EIM Consortium meeting
In 04-05.11.2016 a avut loc intalnirea Consortiumului de colectare date ( EIM Consortium meeting)
Programul a fost urmatorul:
4 November 2016 13.30
Welcome Carlos Calhaz‐Jorge
2013 data collection Veerle Goossens Data not coming from EIM registry
13.45‐14.15 Cross‐border ART care in the US Aaron Levine Associate Professor & Director of Graduate Studies School of Public Policy | Georgia Tech
14.30‐14.45 Results of oocyte cryopreservation study Jacques de Mouzon
14.45 – 15.00 Project to compare American and European data. Where are we? Markus Kupka
15.45‐17.00 General open discussion (Topics proposed by countries; European survey on legal and financial frame about ART; …)
5 November 2016 Different registry systems ‐ strengths and weaknesses
9.00‐9.15 Romania ‐ voluntary Ioana Rugescu
9.15‐9.30 Portugal ‐ mandatory Carlos Calhaz‐Jorge
9.30 – 9.45 Italy – summary data Giulia Scaravelli
9.45‐10.00 France – cycle by cycle Dominique Royere
11.00‐11.15 Governmental registry or registry founded by medical professionals? Markus Kupka
11.15‐11.30 ART registry as the basis for cost effectiveness fertility policy in the Netherlands; first results of a paradigm shift Jesper Smeenk
Beyond efficacy in EIM registry
11.45‐12.05 Safety issues in EIM registry Christine Wyns
12.05 Discussion The future
12.15‐12.45 The future of EIM registry Christian De Geyter
Din partea Romaniei au fost prezenti : Dna Ioana Rugescu (raportorul de date) si dl. dr. Bogdan Doroftei
Dupa mesajul de deschidere au urmat prezentarile conform programului
1) 2013 data collection Veerle Goossens Data not coming from EIM registry
51 European countries (geographically)
EIM is covering nearly 80% of the European countries
Centers 1 167
Cycles 694 779
Children 148 050
2) Cross‐border ART care in the US Aaron Levine
Detalii legate de National Assisted
In special motivatia pentru accesarea tratamentului in US. S-a pus accent pe faptul ca exista ambele tipuri de pacienti in sensul in care accesarea tratamentelor in US o fac si pacientii in a caror tara de origine anumite tratamente sunt ilegale , dar si cei in a caror tara de origine sunt legale ( in acest caz se diferentiaza diferentele legate de unele tehnologii care nu sunt disponibile in tara de origine dar si dorinta de anonimitate)
A fost mentionat gidul de bune practici emis de ESHRE in ceea ce priveste pacientii transfrontalieri precum si pozitia luata de ASRM in legatura cu acest subiect.
A fost mentionat ca nu exista inregistrari exacte in ceea ce priveste pacientii transfrontalieri in niciun registru.
In urma studiului efectuat s-a concluzionat faptul ca , in ceea ce priveste calitatea actului medical , in US nu exista diferente intre pacientii rezidenti sau non rezidenti. Au fost comparate datele intre anii 2006-2013.
Lista tarilor de provenienta este urmatoarea : Canada, Mexic, United Kingdom ,Japan ,China Australia ,France ,Italy ,Germany ,Spain ,Israel ,Dominican Republic ,The Bahamas Switzerland .
3) Results of oocyte cryopreservation study Jacques de Mouzon
OoC: increasing practice in Europe and worldwide
Efficiency of vitrification (1)u
Increasing ART medical indicationsu
Non medical (“social”) demand, biological clocku
Ovarian tissue cryopreservationu used both for children/adolescents (2) and adultsu
No real consensusu
Results relatively pooru
ESHRE ethic and law SIG Recommendations
1. Oocyte vitrification for fertility preservation should not just be available for women at risk of premature pathogenic or iatrogenic fertility loss, but also for those who want to protect their reproductive potential against the threat of time.
2. Fertility doctors should refrain from passing judgement on a woman’s motives for postponing childbearing and requesting fertility preservation.
OoC practice, current knowledge
Practice far from universal or standardised in Europeu
Few data: EIM 2016 (2012):u 5549 Frozen Oocyte Replacement cycles (FOR) from 650 000 cycles (0.85%)
Large differences across countries: 84% in Spain and Italy BUT : number of freezing procedure not recorded (indications, number retrieved, …)
Knowledge gap: stimulation, storage, and use
OoC Study. Results
36 EIM countries contacted
27 countries filled part I questionnaire (lawregulations)
17 countries filled part II questionnaire (data on OoC)
12 countries filled part III questionnaire (data on OtC)
Funding for patients Medical indications
14 with funding
9 among countries with law
5 among countries without law
13 no funding (5 with law and 8 without)
Non medical: never funded
Ovarian tissue conservation
1050 cycles reported in 2013 from 12 countries
52 grafts reported
Laws and conditions for OoC vary in Europe,
14 / 27 countries provide OoC for medical reasons with state funding.
Storage activity has increased in the last 5 years in most countries, however data on use are few apart from oocyte donation cycles.
Data collection not homogeneous to date, several countries plan to collect specific data for OoC in the near future.
Average yield of oocytes per cycle varies according to indications.
Practice / use of OtC recorded centrally only in few countries.
Needs to improve knowledge on practice and results
4) Project to compare American and European data. Where are we? Markus Kupka
Comparatia intre datele din Europa si US rezulta ca media US este mai mare decat cea Europeana. ( US 32% fata de 24.8%) este vorba de rata de nasteri pe cicluri fresh sau crioconservate fara donare .
Pentru 2010 numarul de cicluri in US 147260 Europe 550296 ; numarul de cicluri/ milionul de femei de varsta reproductiva US 2331, Europe 6258.
5) Romania ‐ voluntary Ioana Rugescu
In atasament prezentarea.
6) Portugal ‐ mandatory Carlos Calhaz‐Jorge
Portuguese registry •
IT platforms specifically designed •
Online data insertion
• Different forms for different ART techniques
• Individualized “phases” of data insertion :
1. Demographic and Cycle data •
2. Data on result of the cycle •
3. Data on final outcome of pregnancies •
4. Data on children health at the one year-old
• Time limits defined for each “phase”
How does it work?
• National competent authority built and run the platform
• ART centres insert data
• Many validations try to minimize inconsistencies of data
• Time limits defined for insertion of data, by “phase”:
• 1. Demographic and Cycle data – 31st March of following year
• 2. Data on result of the cycle - 31st May of following year
• 3. Data on final outcome of pregnancies - 31st January of following second year
• 4. Data on children health at the one year – no limit
• Automatic reminders by email in the two months prior to each deadline
7) Italy – summary data Giulia Scaravelli
Summary retrospective electronic data collection made on a web site
THE WEB SITE has different users
• ART CLINICS, which fill in data on their activity on a private area, have a constant contact with the Register staff members and receive calls for proposal for research projects, news, congresses and workshops on particular issues;
• REGIONAL LOCAL AUTHORITIES, that monitor the activities of its own units (20 different regions like Lombardia, Toscana, Sicilia, etc.);
• CITIZENS, that can see the complete list of all authorized clinics by region with the specified range of services they provide, kind of service (public or private), years of activity, contact details, etc;
• NATIONAL REGISTRY STAFF, collect data, analyze and diffuse them.
8) France – cycle by cycle Dominique Royere
French registry : cycle by cycle
Agence de la biomédecine- A french government agency
Data reception in GAIA application
National individual data registry : which benefits?
+ Dedicated quality management resources are guaranteed, including a validation audit
+ Analyses based on individual data allow a better distinction between characteristics of the patients and specificities of each centre
+ The possibility to estimate the actual CLBR for a defined period of time is quite mandatory to get a clear view of the strategies in use among the centres
+ the possibility for professionals to use national data for their own aims will incite them to improve data quality and completeness
+ specific state funding for data collection conditioned by completeness also incites participation by the professionals
9) Governmental registry or registry founded by medical professionals? Markus Kupka
Prezentare a registrului german ( a fost in detaliu la BES2016)
10) Safety issues in EIM registry Christine Wyns
Safety issues in EIM registry ART = treatment complication; OHSS prevalence; Obstetrical outcome Risk of preterm birth: 20‐27w
Need for longer follow‐up data
Need for update the data.
11) The future of EIM registry Christian De Geyter
Time has come for the installment of quality assurance through vigilance in ART
Completeness of data collection depends on the following factors:
1. Local legislation (compulsory vs. voluntary)
2. Local organisation of data registry including personal involvement
Ni s-a propus suportul ESHRE prin organizarea unui campus course pe tema colectarii datelor.
As dori feed-back-ul dumneavoastra in legatura cu aceasta idee.