Which are optimal monitoring

parameters for national IVF

registers?

Tatjana Motrenko Simic

Human Reproduction Centre Budva

Montenegro

▪ To know where you are going you have to

see where you are …

▪ Otherwise we are just geese in the fog or

like sheep without shepherd

ICMART▪ ICMART - The International Committee Monitoring Assisted

Reproductive Technologies (ICMART) is an independent, international

non-profit organization that has taken a leading role in the

development, collection and dissemination of worldwide data on

assisted reproductive technology (ART). I

▪ ICMART provide information on availability, effectiveness and safety

to health professionals, health authorities and to the public

▪ ICMART facilitating collaboration among already existing national

and regional registries and those countries willing to start programs of

their own. So far, South Africa has developed its own national registry

with the collaboration of the Latin American ART registry (REDLARA)

SART reports

▪ The Society of Assisted Reproductive Technology was founded in 1985

▪ published the first annual US IVF data report 31 years ago in 1988 in

Fertility and Sterility

▪ In 1995, the Centers for Disease Control and Prevention subsequently

began collecting data from IVF programs and published their first report in

1997.

▪ Using these data sources, 199 articles have been published by clinicians

and researchers from across the country.

▪ This research has guided the development of evidence-based assisted

reproductive technology (ART) practice guidelines during the past

30 years, which have ultimately led to improved quality and patient care.

CONCLUSION(S):

▪ Since the first SART National IVF data report publication 30 years ago,

SART has achieved its original goals of creating a national IVF registry

that successfully assesses clinical effectiveness, quality of care, and

safety.

SART role▪ The Society for Assisted Reproductive Technology (SART) was

established within a few years of assisted reproductive technology

(ART) in the United States, and has not only reported on the evolution

of infertility care, but also guided it toward improved success and

safety.

▪ Moving beyond its initial role as a registry, SART has

expanded its role to include quality assurance, data

validation, practice and advertising guidelines, research,

patient education and advocacy, and membership support.

▪ The success of ART in this country has greatly benefited from SART's

role

▪ SART continues to set the standard and lead the way.

EIM

Why we have to collect data

▪ To all stake holders:

provide surveillance of ART field

▪ Patients :

proper information regarding treatment success, availability and

options, choosing their treatment options

▪ The Medical Profession and Laboratory Professionals :

checking effectiveness of currently available techniques, provide

optimal care for patients, new methods research, testing and comparing

▪ Public Health Authorities:

providing public safety, developing health care policies and legislation, cost

benefit analysis, reimbursement policies within country allocation of resources

▪ The Public:

Informed about benefit of ART, methods, treatment possibilities, outcome,

success rate, role in infertility treatment, helping childless couples,

socio-cultural influence on population and demographic picture

Which data to collect

▪ More data – more demanding for reporting, time

consuming, increase cost for clinics and Health

Authorities, but provide better and more complex

reports

▪ Less data – easier, but insufficient reports

▪ Meaningful rational solution important

▪ Data accuracy depend of reporting system as well

as of surveillance system ( inspection and

reporting checking)

Data selection▪ Female age ( male age?)

▪ Fertilisation metod ( IVF, ICSI, IUI)

▪ Number of transfered embryos

▪ Fresh or frozen cycle

▪ Freeze all – just started?

▪ All donation ( DO, DS, ED)

▪ Frosen embryo cycle ( FER)

▪ Pregnancy outcome for all

▪ Advese event

▪ Oocyte cryopreservation (FOR)

▪ Fertility preservation results

▪ ART children – mainly CONATAR reports

▪ Cross maching of all mention regarding results and outcome

Patients point of view – data they ask for it

▪ PROM – patients reported outcome measure

▪ Involving of patients - their voice

They seeking for answers:

▪ Long term health effects: for child and women undergoing IVF

▪ Chance to get healthy chance from one cycle

▪ Time to pregnancy in certain group of patient

▪ Cost / affordability

▪ Burden of treatment

▪ Complications

It is crucial to define end points for outcome

▪ What is success (or failure) in treatment: CPR, LBR,

singleton pregnancy, MP, term delivery?

▪ To calculate per started cycle, aspiration, ET?

▪ LB: equal or above 22 wg or BW above 500 g, any sign of

life – this is troublesome

▪ WHO definition of health also troublesome

▪ We need well defined end point, like term live birth rate

▪ Long way from CPR or LBR to cumulative birth rate from

one cycle

▪ CONSORT statement: starting IVF cycle with term or LBR

▪ Focus on couple and child

DATA COLLECTION▪ Important to develop a National ART surveillance system.

▪ The system monitors ART use cycle data and outcomes

from all IVF units within a country or a region.

▪ Two basic options of collecting data:

❖ annual or periodic reports:

Each clinic in the country should prepare an annual report covering

items specified by the national registration body

❖ Direct system – cycle by cycle or on line system:

collection of data for each cycle individually from all IVF units

within a country, better solution by more demanding, one platform for all

Voluntary data collection

▪ Autonomous selection of data depending od personal

or centers interest or aim

▪ No possible to have same platform or data selection

▪ Questionable quality of registered data

▪ No obligatory participation in national register – no

complete information for one country

▪ Surveillance, quality and safety diminished

▪ Long term effect on health policy makers and

professionals

▪ Poorer control

Mandatory data collection (national register for ART)

▪ Need time to be imposed

▪ Professional platform with equal form for all stake-holders

▪ Cycle by cycle reporting most accurate

▪ Important for national evaluation of ART centers

▪ Founds requirements for implementation and maintenance

▪ Need for professionals for data processing

▪ Scientific value - validation of new techniques, improvement

of treatments

▪ Increased safety and quality, patients care

▪ Realistic data important for health policy makers, legislation

and redistributions of founds

▪ Complete cycle coverage easier inspections and regulation

▪ Long time effect on whole country

What we can see from data▪ Results (CPR, LBR, IR, abortion rate, preterm delivery, multiple

pregnancy rate, available treatments)

▪ Trends in ART (number of cycles, method of fertilization,

embryo-transfer policy, genetic testing possibilities, patients

characteristics, …)

▪ Safety and quality

▪ Pregnancy outcome

▪ Long term health effects(patients, newborns–some countries)

▪ Differences in outcome (new techniques, policy changes or in

applied IVF technology – values and results)

▪ Availability

▪ Cost /affordability

▪ Private-governmental health care position

▪ Research

Trends in MAR/ ART

Results

Results - efficacy different embryo stage ET

Results/ Trends

Cumulative delivery rate

Embryo transfer policy Europe

Trends in quality -Multiple births related to ART

Fertilization method

Trends

High utility of ICSI – countries 2015.

0

10

20

30

40

50

60

70

80

90

100

Austria Belgium Bosnia Bulgaria Cyprus France Germany Greece Hungary Italy MontenegroPoland Portugal Serbia Slovenia Spain SwitzerlandUkraine

IVF ICSI

Safety – under reporting

ART children health – long term effects

Infertility effect related to

genetic changes in gametes

ART effect on epigenetic marks

Long term follow up needed for

ART children

Subtle changes in imprinted

genes and epigenetic marks

Avalilability

Cost of treatment/affordability

Balkan region

▪ Respectable number of centers

▪ High ART activity

▪ Most of countries support financially IVF

▪ Annually remarkable founds allocated for IVF

▪ Why government don’t wish to know effect?

▪ Surveillance needed for all stake holders benefit: state,

professionals, patients.

Data collection - government ART

registry

Reporting acc.

TD/NA

Who collect data

Greece + Yes Ministry of Health

Turkey + Yes Ministry of Health

Bulgaria - Yes National Transpl. Agency

Romania - Yes Nat.Transpl. Agency

Serbia -/+ No Min.Health- reimburced cycles

N. Macedonia -/+ Yes/No Min.Health - donation cycle

Health care ins. – reimbur.cycles

Albania - No x

Montenegro - No x

BIH - No x

Croatia +/- Yes Ministry of Health-NA

Slovenia - Yes National Authority

2 / 3 / 11 6 out of 11

coverage Printing

report

Greece ART register properly formed 100% Yes

Turkey ART register – all in, noting out 100%

Bulgaria NA : No of cycles, CPR, 100%

Romania NA - EUROCET form 100%

Serbia Ministry of Health Reimbursed

cycles

?

N. Macedonia Donated cycles-Ministry of Health,

Reimbursed –Health insurance

Paid cycle - nobody

?

Albania x

Montenegro x

BIH x

Croatia ART register formed 2 years ago 50%

Slovenia NA , Ministry of Health 100%

Data

collection G

Financial

support

Validation compulsory Data submission

Greece No no yes Yearly

Turkey No no yes On 6 months

Bulgaria No no yes annually

Romania No no yes On 6 months

Serbia No no yes / no Annually

N.

Macedonia

No no yes / no Annually for donation and

reimbursed cycles

Albania No no no -

Montenegro No no yes / no -

BIH No no no -

Croatia No no yes Annualy

Slovenia No no yes Annually NA – EUTD and

Ministry of health -ART

EIM activitycoverage

Greece NA MAR-registry 100%

Turkey - -

Bulgaria EIM representative partly

Romania Ass.of embryologist 80-90% Sam validation system

Serbia EIM representative 6 out 18 IVF cent.

N. Macedonia EIM representative 5 out 9 IVF cent.

Albania EIM representative 1 out of 10

Montenegro EIM representative 4 out of 5

BIH EIM representative 1 out of 8

Croatia EIM representative 7 out of 15

Slovenia 100 % Data from Min.of Health

Summary – obstacles and pitfalls

▪ no proper ART registers in majority of countries

▪ National Authorities collect just few data ( cycle No,

CPR)related to safety – complete coverage-no proper data

▪ Or no complete coverage - but more useful data

▪ More extra job for collecting data persons

▪ Most of government do not have founds to invest in

software

▪ Majority of countries do not have capacity in Ministry to

complete work related to registers

How you can improve situation

▪ One software for Europe compatible with

existing ones – developed by ESHRE probably

▪ Copenhagen ESHRE annual meeting pre

congress course by EIM 2020– invited

representative of Ministry of Health to see what

data to collect and what knowledge we can drain

out of it

▪ Be ready to call if you need help – we are

prepare to do the job

DREAM and GOAL am end of the

road

▪ Whole Europe to have cycle by cycle mandatory registers

▪ Development of consensus among European countries for data collection on same way

▪ Complete ART cycles coverage

▪ Development of population based health registries

▪ Developing of data base for children born from ART .

Many thanks to whole group