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ART laws put patients at risk and should be changed, warns head of Germany's IVF registry

June 27, 2003

Germany's restrictive legislation on embryo protection is putting women and babies at risk and should be modified, the chairman of the German IVF registry will tell a meeting of international fertility experts.

Professor Ricardo Felberbaum will warn participants at the European Society of Human Reproduction and Embryology annual conference that other countries in Europe should take heed of the German experience when formulating their own legislation on embryo selection, storage and implantation.

Since January 1991, under German law a maximum of three embryos can be transferred to a woman's uterus, but only as many female eggs (oocytes) can be fertilized as planned to be transferred, and then they all have to be transferred in one go, regardless of quality, because embryo selection and storage by freezing is forbidden. Only freezing of oocytes in the pronuclear stage is allowed, which means that selection has to be performed at that stage of development and not later.

These laws were thought to guarantee a low incidence of multiple births, but Prof Felberbaum said that, in fact, this goal was not achieved.

He studied data from 108 IVF centres on 75,086 treatment cycles in 2001. Out of 9,648 children born after ART 62% (5,969) were singletons, 34% (3,326) were twins and 3.6% (353) were triplets. There was a strong correlation between the number of embryos transferred and the incidence of multiple pregnancies. In women under 35, 24% of pregnancies were twins after the transfer of two embryos, and when three embryos were transferred 28% were twins and just over 5% were triplets.

The quality of the embryos transferred dramatically affected pregnancy rates: when two, high-quality embryos were transferred there was an overall pregnancy rate of 32%, but when two, low-quality embryos were transferred the overall pregnancy rate dropped to just 13%.

Prof Felberbaum told a news briefing today (Monday 30 June): "German regulations are putting women and babies at risk because they are directly responsible for a higher rate of multiple pregnancies and all the problems, including a high incidence of pre-term deliveries and maternal and neonatal morbidity, associated with them. Strategies such as elective single embryo transfer are impossible in Germany and this lowers the women's chances of conception. We are not allowed to discard any embryo and freezing is only allowed in an emergency case; this means that doctors are forced to transfer all embryos, regardless of whether they are viable or not."

As freezing is only allowed in oocytes at the pronuclear stage, women have to choose between undergoing one round of IVF treatment in which the maximum number of embryos are implanted in the hope that at least one of the embryos is good quality, or to undergo the time, expense and medical problems (such as ovarian hyperstimulation syndrome) associated with several IVF treatment cycles.
                              
"In spite of restrictive legal regulations in Germany, about 40% of all children born after ART are multiples, of which about 4% are triplets," said Prof Felberbaum. "The only way to reduce this high number of multiple births, and especially to avoid triplets, is to allow embryo selection and to restrict to two the number of embryos that can be transferred to patients younger than 35. At present, Germany's laws reduce women's chances of becoming pregnant, but they do not prevent multiple pregnancies and all the risks associated with them."

In women older than 35 the risk of triplets after transfer of three embryos is significantly lower than in younger patients. Only 1.49% of all deliveries are triplets after three embryos have been transferred, but in younger women 5.36% of all deliveries are triplets after the transfer of three embryos. "Nevertheless, the possibility of embryo selection and the replacement of only one or two high quality embryos would be beneficial to older women too," said Prof Felberbaum.

"We are calling for a change in German regulations. Governments in other European countries who are thinking about new and restrictive regulations in ART, such as Italy, should take into account these observations made in Germany.

"I am not advocating any kind of medical anarchy - without any doubt we need legal regulation of this extremely sensitive part of human medicine. But regulations should always try to make medical treatments as safe and efficient as possible for the benefit of our patients. German regulations are obviously failing to do so."
(ends)

MW Communications