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Infertility tests and therapies questioned

Bupa investigative news - 22 September 2003
written by Rachel Newcombe, reporter for Bupa's Health Information Team

One in seven couples are affected by infertility and one in 100 women are affected by recurrent miscarriage, where they lose three or more consecutive pregnancies. Infertility in men and women can be caused by a number of factors, but in about 20 per cent of cases are the cause remains unknown. Likewise, the reason for recurrent miscarriage may be due to a variety of factors such as genetic defects, hormonal abnormalities, blood clotting disorders, infection, uterine or cervical abnormalities, or unexplained reasons.

But some fertility experts believe that reproductive problems may be caused by immunological abnormalities and have created a number of screening tests and treatments for this. A report by the UK Royal College of Obstetricians and Gynaecologists (RCOG), however, has cast doubt on a number of the methods and suggests the way they're marketed could be exploiting vulnerable couples. So, which are the tests concerned, what's the evidence and which tests and treatments are proven to work.

What were the headlines?

News about the RCOG report was featured in a number of UK websites and newspapers as soon as it was released. Examples of headlines included "Treatments exploit hope for baby", "Infertile couples warned of 'useless' tests" and "Warning over fertility tests".

The coverage varied from single column reports to double page spreads, but all carried the message that some treatments and tests are not scientifically proven and are not be worth pursuing until further reliable research shows otherwise.

What is the bigger picture?

Some experts hold the view that reproductive failure may be due to problems with a person's immune system. In recent years a variety of screening tests and interventions have been developed, many of which are now promoted on the internet for those seeking solutions to infertility.

The Scientific Advisory Committee for the RCOG carried out a review of a selection of these tests and treatments to assess their validity and reliability.

They examined the evidence for a total of 14 tests and found that 13 of them did not have good scientific evidence to support them. The only exception was the investigation for antiphospholipid syndrome (APS) in recurrent miscarriage because this can be successfully treated with aspirin and sometimes heparin.

The RCOG's findings about the specific screening tests and treatments are summarised as follows.

Screening tests

Test	As a test for	Proven reliable
Antiphospholipid antibodies	Recurrent miscarriage	Yes
	Infertility	No
Thyroid antibodies	Recurrent miscarriage:	No
	Infertility	No
Ovarian antibodies	Infertility	No
Antinuclear antibodies	Recurrent miscarriage	No
	Infertility	No
Antisperm antibodies	Recurrent miscarriage	No
	Infertility	No
Cytokines and Th1/Th2 response	Recurrent miscarriage	No
	Infertility	No
Natural killer cells	Recurrent miscarriage	No
	Infertility	No
Shared parental human leucocyte antigens	Recurrent miscarriage	No
	Infertility	No

Treatments

Treatment type	For	Proven effective
Lymphocyte immune therapy	Recurrent miscarriage	No
Intravenous immune globulin	Recurrent miscarriage	No
	Infertility	No
Steroids	Recurrent miscarriage	No
	Infertility	No
Aspirin	Recurrent miscarriage	Yes
	Infertility	No
Heparin	Recurrent miscarriage	Yes
	Infertility	No
Anti-tumour necrosis factor	Recurrent miscarriage	No

Professor Lesley Regan, who carried out the review on behalf of the RCOG's Scientific Advisory Committee, said, "The failure to conceive or carry a baby to term can cause considerable distress to a couple. It is a major concern to clinicians in the UK that patients are turning up to appointments with information downloaded from the web and wanting these unvalidated immunological tests."

She added that, "It is clear that the advice given on many sites is strongly influenced by the personal prejudices of doctors practising non-evidence based medicine. Much of the data they provide has never been exposed to the rigorous scrutiny of peer review. These couples are emotionally vulnerable and there is currently no scientific evidence to justify the use of these tests and treatments."

What does this mean?

Professor Alison Murdoch, chair of the British Fertility Society, said, "We welcome this excellent review, which provides clear details of the evidence available related to the management of these problems. Infertile couples are often desperate to try any possible therapy and it is essential that we only recommend treatments of proven value."

"We support the continuing promising research in this area, but new therapies should only be offered as part of an ethically approved controlled trial with appropriate informed consent," she added.

According to Professor Peter Johnson, head of the reproductive immunology group at the University of Liverpool, "The immune system undoubtedly plays an important role in the way the body normally adapts to allow a pregnancy, and there is also ongoing, but unfortunately often unresolved, research in infertility and recurrent miscarriage."

He added that, "Clinical investigations and treatments that are without a sound scientific basis mislead patients, often at high cost, exacerbating their emotional rollercoaster ride. In addition, these empirical approaches can create a smokescreen masking real research advances, to the detriment of future patients."

CHILD, the National Infertility Support Network, also welcomed the research. Clare Brown, executive director, said, "We agree with the statements made both by Professor Lesley Regan and Professor Alison Murdoch. We support and welcome ongoing research into, not just this form of investigation and possible causes for difficulties in conceiving, but in all research which might enable the one in seven couples affected by it."

She added that patients are "already paying an enormous price, both financially, but also physically and emotionally," and said it's crucial that tests and treatments are "subjected to scrutiny and peer review before being offered to patients."

ISSUE, the UK National Fertility Association, who are merging with CHILD in a few months time, backed up their comments and stressed the importance of ensuring tests and treatments are subject to rigorous testing before being made available.

What does this mean to me?

According to CHILD, it's understandable that people turn to the internet to seek information, especially when they're unable to discover the reason for their infertility.

"It is widely recognised that the inability to conceive has a huge emotional impact on patients. It should also be recognised that a third of patients are unable to get a diagnosis as to why they are not conceiving - unexplained infertility. In this high-tech age it is understandable that patients go to the internet to try and find out as much as they can so that they are more informed - particularly if they are unable to find out a cause for their inability to conceive," they said.

However, they add that, "It is absolutely inexcusable for anyone to give them false hope - or at the very least - unproven hope."

The encouraging news is that there are plenty of fertility or assisted conception treatments available that have a proven track record. Some of these include:

• Ovulation stimulation/induction - where women take drugs to stimulate inactive ovaries into producing eggs.
• ICSI - intracytoplasmic sperm injection, which is used in the case of male infertility and involves the sperm being injected directly into the egg.
• Artificial insemination - where semen is put directly into the cervix. A similar method is interauterine insemination, where semen is put directly into the uterus to help the sperm get closer to the fertilisation area.
• Egg or sperm donation - available when either partner is sterile.
• IVF - in vitro fertilisation, which is where eggs are gathered from the ovaries and mixed with sperm in a test tube. Fertilised eggs are then transferred back into the woman's uterus.

According to Dr. Brian Lieberman, from Bupa Hospital-based, Manchester Fertility Services, the best way to choose a clinic is to look at factors such as the success rates, costs, location and whether it's led by a reputable consultant. He also suggests contacting the Human Fertilisation and Embryology Authority (HFEA) for a copy of the Patients' Guide to IVF Clinics.

Summary

Coping with infertility problems can be very stressful for people and tests or treatments that offer hope but have little scientific basis may cause in even more distress. It is, therefore, crucial that tests and treatment undergo scientific scrutiny and peer review before being offered to the public. It is also important that individuals go to reputable consultants and clinics for help and advice.

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Links for more information

• Bupa assisted conception factsheet
• Royal College of Obstetricians and Gynaecologists
• Human Fertilisation and Embryology Authority (HFEA)
• HFEA Patients' Guide to IVF Clinics
• HFEA Patients' Guide to Infertility
• CHILD
• ISSUE
• British Fertility Society