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ONE MILLION CYCLES IN THE GERMAN IVF-REGISTRY K. Bühler Chairman of the German IVF Registry [Deutsches IVF-Register, D·I·R] Centre for Gynaecological Endocrinology & Reproductive Medicine Langenhagen (Hanover) & Wolfsburg www.ivf-germany.com *** www.deutsches-ivf-register.de INTRODUCTION: Systematic data collection in the field of IVF treatment has been established in Germany since nearly 30 years. In 1982, the year when the first IVF baby was born in Germany , 5 centres put their results together showing transparency of this new treatment option in treatment of fertility problems. In 1996, 71 centres participated, a reorganisation was performed: data transfer is only possible by electronic way allowing prospective data collection and on-line control of plausibility of the data. Prospectivity was define d as announcing the treatment cycle at least at day 7 of stimulation. In 1998, the German Medical Association declared it mandatory for all centres to participate at the Deutsches IVF-Regi ster. Since 1982 till 2009 (incl.) all in all 1.048.745 are collected. 90% of the "fresh" cycles are collected prospectively , so showing good data quality and reliability allowing powerful statistical evaluations of the daily practice in ART treatment in Germany 1 ). Since 1996, a year a "Yearbook" is published and can be seen by every one at the registries homepage ; in 2010, the annual 2009 was also published for the first time in English (http://www.kup.at/kup/pdf/9318.pdf ). As data collection software, the participants can use the RecDate program which fulfils all needs for the electronic organisation & surveillance of an IVF centre (commercially available: http://www .meditex-softwa re.com/index.ph p/en/products / ivf-software ) or the electronic questionnair e developed by the registry itself. The real time communication with the registry is effected by a "DIRdll-interface" by which the plausibility and prospectively control is performed instantly. Since 1996 the registry is financed by the members and in this time they paid > 1,6 Mill €. RESULTS: fig. 2 18,1 18,6 25,0 23,3 17,0 20,0 23,0 26,0 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 IVF ICSI TESE-I CSI Cr yo fig. 3 Data collection is performed cycle-by- cycle; the results are published in an anonymous way; only the regional medical associations know the centre specific results. Fig. 1 shows how the yearly OPU rates developed in Germany over the years. It is obvious how political decisions can influence the frequencies of ART treatment (): in the year 2000 the NHS didn't pay f or ICSI treatment; in 2004 the couples have to pay of the costs themselves. The clinical PR depending from age and numbers of embryos transferred is shown in fig. 2 . With these > 500.000 cycles it can clearly be demonstrated that after the age of 33 years of the treated women there is a clear decrease in chances to get pregnant. Concerning miscarriage rates ( fig. 3 ) there is a slight decrease over the years, but the rates after transfer from cryopreserved and thawed oocytes in the 2-PN stage is all the time 3-5 percent points higher. With further studies it must be clarified if this is due to the cryopreservation process or due to the fact that normally the best looking oocytes are used for the fresh transfer. At least, twice a year every centre receives by the registry so called centre profiles (fig 4a / 4b ) in which for about 120 items the centre specific data are compared with the results of al centres. So every centre is enabled to see the own position for every item on the national filed. 1 ) M Bals-Pratsch, K Bühler , J Krüssel, et al.: "Extended Analyses of the German IVF Registry (D·I·R): Andrologica l Aspects, Medical-Econ omical Assu mptions Related to the Shift From IVF to ICSI and Stimulation with Gonadotropins." J Reproduktionsmed Endokrin ol 2010; 7: 40–4. 2 ) M. Ludwig, T . Rabe, K. Bühler, et al.: "Wirksamkeit von rekombinante m humanem FSH im Vergleich zu urinäre m hMG nach Downregulation im langen Protokoll – Eine Analyse von 24.764 ART-Zyklen in Deutschland." J Reproduktionsmed Endokrinol 2004; 1: 284–8 With such profiles the registry is able to exert an educational effect also. So, D·I·R could convinced the centres to reduce the number of transferred embryo s and continuously a decrease can be observed: in IVF and ICSI cycles a reduction of 18,5% to 19,5% from 1997 to 2009 yielding in a reduction of triplets born compared to all children born after ART procedures of nearly -80% (fig 5a / 5b ). CONCLUSION: Registries are necessary to show great transparency relating to all acts performed in the field of reproductiv e medicine. With such a great data base and due to accurate, continuous & prospectiv e data capture reliable conclusions can be drawn, especially regarding the daily use of these procedures . Compared to RCT in our daily work we dispose very seldom over the "ideal patient". The German IVF Registry (D·I·R) is established as a standard for quality control & assurance, both within individual centres and nationwide in the context of data capture for the IVF register 2 ). - 18,5% - 19,5% - 11,1% - 78 % fig. 5b n = 769.064 fig. 1 fig. 5a fig.4a fig.4a fig. 4b fig. 4b

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ONE MILLION CYCLES IN THE GERMAN IVF-REGISTRYK. Bühler

Chairman of the German IVF Registry [Deutsches IVF-Register, D·I·R]

Centre for Gynaecological Endocrinology & Reproductive MedicineLangenhagen (Hanover) & Wolfsburg

www.ivf-germany.com *** www.deutsches-ivf-register.de 

INTRODUCTION:

Systematic data collection in the field of IVF treatment has been established in Germany since nearly 30 years. In 1982the year when the first IVF baby was born in Germany, 5 centres put their results together showing transparency of thisnew treatment option in treatment of fertility problems. In 1996, 71 centres participated, a reorganisation was performedata transfer is only possible by electronic way allowing prospective data collection and on-line control of plausibility ofdata. Prospectivity was defined as announcing the treatment cycle at least at day 7 of stimulation. In 1998, the GermanMedical Association declared it mandatory for all centres to participate at the Deutsches IVF-Register. Since 1982 till 2(incl.) all in all 1.048.745 are collected. 90% of the "fresh" cycles are collected prospectively, so showing good data quaand reliability allowing powerful statistical evaluations of the daily practice in ART treatment in Germany 1).

ce 1996, a year a "Yearbook" is published and can be seen by every one at theistries homepage; in 2010, the annual 2009 was also published for the first time

English (http://www.kup.at/kup/pdf/9318.pdf ).

data collection software, the participants can use the RecDate program whichls all needs for the electronic organisation & surveillance of an IVF centremmercially available: http://www.meditex-software.com/index.php/en/products/ software ) or the electronic questionnaire developed by the registry itself. The reale communication with the registry is effected by a "DIRdll-interface" by which theusibility and prospectively control is performed instantly. Since 1996 the registrynanced by the members and in this time they paid > 1,6 Mill €.

RESULTS:

fig. 2

18,1

18,6

25,0

23,3

17,0

20,0

23,0

26,0

1 997 19 98 1 999 20 00 2 001 2 00 2 2 003 2 00 4 20 05 2 00 6 20 07 2 00 8 20 09

IVF IC SI TESE- IC SI C ryo

fig. 3

Data collection is performed cycle-by-cycle; the results are published in ananonymous way; only the regionalmedical associations know the centrespecific results.

Fig. 1 shows how the yearly OPU rates developed in Germany over theyears. It is obvious how political decisions can influence the frequenciesof ART treatment (): in the year 2000 the NHS didn't pay for ICSItreatment; in 2004 the couples have to pay of the costs themselves.The clinical PR depending from age and numbers of embryostransferred is shown in fig. 2 . With these > 500.000 cycles it can clearlybe demonstrated that after the age of 33 years of the treated womenthere is a clear decrease in chances to get pregnant.

Concerning miscarriage rates (fig. 3 ) there is a slight decrease over theyears, but the rates after transfer from cryopreserved and thawedoocytes in the 2-PN stage is all the time 3-5 percent points higher.

With further studiesit must be clarified ifthis is due to thecryopreservationprocess or due tothe fact thatnormally the bestlooking oocytes areused for the freshtransfer.

At least, twice a year every centre receives by the registry so called centreprofiles (fig 4a / 4b ) in which for about 120 items the centre specific data arecompared with the results of al centres. So every centre is enabled to see theown position for every item on the national filed.

Bals-Pratsch, K Bühler, J Krüssel, et al.: "Extended Analyses of the German IVF Registry (D·I·R): Andrological Aspects, Medical-Economical Assumptions Related tift From IVF to ICSI and Stimulation with Gonadotropins." J Reproduktionsmed Endokrinol 2010; 7: 40–4.Ludwig, T. Rabe, K. Bühler, et al.: "Wirksamkeit von rekombinantem humanem FSH im Vergleich zu urinärem hMG nach Downregulation im langen Protokoll – Einalyse von 24.764 ART-Zyklen in Deutschland." J Reproduktionsmed Endokrinol 2004; 1: 284–8

With such profiles the registry is able to exert aneducational effect also. So, D·I·R could convinced thecentres to reduce the number of transferred embryosand continuously a decrease can be observed: in IVFand ICSI cycles a reduction of 18,5% to 19,5% from1997 to 2009 yielding in a reduction of triplets borncompared to all children born after ART procedures ofnearly -80% (fig 5a / 5b ).

NCLUSION:

gistries are necessary to show great transparency relating to all acts performed in the field of reproductive medicine. With such a great data base and due tourate, continuous & prospective data capture reliable conclusions can be drawn, especially regarding the daily use of these procedures. Compared to RCT in oury work we dispose very seldom over the "ideal patient". The German IVF Registry (D·I·R) is established as a standard for quality control & assurance, both withinvidual centres and nationwide in the context of data capture for the IVF register 2).

- 18,5% - 19,5% - 11,1% - 78 %

fig. 5b

n = 769.064

fig. 1

fig. 5a

fig.4a

fig.4a

fig. 4b

fig. 4b