A year after the law regulating in-vitro fertilisation came in, there are calls to make it less restrictive. But Embryo Protection Authority vice president Simone Attard tells Kurt Sansone it is too early to change the rules.

The pregnancy rate for in-vitro fertilisation is “in line” with that of other European countries despite claims it halved because of new rules, according to the IVF regulator.

Simone Attard, vice president of the Embryo Protection Authority, insists that a 28 per cent pregnancy rate last year compared well with the 32 per cent success rate reported by the European Society of Human Reproduction and Embryology.

Last week Josie Muscat, the owner of St James Hospital, the only private hospital that performs IVF, criticised the legal limit that allows doctors to try to fertilise only two eggs.

He argued that the limit reduced the chances to achieve pregnancy by almost half – in 2012 St James Hospital reported a pregnancy rate of 50 per cent.

The controversy began after the Embryo Protection Authority, the regulator, released its first annual report since it became operational last year.

But Ms Attard has cautioned against a direct comparison between the IVF figures for 2013 – when the sector started being regulated – and the previous years.

“Statistics published before the enactment of the law were for procedures that were being carried out with no regulation in force and have not been peer reviewed,” she said.

Although IVF was pioneered in Malta by St James Hospital 20 years ago, the sector remained unregulated until 2012 when Parliament enacted the Embryo Protection Act.

The authority to regulate the sector is tasked with monitoring clinics that provide IVF treatment and draw up procedural protocols.

It also gives permission for couples to undergo IVF after assessing their eligibility.

The law restricts fertilisation to two eggs, except for certain cases that have to be approved by the authority when three eggs are allowed to be fertilised.

The limit was introduced because legislators wanted to prevent higher-risk multiple pregnancies. Although practitioners agreed with the reasoning, they argued for the limit to be lifted and extra embryos produced during the process to be frozen.

The law disallows embryo freezing and Ms Attard does not believe it should be changed any time soon.

“Before considering any changes in the current legislation, more time is to be allowed to assess the situation, get all stakeholders involved while ensuring the safety and wellbeing of the embryo, the child and the mother,” she said when asked whether the authority should recommend changes to the law.

Ms Attard pointed out that in European clinics there was a notable decline in the number of embryos transferred to the mother’s womb in a given cycle.

Increasing the embryos transferred heightens the chances to achieve pregnancy but it also increases the likelihood of having twins, triplets or more.

This had been a concern for paediatricians in the past since multiple births posed a higher risk for newborn babies and put a strain on resources.

Ms Attard said studies showed there were fewer three-embryo transfers nowadays and more single embryo transfers being performed.

“As a result of this, the number of both triple and twin multiple pregnancies have fallen considerably.”

Statistics published before the enactment of the law… have not been peer reviewed

Quizzed about the authority’s first year in operation, Ms Attard said decisions on whether to allow three eggs to be fertilised in certain circumstances were taken on a case-by-case basis.

The authority received 52 applications from clinics to try 10 fertilise three eggs but only approved 38.

Approvals were based on established criteria agreed between the authority and the association of obstetrics and gynaecologists, she added.

The criteria included the age of women undergoing the IVF treatment and previous failed cycles experienced by the couple.

“Decisions are taken on a case-by-case basis during specific meetings held by the authority together with two appointed representatives from each association as requested by the Embryo Protection Act,” Ms Attard said.

She said no requests were received for embryos to be frozen as a result of grave circumstances, such as when a woman had an accident just before the date of implantation.

But apart from regulating the medical aspect of IVF, the law also makes it obligatory for couples to be given information and counselling during and after the procedure.

Ms Attard insisted that infertility counselling sessions were “very crucial” for the whole process.

“Couples undergo relentless tests and may fail in the process with significant distress, which could lead to devastating effects on the couple’s lives,” she said.

Asked whether the authority was satisfied with the level of counselling given to couples, she acknowledged the information provided to prospective parents by the clinics was primarily of a medical nature.

The authority took the issue of infertility counselling very seriously, she added, and protocols governing this aspect were released in October last year.

She said the authority was working to increase general awareness of the whole infertility problem.

“Adopting healthy lifestyles, such as addressing obesity, smoking, alcohol and a lack of exercise and in particular stress help to address infertility issues.”

ksansone@timesofmalta.com