Deciding on IVF treatment is one thing – getting into details about complicated regulations and legislation is another. Have you been wondering what are the legal aspects regarding IVF treatment with donor eggs, donor sperm and embryo adoption/donation? If you have, then this webinar will undoubtedly meet your needs. Dr Maria Arqué, Medical Director at Fertty International, takes up a challenge and explains to you the complexities of IVF law and donor treatments.
ART (assisted reproductive technology) legislation regulates the use of assisted reproductive technology, including its legal, ethical and social aspects. Dr Arqué reminds us that such legislation differs in different countries – that is why the choice of an IVF destination should always be proceeded with thorough legal research. Spain is one of the first countries to have introduced IVF legislation – moreover, it has already been updated several times in order to adapt to ever-changing reality and circumstances.
ART legislation objectives
Dr Arqué gives us a general definition of the law on assisted reproduction. First of all, this law aims to regulate the application of scientifically and clinically indicated proven ART. It also regulates the use of ART in the prevention and treatment of genetic diseases (through the use of PGT) – provided that there are sufficient diagnostic and therapeutic guarantees and they are authorised in the terms provided for this law. It refers to the assumptions and requirements for the use of cryopreserved human gametes and pre-embryos, too.
The conditions under which assisted reproductive treatments can be performed are strictly defined as well. The use of ART is possible when there are reasonable chances of success, when there is no risk to the woman’s and her offspring’s health and when she has been previously informed of the possibilities of success as well as risks and conditions of such application – and consciously agreed to all of that. The legal age limit for a female patient is different in different countries. Although in Spain the latter is not clearly regulated by the law, there is a general agreement between IVF clinics not to treat patients who are over 50 years old.
When it comes to assisted reproductive techniques available in Spain, their range is quite wide and diversified. They include ovulation induction (OI), intrauterine insemination (IUI) and in vitro fertilization (IVF) (both with partner’s sperm or donor sperm), egg donation and shared motherhood. Additionally, it is possible to perform
pre-implantation genetic testing (PGT-A, PGT-M, PGT-SR) that can help to identify embryos with genetic abnormalities and – as a result – increase the possibility of a successful pregnancy after IVF.
Egg and sperm donation in Spain
Egg donation, the process in which a fertile woman provides her eggs to an infertile woman for purposes of ART, is anonymous according to the Spanish law. It means that neither a patient nor an egg donor can know each other’s identities. Dr Arqué highlights the fact that egg donation is an altruistic act in Spain, meaning that the only compensation the donors will get is a refund for the days they devoted to coming to the clinic for necessary tests. Under Spanish legislation, it is the medical team that is responsible for selecting an egg donor. They are obliged to seek the maximum phenotype and immunological similarity between the donor and the person who’s going to receive the eggs. The rules of sperm donations do not differ much from those of egg donations. The process is also anonymous and altruistic and involves a medical team that is choosing the best donor in terms of phenotype and immunological similarity.
Donor selection requirements
Egg donor selection criteria is the subject that interests potential IVF patients the most. First of all, egg donors must be healthy women and sperm donors must be healthy men between 18 and 34 years old. Dr Arqué says that the medical team has to conduct exhaustive medical and family history interview to make sure that there are no hidden medical problems running in the potential donors’ families. Additionally, donors undergo psychological assessment as well as medical tests (including blood type, Rh factor and infectious diseases) and screening for sexually transmitted diseases (STD).
Another important part of egg/sperm donors’ assessment is genetic screening. From the genetic perspective, there are two different kinds of tests:
- karyotype (the so-called ‘map of chromosomes’ checking for alterations in the structure of chromosomes)
- and a panel of recessive monogenic diseases.
The latter refers to the diseases we might no be aware of carrying (as they are not affecting ourselves) but that could pose a serious risk to our potential offspring. These diseases include:
- cystic fibrosis mutations,
- muscular spinal atrophy
- and X-fragile syndrome testing.
Being aware of them allows for selecting the best donor in terms of genetic information. Apart from the genetic matching, Dr Arqué mentions also gynaecological tests (AMH, TV-scan) and semen analysis. In order to better control the reproductive outcomes of the donor cycles, there is a National Donor registry in the phase of implementation in Spain. According to Dr Arqué, this Assisted Human Reproduction System (SIRHA) has been requested by Spanish fertility clinics for a long time and in the near future, it will help them to connect and cooperate more efficiently.
Spanish law and embryo adoption
Apart from egg and sperm donation, there is also the possibility of embryo donation (or ’embryo adoption’). Just like the two previously described donor treatments, it is also anonymous and altruistic in Spain. There are some medical criteria introduced to make sure that the donated embryo can be used for other infertile couples. The first one says that the woman, with whose genetic material the embryo was created, has to be under 35 years old in the moment of the embryo creation. According to dr Arqué, the reason for that is simple: after 35, the eggs’ quality and quantity decreases a lot, which may result in different chromosomal abnormalities affecting the potential child. Additional medical requirements for embryo adoption are negative vital screening for both male and female and the absence of any known genetic diseases in the family or genetic parents themselves.
It is good to know that the Spanish law establishes a maximum of 3 embryos per embryo transfer. However, Dr Arqué admits that – according to the general medical recommendation – in 90% of all cases, they transfer only one embryo. The reason is that a single blastocyst transfer (SET) helps women avoid several risks to their own health that are associated with carrying multiple pregnancies.
Preservation of human genetic material
Dr Arqué says that one of the most frequent questions that patients ask her is for how long embryos, eggs or sperm can be frozen in Spain. According to the law, human embryos and eggs can remain frozen in storage until the patient who is freezing them reaches the legal age limit (which is 50 years old for women in Spain) or until she doesn’t have any medical condition that contraindicates their use. In case of sperm, the Spanish law states that it may remain frozen during the whole life of the man.
Fertility patients often have to deal with concerns regarding the possible destinations of their frozen eggs, embryos or sperm. What Dr Arqué recommends them to do is to save them for heir own use until they have the certainty that they have achieved a pregnancy and/or have already had a child. Such a decision (which should be marked with informed consent) can always be withdrawn afterwards and the destination of one’s own frozen genetic material can be changed. It can always be donated for reproductive purposes to other couples or for research purposes. There is also the option of the cessation of the genetic material conservation without another use.
Reporting obligations
In Spain, fertility centres have to report their results to the Spanish Fertility Society (SEF) – independent scientific audit body. Additionally, in Catalonia, there is the Catalan Transplant Organization (OCATT). According to Dr Arqué, the fact that clinics have to report all those results guarantees control, quality, transparency, security and traceability of all the ART processes that they perform. Moreover, it gives much more security to any patient who is willing to undergo a fertility treatment in Spain – and that’s undoubtedly the most important value and advantage.