Robert Edwards, the founder of ESHRE and pioneer of IVF, has been awarded the Nobel Prize for Medicine. This prestigious honor recognizes Edwards' lifelong work developing IVF and bringing the first "test tube baby", Louise Brown, to birth in 1978. As the joint founder of ESHRE, Edwards has had a distinguished career advancing reproductive medicine and was instrumental in the founding and growth of ESHRE into a leading society in the field. The Nobel Prize is a much deserved recognition of Edwards' pioneering contributions to reproductive medicine and infertility treatment.
1. Focus on
REPRODUCTION
European Society of Human Reproduction and Embryology // JANUARY 2011 //
Robert Edwards honoured
as Nobel prize winner
l ESHRE news
l Fertility preservation in women
l Charting the progress of IVF in Germany
2.
3. EXECUTIVE COMMITTEE
Chairman
Focus on
Luca Gianaroli (IT)
Chairman Elect
Anna Veiga (ES)
Members
REPRODUCTION
Ursula Eichenlaub-Ritter (DE)
Jean-François Guerin (FR) l Chairman’s introduction
Timur Gürgan (TR)
Antonis Makrigiannakis (GR)
Carlos Plancha (PT) This new year issue of Focus on Reproduction reflects a
Françoise Shenfield (GB) rich vein of events related to ESHRE and assisted
Miodrag Stojkovic (RS) reproduction but none more so than the award to Robert
Anne-Maria Suikkari (FI)
Edwards, the founder of our Society, of the Nobel prize
Etienne Van den Abbeel (BE)
Heidi Van Ranst (BE) ‘for the development of in vitro fertilization’. This
Veljko Vlaisavljevic (SL) prestigious and long-deserved honour, awarded to the man
Ex-officio members who inspired our work, takes on even greater significance
Joep Geraedts (Past Chairman) as a mark of recognition for reproductive medicine among
Søren Ziebe (SIG Sub- the leading disciplines of medicine.
committee)
ESHRE’s scientific activities, the core of the Society, have
FOCUS ON REPRODUCTION now maintained their high standards over many years, and
EDITORIAL COMMITTEE it was richly deserved that the European IVF Monitoring consortium celebrated its
Paul Devroey tenth anniversary with a commemorative meeting last September in Munich. We
Bruno Van den Eede also took part with the ASRM in the third consensus workshop on PCOS, this
Hans Evers time on its non-fertility health implications. The report from the first consensus -
Joep Geraedts on the diagnosis of PCOS - has become a citation classic.
Luca Gianaroli From a social perspective, the European legislative framework for ART is
Hanna Hanssen
Anna Veiga
presently going through something of a turmoil. Legislations in several countries
Søren Ziebe (Germany and Malta, for example) are being exposed to the legal test following
Simon Brown (Editor) judgements from different national and international courts. I am proud to report
that in most of these cases ESHRE has been chosen as an authoritative and
Focus on Reproduction
is published by privileged interlocutor by the governments dealing with them.
The European Society of Human Particularly significant in this same context was the participation of ESHRE in
Reproduction and Embryology the European Health Forum held in Gastein, Austria, in October. This meeting was
Meerstraat 60
Grimbergen, Belgium a unique opportunity to present our view of the current problems in reproductive
info@eshre.eu health to an audience of healthcare managers and European policymakers. It seems
www.eshre.eu likely that 2011 will see many changes as far as these issues are concerned, which
All rights reserved.
hopefully will prompt greater harmonisation in European legislation, a goal that
The opinions expressed in this ESHRE has always pursued.
magazine are those of the Several opportunities are now opening up for ESHRE outside its traditional
authors and/or persons interviewed
and do not necessarily reflect the
fields of interest. A collaboration between our Task Force on Management of
views of ESHRE. Fertility Units and a leading insurance group is behind a workshop planned for
Venice in February. This will be the first time that professionals in the fields of
JANUARY 2011 ART and insurance have collaborated in such a way, but, as the Task Force reports
Cover picture: Nobelprize.org in this issue, there are clear areas in the management of fertility centres where we
can improve, both for the sake of ourselves the professionals and our patients.
Luca Gianaroli
ESHRE Chairman 2009-2011
CONTENTS NEWS FEATURES
4 Rome 2010 reviewed 32 Fertility preservation in women
6 Robert Edwards Nobel laureate Richard Anderson and Claus
Yding Andersen review progress
10 New data system for PGD Consortium so far and the realistic options
11 ESHRE’s foray into social media before cancer treatment
12 From Fertility Europe 35 One million cycles recorded
Markus Kupka on the
14 Ten year review from the EIM
story of IVF in Germany
Consortium and how its voluntary
17 Third consensus meeting on PCOS registry has recorded
every cycle
18 European Health Forum Gastein
20 From the Special Interest Groups
27 From the Task Forces
Focus on Reproduction January 2011 3
4. ANNUAL MEETINGS 2010, 2011
Rome retrospective
Survey reveals high scientific content scores but
some dissatisfaction with logistical arrangements
A face-to-face survey of 500 participants during last year’s
annual meeting in Rome found an enthusiastic response to Deadline for Stockholm abstract
scientific content, but a higher-than-usual level of
dissatisfaction about the congress venue and transportation
submission is 1st February
arrangements. As a result, ESHRE’s Executive Committee Full details of ESHRE’s abstract submission policy are
has determined to address these problems specifically and on the ESHRE website (www.eshre.eu), but please
ensure they are not encountered again. note:
The survey was the fourth to be conducted by ESHRE, l All abstracts must arrive at ESHRE’s Central Office
following similar exercises in Lyon (2007), Barcelona no later than 23.59 CET on 1st February 2011.
(2008) and Amsterdam (2009). Last year’s questionnaire l Abstracts should be submitted in English only.
l Any investigator submitting an abstract can only be
covered both organisational and scientific content.
the first author for one abstract.
As ever, scientific quality - in both the precongress
l The material presented should be unpublished and
courses and main programme - proved highly rated; on a original material, which has not yet been presented in
scale of 1 (minimum rating) to 5 (maximum), scientific any other meeting.
content in the invited lectures and oral communication l All abstracts will be refereed ‘blind’.
sessions scored 3.9 and 3.7 respectively, ratings consistent l Authors are requested to indicate their preference
with those of previous years. Most respondents (75%) for oral and/or poster presentation on the abstract
thought the balance of science and clinical medicine ‘just submission form. The decisions of the selection
right’, and most (71%) actually took time to view the committee are final.
paper posters (a big increase on 2009). It was thus not
surprising to find that 51% preferred paper posters, though
22% gave a preference for both paper and electronic which was based on a ten-minute questionnaire interview
presentation. This was a big advance in response to poster in Rome, are inevitably the growing pains of a congress
viewing opportunities. whose size and shape are so rapidly increasing. ESHRE’s
Local chairman Filippo Ubaldi also notes a very Executive Committee now has to plan for a capacity of at
favourable response to the congress’s social programme set least 10,000 delegates, and that necessarily limits choice.
against the backdrop of one of the world’s most attractive Complaints of those interviewed in Rome were
cities. The congress party at the spectacular Villa Miani, concentrated on three organisational aspects: the congress
before a panorama of St Peter’s and Rome below, proved a centre itself; transportation; and catering. Many
popular and much enjoyed event. respondents were unhappy with the congress venue; the
Many of the logistical problems exposed by the survey, congress centre rated a mean satisfaction score of only 3.
This rating compared unfavourably with previous venues in
Amsterdam (mean rating 3.8) and Barcelona (mean rating
4.3). Venue selection is clearly essential to the success of
any annual meeting, and, says the Executive Committee,
must be given the highest priority in future.
Venue selection - and its location - was also at the heart
of transportation complaints, which were mainly a lack of
ESHRE CHAIRMAN LUCA buses during off-peak hours. Despite the shuttle service,
there were many who complained that access to and from
GIANAROLI: ‘THE
the congress centre was difficult (and expensive by taxi)
SURVEY HAS EXPOSED outside the shuttle time-table, which, says Ubaldi, was
PROBLEMS AND WE concentrated on morning and evening peak times. The local
MUST LOOK AT THEM.’ organisers and ESHRE’s agents in Rome did their best with
4 Focus on Reproduction January 2011
5. Scientific content in
all parameters
measured scored
highly among the
survey respondents.
the shuttle services within a reasonable budget, but clearly
ease of travel - preferably by public transport - is a
priority for future consideration.
Catering in Rome also scored poorly, with a mean
satisfaction score of just 2.4. Complaints were mainly
focused on lunch queues on the opening Monday, when
catering services proved inadequate for such numbers.
Food quality was always high, however, and the logistics
of service had improved dramatically by Tuesday.
‘We were not happy with some of these findings,’ said
ESHRE’s Chairman Luca Gianaroli, ‘and it’s clear that
many participants were disappointed in some of the
organisational arrangements. The survey has exposed
problems and we must look at them. I want to reassure
our members that we will do our best - even at the earliest
stage of venue selection - to ensure we don’t have such A big advance in numbers viewing both paper and electronic posters.
complaints again.’
Gianaroli was also confident that many of the logistical
problems reported in Rome will not be encountered this
year in Stockholm. The venue, Stockholmsmässan, is
familiar with large medical congresses and importantly is
just nine minutes away by commuter train from
Stockholm Central Station. Trains are frequent and
efficient, and the congress station is just a two-minute
walk from the congress centre. The EC and local
organisers will also be paying particular attention to
catering and meeting-room logistics.
The invited scientific programme and precongress
courses for Stockholm are already in place, and deadline
for the submission of abstracts is 1st February. All
abstracts will be scored (blind and weighted) by the
Scientific Committee. Last year’s event prompted an
unprecedented number of abstract submissions, and,
despite the shortcomings of Rome, a similar response is
expected this year. Almost 70% of those questioned in The congress party, set against the panorama of St Peter’s and Rome,
Rome said they expected to be in Stockholm in 2011.q proved a popular and much enjoyed event.
Focus on Reproduction January 2011 5
6. COVER STORY
Bourn Hall days:
left, Bob in 2008 at a
celebration of 30 years of IVF;
below, Lesley Brown with
Louise in 1978, and in 2008
at Bourn Hall with Louise and
her own baby.
Robert Edwards,
joint founder of
ESHRE, honoured
as Nobel laureate
am sure that every member of ESHRE was delighted to hear the
Klaus Diedrich, Chairman
of ESHRE from 1993 to I news that Robert Edwards had been awarded the Nobel Prize for
Medicine. Bob, who was born in 1925, has had to wait many years
for this richly deserved appreciation of his lifelong and pioneering
1995 and a member of work. The award is also a tribute to the whole sector of reproductive
the Society’s original medicine.
Bob’s original work was in physiology at the University of
temporary committee, Cambridge. As early as the 1950s he was studying the physiology of the
congratulates Bob oocyte and the control of maturation, and by the 1960s had achieved
the in vitro fertilisation of an oocyte in an animal experiment.
Edwards on this much It was in the late 1960s that Bob, who by now was Head of the
deserved honour and Department of Physiology in Cambridge, met the gynaecologist Patrick
Steptoe. The latter was head of department in Oldham, UK, and one of
recalls his distinguished the pioneers of laparoscopy. Before then the retrieval of oocytes was
place in ESHRE’s history. performed via laparotomy - unthinkable to Edwards and Steptoe even
at that time. They thus developed a concept for detecting the time of
optimal oocyte maturation for the retrieval of oocytes by laparoscopy.
And, as might be expected with Bob’s experience in animal models, it
Pictures: did not take long before the first in vitro fertilisation was achieved.
Robert G. Edwards - Photo Gallery. Nobelprize.org
Embryo survival, however, proved a challenge, as did the
ESHRE archives
Klaus Diedrich encouragement of his peers and financial support. But Bob and Patrick
6 Focus on Reproduction January 2011
7. ESHRE days:
never gave up, and in 2008 Bob recalled: ‘I in Lübeck in 1983. top, welcoming Patrick
Steptoe to ESHRE’s first
will never forget the day when I first saw a The third World Congress of IVF was held annual meeting in Bonn,
human blastotocyst under my microscope. It in Helsinki in 1984 and it was here that Bob 1985, with joint founder
was wonderful.’ This happened in 1972, but it and the French gynaecologist Jean Cohen set Jean Cohen and local
would take six more years before the first IVF about the creation of a European society in congress chairman Klaus
Diedrich;
baby, Louise Brown, was born. That world- reproductive medicine, which would very soon above left, in 2004 with
famous team of Edwards and Steptoe become ESHRE. From then on ESHRE ESHRE’s chairmen thus far
continued to work together until Steptoe’s congresses were held every year, and even the (l to r), Pier Giorgio
death in 1988. first, which I organised in Bonn in 1985, Crosignani, Basil Tarlatzis,
Jose Egozcue, Lynn Fraser,
* * * * began with 650 participants. Even so, it was Klaus Diedrich, Jean Cohen,
I first met Bob in 1978 at a reproduction still possible for Bob and Jean Cohen to greet Bob Edwards, André Van
meeting in Japan. At the time societies in everyone personally at the door. Steirteghem, (seated) Arne
reproductive medicine were springing up all Edwards was the founder and for many Sunde, Hans Evers;
above right, accepting
over Europe, and the foundation of our own years the editor of ESHRE’s journals Human honorary membership of
society in Germany took place with the close Reproduction, Human Reproduction Update ESHRE in Thessaloniki
collaboration of our colleagues in Britain. We and Molecular Human Reproduction. These 1993.
had three centres performing IVF: in Erlangen remain among the leading international titles
under the lead of Siegfried Trotnow, Lübeck in O&G and reproductive biology. Bob also
under Dieter Krebs, and Kiel under Lieselotte founded Reproductive Biomedicine Online in
Mettler. Germany’s first IVF baby was born in 2000, following his resignation from the
Erlangen in 1982 (see page 35) and a second editorship of Human Reproduction. It was a
Focus on Reproduction January 2011 7
8. Bob makes the front cover of a 1993
Focus on Reproduction alongside
ESHRE’s next four chairmen: Van
Steirteghem, Cohen, Crosignani and
Diedrich; right, with a note to Klaus
Diedrich after the first ESHRE congress
in Bonn, 1985.
move typical of his
character, always
searching for new
things to discover,
realising new
visions. Indeed, in
reproduction he
was the first to
cryopreserve surplus embryos and perform time with him, and I am proud to say that Bob was
preimplantation diagnosis on animal embryos, awarded honorary membership of the German
confident that both techniques would be developed Society of Obstetrics and Gynecology when Dieter
for human application. Remarkably, he had Krebs led the society’s congress in Berlin in 1992.
experimented with in vitro maturation and The Nobel prize is a fitting tribute to the influence
fertilisation in animal models as early as 1965. that Bob’s work has had on infertility throughout
Bob and I organised many conferences and the world and for so many years. The members of
workshops together, and he was the scientific father ESHRE congratulate Bob and send him their kindest
of many German endocrinologists - as well as the regards.
driver of infertility treatment in Europe. It was Klaus Diedrich
always a special and inspiring experience to spend University of Lübeck, Germany
Ruth Edwards accepts the prize on his behalf
Too unwell to be in Stockholm for the Nobel prize ceremony in December, Bob was represented by his wife Ruth
(who as Ruth Fowler had collaborated with him on several papers on the induction of ovulation in mice in the 1950s).
His absence meant that the traditional lecture given by each Nobel laureate was replaced by a
symposium in Bobʼs honour. The principal speaker was one of Bobʼs former students in
Cambridge, Professor Martin Johnson, who in a detailed and finely illustrated lecture
described the many years of research which lay behind the triumph of Louise Brownʼs birth.
Professor Johnson closed his lecture with two moving film clips of Bob describing his first
association with Patrick Steptoe and
forecasting that ʻnext yearʼ (this was shortly
after the opening of Bourn Hall in 1981) ʻ1500
IVF babies would be born worldwideʼ. Two
follow-up lectures - on the development of IVF
and its future directions - were given by Lars
Hamberger, whose group achieved Swedenʼs
first IVF success in 1982, and Outi Hovatta of
the Karolinska Institute. The Nobel Prize in
Physiology or Medicine is awarded by the
Nobel Assembly at the Karolinska Institute.
Martin Johnson delivers the symposium’s first
lecture, with Ruth Edwards (inset) also present.
8 Focus on Reproduction January 2011
9. Six handshakes of separation between the
‘Bob picture’ and the rest of the world
Former ESHRE Chairman
Hans Evers with his own
tribute to Bob Edwards
Did you ever shake hands with Barack Obama?
Does Lady Gaga recognise your e-mail address? Do
you know a Nobel laureate on a first-name basis?
According to the ‘small world’ hypothesis proposed
by Stanley Milgram, each of us is no more than six
handshakes away from every other human being on
this planet. In 1967 Milgram developed an
experiment to test his hypothesis that members of
a large social network, in this case the entire
population of the USA, would be connected
through a relatively short chain of in-between
contacts. He sent a message to 400 randomly
selected people in Wichita, Kansas, and Omaha,
Nebraska, (the starting points) and invited them to
forward it to a colleague or friend whom they
thought more likely to know a given target person
in Boston, Massachusetts (the endpoint), whose
name was completely unfamiliar to them. The
reason for selecting Wichita and Omaha at one end
and Boston at the other was that according to
Milgram they represented as long a geographical
and social distance in the USA as possible.
His experiment turned out to confirm the theory; Two ‘Bob pictures’ from ESHRE’s first annual meeting in 1985. Bob
greets two future chairmen of ESHRE (the first who insists on remaining
it took on average six persons to reach the hitherto
anonymous, and the second whom we cannot even identify).
unknown target person - a phenomenon
which later became known as the ‘six On hand was a photographer to owner of a ‘Bob picture’ . . . jackpot!
degrees of separation’. The most record the moment, and we all still The Nobel prize has been awarded
successful chains were composed of treasure our ‘Bob picture’ from that to Bob Edwards. Finally! The Swedes
professional rather than social links. occasion - as the many resurrected are a brave and independent bunch.
Social networks are usually more photos suggest. Against all odds (ie, the Vatican) they
closely knit, all members know all And Bob was our introduction to honoured Bob, and they honoured
other members and the community of the world at large. He went on to win Alfred Nobel, who died childless and
friends does not usually extend far the Lasker award, the King Faisal thus had to find a destination for his
beyond its original nucleus. award, and the Nobel prize. After accrued capital. What would be more
Professional networks are less shaking hands with us (handshake 1) appropriate than a Nobel prize for
compact but they reach farther. in Bad Godesberg he received the fighting childlessness? And what
ESHRE is a global network of King Faisal award from the hands of would be more appropriate for
professional links. At its first annual the late King Fahad of Saudi Arabia ESHRE than to have its annual
meeting, in Bonn in 1985, its (handshake 2), who later shook meeting in Stockholm this year?
founding father, the 2010 Nobel hands with George Bush senior And finally, what would be more
laureate Professor Robert G. (handshake 3), the father of George appropriate than for our present
Edwards, personally welcomed every W. (handshake/spanking 4), who chairman, Luca Gianaroli, to
individual participant (all 650 of shook hands with Barack Obama personally greet all participants in
them!) at the entrance to the opening (handshake 5) at the latter's Stockholm, the city where Alfred
reception in the 'Redoute' in Bad inauguration. So, if next time we Nobel was born, with a welcoming
Godesberg. meet you shake hands with the proud handshake?q
10. // PGD CONSORTIUM //
An update from the working groups
Gary Harton took over from Joyce Harper as Chair of
the Steering Committee in June during last year's Steering committee members
annual meeting in Rome. Shortly after, a ballot was The current Steering Committee comprises:
held to ratify the revised Statutes governing the Gary Harton (US, Chair)
running of the Consortium. With the Statutes ratified, Joanne Traeger-Synodinos (GR, Deputy Chair)
a vote was held to re-elect current members of the Joyce Harper (GB, Past Chair)
Steering Committee and elect two new members to Céline Moutou (FR), Katerina Vesela (CZ),
begin their term of office immediately. Sioban Sengupta (GB), Georgia Kokkali (GR),
Another round of data collection and analysis is Leeanda Wilton (AU), Martine De Rycke (BE),
well under way and will be published sometime this Tugce Pehlivan (TR), Pamela Renwick (GB),
year. Our Working Group on Guidelines recently Edith Coonen (NL), Francesco Fiorentino (IT)
published a set of four documents as a Best Practice
Guideline for PGD and PGS. The documents cover clinical PGD analysis and embryo follow-up results, and
Organization of a PGD Center, Polar Body and Embryo give a more complete evaluation of the potential rate of
Biopsy as it relates to PGD, Amplification-based PGD misdiagnosis. Additionally, it should identify likely
and FISH-based PGD and PGS. The guidelines were reasons of discordance (which could include protocol-
published online by Human Reproduction in October. related parameters, embryo quality, embryo biology)
We have now formed a new working group to highlighting important criteria for optimising clinical
consider array-based testing in PGD, which includes PGD results. Data analysis is on-going for both studies,
members of the Consortium as well as non-members with completion aimed for Spring 2011 and results
interested in array-based technology in single cell and published as multicentre studies.
embryo testing. The Array Working Group will be l The Database working group has updated the
chaired by Dagan Wells and Leeanda Wilton and will FileMaker Pro database (see box below); the main
hold its first meeting in London in March. modification is the use of OMIM numbers for
l The Diagnosis Monitoring and Audit group has indications. In addition, the group has contacted
progressed with two follow-up studies for the Patrick Haentjens for statistical analysis of the large
reanalysis of untransferred and supernumerary amount of data collected since 1997. We are merging
embryos. One study is for PCR-based PGD cycles (co- all databases to allow this analysis.The aim of the
coordinated by Joanne Traeger-Synodinos, with Jos analysis is to assess reproductive outcome of PGD, and
Dreesen as deputy) and the other for FISH-based PGD to evaluate the evolution of this activity with success
cycles (co-coordinated by Tugce Pehlivan, with Edith rates in relation to various confounding factors. The
Coonen and Gary Harton as deputies). Data analysis group is also working on new ways to collect and assess
should identify the rate of discordance between data on frozen embryo cycles, including from groupsa
The new method of data collection will be launched The data can be entered in real time so that an
later this year. Submission of data via the current accurate and up-to-date record can be logged for
FileMaker Pro system has been problematic and each PGD cycle. There will be an option to enter
time-consuming, both for centres entering data and referral data for tracking patient history and the
the Consortium steering committee trying to analyse database will incorporate options for embryo freezing
it. The new on-line system will be an intelligent and at any stage of the process.
easy-to-use method of entering, storing, analysing This is an exciting new venture from which we are
and submitting PGD data. This new system will now sure many PGD centres will benefit. All Consortium
allow PGD centres to easily analyse their own data. members should wait for the e-mail announcing how
Once data is entered, it will be simple to produce to register your centre. Anyone who is not already a
tables which include your key quality indicators (or member and wishes to join the Consortium, please
key performance indicators), such as number of eggs visit the PGD Consortium web page at
collected, number of embryos biopsied, and http://www.eshre.eu/ESHRE/English/Specialty-
efficiency of the biopsy, diagnosis, pregnancy rates, Groups/SIG/Reproductive-Genetics/PGD-Consortium
delivery rates, and so on. Joyce Harper
10 Focus on Reproduction January 2011
11. NEWS
// COMMUNICATIONS //
ESHRE tweets to a new
community of friends
and fans in the online
world of social media
It’s now more than a year since ESHRE began its foray
into the social media of Facebook, Twitter and YouTube,
and first results - as expected - reflect a relatively high and
growing level of involvement. We now have more than
1300 Facebook fans, with the majority of users apparently
aged between 25 and 34, and female. Facebook posts have
been used for press releases, workshop announcements,
ESHRE statements and ESHRE news. A click on the
Facebook icon on the ESHRE website will take visitors
straight to their Facebook page and links to all ESHRE
postings (which so far total almost 50).
Similarly, a click on the Twitter icon will take visitors to
Twitter where they can follow ESHRE from their own
account, or open a new account. Twitter now lists more
than 180 ESHRE followers - with instant reaction and
inter-reaction to ESHRE’s own tweets - which include
patient groups, exhibitors, clinics, journalists and
Top, clips from a selection of ESHRE videos can be found on YouTube;
government bodies. ESHRE itself follows 25 tweeters, such
below, the age range of ESHRE’s 1300 Facebook fans.
as the BMJ, NatureHealth, New Scientist, and Bionews.
Other sites - like Flickr or YouTube - have also been used
by ESHRE to make audio and visual material available, incorporated into one platform for those subscribing to
particularly from last year’s annual meeting in Rome. ESHRE’s RSS feed.
Currently, around ten names are signing up each week to A copy of ESHRE’s guidelines on the use of social media
any of the ESHRE social networks, and all of them can be can be found on the ESHRE website (under ‘ESHRE
community’). The guidelines make clear that these new
networking technologies are to encourage open dialogue
and exchange of ideas.
using embryo freezing or vitrification in all IVF cycles. l The main focus of the Molecular Methods group has
l The Accreditation working group continues to spread been the primer database, which is available to full
the word about improvements in the laboratory Consortium members only. The main aim of the
following accreditation and continues to perform a database is to share molecular PGD protocols among
yearly survey of the status of accredited centres for full Consortium members. It is hoped that the
presentation at the ESHRE annual meeting. The database will benefit PGD groups and allow them to
number of centres accredited to ISO 15189 or other save time for optimisation, reduce cost, improve
local standards is growing, although at a very slow standardisation, find consensus on specific protocols,
pace. It is hoped that an increase will be seen during and be used as a reference. PGD Consortium members
this year, as several centres are just in the process of are invited to submit their protocols in order to
accreditation. A Campus workshop on Quality populate the database. Any suggestion to Francesco at
Management Towards the Accreditation Process is fiorentino@laboratoriogenoma.it .
being planned for Athens in the autumn and will be Gary Harton
organised in co-operation with Eurogentest. Chair, PGD Consortium
Focus on Reproduction January 2011 11
12. ‘Special Families’ project
looks for postcards telling
many thousands of stories
Fertility Europe’s mission is to bring fertility organisations The idea behind the project is that people send ‘messages
together with opportunities for networking and sharing of hope’ - in pictures and words - as an explanation of
best practice and information. Well, we certainly did that why a family which had met problems in having a child
at our annual meeting in Rome last year. We welcomed 31 now sees itself as ‘special’ in achieving its dreams. The
participants representing 19 organisations from 17 pictures and stories, in the native language, are then made
countries. into postcards.
We unanimously voted in nine organisations as Effective Some of the stories sent in for the pilot were very
Members; these were ‘Iskam bebe’ of Bulgaria, ‘Sdruzhenie powerful and show enormous courage and determination -
Zachatie’ of Bulgaria, ‘Association Maia’ of France, as well as the multitude of ways for becoming a special
‘Kiveli’ of Greece, ‘Országos Lombikbébi Támogató family. The project has several aims: to raise awareness of
Alapitvány’ of Hungary, ‘Nasz Bocian’ of Poland, fertility problems and their impact on those affected; to
‘Associacão Portuguesa de Fertilidade’ of Portugal, ‘SOS show how successful treatment can be and the joy it brings
Infertilitatea’ of Romania, and ‘Barnlängtan’ (formerly to people; and to raise awareness of how you can protect
IRIS) of Sweden. your fertility. Our aim is for hundreds of thousands of
We were delighted to postcards to be presented in Stockholm later this year.
welcome Anna Veiga,
Chairman Elect of
ESHRE, to the Template postcard
meeting. Anna spoke for the Special
on ‘The latest Families project.
challenges in ART’, Fertility Europe
which again generated hopes to receive
much discussion and many thousands of
many questions. We postcards
would like to thank Anna for taking time out reflecting the
Anna Veiga,
impact which the
Chairman Elect of from what I know was a busy schedule for her in
treatment of
ESHRE and seen Rome.
infertility can
here with sample We also agreed in Rome to form a sub-group
have on families.
cards from the for developing Fertility Europe policy statements,
Special Families which includes Sweden, France, Belgium, Czech
project, spoke at
Republic and the UK. The first two policy
Fertility Europe’s
statements will be on reimbursement for fertility
annual meeting
about the treatment and single embryo transfer; the drafts
challenges now will be discussed and hopefully ratified by
facing ART. members in Stockholm. We do recognise that
Fertility Europe is not there to force any one
view on members; however, we hope that this
initial work will form a template for future policy
statements on, for example, surrogacy and donor
anonymity.
Special Families project
One of our most visible activities is the Special
Families project, which was successfully piloted So what are our other plans for 2011?
ahead of last year’s annual meeting. At the time of l We will consolidate the results achieved in 2010 from
writing, we are waiting news of sponsorship but are very enlarging our network of associations as a ‘reliable voice’
confident that the project will continue successfully. at the lobby level. a
12 Focus on Reproduction January 2011
13. NEWS
// LEGISLATION IN EUROPE //
Despite protests, Danish Austria granted right to
government abandons its appeal after European court
policy of state-funded ART finds ART law ‘discriminatory’
Denmark has formally abandoned its policy of fully state- In April last year the European Court of Human Rights
funded ART after the Danish government, supported by in Strasbourg upheld the complaint of two Austrian
the Dansk Folkeparti, approved new legislation in mid- couples that Austria’s legal ban on (heterogeneous)
December introducing patient co-payment for ART. oocyte and sperm donation was discriminatory and in
The move, which became operative on 1st January, was violation of the couples’ rights under article 14 of the
strongly opposed by professional organisations in European Convention on Human Rights on ‘prohibition
Denmark, including the Danish Fertility Society, which of discrimination’, and article 8 on their ‘right to
unanimously but unsuccessfully advised against the respect for family life’.
introduction of patient co-payment. Now, in November, a five-judge panel of the Court has
Denmark’s former system allowed free-of-charge fertility granted Austria the right to appeal the ruling before the
treatment in public clinics up to a maximum a three Court’s Grand Chamber.
completed ART cycles for childless couples. Those who The original case involved two couples seeking
did conceive a first child in a public centre were referred treatment for infertility, one of whom required IVF with
to a private clinic for subsequent treatments; however, all donor sperm and the other male and female gamete
medication costs were reimbursed for all patients, whether donation.
for public or private treatments. In its April judgement the Court said that the ‘wish
Now, all patients having fertility treatment must pay for for a child’ is protected by the European Convention,
their medication (up to a maximum of DKK 15,000 and that its fulfilment through ART should not be
[~2000 euro] per year). In addition, in the public clinics a prevented by ‘unjustified discriminations’. ‘Moral
fee of DKK 5000 (~670 euro) is now charged for a fresh considerations’, the Court added, or concerns about
cycle of IVF or ICSI, DKK 3000 (~400 euro) for a frozen social acceptability, ‘are not in themselves sufficient
cycle, and DKK 1271 (~170 euro) for a cycle of IUI. reasons for a complete ban on a specific artificial
Patients are also charged for any donor sperm used. The procreation technique such as ova donation’.
new regulations thus cover all types of treatments -except The April decision created a storm among pro-life
(possibly) PDG, which may be free of charge. organsiations, one warning that ‘If this decision is
Rates of access to ART in Denmark have consistently upheld by the Grand Chamber, the flood gates will open
been among the highest in Europe, with registries for the recognition of a protected right for same sex
recording ART birth rates as high as 8-10% of all babies couples to access artificial procreation with egg or
born. Now, says Søren Ziebe, IVF laboratory director at sperm donors exactly like a couple composed of a man
the Rigshospitalet fertility clinic in Copenhagen, there are and a woman’.
fears that the uptake of IVF will decline (as happened in ESHRE itself is seeking advice whether it (and other
Germany when patient co-payment was introduced in interested groups) has the right to submit expert opinion
2004), treatments will become more aggressive, and the (‘ad adjuvandum’) to the Grand Chamber court.
opportunities for research will shrink.
l We will also continue to work closely with ESHRE and continue to collect information about ART and
in terms of communications and patient representation. national regulation and reimbursement.
l We will continue to actively reach out to increase our Do visit our website at www.fertilityeurope.eu to find
membership so that we can all share our activities with out more. And when you do, if you notice that we
more patient organisations and in turn help them in don’t have a European patient organisation listed for
their work in their own respective countries your country and you know of one, please get in touch
l We will continue to review and add content to our with us.
website, increase and diversify our income, develop our Finally, but very importantly, we thank ESHRE for
FE policy programme, agree our business and processes their continued support.
plan, begin planning for ESHRE 2011 in Stockholm Clare Lewis-Jones, Chair Fertility Europe
Focus on Reproduction January 2011 13
14. EIM CONSORTIUM
// TEN YEARS OF IVF MONITORING REPORTS //
More than 600,000 ART and IUI cycles
now monitored by ESHRE each year
High quality measurement is a prerequisite of confidence
The Campus event held in September last year to third most active ART country (behind France and
celebrate ten years of ESHRE’s European IVF Germany), can provide registry data on only 60% of
Monitoring (EIM) consortium was not just about its activity. Moreover, although amendments to
reminiscing, nor even about celebrating. This was Spain’s legislation in 2006 required the country's 17
also a meeting about the EIM’s future and how administrative regions to collect audited data on a
many of the problems faced in building a cycle-by-cycle basis, only one - Catalonia - is fully
comprehensive database of ART activity in Europe compliant. As a result, said Jose Antonio Castilla
can be resolved. from the University Hospital of Granada, the
According to the EIM’s present chairman Jacques responsibility for a registry of nationwide ART
de Mouzon, the latest round of data collection - for performance is left to the Spanish Fertility Society
2007 - gathered registry data from 32 European (SEF) and a voluntary system of summary reports
Most of the 32 countries (including Turkey) representing 88% of (clinic-by-clinic, not cycle-by-cycle) which are
countries now clinics in these countries. And, while this is more neither audited nor official. Castilla, who is co-
supplying registry than enough to provide a realistic picture of ART ordinator of the SEF registry, said that in 2008 no
data to the EIM
life in Europe, there are still major omissions. more than 60% of Spain’s ART cycles were reported
were represented at
the celebration Spain, for example, which is ranked as Europe’s to the registry - and from only 50% of its clinics.
review in Munich. Moreover, the number of centres participating in the
scheme in 2008 actually fell by 14% on the previous
year.
Spain, along with Cyprus, Greece, Switzerland
and several countries of eastern Europe, is one of 13
countries to supply only partial information to the
EIM. Nevertheless, there was strong representation
at this meeting from eastern European registries,
including presentations from Russia and Slovenia,
and most countries (with the exception of Albania,
Croatia, Romania and Slovakia, which did not
supply data in 2007) seem keen to be involved.
Indeed, Tomaz Tomazevic from the University
Clinical Center in Ljubljana, reported that the EIM’s
own data reporting system is now the formal
mandatory data collection system for the Slovenian
Ministry of Health. This official registry, he added,
is able to provide ‘optimal endpoint’ data (delivery
rate per started cycle) with real demographic impact,
for it was on the basis of the annual EIM reports
that Slovenia’s public health insurance scheme
supported the use of elective single embryo transfer
in the first two cycles of treatment by extending
coverage from four to six cycles.
Such complete systematic reporting - alongside
Slovenia’s progressive legislation on ART - is an
illustration of how comprehensive data collection
can have an effect on national (and Europe-wide)
14 Focus on Reproduction January 2011
15. of such detailed data has allowed benchmarking for
EIM data then and now national comparison of efficacy, efficiency,
1997 2007 availability and - to some extent - safety. Certainly,
Countries 18 32 with multiple pregnancy the acknowledged major
Clinics 482 1016 risk of ART, multiple pregnancy rates and trends as
Proportion ? 88% determined by the EIM have reflected ART’s safety
Complete reports 10 19 potential as well as its risks. The data, however, have
ART cycles 203,893 479,288 not allowed the monitoring of emerging safety
IUI cycles None 168,178 parameters, especially in relation to such newly
PR per ET IVF 26.1% 32.9% introduced techniques as vitrification or oocyte
PR per ET ICSI 26.4% 33.3% cryopreservation.
PR per FET 15.2% 22.5% Similarly, the long-term effects of assisted
PR egg donation 27.1% 46.3% conception remain beyond the scope of EIM data,
SET 11.5% 22.8% and even, in some countries at least, the obstetric
DET 35/7% 57.5% outcome of pregnancy. Indeed, the standardisation of
Single delivery 70.4% 78.2% all inputs to the database remains a theoretical
Twin 25.8% 20.5% objective, said Andersen, although many countries -
such as Germany and France - with newly upgraded
data systems have the ability to provide detailed cycle
demographic initiatives, and this was one of the data with linkage to delivery outcome.
EIM’s achievements singled out by its co-founder Taraneh Shojaei reported that responsibility for a
Anders Nyboe Andersen. ‘Indeed,’ said Andersen,
‘demographic impact is perhaps our finest
achievement, and trends identified by our annual
reports are now recognised outside the professional
Putting the show on the road
community.’
Not only has EIM data confirmed substantial
inequalities in access to treatments, but have also
underlined the ever increasing age of ART patients
and the link between infertility and deferred
pregnancy. Such links are now well recognised by
the EU, and the European Parliament’s 2008 report
on ‘the demographic future of Europe’ called on the
European Commission to address infertility as a
demographic issue; such urging, said Andersen,
could not be possible without the strength of the
EIM database.
The database has also identified a marked but
steady increase in pregnancy rate per transfer
ESHRE's Executive Committee had already heard one or two
throughout the past decade, which has risen from
suggestions for surveillance data collection before Karl Nygren and
26% for both IVF and ICSI in 1997 to 33% in
Anders Nyboe Andersen, pictured above, submitted a formal proposal
2007. Similar increases have been seen in pregnancy
in March 1998 for the establishment of a European IVF monitoring
rates from frozen embryo transfers (from 15% to
(EIM) committee. The two Scandinavians spoke of data 'monitoring'
22%) and in oocyte donation (from 27% to 46%).
and not data 'collection', although in their proposal collecting and
Andersen further noted that ‘without the EIM
auditing data (from national registries) were essential activities.
reports no-one would be aware of the positive
European monitoring, they said, was needed to prevent IVF activities
trends’ in the number of embryos transferred. In
in any country from 'derailing' as a result of negative publicity.
1997 more than one-third of transfers were with
The EIM consortium was formally established at the 1999 annual
three embryos, but this rate had more than halved
meeting in Tours, and attracted to its first meeting representatives
by 2007. Current data suggest that transfer trends
from 19 European countries, who each provided an overview of
are now relatively stable; two embryos were
national data collection registries.
transferred in 57% of cycles in both 2006 and
The EIM's first report - on ART activity in 1997 - was published in
2007, and one embryo in 22% of cycles.
2000, and its 11th report - on activity in 2007 - presented in Rome
However, as Jacques de Mouzon has also insisted,
prior to publication. Annual citations of EIM reports now total more
the EIM reports highlight the variability, not the
than 100.
homogeneity, of European ART, and the collection
Focus on Reproduction January 2011 15
16. registry data in France has now passed from
FIVNAT to the government’s Agence de la
Biomedecine (of which she is the evaluation
MART safety monitoring
department manager), with a legal requirement that project is now ‘making
all clinics must participate in the scheme and submit
at least summary data, and by 2012 individual cycle
real progress’
data. The system, said Shojaei, combines registry,
licensing and monitoring requirements in ART with
those of the EU’s Tissue and Cell Directives.
Similarly, the meeting’s local organiser, Markus
Kupka from Munich University Hospital, reported
that the German IVF register, whose cumulative
data collection is now approaching 1 million cycles
since its inception in 1982, allows the submission of
individual cycle data through various software
packages to a centralised linkage library.
A recent analysis performed by the German
registry (of almost a half million cycles) suggests
that prospective data input is a mark of quality and
associated with higher pregnancy rates. ‘Our
experience of prospectivity,’ said Kupka, ‘is
positive.’ The German data also show that the
number of treatment cycles is beginning to rise once
again (by around 10% per year) following Following a feasibility report in 2006 and with
restrictive changes to reimbursement policy in 2004. funding in place from ESHRE, the University
Comprehensive cycle-based systems such as those of Copenhagen and the Danish Agency of
in Germany, France or the UK provide what the Science, Technology and Innovation, work on
EIM’s other co-founder Karl Nygren called those the MART (Morbidity in ART) project began in
‘high-quality measures which are a pre-requisite for 2008 and has now assembled a provisional
building confidence in ART’, and this, he readily database of almost a 100,000 IVF children -
acknowledged, was the mission of the EIM’s 21,398 IVF children born between 1984 and
foundation more than a decade ago. The challenges, 2007 in Norway, 35,017 in Sweden, 19,065
Nygren added, remain in the definition of ‘key data’ in Finland, and 23,477 in Denmark, all
and ‘key outcomes’, but would ideally concentrate matched with around 400,000 controls.
on benefit indicators (access, efficacy, safety and The plan now, said Anna-Karina Aaris
cost) according to specific interventions. However, Henningsen, pictured above, who is co-
there still remains huge variability in definition, ordinating the project from the University
tension in the submission of cycle and/or summary Hospital in Copenhagen, is to pool the ART
data, and a reliance on extrapolation for data and cross-link with national health system
comprehensive coverage. Moreover, said Nygren, registers in the four countries. The sheer size
there are still deficiencies in reporting, with many of the cohort, said Henningesen, should reflect
pregnancies lost to follow-up and inadequate the prevalence of even rare epigenetic
coverage for full risk assessment. disorders or the effects of newly introduced
The future, added Nygren, may apply a more techniques. Similarly, the database may well
relevant and comprehensive way of reporting over time reflect the perinatal and
efficacy (pregnancies, deliveries, singletons, healthy developmental health benefits derived from the
singletons . . . ) and a more appropriate definition transfer of fewer embryos.
of intervention (started cycles, fresh and frozen, Danish data are ready, and Finnish, Swedish
cumulative . . . ), but for the moment he urged and Norwegian data almost available for
ongoing surveillance and continuing commitment to pooling. Once completed, the project should
the project. There is, he noted, no other comparable not only provide an unequivocal assessment of
database in the world, and continuing confidence in the perinatal outcome of 98,957 IVF births in
the treatments monitored depends on the these countries, but a clear picture of
availability - and transparency - of such data. morbidity trends over time associated with
Simon Brown assisted conceptions.
Focus on Reproduction
16 Focus on Reproduction January 2011
17. // PCOS CONSENSUS WORKSHOP //
Attention now turns to the health risks of PCOS
The report from the first joint Somewhat later in the reproductive
ESHRE/ASRM consensus conference lifespan, Felice Petraglia, University
on the diagnostic criteria for of Siena, reported that the presence
polycystic ovary syndrome has, in of PCOS had been associated with a
just seven years since publication, higher incidence of miscarriage and
become a citation classic. The an adverse pregnancy outcome. There
'Rotterdam criteria' developed at that was some discussion from the floor
meeting recognised that women with about the former, with London
PCOS represent a heterogeneous endocrinologist Steve Franks
population which cannot be defined doubting the strength of the
by strict definitions. Thus, miscarriage data, and Rick Legro
Rotterdam concluded that PCOS from Penn State College of Medicine
might be confidently diagnosed in noting that in the US randomised
women with any two of three trials on the use of metformin there
features: polycystic ovaries seen on was no difference found in
ultrasound, hyperandrogenism and miscarriage rates among the different
oligo/amenorrhoea. The NIH criteria of Bart Fauser, chairman of patient groups. However, Petraglia
1990 which the Rotterdam consensus the writing committee emphasised the adverse effects of PCOS on
superseded had required only two for this third PCOS pregnancy outcome through the mediators
consensus statement.
diagnostic features: hyperandrogenism and of gestational diabetes, pregnancy-induced
chronic anovulation. hypertension, pre-eclampsia and fetal
As of November last year, the Rotterdam consensus growth retardation. He also noted that this adverse
report - published jointly by Human Reproduction effect was not just a matter of obesity, citing data
and Fertility & Sterility - was HR's most frequently showing far higher rates of gestational diabetes in
cited publication, and F&S's second. PCOS subjects than in those who were only obese.
The second consensus statement, like the first, However, in later life the overriding risks of PCOS
considered PCOS from the perspective of infertility, lie with type 2 diabetes and cardiovascular health,
and developed consensus on treatment. After lifestyle risks which are amplified anyway in obese women.
advice, first-line management was defined as Steve Franks cited the observational Nurses Health
ovulation induction (with clomiphene citrate) followed Study to show that the risk of type 2 diabetes was
by gonadotrophin therapy or laparoscopic ovarian more than doubled in women with a history of
surgery and IVF. irregular cycles. Obesity, he added, would increase
Now, a third consensus conference, held in that risk. However, Franks emphasised that PCOS is a
Amsterdam in November last year, has shifted the 'prediabetic' state which invariably presents at a
focus from infertility to the health implications of younger age; thus, diet and lifestyle advice are the
PCOS in early and later reproductive life. 'So it's very most important ways for reducing the diabetes risk in
different from the two previous statements,' said Bart later life.
Fauser, chairman of the writing committee, with the And it is, of course, the presence of type 2
perspective now moving from reproductive disorders diabetes which increases the risk of CVD. The
to a population deemed at risk of type 2 diabetes and landmark Interheart case-control study found that
other cardiovascular diseases. diabetes was associated with a 4.2 relative risk for
In the adolescent, however, even the definition of myocardial infarction. Advice from this meeting,
PCOS is 'confusing', according to Leeds gynaecologist therefore, was to take a multifactorial approach, with
Adam Balen, a member of the six-man writing the usual recommendations of weight loss, exercise,
committee. Many of the normal features of smoking cessation, and medication.
adolescence are similar to those of PCOS, he said, Fauser expects that this broad-scope consensus
such as ovarian morphology and cycle regularity. statement will be published later in 2011. Its
However, Balen confirmed that oligomenorrhoea development is now in the hands of a writing
persisting two years after menarche in the adolescent committee composed of three ESHRE and three
is an early sign of PCOS - and a better predictor than ASRM representatives, and publication will once
LH or androgen concentrations. again be a joint exercise by both groups’ journals.q
Focus on Reproduction January 2011 17
18. ESHRE NEWS
// EUROPEAN HEALTH FORUM //
The legislative inconsistency behind
cross-border reproductive care
ESHRE’s perspective at waiting times for treatment, cost, success rates and
availability of donor gametes as the leading reasons for
Europe’s leading forum travel. ‘Perhaps it’s because their fertility declines as each
for health policymakers month goes by which makes waiting time so sensitive,’ said
Clare. Almost all patients (88%) made travel and clinic
arrangements themselves, and most were happy with the
ESHRE took part in Europe’s leading conference on health outcome.
policy in October last year, hosting a workshop on The increasing attraction of clinics in eastern Europe,
‘Individual choice in reproductive health’. The workshop, said Clare, is cost and limited regulation, with prices in
which took place at the European Health Forum in Romania, Ukraine and Russia reportedly a quarter that of
Gastein, Austria, considered infertility and its treatment private treatment in western Europe. However, her
from the perspective of the patient, the drug industry, the underlying theme was the inconsistency of treatment
politician and society. regulation throughout Europe. Her recommendations on
However, all four presentations ultimately pointed in the behalf of the patient were:
one direction of cross-border reproductive care and the l Consistent regulation and recommendations across the
multiplicity of regulation and practice now present in whole of Europe, with the same rules applied
Europe. It is this very multiplicity - as the panel discussion l Standardised health information (in a range of
made clear - which is now driving cross-border movement languages) from health professionals/governments/EU and
in European fertility treatment. patient organisations
In particular, Clare Lewis-Jones, chair of Fertility Europe l A common minimum standard of care across Europe
and speaking on behalf of the patient, described a l Consistent counselling support
patchwork of legislation and reimbursement policies which Similarly, from the social perspective ESHRE Chairman
made, for example, anonymous donor insemination Luca Gianaroli defined the controversies in ART as
allowed in France and Belgium, but outlawed in the surrogacy, anonymous and non-anonymous gamete
Netherlands, Germany and UK. donation, embryo freezing and PGD, which were each
A survey performed by Infertility Network UK on ‘the reflected in inconsistent national legislation. However, the
attraction of overseas clinics’ for UK patients found short legislative anomalies, he said, are increasingly subject to
The workshop was chaired by ESHRE’s Past Chairman Joep Geraedts, with presentations by (left to right) Luca Gianaroli,
Clare Lewis-Jones, Joan-Carles Arce, and Isabel de la Mata Barranco.
18 Focus on Reproduction January 2011
19. ‘Heterogeneous legislation’ also blocks industry’s
‘stagnating’ fertility development pipeline
Despite a background of great social and medical need and an ART success story
which boasts delivery rates comparable to spontaneous conception, industry research
into fertility now commands only a minute proportion of an annual R&D expenditure of
$34 billion. Based on data from 22 pharma companies and bundled into the category
of 'GU/sex hormones', fertility (alongside contraception, menopause, BPH and erectile
dysfunction) represents no more than 3% of industry's total R&D budget, with little
prospect of any advance, according to Joan-Carles Arce, Vice President of Clinical
Research & Development at Ferring Pharmaceuticals.
He described the development pipeline of the three 'big players' in fertility as
'stagnating', with only two new entities in phase II, and just one in phase III. Past developments, he added, have
not realised aims to improve efficacy or safety, but have improved convenience (in new presentations, delivery
routes, and longer action). Dr Arce described biomarkers for diagnostics and treatment, drug delivery technology,
and embryo selection processes as new areas with potential for progress.
However, he said, any pharma developments in fertility today are constrained by complex targets (notably
confined to sub-groups of patients), increasing regulatory requirements (for documenting efficacy and safety),
heterogeneous legislations, a necessity to duplicate clinical trials, and cost.
There is, he added, a need for joint efforts between industry, governments and organisations to allocate
resources and establish structures to ease the burden of infertility, and for realistic drug development objectives
and reward to stimulate further development activities in fertility.
legal challenge. Gianaroli not only cited the successful concerns and amendments over the outward flow of
challenges to Italy’s Law 40 requirements (to transfer all patients (and whether prior authorisation is necessary for
fertilised oocytes), but a 2010 judgement from the hospital procedures) and over the quality and safety of
European Court of Human Rights that Austria’s Artificial care. Many member states had insisted that prior
Procreation Act - which disallows gamete donation - was in authorisation should be necessary, while the Commission
violation of the Convention because the claimants could itself insisted that any prior authorisation would be an
not conceive by any other means than gamete donation. obstacle to the free movement of citizens - which the Court
The European overview presented by Gianaroli - as also of Justice would not allow.
found on the ESHRE website under ‘Guidelines and Legal’ Now, in its final draft the Council has not only agreed
- proved salutary to the audience of health policymakers, that patients are to be reimbursed up to the level they
who appeared astonished at the disparities. ‘There can be would have received in their home country (ie, what would
no other areas of medicine with such diversity of have been paid for by its own social security system) but
legislation,’ said one bemused guest from the floor. has also added a new provision that member states may
decide to cover other related costs, such as accommodation
EU cross-border directive and travel expenses (which may still need prior
While ESHRE’s own Task Force on cross-border authorisation). The latest draft thus lists reasons why
reproductive health is moving ahead with its own member states may refuse authorisation, which seem to
guidelines, Isabel de la Mata Barranco, a Principal Adviser involve entitlement to treatment, standards and safety.
to the European Commission (DG SANCO) with a special The draft also suggests that each member state must
interest in public health, reported that the draft directive on ensure, via ‘national contact points’, that patients from
cross-border healthcare (which was approved by the other EU countries can receive information on safety and
Council of EU ministers in June 2010, backed by the quality standards to make an informed choice.
Parliament’s public health committee in October, and is It now seems that the draft proposal has broad support
now in its second reading in Parliament) will only allow in the EU Parliament and is likely to be accepted at its
reimbursement of costs up to the amount that would have second reading this year. Should that happen, the directive
been paid had they received that treatment at home. could be adopted as ‘soft’ law by June.
Procedures not allowed (or not reimbursible) in the home Speaking to the press in October last year, French MEP
country will not be reimbursed. Françoise Grossetête, who has been the Parliament’s
The directive, said Ms de la Mata, is intended to smooth rapporteur on the directive, said: ‘This directive is designed
cross-border healthcare and ensure free citizen movement to allow patient mobility. We already have mobility of
among member states (in compliance with Article 25 of the workers and students. It’s part of the fundamental rights of
original treaty of Europe) while ensuring each country’s European citizens. This does not however encourage
rights to run its own health systems. medical tourism. We simply want to allow a wider range of
The directive has been bogged down in financial public health for patients.’q
Focus on Reproduction January 2011 19
20. SPECIAL INTEREST GROUPS
// REPRODUCTIVE ENDOCRINOLOGY //
New elected officers in place after Stockholm
The SIG RE ended 2010 with period. Examples of how
continuing activity in joint Officers nutrition, environmental factors
meetings, the latest in September Adam Balen (GB), Co-ordinator and fertility interventions may
in Dubrovnic, Croatia, on ‘A Richard Anderson (GB), Deputy Co-ordinator affect developmental
healthy start - The determinants of Juan Garcia-Velasco (ES), Deputy Co-ordinator endocrinology, long-term health
a successful pregnancy’. This was a Georg Griesinger (DE), Junior Deputy and fertility in the offspring will
joint Campus event with the SIGs Nick Macklon (NL), Past Co-ordinator be reviewed, and intervention
Early Pregnancy and Reproductive strategies discussed.
Surgery but unfortunately there were fewer delegates than We agreed at our AGM in Stockholm that this year’s
speakers - a great shame, as the quality of the precongress course will be titled Ovarian ageing and will
presentations and the high level of discussion were very cover the formation of oocytes in the ovary and
stimulating. We do need to ensure that our meetings are determinants of their rate of loss. The causes and
well attended, especially as they are now held in varied management of premature ovarian failure will also be
locations and our speakers take a lot of time out of busy described, as will ways to preserve fertility by oocyte or
schedules to share their knowledge and participate in our ovarian tissue cryopreservation. The day will conclude
academic sessions. with a socio-ethical talk on the effect on society of
The third joint ESHRE/ASRM PCOS consensus meeting postponing pregnancy.
on medical problems associated with PCOS took place in We shall be holding a further training workshop with
November hosted by Bart Fauser and Basil Tarlatsis, both our colleagues in the Paramedical Group and SIG
former co-ordinators of the SIG RE. The programme Embryology in St Petersburg, Russia, from 7-8th
started with a one-day open meeting and continued with a September. The first of these courses in Kiev last May was
two-day, closed consensus workshop along the lines of the very popular and so we encourgae you to register early!
earlier Rotterdam and Thessaloniki meetings. As our short We are also considering a meeting on PCOS for Bulgaria
report on page 17 indicates, the aim was to develop a later in the year.
consensus on the impact of PCOS on early and later
reproductive life, and those aspects not necessarily seen . . . and into 2012
from a fertility perspective (as in the two previous reports). The precongress course in Istanbul in 2012 will be
Thus, on the agenda were quality of life, obesity, hyper- Optimising the IVF protocol and the use of adjunctive
androgenism, pregnancy and, in later reproductive life, therapies, covering such controversial issues as aspirin,
type 2 diabetes, the menopause and cardiovascular health. DHEA, growth hormone, steroids, heparin, acupuncture,
homeopathy etc, etc...
Training programme in 2011 Also in 2012 we plan an update on the use and role of
For 2011 we encourage you to register for the first GnRH antagonists to be hosted by Georg Griesinger in
Campus in Kempten, Bavaria, on 4th February on ART Luebeck, Germany. And in the Spring in Lille, hosted by
and the oncological impact, hosted by Ricardo Dideir Dewailly, an update on AMH. We also have a
Felberbaum. The programme includes presentations on: proposal for a meeting in Montenegro to be hosted by
Sexual steroids and their oncogenic potency; Estrogens, Tatjana Motrenko Simic, the programme for which is still
endometriosis and ovarian cancer: is there a missing link; to be finalised.
Cancer incidence in infertile women after COH; Incidence I stand down as Co-ordinator of the SIG RE in 2011
of malignancies in children born after IVF - results of and would like to thank the committee for their hard
epidemiological studies; Ovarian protection during work, help and suggestions. Georg Griesinger takes over as
chemotherapy by GnRH agonists. Co-ordinator at Stockholm. We have just held our first
Nick Macklon will be hosting The embryo as patient on fully open election to the committee and we are pleased to
13-14th May in Winchester, UK. It is now clear that the announce that joining as Deputy Co-ordinators are Frank
periconceptional period determines not only perinatal Broekmans and Stratis Kolibianakis, with Daniela
outcomes but has an impact on the long-term health of Romualdias the new Junior Deputy. I wish Georg and his
mother and child. This one-day course will cover the new team all the very best for the coming years.
evidence base supporting the developmental origins of Adam Balen
health and disease (formerly referred to as the ‘Barker Co-ordinator SIG Reproductive Endocrinology
hypothesis’), and how this relates to the periconceptional adam.balen@leedsth.nhs.uk.
20 Focus on Reproduction January 2011
21. // SAFETY & QUALITY IN ART //
Central Office research support for guidelines
It is now three years since an design, preparation, review,
invitational meeting was convened Officers dissemination and evaluation of
by the SIG Safety & Quality in Petra De Sutter (BE), Co-ordinator guidelines. And it was according to
ART (SQUART) - represented by Karl Nygren (SE), Deputy Co-ordinator these internationally accepted
Past Co-ordinators Christina Bergh Willianne Nelen (NL) , Deputy Co-ordinator criteria that the SIG SQUART
and Jan Kremer - in Nijmegen to Jan Kremer (NL), Past Co-ordinator developed an ESHRE manual for
consider the future of ESHRE’s guideline development; the
clinical guidelines. After two days of discussion, guideline programme has now become one of the core
representatives of ESHRE’s SIGs, journals and Executive activities of the SIG SQUART, with Willianne Nelen as
Committee (as well as the Cochrane Collaboration) programme co-ordinator.
concluded that ESHRE, as an authority in reproductive Publication of the ESHRE manual for guideline
science and medicine in Europe, does have a responsibility development has in the meantime also sharpened the rules
to set guideline standards for high-quality clinical practice. for publication of other ESHRE documents. Thus, any
Thus, at the end of this meeting the ESHRE guideline ESHRE document (eg, position statements, speciality
programme was born - at least in name - and the rules of reviews, notice of intention and clinical guidelines) must
the game determined. now either be commissioned by the Executive Committee
The overall aim of the guideline programme is to itself or its subject approved in advance. In addition,
decrease practice inconsistency and increase the overall manuscripts must be posted on the ESHRE website for
quality of patient care in reproductive medicine in Europe. review by members (fixed as one month) before their
Thus, it was agreed that the guidelines emerging from the publication. The rules, said past ESHRE Chairman Joep
ESHRE programme would be authoritative, based on the Geraedts, were introduced to bring some consistency - as
best available evidence (most relevant and highest level), well as authority - to the increasing output of ESHRE
reliable and consistent in style and approach. It was clear documents, and an accepted and uniform methodology for
that such guidelines would be aimed at professionals composition and approval will inevitably raise the value of
(doctors, scientists, paramedics, etc), with patients the documents.
involved as stakeholders in a consultation process. However, the principal aim of the manual is to provide a
Production would be according to up-to-date process and stepwise practice tool for members of ESHRE’s guideline
quality indicators. development groups and is available for consultation on
The development of clinical guidelines has generally the ESHRE website. Each chapter of the manual
become a formalised process in recent years. Instruments corresponds with one of the interdependent activities of
such as that of the Appraisal of Guidelines for Research guideline development (eg, scoping, search and selection
and Evaluation in Europe (AGREE) collaboration (see of evidence, dissemination) and consists of a description,
www.agreecollaboration.org) provide structures for the an overview in flow chart form and some practical a
ESHRE’s new research specialist for guideline development
The missing link in full-speed ESHRE guideline development has been the absence of
a research specialist, but now, with the addition of a full-time researcher in Central
Office from October last year, that gap has ben filled. Nathalie Vermeulen, 27, has
been appointed as a research specialist on behalf of the ESHRE guideline programme.
She graduated in biochemistry from Leuven in 2005 and obtained her PhD on
serological markers in inflammatory bowel disease in January 2010. Before starting at
ESHRE, she was employed as a pharmaceutical company product manager.
As a research specialist Nathalie will assist the SIGs in the development of
guidelines, and in that capacity will document existing guidelines, conduct stepwise
literature search and summarise evidence, formulate and classify recommendations,
record evidence gaps and update the literature search every two years for every
guideline. Nathalie can be contacted at nathalie@eshre.eu
Focus on Reproduction January 2011 21