'If I'm able to help women have healthy babies, then all the controversy can just go on for ever. Helping couples to have healthy babies is good enough for me. I know we get good results. I'm open and honest about the treatment. There is no guarantee of success and the patient has to give informed consent. But the measure of outcome is glaringly obvious. The woman either has a healthy baby or she does not."
Dr George Ndukwe, the clinical director of the Care Clinic at Nottingham's private Park Hospital, is pretty forthright about the immunological programme that he offers women who have suffered several recurrent miscarriages or repeat IVF failures. To the 200 or so patients a year who have been successfully treated at his, and the one other clinic currently offering the treatment in Britain, after years of heartache, he is seen as nothing short of a guardian angel.
However, not everyone delights in Ndukwe's methods - the most common of which is injecting women with a medication made from blood donations, known as intravenous immune globulin (IVIg) early in the IVF cycle, along with heparin injections and baby aspirin to stop blood clotting. "It's a fringe treatment, on the edge of medicine," says Professor Gedis Grudzinskas, a fertility expert and medical director of the Bridge Clinic, a private hospital in London. "I'm a numbers man. I need to see the data. The success stories are merely anecdotal. What about the failures? How can we be sure that women are not just wasting more money, time and emotion?"
The biggest problem with these treatments, which are far more widespread in the United States, is that there is little in the way of randomised placebo-controlled studies to give "evidence-based" authority for their use. IVIg is traditionally used to help protect the body from developing cancer, but no one has scientifically proved its efficiency for combating fertility issues.
The way in which these new treatments are thought to work relates to what is known as the "immunological paradox" in pregnancy; the fact that the body is designed to reject foreign tissue. The unique thing about a normal pregnancy is that the mother's body accepts the embryo (despite it being 50% foreign tissue). But, if there are abnormal immune responses, such as a raised number of natural killer cells (white blood cells that kill tumor- and virus-infected cells as part of the body's immune system), or blood clotting disorders, miscarriage can occur. "Unexplained infertility, from repeat miscarriages or failure of IVF treatments, is often due to the failure of the embryo to implant in the womb, and may have an immunological cause," says Dr Jonathan Scher, a New York obstetrician.
Though immunological treatments such as IVIg have only recently been tried in the UK, initial research into immunological causes and methods of treatment was first pioneered in the US more than 20 years ago by Dr Alan Beer, a respected (though to some almost maniacal) member of the prestigious Chicago Medical School. Before he died, Beer worked with Drs Ndukwe and Taranissi in the UK.
Sam Mayo found Beer's website by doing her own research when she found herself at her wits' end after four miscarriages in three years, and finding doctors at a specialist miscarriage clinic in London "dismissive" and generally unhelpful. Desperate for a baby, having married at 36, she was willing to try almost anything and, encouraged by what she had read on the internet, she signed up with Ndukwe.
"Tests from the US showed that I had highly elevated levels of natural killer cells and anticardiolipin antibodies. However, my GP felt there was no way that I could be treated locally," says Mayo. "I searched on the internet and discovered Dr Ndukwe in Nottingham. I phoned his office and he saw me the following day. He was incredibly supportive the whole way through this pregnancy."
In the early stages of her pregnancy she was treated with four doses of IVIG. She was also given prednisone (a steroid) for 15 weeks, aspirin and injected herself with heparin (to prevent her blood clotting) for four months. It was a hard slog, but the result was worth it: a baby boy called Thomas, who is now 11 weeks old.
New Yorker Elisabeth, who has a degree in neurobiology, had gone through 12 failed IVF cycles before reading up on the internet: "In the end, I insisted on having the IVIg treatments. I'll never do IVF again without IVIg. It seems to me to have become purely political. Some doctors refuse to treat women immunologically, even after they have undergone several failed IVFs. So the women go secretly to get the treatment. I've heard some doctors say that it's akin to witchcraft."
While a child is priceless to women like Mayo and Elisabeth, the costs can be very high. IVF treatments run to about £3,000 a time. IVIg treatment can be £1,000 each, as the infusion has to be given by a nurse, either at home or at the clinic. Other medications may be up to another £1,000. Then there are the consultant's fees. One woman came from Edinburgh to be treated in Nottingham and estimates that, including 11 previous IVF cycles, her healthy baby had cost her a total of around £100,000.
But is it not unethical to charge so much for an unproven treatment? In the Royal College of Obstetricians and Gynaecologists' (RCOG) 2003 review, Professor Lesley Regan reported: "It is a major concern to clinicians in the UK that patients are turning up to appointments armed with information that they have downloaded from the web, and are wanting these unvalidated immunological tests."
Ndukwe accepts that randomised controlled studies may be needed but says it is too difficult to carry them out. "How do you run these trials on such a vulnerable group? Patients just won't do it. The majority of women who are offered the chance to take part in random studies (even if they are free) will prefer to take the risk of the actual treatment rather than risk receiving the placebo. I've been using IVIG for over three years. Not all medicine currently in use is evidence-based".
· Preventing Miscarriage - The Good News, by Dr Jonathan Scher and Carol Dix is published by Collins.
