. “He is living a perfectly normal life,” says Marie. “He is getting on well at school, eating really well and putting on weight.”

It’s also only now that they have started to question whether Mackenzie’s problems were a direct result of how he was conceived.

Medical controversy surrounding the potential risks of IVF to babies and mothers has raged for years, focusing particularly on the ICSI procedure. This intensified following news that the UK government plans to raise the upper age limit at which women can have IVF treatment on the NHS to 42.

The latest study earlier this month claimed ICSI babies are twice as likely to suffer birth defects. Some scientists suggest this is because ICSI subverts natural selection, in which only the best, strongest sperm wins the race to fertilise the egg.

This, they fear, could raise the embryo’s risk of congenital defects.

More than 120,000 children in the UK have been born using ICSI since 1992. Just over half of assisted babies are conceived that way in the UK. While delighted she was able to conceive using this method, Marie says she was never warned of any possible risks to her baby.

“I remember the doctors mentioning risks to my own health - I had to inject myself with hormones,” she says. “But at no point did they mention any health risks to the baby.

“The stories about ICSI are worrying.”

Worrying, indeed - and confusing.

It should be pointed out that the vast majority of babies born via ICSI or conventional IVF are perfectly healthy. However, there are growing concerns about the possible risks associated with fertility treatment.

A recent study made shock headlines when it reported that ICSI babies are twice as likely as those conceived naturally or by conventional IVF to suffer birth defects such as cleft palate, heart and lung conditions, cerebral palsy and blood disorders.

Professor Michael Davies, author of the study into 6,100 children born from fertility treatment in South Australia over 16 years, described the ICSI risk as “sky high”.

Dr Allan Pacey, a Sheffield University fertility expert, says scientists are concerned over ICSI because it was introduced quickly and with little prior testing.

“IVF, by comparison, had a lot of animal testing beforehand,” he says.

“People have worried about ICSI babies for a while and these children have been studied since the earliest days - there has been a lot of genetic, developmental and educational analysis.”

But all that analysis has produced wildly conflicting results. This helps to explain why, only last month, a report by experts at Nanjing Medical University, China, in the journal Fertility and Sterility, concluded there is no difference in risk for babies between IVF and ICSI.

Their research amalgamated the results of 56 previous studies. So why the confusion? The sad fact is that research into assisted conception has become entangled in a mass of contradictory evidence.

The Chinese researchers began by looking at 925 clinical studies, but had to reject more than 850 of them. Some were badly run or poorly designed, and others were too small to provide a representative picture.

As a result, we end up with a confused, often scary picture. For example, in January last year, a small survey of women pregnant via IVF who were seen at Yale University found their babies were up to 12 times more likely than normal to have congenital heart defects.

Other studies have flagged risks of heart disease in later life, as well as increased dangers of spina bifida and brain abnormalities.

Concerns over other forms of assisted conception have also been raised. An unexpected finding of Professor Davies’s research was that the risk of birth defects among babies tripled in women who had used clomiphene citrate. This is a drug that stimulates ovaries to produce eggs and is known by its generic name, Clomifene, or its brand name, Clomid.

“While confined to a small group in our study, this is of concern because clomiphene citrate is widely available at low cost,” said Davies.

The drug is readily available on the internet, prompting even more concerns.

Sam Major, 40, from Bolton, believes it may have contributed to her son Callum’s significant developmental delays.

“I already had three children when we married. We decided we wanted a child together, but I have had a series of miscarriages - 11 in all,” says Sam, who is setting up a nursery with second husband Craig, 38.

Sam’s hospital consultant told her that rather than giving her tests to find why she was suffering serial miscarriages, he would put her straight on Clomid.

“My GP did not approve and thought I should not be given the drug,” says Sam. “But I went with the consultant’s opinion.”

Three months later she was pregnant with Callum, who is now ten.

“As soon as I found out, I rang the consultant and was told I should discontinue Clomid.”

But almost since Callum was born, Sam has worried about his delayed progress. “He did not sit up until he was a year old, didn’t walk until he was two-and-a-half and has to wear a hearing aid,” she says. At school, his reading and maths are behind.

“I have always worried that his problems were down to the fertility drug. He has been seen by various specialists and had various tests, but they have never found a reason.

“When I was given the drug, I’d never heard of any potential problems. Now I think that there should be a lot more research done.”

While understanding women’s desperate longing for a baby, Sam is concerned how easy it is to buy clomiphene citrate on the internet.

“Friends have said they were considering buying it online,” she says. “I told them not to. If it’s risky with a prescription, it’s dangerous buying it without one.”

Beyond fears about clomiphene citrate, there remains a mass of unresolved questions about assisted fertility treatment.

There have been widespread fears about cancer, for example. In April, French researchers warned that ovarian-stimulation drugs more than doubled the risk of children being born with one of two types of childhood leukaemia: acute lymphoblastic leukaemia and acute myeloid leukaemia.

Other studies have warned of future problems with fertility for IVF babies. A Danish study in 2007 of 47 young men conceived through IVF found that they had much poorer or abnormal sperm compared to their peers.

Then there is the theory that subtle DNA changes found in blood tests of IVF babies may increase their risks of diabetes and obesity in adulthood.

There are also mental health concerns. A US study of 173 assisted conception children aged between 18 and 26 found increased rates of depression and attention-deficit hyperactivity disorder.

It’s no wonder many mothers who initially saw IVF as a wonder- ful boon are worried for their children’s health. Karen Veness, 45, from Nottingham, is one such woman. The married mother of two had IVF to conceive her first daughter, Holly, who is now 13.

Karen was in her late 20s when tests revealed she had blocked fallopian tubes. She and her husband underwent IVF. It worked the first time.

“A year later, I became pregnant naturally with Georgie.”

But the IVF process has left her with a legacy of fear. “Whenever I or my children have any health issues, I think of the fertility treatment and worry whether all those drugs have had a long-term effect,” she says.

Much of the research suggests that not only children are at risk - mothers may also have been harmed.

Researchers at the Netherlands Cancer Institute in Amsterdam warned last October that a broad range of ovulation-stimulating fertility drugs taken by thousands of British women may double their risk of ovarian cancer.

The 15-year global study of more than 19,000 women found the pills made the development of borderline cancerous tumours in the ovaries twice as likely.

“I don’t know whether, thanks to IVF, anything is happening in my body long-term,” says Karen.

“But unless you’ve been through infertility you don’t know how desperate you can become and how keen you are to take the drugs.”

Karen, an advocate for the charity Infertility Network UK, adds: “Whenever one of these stories comes out, there is a wave of fear among women who have had fertility treatment. The information is very confusing.”

Soon we may have definitive answers to many of the questions haunting these parents, thanks to a UK law change that finally opened up the vast database of medical records held by the British regulator, the Human Fertilisation and Embryology Authority (HFEA).

This information was previously inaccessible because, when it was compiled on all the IVF parents and children in Britain, they were not asked for permission for their personal details to be shared.

Now, in anonymous form, this mass of information is being linked to national databases to build an accurate picture of what happens later in life to babies conceived by IVF and their mothers.

Dr Alastair Sutcliffe, a child-health researcher at University College London, is leading two major studies of the HFEA data.

“The first study is of 110,000 children,” he says. “We are comparing their health records against the Childhood Cancer Research Group’s register at Oxford University, which is the national database.

“This study will be five times bigger than the previous largest survey and so will produce much more reliable results.”

Dr Sutcliffe’s second study is to see whether women who had IVF have a higher risk of cancer. ‘We will have to look at the data very carefully because it’s complex.’

Until the results have been compiled, only one thing is clear: the medical breakthroughs that parents once viewed as a precious gift will continue to cause them unimaginable anxiety. - Daily Mail

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