Director of the IVF laboratory in HM Fertility Center Montepríncipe (HM Hospitals)

Dr Prados is the coordinator of the National Spanish Register Committee and member of the European Society of Human Reproduction and Embryology (ESHRE) Embryology Certification Committee. Due to his broad experience in ART (Assisted Reproductive Techniques) and his strong connection with ESHRE, Embryologist Media has contacted him to ask about his view on the current situation of ART and what the future perspectives of ART development are in Spain.

The techniques offered in Spain perfectly reflect the ‘state of the art’ in IVF

First of all, we would like to express our gratitude on behalf of the entire EM team for granting us this interview. It is our pleasure to have the opportunity to talk about human reproduction with such an experienced embryologist.

E.M. Let’s begin talking about quality. How does Spain rank in terms of quality regarding techniques and approaches in assisted reproduction?

F.P. Spain has a good-quality IVF. In terms of national results, we can be compared to the best performing European countries, and the equipment of many of our clinics is very much up to date. The techniques offered in Spain perfectly reflect the ‘state of the art’ in IVF.

E.M. What are the reasons behind Spain´s achievements in this field?

F.P. Mostly the good preparation and commitment of our professionals. The Spanish assisted reproduction legislation is one of the most advanced in the world, allowing for developments to be improved without great difficulties. It is also remarkable that the private sector dominates IVF in Spain, and private centres need to compete in quality to maintain patient confidence. However, there are still some aspects that need to be improved, like the relevance given to the IVF laboratory inside an ART centre. The general situation of embryologists is far from correct, and their high level of responsibility is often neglected by the directors of the clinics. Very often the laboratory staff is working in stressful timetables with a huge workload. In my opinion, the relevance given to embryologists and their working conditions are the main obstacles faced by many centres to achieve better success rates.

E.M. One of the latest European reports showed that the use of ICSI has increased within the last 15 years, specially in Mediterranean countries like Spain. These data are quite surprising, since it seems that ICSI is performed in many non-male infertility cases. Why would you say this is happening?

F.P. The main reason to perform ICSI in cases of non-male infertility is the fear to complete fertilization failure. Neither patients nor clinics want to face that risk, which is undoubtedly higher after conventional IVF. In global success terms, ICSI is not superior to conventional IVF except in cases of male infertility (very common anyway). However, every time a couple ends up with unexpected total fertilization failure one cannot help the feeling of having been wrong about the choice of the fertilization technique. That being said, ICSI implies more aggressive manipulation of the oocytes, and could then produce deleterious effects on the early embryo development; therefore, it should not be overused.

E.M. Spain has one of the most open legislation in ART among European countries. Could this be a contributing factor to Spain being ranked highly regarding the number of treatments/cycles?

F.P. Yes, this is surely one of the main reasons for the high number of IVF treatments performed in Spain. The requisites for the opening of an IVF centre are not too demanding. There is no excess of restrictions for the handling of human gametes and embryos. In some countries, religious or moral concerns impose some rules that lead to obstacles to access to certain treatments for some patients, and even to the possibility of application of clinically efficient ART techniques like egg donation, pre-implantation genetic testing or oocyte vitrification.

E.M. Spain, like other European countries, has adopted the EUTCD (European Union Tissue and Cell Directives) in order to accomplish the European laws in terms of safety and security. What is the current situation regarding this directive and what has been the impact of the addition of this new regulation on IVF facilities?

F.P. The regulations of the EUTCD affect mainly the management of gamete and embryo donation, which is a relevant part of Spanish assisted reproduction treatments. It involves regulation of the testing and control of donors. The national donation registry will be implemented within the next months. This registry will incorporate the use of the Single European Code to ensure full traceability of samples as established in the EUTCD.

E.M. In your own opinion, which factors are motivating the delayed implementation of the national donation registry?

F.P. The national registry of donors and donations was included in the 2006 ART law. However, its implementation has since been delayed because of the need for the generation of an adequate online platform that would allow for the management of that information. The [previous] Health Ministry, with the guidance of experts in IVF, has finally developed SIRHA, the software platform that will host that registry and, also in the near future, the ART activity registry and the bio-vigilance module. The use of this software by all IVF centres is going to be enforced in successive steps to allow for system improvements.

E.M. Currently, there exists a debate about whether surrogacy needs to be incorporated into the regulation. What is your opinion on this topic?

F.P. This is a very sensitive issue. It can be beneficial for some patients but it must be very well regulated to avoid misuse. The health and welfare of the surrogate mother must be protected above all other considerations.

E.M. Would you say the maintenance of quality standards in IVF facilities is currently under a strict national regulation?

F.P. It is, but there is still room for control improvement. Inspections should be based on real IVF quality standards and not only on general laboratory or clinical quality systems. In this respect, it is excellent news the ESHRE initiative of creation of the ‘ART Centre Certification for Good Clinical Practice’ system. Such certification will be based upon the centre’s accomplishment of the European society’s guidelines for good clinical practice and the demonstrations of a good performance according to the recommended values of internationally recognized Key Performance Indicators.

“The health and welfare of the surrogate mother must be protected above all other considerations”.

E.M. Do you think Spain should incorporate more efficient and strict policies in order to maintain high-quality standards?

F.P. One of the most striking aspects of the IVF regulation in Spain is that the professionals that produce, take care, evaluate and prepare human embryos for applying them to patients are not regarded as ‘health professionals’. This lack of regulation of one of the main actors in IVF care leads to a downgrade in the protection of couples suffering from infertility. Furthermore, there should be a more ambitious restriction on the number of embryos per transfer. The current success of the embryo cryopreservation techniques makes it absolutely unnecessary the risky transfer of three embryos at a time. Even the transfer of two embryos should be exceptional. This is the only way to reduce the risk of multiple pregnancies, which represents the most common medical complication associated with IVF.

​(…) there should be a more ambitious restriction in the number of embryos per transfer

E.M. Which is (approximately) the current public vs private centres ratio in Spain compared to other countries?

F. P. Around 80% of the IVF centres in Spain are private units in which patients have to pay the whole cost of the treatment (data from the Spanish Registry 2015). This situation is similar to that from other countries like Italy, but normally the public sector is more relevant in the rest of European countries, like for example, Belgium, The Netherlands and Nordic countries, where government partially reimburses the cost of most of the IVF cycles.

E.M. Is there any difference in terms of quality of the service between these two types of models?

As I said, private centres have normally better financial capability, and this means the possibility to employ more staff for a reduced workload and access to better equipment. This is mostly true for medium- to large-size private centres. However, the situation in Spain, with many very small private IVF centres, is not the most appropriate. It is common for such small centres to only have one embryologist on the payroll, at least during holidays or maternity leaves, with the obvious deterioration in quality and safety of the treatments.

E.M. Looking into the future, what kind of challenges will ART in Spain be facing in the next 25 years?

F.P. Probably the same challenges other countries will face. The possibilities for genetic testing of the donors and embryos will increase with the new scientific advances and knowledge. And ART treatments will need to be quickly adapted accordingly.

Other technical improvements involving new systems for embryo culture and selection will need to be introduced into the clinical practice in an efficient but careful way. But there are some risks. In the near future, ART will need to maintain the current high standards of quality, rather than indulging in a situation in which the economic profits of the IVF centres become the driving force of this medical sector.

E.M. Do you foresee experts performing ART treatments to women in their fifties?

F.P. No, this is a very unlikely scenario. The difficulties and side effects of these treatments are too relevant to be neglected. Besides, the demand for this kind of treatment is rather exceptional.

E.M. Spain has one of the lowest birth rates in Europe (1.32 children per woman). This is mostly due to a variety of specific factors from the national culture, high rate of unemployment, non-flexible work schedules and the lack of a specific pack of political initiatives to promote assistance to future parents. This situation is unlikely to change in the near future. Does it mean ART procedures in Spain will keep growing among the population?

F. P. Surely, unless those social factors are relieved, the delay in the decision for (mainly) women to become pregnant will continue to force them to resort to assisted reproduction techniques and even to fertility preservation. This is a dangerous situation for our current society and we should take measures to stop this trend.

“In the near future, ART will need to maintain the current high standards of quality and not indulge in a situation in which the economic profits of the IVF centres become the driving force of this medical sector.”

E.M. At this moment, Spain is a reference in Europe regarding the number of treatments and quality, but the government does not recognize Embryology as a medical speciality. What is the current situation regarding this controversy?

F.P. As I mentioned earlier, this is an inappropriate situation. Embryologists are undoubtedly health care practitioners. Infertility is a pathology and clinical embryologists are therapists that treat that specific condition by producing, caring, selecting and handling human gametes and human embryos. Not only not being considered health care professionals downgrades the human IVF practice, but it also minimizes the importance given to the quality and safety of the treatment offered to our patients, which have every right to being cared for only by officially certified clinical specialists.

The Spanish association for embryology (ASEBIR), in collaboration with the Spanish board of biologists, is currently preparing a series of measures to progress towards the recognition of clinical embryologists as medical specialists. First of all, the creation of a Master degree that credits the graduate with his/her recognition as a ‘health care professional’.

Embryologists are undoubtedly health care practitioners. Not only not being considered health care professionals downgrades the human IVF practice, but it also minimizes the importance given to the quality and safety of the treatment offered to our patients

Many thanks for your time, Dr Prados. It has been a real pleasure to talk to you and to hear about the actual status of ART in Spain from an expert like you