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IVF and ICSI fears allayed by major study

Bupa investigative news - 7 July 2003
written by Clare Bowerman, reporter for Bupa's Health Information Team

Up to one in six couples have difficulty conceiving, and every year babies are born using the fertility techniques IVF (in-vitro fertilisation) and ICSI (intracytoplasmic sperm injection). But there had always been concerns that these babies' physical and intellectual development might not be as good as their "natural" peers, because of the way they had been conceived.

To find out if these fears were groundless, researchers studied the development of almost 1,000 IVF and ICSI children. The good news is that they found that there were few differences between babies conceived through IVF, ICSI and those conceived through natural methods. At the age of five, all the children were at the same stage in terms of IQ, physical growth, and emotional development. There was only a slight increase in risk of medical problems at birth in ICSI children compared with naturally conceived children.

What were the headlines?

The findings were widely reported in the media. Some newspapers emphasised the good results for the general development of IVF and ICSI babies. However, others focused on the fact that babies born after ICSI had more medical problems than the other groups.

Examples of headlines were "IVF injection 'doubles the risk of birth defects'", "Therapy raises abnormality concern", "Abnormal baby fears allayed", "Study finds little evidence for ill-health", "Public reassured on IVF safety", "Study shows in vitro children healthy".

What is the bigger picture?

IVF and ICSI are common treatments for infertility, and around 6000 babies are born through IVF every year.

IVF is the more established of the two techniques, and is used to help couples with a variety of fertility problems. Using this technique, the woman's egg is surgically removed from the ovary and fertilised in a laboratory using the man's sperm. The embryo is then transferred to the woman's uterus and, if all goes well, a pregnancy is achieved.

ICSI is a technique where a single sperm is injected directly into an egg, which can then be implanted into the womb. This technique is often used when the man has a very low sperm count or very poor sperm movement, both of which make normal fertilisation unlikely.

There have been worries that using fertility treatments in general could result in harm to the baby simply as a result of the technique itself. And there are specific concerns with the use of ICSI. The first is that men who are infertile for genetic reasons could pass these problems on to their children. The second is that the actual process of injecting the sperm directly into the egg might be damaging to the child.

Richard Fleming, chair of the Policy and Practice Sub-Committee of the British Fertility Society explains: "There has been a concern that sterile fathers could pass down the genetic basis for sterility to their male children through ICSI. People have also questioned whether the process of single sperm injection could damage the embryo."

To discover whether or not these concerns were valid, London paediatrician Dr Alastair Sutcliffe started a study to look at the general development of assisted conception babies. It is ongoing and involves researchers and babies from five different countries.

The first set of findings from this study were presented at the annual meeting of the European Society of Human Reproduction and Embryology on the 2nd July 2003. It compared 541 ICSI children and 440 IVF children with 542 normally conceived children, and followed them up to the age of five. All the children were tested on various developmental markers. At the age of five, the ICSI and IVF babies were doing just as well as the naturally conceived babies in many areas:

• Height and weight of all the groups was similar
• There were no differences between the verbal performance, overall IQ or motor development in the groups.
• There were no behavioural or temperamental differences between the assisted conception and normal conception groups
• Levels of parental stress were similar across the three groups

The rate of medical illnesses was similar for all children, but hospital admissions were slightly higher for the ICSI and IVF babies, although still very low overall. The only "negative" aspect was the finding that there was a slightly higher level of malformations among the IVF and ICSI children.

Margaret Allinson, spokesperson for the European Society for Human Reproduction and Embryology (ESHRE) explains: "Malformations occurred at the rate of around 6% for the ICSI babies, around 4.5% for the IVF group and around 2.5% for the naturally conceived babies. This means that there was a statistically significant difference between ICSI babies and IVF babies, although the numbers are low overall."

What does this mean?

Richard Fleming feels that the study is very good news for both techniques - despite the reported malformations. "The developmental markers in this study are excellent and the rate of malformations is actually much lower than past studies. As the biggest study of its kind, this seems excellent news, and seems to allay some of the concerns about ICSI in particular."

Margaret Allinson agrees that the study results were very positive, and emphasises that the malformations that did occur were all treatable. "The malformations that occurred in the babies were mostly uro-genital - problems from the kidneys down - and musculo-skeletal. However, all of them were correctable by surgery, so by the age of five, the children were at the same stage of development."

What is more, Allinson argues, the rate of malformations in the ICSI and IVF might actually be relatively lower than they appear due to a flaw in the study's design. This flaw could act to hide the true level of malformations in normally conceived children. "The study looked at babies from five different countries - Sweden, Denmark, UK, Belgium and Greece. In all the countries, IVF and ICSI babies were recruited into the study from birth. But in three of the countries involved the normally conceived children were recruited at the ages of 3-5 years from local schools. This added a bias into the study, because severely handicapped children are usually kept away from normal school, so the 'naturally conceived' children weren't a random group."

What does this mean to me?

Doriver Lilley, spokesperson for ACeBabes, the support group for parents of children born through assisted conception, says that the study should be good news to you if you are considering ICSI and IVF treatments, or if you already have a child who was conceived through these methods. "It's great to see research that's so reassuring about IVF and ICSI. Couples who are considering ICSI are warned of the possible risks to the child. It is very stressful undergoing IVF and ICSI and a lot of couples feel very guilty at the thought that the process could damage their child. The more clear, balanced information we have, the better."

Richard Fleming agrees that the results are reassuring to IVF and ICSI parents. However, the issue of ICSI fathers' infertility being passed on to their sons has yet to be fully resolved and he hopes that the continuing study will provide the answer when the children reach sexual maturity.

ESHRE's Margaret Allinson says that the study should be very reassuring to parents concerned about the general development of their ICSI or IVF baby. She agrees that further research is needed into the area. "The study was designed to look at the general development of ICSI and IVF babies, and the results are very encouraging in this respect. It wasn't really set up to look for malformations - future studies should concentrate on this area more closely."

Summary

IVF and ICSI offer a chance of conceiving to many infertile couples, and every year, around 6000 babies are conceived by these methods in the UK. The results of this latest study give very encouraging news about the general development of ICSI and IVF babies. The rate of medical problems in the assisted conception groups was also relatively low. Continuing research will shed more light on the area.

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Links for more information

• Bupa Treating infertility article
• British Fertility Society
• ACeBabes
• Human Fertilisation and Embryology Authority
• European Society of Human Reproduction and Embryology