A study published in the Malta Medical Journal shows that the unregulated and completely privatised administration of infertility treatment has led to an increase in the birth of triplets and quadruplets, a greater health risk to newborns.
The article, “Higher order multiple pregnancy outcomes in the Maltese islands 2000-2004”, published last March, is a wake-up call for action in a field which successive governments have left unregulated.
Reproductive technology, which includes the use of fertility pills and in vitro fertilisation, only accounts for 0.7% of single births. But the same methods were used in 28% of cases involving triplets and 50% of cases involving quadruplets.
The birth of triplets and quadruplets is considered by the medical profession as more prone to health risks due to the greater likelihood that these children will be born prematurely.
Charles Savona Ventura an associate Professor of Obstetrics and Gynaecology in the Faculty of Medicine and Surgery and one of the authors of the study believes that the state should start offering infertility treatments in the national health scheme.
One reason for state intervention in this sector is affordability.
“The problem I see is that hi-tech management of infertility in Malta is only available to those who can pay or are ready to make tremendous sacrifices to pay the costs of treatment.”
Savona Ventura is concerned by the psychological impact on these parents.
“Infertile couples are so desperate that they are ready to undertake extreme sacrifices to try and achieve a pregnancy. This can result in further stresses in their relationships.”
One justification for a national programme to assist infertile couples is to “enable the low-moderate income groups to avail themselves of hi-tech options when necessary.”
Surely prices are high because both medicines and equipment are expensive.
“To be fair to the current providers, the high costs of these hi-tech management options, such as what is popularly known as "test-tube baby", involve the medication and laboratory workups. Not all the costs are pocketed by the providers.”
But should infertility treatment by offered at no charge at all?
“This is a political decision and should be made by the politicians on the advice of the health regulators.”
But Savona Ventura notes that: “if the state hospital is already making freely available non-medically essential treatment options in other branches of medicine, then infertility management should be considered for introduction.”
He also cites studies confirming that it would be financially cheaper to introduce a regulated infertility service than to be forced to care for the premature infants born from unregulated high tech infertility management.
In fact the main reason justifying the provision of this service by the state is to ensure that it is properly regulated.
“More importantly, these couples will have a service that is regulated and audited regularly… a service run by the National Health is more easily controlled and regulated than one run privately.”
Malta would not be re-inventing the wheel by introducing this service in its health scheme. The health service provisions in the EU vary from one country to another.
“Most countries have a comprehensive infertility service provided for in the National hospitals, but this is not always offered free of charge,” Savona Ventura explains.
Introducing regulations would be a step in the right direction, but it would not be enough because it would be very difficult to enforce them.
“I believe that any Regulatory Body would be hard stretched to control all the activities of a process that is so private and confidential in nature.”
It is also important, the gynaecologist points out, to ensure that only accredited specialists perform infertility treatment.
Since joining the EU, the government has been forced to introduce the long-awaited specialist register. Therefore, a body that defines what every member of the medical profession is capable of doing already exists.
“One would not allow a family doctor perform a cardiac bypass surgery; so too should one not allow a non-specialist to carry out procedures that are not within his training portfolio.”
In 1992 the Malta College of Obstetricians and Gynaecologists issued a circular to regulate the use of medications associated with a very high risk of super-ovulation and hence more likely to produce twins, triplets or even quadruplets.
“While agreeing in principle, the Health Department failed to take definite action and ensure that these medications are prescribed by people truly knowledgeable in their use.”
Based on a study of 20,125 infants born between 2000 and 2005, the study co-authored by Prof. Savona Ventura shows that while artificial reproductive technology is only used in 0.7% of singleton births, the percentage rises to 28% in cases of triplets and 50% in cases of quadruplets. What are the health risks posed by a growing rate of multiple births?
“All multiple pregnancies, but even more so triplets and quadruplets, are associated with significant risks to the mother and children. The main risks are to the children who are generally born prematurely.”
This could expose them to all the risks associated with premature births, like respiratory problems and cerebral haemorrhage.
“These problems can and do result in infant death or infant damage which can have life-long consequences.”
With regards to the mother, the main risks arise from the risks of Caesarean section such as anaesthetic complications, intra-operative and postoperative haemorrhage or postoperative infection.
“There is furthermore the psychological trauma of losing the children or facing a significantly damaged brain-injured child.”
Savona Ventura believes that a regulatory body should penalise clinics who misuse reproductive technology by contributing to multiple pregnancies.
“If and when such a regulatory body is established, it could review all cases of high order births such as triplets and quadruplet and if these are found to be the result of high tech reproductive management, then severe and significant action should be taken on the original providers of these services.”
The main reason contributing to the rise in the rate of multiple pregnancies is that more than two fertilised ova are implanted in the mother in a particular cycle. At present, infertility treatment works in this way.
The woman is administered fertility medication for a whole month. The medication normally comes in the form of an injection. The aim of the treatment is to stimulate the production of ova.
Regular monitoring by ultrasound to assess the development of the ova determines for how long the medical treatment is required and the dosage. The treatment is expensive, with a single injection costing anything up to €35.
The amount of injections required for treatment varies from woman to woman and from month to month.
Once the stimulated ova are ripe for fertilisation the process can continue naturally with the couple having intercourse in the hope that a pregnancy will ensue. The medical treatment means that more than one ova could be stimulated and hence the higher risk of multiple births.
If the natural method is not appropriate the couple can then opt for IVF.
After the treatment with medication, the stimulated ova are extracted from the woman’s body and fertilised in a test-tube. The artificially fertilised eggs are than transferred back into the woman’s womb.
The fact that all fertilised eggs are transferred into a woman’s womb contributes to the higher risk of multiple births. Freezing of fertilised ova would lower the risk of multiple births and at the same time avoid some of the discomfort and pain a woman undergoes each time she is administered fertility medication
“If one implants two ova, one may be faced with twins; if three ova, with triplets; if five ova, with quintuplets. It is a question of the fewer ova implanted, the better the prospective outcomes for the children.”
He acknowledges that there is also “the proverbial opposite side of the coin, in that the more ova implanted the greater are the chances of a pregnancy success.”
But the health costs of this logic are more than counterproductive, Savona Ventura insists.
The obstetrics professor also believes that one cannot have an IVF or hi-tech programme without facilities for freezing and storage of excess fertilized ova.
But he also expects parents to take responsibility for the fertilised ova, thus ensuring that none of them are wasted.
He argues that any excess ova can be implanted in the mother's womb in a subsequent cycle, say two-three years after the first pregnancy.
“Couples embarking on hi-tech reproductive procedures should be ready to take on the responsibility of their actions, and be ready to care for all fertilized ova should all of them result in a live child.”
In 2005 parliament's social affairs committee had come up with a proposed set of regulations, which were not very clear on how in vitro fertilization should be regulated. In fact the committee gave two options regarding the implantation and freezing of fertilised ova. According to the first option, freezing was completely excluded except in cases when the mother became sick and is unable to carry out her pregnancy after the test tube fertilisation.
According to the second option, the freezing of ova was to be allowed, but parents would be legally obliged to implant any excess embryos at a later stage. Legal sanctions were also envisioned against parents who refrain from doing this.
But it seems the regulations were met with behind-the-scenes resistance, and were never transposed into law. Why is it so difficult for politicians to agree on these regulations?
“Ask that to the politicians! It is easy for politicians to set up advisory boards to study and report on a problem. It is more difficult to truly intervene and take definitive action. This reminds me of the civil service described in the Yes Minister series on the BBC.”
In the absence of regulations is it safer for parents with infertility problems to get infertility treatments in other European countries?
“I would like to see the success rates of the units providing these services in Malta to be in a better position before advising patients whether it is better for them to seek treatment overseas. However, it is definitely more convenient and possibly less expensive overall to seek treatment locally.”
Although he is very critical of the current situation, Savona Ventura does not pass any hasty judgements on doctors who are currently offering the service in the private sector.
“The current providers are actually providing a good service within their capabilities and the pressures placed upon them by the social circumstances, the ethical conceptions or misconceptions and by the patients themselves. I am sure that they have set up their own boundaries within these constraints but on a national level, it remains the obligation of the government and the health authorities to regulate practice to ensure that it is safe.”