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Research from Belgium shows that if governments restrict the numbers of embryos transferred during fertility treatment, and combine that restriction with a policy of reimbursing six cycles of assisted reproduction technology (ART), there is no detrimental impact on pregnancy and delivery rates.
A study, published online in Europe's leading reproductive medicine journal Human Reproduction, investigated delivery rates three years before and after Belgium introduced such a policy in July 2003.
Dr Karen Peeraer, adjunct head of clinic at Leuven University Fertility Center, Leuven, Belgium, who led the research, said: "Our study is the first to calculate the cumulative delivery rate in a real-life scenario for up to six cycles or 36 months over a period of three years before and after the implementation of the Belgian legislation limiting the number of embryos transferred.
Study authors write: "The results of our paper have implications for public health policies worldwide with respect to quality, safety, regulation and financial control of treatments with ART. From a public health point of view the 'Belgian model' can now be considered by other governments for application worldwide.
The researchers believe that introducing the Belgian policy may result in financial savings for governments through the reduction in multiple pregnancy rates.
Delivery rates among 463 patients treated at the Leuven University Fertility Center between 1 July 1999 and 30 June 2002 were compared with 795 patients treated at the Center between 1 July 2003 and 30 June 2006. Women younger than 43 were followed until six ART cycles had been completed, until a baby was born, until discontinuation of treatment, or for 36 months.
In patients younger than 36 years: First cycle - only one embryo can be transferred, regardless of embryo quality. Second ART cycle - one embryo transferred, but two if they are poor quality. Next four cycles - a maximum of two embryos can be transferred in each.
The researchers looked at pessimistic, optimistic and realistic scenarios.
Dr Peeraer adds: "We found that among women treated after July 2003 there was a higher proportion of single embryo transfer cycles, a higher singleton delivery rate and a lower twin delivery rate (12% versus 24%) compared to women treated before that date."
Prof D'Hooghe concluded: "We hope that this study, together with results from Sweden, will convince other governments to couple ART reimbursement to strict embryo transfer policies."
SUMMARY ANSWER The introduction of Belgian legislation in ART had no negative impact on the CDR per patient based on realistic estimates within six cycles or 36 months.
WHAT IS KNOWN ALREADY The introduction of Belgian legislation limiting the number of embryos for transfer resulted in a reduction of the multiple pregnancy rate (MPR) per cycle by 50%.
STUDY DESIGN, SIZE, DURATION A retrospective cohort study with a study group after implementation of the new ART legislation (July 2003 to June 2006) and the control group, before legislation (July 1999 to June 2002).
PARTICIPANTS/MATERIALS, SETTING, METHODS CDR was compared in an academic tertiary setting between a study group after legislation (n = 795 patients, 1927 fresh and 383 frozen-thawed embryo transfer (FET) cycles) and a control group before legislation (n = 463 patients, 876 fresh and 185 FET cycles) within six cycles or 36 months, delivery or discontinuation of treatment. The CDR was estimated using life table analysis considering pessimistic, optimistic and realistic scenarios and compared after adjustment for confounding variables. In the realistic scenario we included information on embryo quality to define the prognosis of each patient discontinuing treatment.
MAIN RESULTS AND THE ROLE OF CHANCE In the realistic scenario, CDR within 36 months was comparable (all ages, P = 0.221) in study group (60.8%) and control group (65.6%), as well as in different age groups (<36 years, P = 0.242; 36–39 years, P = 0.851; 40–42 years, P = 0.840). In the realistic scenario applied to six cycles, we found lower CDRs in the study group than in the control group within the two first cycles (all ages, P = 0.009; <36 years, P = 0.007) but no difference in CDRs between the two groups within the four subsequent cycles (all ages P = 0.232; <36 years, P = 0.198). The CDR within six cycles was 60 and 65.3% for study group and control group, respectively, for all ages, and 65.8 and 70.4%, respectively, in the subgroup younger than 36 years. In women ≥36 years, CDR within six cycles was comparable in both groups (36–39 years, 43% in study versus 44.4% in control group, P = 0.730; 40–42 years, 21% in study versus 23% in control group, P = 0.786).
LIMITATIONS, REASONS FOR CAUTION A retrospective cohort study design was the only way to study the impact of legislation on CDR. Owing to the retrospective nature of this analysis over a long period of time, our data are potentially influenced by improvements in techniques and therefore improved success rates in ART over time.
WIDER IMPLICATIONS OF THE FINDINGS This ‘Belgian model’ can now be considered for application worldwide in countries with the aim to reduce the main ART side effect (high MPR) and its associated costs without a negative effect on the main intended effect (high CDR).
STUDY FUNDING/COMPETING INTEREST(S) The authors have no conflict of interest to declare. No funding was obtained for this study.
 Before 2003 laboratory costs varied from centre to centre in Belgium but were usually between €1,000-1,500 Euros per cycle. Medication costs are partially reimbursed by the state and patients still need to pay around €100 per cycle. Costs of blood tests and ultrasound monitoring are also partially reimbursed by the state and patients still need to pay approximately €100 per cycle. The policy on reimbursement (and costs) for medication, blood tests and ultrasounds is largely unchanged from before 2003.