1. Quality in Medically Assisted Reproduction
perceived by the Eastern European patient
Alina Beatris DAVID
July, 2012

2. Introduction
Six Eastern European countries have been taken into consideration for
this presentation:
Bulgaria (BG) Czech Republic (CZ) Croatia (HR)
Poland (PL) Romania (RO) Slovakia (SK)
Common features:
- Former communist countries
- The number of clinics has grown rapidly in the last years
Country No. of public clinics No. of private clinics Total no. of clinics
Bulgaria 4 26 30
Croatia 7 7 14
Czech Republic 5 34 39
Poland 4 43 47
Romania 2 21 23
Slovakia 2 7 9

3. The situation regarding legal framework
for MAR and regulation:
Country MAR legislation EUTCD Competent Accreditation Reporting to
implemented Authority compulsory a National
for licensing Registry
in place
Bulgaria Specific Yes Yes Yes Compulsory
Croatia Specific Not in EU Yes Yes Compulsory
Czech Specific Yes Yes Yes Compulsory
Republic
Poland No No (signed, not No No No
implemented yet)
Romania General health Yes Yes Yes Compulsory
law
Slovakia Only No No Yes – simple to No
recommendations get from Ministry
of Health
Source: ESHRE Comparative analysis on MAR in EU: Regulation and technologies 2009,
updated with Patients Associations info 2012

4. Quality
Dimensions of quality of care
Donabedian Department of Health (UK) Council of Europe
Maxwell (1992) IoM (2001) JCAHO (2006)
(1988) (1997) (1998)
Effectiveness X X X X X X
Efficiency X X X X X X
Access X X X X X
Safety X X X X
Equity X X (X) X
Appropriateness X X X X
Timeliness X X X
Acceptability X X
Respect
Respect Choice Pacient -
Responsiveness
Information centred-
ness
Satisfaction (X) X
Health improvement X X
Continuity X
Technical Availability
Other competence Efficacy Prevention/
Relevance early detection
Source: Assuring the quality of health care in the Euroean Union – Helena Legido-Quiley et al., 2008
Notes: IOM: Institute of Medicine; JCAHO: Joint Commission on Accreditation of healthcare Organnizations

5. Four dimensions of quality in MAR - relevant from
the patient’s perspective:
Safe
Patient
Access Patient centred
Effective

6. Safety
The most common risks:
- OHSS (ovarian hyperstimulation syndrome)
incidence rate in 2008 – 0,8% of all stimulated cycles (de Mouzon et al.,2010)
- Multiples pregnancies
20,60% twin pregnancies in Europe in 2008 (EIM data - Focus on reproduction, sept 2011)
FACT:
 In CZ the SET (single embryo transfer) is encouraged by de law
 In RO, PL - the patients are pleased when:
- more than two embryos transferred
- twin pregnancy
Causes: insufficient information regarding the risks & financial aspects/ reimbursement
 More than 50% transfers in BG and RO were of three embryos or more in 2008 (EIM data - Focus on
reproduction, sep. 2011)
 In SK – no data regarding the complication of treatments and multiple pregnancies
 In HR there were a significant number of triplets born after 2009 (according to the Croatian patient
association) due to the restrictive law (maximum 3 oocytes to be fertilized)

7. Effectiveness
Success rate (pregnancy rate, delivery rate etc.) = important aspect for the
patient
FACTS
 BG, CZ, HR, RO – the MAR statistics become public after > 1 year
 PL, SK – without compulsory National Registry to report the results
- Lack of transparency Affect the patient’s
decision regarding the
choice of the fertility clinic
- Types of results with no explanation or details

8. Patient Centred Infertility Care
“Patient centeredness of fertility care and patient well being are related. Patients with a
better QoL or lower levels of anxiety and depression report higher levels of patient
centred fertility care.” (Aarts et al., 2011)
competence of clinics attitude of and the
The concept includes 10 dimensions and staff, coordination relationship with staff,
divided in system factors and human and integration, communication,
accessibility, continuity patient involvement
factors (Dancet et al., 2011) and transition, and privacy, emotional
physical comfort support
 Communication between patients and clinics - vary greatly both from country to country
and from clinic to clinic
The patients in SK:
- insufficiently informed about the possibilities they have regarding frozen embryos
- they want a lead doctor during the treatment
(According to a study made by the patient association from SK in 2008 – 2010)

9. Counseling & Support
 Counseling
Country Counseling
BG National program of social and psychological adaptation
to couples with reproductive problems (2008 – 2011)
CZ Available, no payment required for counseling during
the treatment
HR Compulsory before treatment
PL Some clinics recommend it, most patients do not seek it
RO Some clinics recommend it, other clinics have it as a
compulsory requirement
SK Some clinics recommend it, most patients do not seek it
 Support
• The level and type of support offers by the clinics varies widely
• The support given by the clinic staff is not given as a result of training
• In RO and BG the patient associations organize support groups for the patients, under the
coordination of psychologists

10. Patient associations campaigns
• BG - “To donate life” - awareness campaign to encourage eggs and sperm donation
- “Stay in the loop” – prevention and information campaign for teenagers
• CZ - ”On non-genetic parenthood in another way” - education campaign
- “How old would you like your parents to be?” – study
• HR - Awareness infertility walk
• PL - “Daddy – the most important word for every man” - awareness on male
infertility
- “Telling and talking” - issues on gamete and embryo donation
• RO - “Infertility is a medical condition. Having a child should not be a luxury” -
awareness and advocacy campaign
- “Infertility exists. And it hurts.” – sensibilization campaign
• SK - “Fertility tour” – each year, information and awareness concerning infertility
and reproductive health

11. Access
European Parliament “calls on the Member States, therefore, to ensure the rights of couples
to universal access to infertility treatment”
(European Parliament Resolution on the demographic future of Europe, 2008)
• Criteria for access to MAR treatment
differ from country to country
• Type of treatments allowed
Country No. of cycles IUI No. of cycles IVF/ICSI
r
e BG - 3
A i
c m CZ 6 4 if the first 2 are with SET
c b or 3 without SET
e u HR No limitation 6
s r
s s PL - -
e
t m RO - Since 2011 – 1 IVF cycle for
o e a limited no. of couples
n
SK - 0 to 3 (depends on the type
t of health insurance)
Source: “Equality of Access to MAR across Europe”, 2012 - Fertility Europe

12. Cross Border Reproductive Care (CBRC) - a consequence of the access limitation to MAR
Other reasons for travelling (Pennings et al., 2008a; Shenfield et al., 2010)
- better quality of care
- cheaper treatment
CZ and SK
as favorite
destinations
CZ Donation of
gamete allowed
Many donors
SK Lack of regulation
Treatments less
expensive
15% of the Possible to have
oocytes donations similar
in Europe percentage – no
reports and
(EIM data) studies to confirm

13. Conclusions
 There is a huge gap regarding regulation in many of these countries
 Patient and professional associations must advocate together for regulation in
this area and convince the policy makers that a legal framework which will
allow high quality MAR treatments is necessary
 Future studies need to be done by adapting instruments that have been
successfully tested in some Western European countries (e.g. Patient -
centredness questionnaire infertility – van Empel et al. 2010)
Patient associations could get involved!
Challenges:
 Resource management (including funds)
 Language & cross-cultural barriers
 The availability and willingness of MAR treatments providers and beneficiaries

14. Acknowledgements
Iskam bebe (I want a baby Foundation) – BULGARIA www.iskambebe.bg
Sdruzhenie Zachatie (Association Conception) - BULGARIA www.zachatie.org/
ADAM (Association Conception) - CZECH REPUBLIC http://www.adamcr.cz/
Nasz Bocian (Our Stork) - POLAND http://www.nasz-bocian.pl/
RODA (Stork) – CROATIA www.roda.hr
SOS Infertilitatea (SOS Infertility) – ROMANIA www.infertilitate.com
Občianske združenie BOCIAN (Civil Association Stork) - SLOVAK REPUBLIC
http://www.bocianoviny.sk/
Fertility Europe - the umbrella organization of 22 patient associations, with a potential of
25 million people who have difficulties in conceiving across the European Union.
http://fertilityeurope.eu/

15. Thank you!