1. Jacques de Mouzon, EIM chairman
Report
On The Ten Years’ EIM Meeting
Munich, 11th September 2010
Jacques de Mouzon, EIM chairman

2. EIM – The beginning
First discussion in Goteborg in 1998 by Karl Nygren Luca Gianaroli and Bruno Van Den Eede
First meeting: Tours June 1999, 19 European countries,
At first data collection on paper. Now by a software.
First results presented at the 16th Annual Meeting (Bologna), June 2000.
10 reports published so far, 11 presentations

3. EIM – Present Steering Committee (2009 – 2011)
Chairman
J. de Mouzon, France
Past Chairman
A.N. Andersen, Denmark
Chairman-elect
A.P. Ferraretti, Italy
Coordinator data collection
V. Goosens, Belgium
Members
K. Nygren, Sweden (advisor)
 S. Bhattacharya, UK
 M.S. Kupka, Germany
J.A. Castilla Alcala, Spain
V. Korsak, Russia

4. Meeting objectives
- (1) To show the importance of building national and European registers in getting data on the practice and results in a major field for human being, reproduction and its treatments
- (2) To detail the main aspects to consider when building a register on ART
- (3) To progress in the EIM register functioning
- (4) To celebrate a 10 years of experience and success at the level of Europe through ESHRE

5. Course organization 4 sessions Course principles Main achievements
General aspects of national registers
Registries experiences
EIM register discussion
Course principles
To share experiences
To let as many countries as possible participating
To improve EIM functioning

6. Session 1. Main achievements
1. ART data in Europe. An overview. Anders Nyboe Andersen
2. Use of ART data from Europe and World – what have we learned? Karl G. Nygren

7. Number of citations of the EIM reports published in Human Reproduction
Source: Web of Science
Total: 461 times

8. Reporting to the EIM ( 1997 data )
Red: No data
+ Russia

9. Reporting to the EIM ( 2007 data )
Red: No data
+ Russia
+ Ukraine
+ Turkey

10. 1997 2007 Development in the EIM reporting system from 1997 – 2007.
Countries
Clinics reporting
Proportion of clinics Unknown 88%
Countries with
complete reporting
ART cycles
IUI reporting No
All cycles

11. Countries with complete (100% of clinics) Reporting to the EIM regarding 2007 data.
Red: incomplete
+ Russia
+ Ukraine
+ Cyprus
Green: complete
+ Turkey

12. Availability. Number of cycles per 1 mill inhabitants (2007)
Demographic aspect
Availability. Number of cycles per 1 mill inhabitants (2007)
The concept of ”availability” introduced and used by the EIM

13. Distribution IVF / ICSI (1997-2007)

14. Number of embryos transferred. IVF and ICSI, 1997 - 2007 (%)
No data from: Albania, Austria,Croatia, Czech Rep, Cyprus, Lithuania, The Netherlands, Norway, Spain and Turkey

15. Pregnancy rate per transfer 1997 - 2007
IVF
ICSI
FER ED

16. Percentage singleton, twin, triplet and quadruplet deliveries
Percentage singleton, twin, triplet and quadruplet deliveries. IVF and ICSI,
Singleton
Twin
Triplet
Quadruplet
From 2006 on, the number of quadruplet deliveries was included in the number of triplet deliveries.
In 283 deliveries, multiplicity is not known.

17. Other achievements Analysis of national differences: Transparency
transfer policies / multiple pregnancies, cumulative PR, Benchmarking
Transparency
Collaboration to World register (ICMART)
Trends, citations, promotion of ICMART glossary
Still to be improved
Consensus on minimal data set for ART
Explanation for large countries differences

18. Session 2. General aspects of national registers

19. Six main aspects of a national register
From a professional to a public health authorities register. French experience. T Shojaei
Prospective digital recording: the German organization. Marcus Kupka
Use of the Italian register data following the change of the Italian law on ART. Anna Pia Ferraretti and Giulia Scaravelli
The Nordic MART project. Possibilities and limitations with pooling of ART outcome data from different countries. AK Henningsen (Denmark)
Is a voluntary register valid for collect data of cross-border patients. Jose Antonio Castilla (Spain)
Pros and Cons of the UK data disclosure system. Siladitya Bhattachayra (United Kingdom)

20. From a professional to a state register
FIVNat
Agency of biomedicine
Responsible
Health professional association
Health authority
Nominative data No
Yes (informed consent)
ART definition
IVF, ICSI, FET
+ OD, ED
ART vigilance
Yes (AMP Vigie)
Individual data: forms
ABM
Participation
Voluntary
Compulsory (2012)

21. From a professional to a state register
Improvement
Professional register
Comprehensive aspects of register
Data transmission from the centres through software
Higher financial potential
Nominative data
Increase in transparency
Risk
Professional less involved
Decrease in research

22. Prospective digital recording: Germany
interview
with fixing
of the treatment
beginning of the
stimulation
Information
coming from the
Patient via phone
or mail
end of
pregnancy
Embryo-
transfer
first monitoring
appointment
beginning of the
down-regulation
in a long protocol
Information
coming from the
Patient via phone
or mail
8 days
for
initiating
the record
hcg-test

23. From a professional to a state register
2000 to 2008 = 9 years
prospectivity
no prospectivity
IVF
(92.2 %)
(7.8 %)
ICSI
(91.2 %)
(8.8 %)
IVF/ICSI
6 097 (92.8 %)
471 (7.2 %)
cancelled cycles
(92.2 %)
4 333 (7.8 %)
total
(91.7 %)
(8.3 %)

24. Impact of law on ART: Italy
mandatory national data collection
accreditation and licensing
heterosexual infertility couples only
Gamete and embryo donation forbidden
No more than three embryos, cryopreservation forbidden
2009, less restriction on freezing, embryo number, PGD

25. Number of embryos transferred per cycle in Italy, from 2005 to 2008
(max 3 embryos transferred per cycle, mandatory by law from 2004)
1 embryo
2 embryo
3 embryo
2009 ??
18,7
20,4
20,0
30,9
30,4
30,5
30,7
50,4
50,9
49,1
49,4
0,0
10,0
30,0
40,0
50,0
60,0
70,0
80,0
90,0
100,0
2005
2006
2007
2008
2 embryos
3 embryos
Mean value
2,32
2,29 % 25

26. Fresh cycles multiple delivery rates in Italy, from 2005 to 2008
Twin deliveries
Triplets
2009 ??
21,2
2,7
21,6
21,0
20,6
2,8
0,0
5,0
10,0
15,0
20,0
25,0
30,0
2005
2006
2007
2008 %
Triplets and +
24,3
23,8
23,4
23,9
21,8
0,8
20,8
0,9
19,9
ESHRE zone 26

27. Italia Italy- Pregnancy rate/ET %
2003 voluntary data collection for EIM centers
2004 mixed data collection centres
2005 National Register centres %
IVF
ICSI
total
S.I.S.ME.R.
VISION 2000
P<0.001

28. DATA FROM EUROPEAN IVF MONITORING (EIM – ESHRE)
Italy vs Europe
DATA FROM EUROPEAN IVF MONITORING (EIM – ESHRE)
PR/ET
PREGNANCY RATE PER TRANSFER
Europe %
Italy 17

29. Possibilities and limitations with pooling of data from different countries The Nordic MART project
Documentation of the safety of ART: children’s health/morbidity
Funding
ESHRE, University of Copenhagen
Danish Agency of Science, Technology and Innovation
National health registers in the Nordic countries
Unique personal identification numbers
Cross-linking of registers

30. Pooling of data from different countries The Nordic MART project
Strenghts
Prevalence of rare disorders, new technology survey, Long-term consequences
Limitations
Differences in ART registration, details of health data, ICD-8/9/10
Studies
Perinatal outcome and risk of perinatal death among 98,957 ART children born in the Nordic countries
Birth defects among children born after ART
Long-term morbidity in ART
Imprinting diseases and ART in 4 Nordic countries
Trends over time in assisted reproduction
Pregnancy complications among women who have conceived after ART

31. a voluntary register valid to collect the data of cross-border patients? Spain example
SEF Register 2008: 38,245 cycles: 1,919 patients from abroad: 5%
CBRC estimated by participation rate in SEF Register 2008:
3200 cycles for patients from abroad
1,300 own egg, 1,900 egg donor
Underestimation
CBRC in Spain estimated by comparison FIVCAT / SEF
17,000 cycles for patients from abroad, 5,000 own egg, 12,000 egg donor
Overerestimation
Conclusion
A voluntary register is not valid for CBRC data but it can help to estimate them

32. the UK data disclosure system
Clinical data on all IVF/ICSI/donor treatments since 1991
2008: substitutes:
Disclosure of information by
Disclosure for the purposes of medical or other research
Anonymised HFEA data: access & uses
Free online access to full anonymised dataset
Measures to protect anonymity
From 1 October 2009,
release of patient-identifying information to researchers only with explicit consent from patients
Patients registered with a clinic before 1 October 2009, but returning for future treatment will be required to provide consent

33. Consent to disclosure of data
Since October 2009, opt in rate = 10,124/ 27,421 (37%)
Pros
Complete detailed coverage to continue
Increased transparency
Informed consent
Greater ease of use of anonymised data
Cons
Greater complexity
Agreement to give researchers identifying data problematic
Poor option in rates
Potential for bias in longitudinal studies

34. Session 3. Registries experiences

35. 6 presentations on national experiences
Session Plan
6 presentations on national experiences
Turkey: 122 centres, cycles 2008
State data collection, compulsory but imperfect, Summaries
Needs for involving professional
Russia: 78% participation, cycles, low ICSI
Increase in SET, DET, surrogacy allowed
Austria: analysis of differences public/private (Better results)
Belgium: compulsory register held by"College of Physicians Reproductive Medicine.
Law : decrease in multiple, from 30-35% to 12-14%, reimburs.
Slovenia: 3 centres, high activity, SET encouraged
Switzerland: experience of data auditing: improvement in data collection; hopes in a new software

36. Improvements in the Quality of the Data Collection
clinical pregnancies reported
clinical pregnancies, lost during follow-up
Number
Year

37. Improvements in the Quality of the Data Collection (2)
Loss of follow-up on clinical pregnancies
Loss of follow-up on neonatal data
Relative number (%)
Year

38. Session 4. Round tables

39. EIM organization: Proposition for
Three round tables
EIM Forms :
small changes (semen donation, more info on IUI)
clarification
EIM organization: Proposition for
modifying country representation,
steering committee election process (ESHRE / registries)
Organizing meetings like this one
Assistance for countries
Additional studies
Increase them
Board meeting will prepare propositions for next ESHRE congress in Stockholm

40. Conclusion Very fruitful meeting Participants satisfied To be renewed
12 experiences shared
Covering most of the fields
Active participation
Participants satisfied
To be renewed