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.
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 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.
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:
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:
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.
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.
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.
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.
Shared motherhood is a treatment that we can offer to same-sex couples. It is performed when two females in a couple want to undergo a fertility treatment and they both want to participate in it. One of them would undergo a stimulation – just like she was about to do the IVF cycle. Then we would do the egg collection, we would put the eggs with the sperm of a sperm donor in the lab, we would let those eggs to be fertilised and develop until they reach the stage of a blastocyst. In the meantime, the other girl of the couple would do the endometrial preparation and when she is ready, we would conduct the embryo transfer. In that way, both of them can participate in the process.
We always select an egg donor using phenotype of the patient or the partner of the couple who is about to do the treatment. There’s always a team of biologists, nurses and doctors who are participating in the process. First of all, we are going to ask you to fill in a form with all your physical characteristics. Then we’re going to ask you for pictures and we use an artificial intelligence device in the clinic that helps to analyse more than 100 points in the face, to try to achieve the maximum similarity.
Basically, you can only know the general information about the donor. You can know the donor’s ethnicity, age, blood group and general physical characteristics.
Yes, we have donors from all other ethnicities, apart from Caucasian. I don’t think that we should have a problem with finding any ethnicity among our donors. It is true that there are some specific ethnicities that might be a little bit more difficult to find – because of cultural aspects or other reasons that are not so common among the natives. So it might be a little bit more tricky. It can take a little bit longer to find oriental donors, like Indian or Japanese, but so far, we’ve had eggs from all ethnicities.
Honestly speaking, sometimes we don’t have the information about the level of donor education. So it’s not disclosed because a lot of times we simply don’t have it.
It’s a matter of the offer and the demand. It’s as simple as that. Probably there’s a high demand for Thai donors and a very little offer – and that’s the main reason why it is more expensive.
Egg and sperm donations in Spain are anonymous so the only information that the child will have is what the person, who has done the treatment, decides to disclose. The kids will be able to know the additional characteristics that have been given, but that’s it.
Yes, it is possible to find you a donor. I have a lot of patients from all over the world and a lot of patients with brown skin, too. We always find right donors so that should be no problem.
Even though in Spain the law states that donors should be between 18 and maximum 35 years old, the vast majority of our donors are between 20 and 33. First of all, it’s because there are some studies saying that, when donors are very young, their eggs’ quality is not as good. It may be because they have not reached that point of maturity yet. Secondly, it might be so just to make sure that the donors are completely aware and conscious of what they are doing. So I think that these are the main reasons – but nothing else.
We have Spanish donors and we have donors from other nations as well. You have to remember that Barcelona is a very cosmopolitan city that attracts people from all over the world, but especially from all over Europe. So we have a lot of donors who are young professionals or students at college – they are residents here in Barcelona and they donate their eggs. So we have donors from a lot of different nationalities around Europe.
No, we don’t use Time-Lapse. Some people are saying that Time-Lapse can give you useful information in terms of the exact times when the embryo is dividing – then you see if the chronobiology of the embryo is exactly how it should be and it could help you to to select the right blastocyst. However, the main criteria that most biologists end up using, when they are about to choose the embryo to transfer, is the morphology. The morphology that the embryo has on day 5 – that’s the most important criteria. There is some controversy regarding the use of Time-Lapse and whether it might increase the success rates or not. We are sticking with using the morphology as the main criteria and so far, we’ve had very good results with it.
If there was a baby born with a genetic problem, then, first of all, we’d have to know which genetic disease it was. We’ll have to check if it comes from the father or if it comes from the donor or if it is a ‘de novo mutation’. Even though we do genetic tests to the donor and we try to minimise the risk of having any genetic problem, there are some genetic diseases that we cannot predict and we cannot do tests for. Obviously, that’s also a risk when you are having a child with your own eggs. So if that was the case, the first thing that we would do, would be to block this donor so that they would not be used for anyone else. Then we would run all the necessary tests on the donor and on the sperm, regardless of the fact if the sperm is from a sperm donor or the partner. We would do all of this to assess where the problem comes from and if that could have been prevented or not. Then, depending on the result, we would take it from there and analyse the situation. We have to report all the results to the Spanish Fertility Society. That’s the main reason why we do that. We have to track any baby with a genetic problem and check if it came from a donor, etc.
Yes, you can. You don’t need to know any couple who’s ready to provide you with an embryo to do embryo adoption in Spain. You can do it at our clinic and it would be anonymous. We offer such services. I’m going to explain to you how that works. For example, there is a couple who have done a cycle and they had e.g. six blastocysts. They’ve already had two blastocysts transferred, they had two children and they don’t want to do any more transfers. They don’t want to have any more children and they want to donate their embryos. The woman was less than 35 years old, they didn’t have any genetic problems, any sexually transmitted diseases or infectious diseases – the embryos were okay. So you come to our clinic and tell me that you would like to do an embryo adoption because you have poor eggs’ equality and your husband has also sperm problems. You just prefer to adopt an embryo. In such a case, we would be responsible for selecting an embryo that looks like you as much as possible. And there would be neither involvement nor any contact between the couple that generated this embryo and you and your partner.
There is such a possibility but it’s only under some specific circumstances. There are some requirements that have to be fulfilled in order to be able to discard the embryos. It’s not as easy as it sounds. For example, it would be possible in case you are no longer 50 – because if you are over 50, you cannot use them for your own purpose. Also, if you don’t want to donate them to other couples and you don’t want to donate them for reproductive purposes – then, in such cases, the embryos can be discarded.
If the embryos are donated for the purpose of the investigation, then yes – they can be used in such a way. But again, it’s not so easy. There has to be a specific program or project investigating some specific embryo-related issues – and only then the embryos can be donated for it.
I have never had such a situation before – but it doesn’t mean that it could not happen. Let me explain you about Down syndrome. Down syndrome is not a genetic problem that we can detect beforehand, when are doing the test on the donor or on the partner. Down syndrome is a
‘de novo problem’ and it’s generated by an alteration in the karyotype, in which – instead of having two copies of the chromosome 21 – the embryo has 3 copies. That kind of alteration usually happens in the moment in which the embryo is created. There is some kind of alteration in the division of the chromosomes and that’s the reason why we cannot do a test on the donor to see if they have it in the genes. The way to detect Down syndrome in the offspring would be to do pre-implantation genetic testing (PGT). That’s something that can be done on the embryo. It’s a biopsy that we do on the embryos that have 5 days of life. And we do a karyotype on the embryo as well. Karyotype is a mandatory genetic test that we do to all donors. It has to be normal – otherwise, we cannot accept a donor for a donation. So we can also do a karyotype test to the embryo and in that way, we can check if the embryo has a genetic problem or not. In case the pre-implantation genetic testing is not done, what we usually recommend to do is the pre-natal screening that is regularly done in the first trimester of pregnancy. It’s done through a blood test and a scan. And there’s one more blood test that can be done in the first trimester of pregnancy. There are a lot of different brand names for it right now, like e.g. the Harmony test. It can help you predict the likelihood of you having a baby with some of the most important chromosomal alterations like Down syndrome or Patau syndrome. And in case it is negative, the likelihood would be very low. If it was high, then there is the option of doing a chorion biopsy or amniocentesis and, depending on the moment of the pregnancy in which you are and your prognosis, deciding on what to do.
If you’ve done PGT, it would be extremely unlikely that you had a baby with Down syndrome – because that would be detected with PGT. Mental illness, on the other hand, has a very wide meaning. It can happen for a lot of different reasons: it can be what we call ‘de novo mutation’, these can be problems that are not related to genetics, problems related to a difficult labor or other things. So there can be many different aspects involved.
For the moment, we cannot restart fertility treatments. However, the Spanish Fertility Society and ASEBIR (Spanish Association for the study of Reproductive Biology) have already issued the recommendations and the steps that we need to follow to try to minimise the risk of COVID-19 infection and the risk for patients. The idea is that – if everything goes well – we will most likely restart our activities little by little towards the end of May/ the beginning of June. But I don’t want to give anyone any information without having the formal confirmation from the main societies. That will also depend on how the pandemic evolves in the following weeks. For now, we don’t have enough information about how COVID-19 can affect pregnancies. The information that we have now is very little because there are not that many studies done. Some of them are saying that it might be related to a higher risk of miscarriage, other data say that it may result in pre-term delivery. So we’re still gathering data to see if it would be safe or not. It doesn’t seem as if it had teratogenic effects or that there was a vertical transmission – so the transmission from a mother to her baby (in case the mother is infected). But we still have to have a little bit more information. So that’s the only information that I can give you for now. In Spain, we’re still confined and the idea is that towards May, 9, we will start to de-confine little by little – if things keep on going well. So it looks like we’re starting to see a little bit of light at the end of the tunnel. But there’s no certainty yet. So that’s all I can tell you now.
It is blocked as well.
When egg donors come to us to donate their eggs, they obviously have to sign an informed consent. We are very clear about everything and we explain everything to them. They are very aware about what it means to donate the eggs and that they cannot claim anything from the baby afterwards. Apart from the fact that, of course, everything is anonymous so there would be no connection between the egg donor and the baby. So it should not happen. I mean, it has never happened so far.
We don’t check the financial situation of donors.
Yes, we have both of them with our egg donation programme. Our standard egg donation programme guarantees a minimum of eight mature eggs from the donor and two blastocysts for the transfer. The average number of blastocysts that we get out of an egg donation cycle is between three and four, but the guarantee is two. We don’t have a pregnancy guarantee programme but we have a baby guarantee programme – so the guarantee is a baby born. There are of course some specific medical criteria that you have to fulfil to be eligible for that but yes – that is an option. Basically, for baby guarantee programmes, you have to pay for the three full cycles and if after the three full cycles, you don’t have a baby born, the full money that you have paid for the cycle would be refunded. As I said, there are many medical criteria and in case you’re doing the treatment with your male partner, he will have to do some specific tests, too. There are some genetic tests to check if there are no important alterations in the sperm. You’d also have to check that your uterus is fine and all those things, etc. When it comes to price, all medications that you need are included, as well as all the frozen embryo transfers from all the embryos that we get out of each egg donation cycle.
Yes, sometimes we have trainees. It would be a matter of discussing that with the lab manager to see if there is something that can be done about that. So it’s worth checking that out.
In our guarantee programme, the maximum age for egg donation is 50. That’s the maximum legal age limit for egg donation in Spain. For IVF with own eggs, there are different kinds of guarantee programmes. It’s a little bit different when you are 35 or when you are over 35 because – obviously- the likelihood of having a successful outcome is different as well. BMI is also limited and it has to be under 35. If you still have questions concerning our baby guarantee programme or want to be informed about what it involves or need the assessment of your specific case, please contact the team and we will be more than happy to assist your case and see what would be the best option for you.
At the age of 44, the chances of having a successful outcome – even if you had higher AMH – would already be very low. It’s mainly because of eggs’ quality. Of course, I cannot say that it is impossible because it’s medicine – it’s not like mathematics and sometimes there are some exceptional cases. But with AMH of 0.02 and at the age of 44, I think that the chances of having a pregnancy with your own eggs would be extremely low. My very strong recommendation would be to undergo the cycle with an egg donor rather than with your own eggs. Obviously, I have very little information about your case. There are a lot of things that I’d usually like to assess before giving any advice. However, with the information that you’re giving me, what I can tell you is that the chances of a successful outcome with your AMH, your age and own eggs are unfortunately very low.
Yes, absolutely. There are no restrictions regarding this in Spain. A single lady can also adopt an embryo, no problems with that.
I’m sorry but I don’t usually inform patients about the costs. I don’t want to give any misleading information so I would really recommend you to send an email to Fertty International, asking for the quotation. And if you wanted some more specific evaluation of your case, we can offer you a free online consultation during which we discuss the treatment options. You can also discuss the quotation for embryo adoptions and then you take it from there and check which treatment suits you better – according to everything that you have.
Yes, we have embryos in our embryo bank so for now, there is no waiting list for that. And yes, we have couples who are willing to donate their embryos – that’s the reason why we have the embryo bank. These are patients who don’t want to continue paying for the maintenance of their embryos but – at the same time – don’t want to destroy them. They usually have had a very difficult fertility journey and they are very conscious about that and they just want to help other patients with their surplus embryos. They say: ‘Let’s help someone else have children and be as happy as we are right now – as parents’.
Egg donation in Spain is anonymous so you cannot provide your own donor. The only way that you could provide your own donor would be if we had the certainty that it is an anonymous donor and that you have not intervened in the donor selection. So it’s kind of a tricky situation, so to say.
Yes, it’s the same thing but people use different names – so that’s why we put both of them.
Yes, we collaborate with different courier companies. But again, I prefer to double check the list of all these companies with our lab and then get back to you with a recommendation of a courier that is safe, fulfils all the quality criteria and can give you some guarantees.
I believe what you mean is if we do the semen analysis in our clinic – then yes, of course. However, if you’re asking if we have our own sperm donors – then no. We use sperm banks. But we have our own egg donors – only in some specific cases, for some specific phenotypes, we might need to request eggs from an egg bank. But 95% of our cycles of egg donation are with eggs from our own donors.
You can get the medications in France. Otherwise, if you have to come to the clinic for anything, we can give you a prescription and you can buy them here. Or we can send you a prescription and you can get the medications in France. Almost all our patients from France are able to get the medications there without any problems.
It’s kind of tricky to say anything related with autism because autism is a multifactorial disease. It means that there is a part of it that is genetic but there are other parts that might not be genetic. So even if you wanted to do PGT of the embryos that are left frozen, there is no full 100% guarantee that this could be detected. So I completely understand the concern. I think that probably the best thing would be to do a consultation with a geneticist to explore all the different possibilities.
Yes, we do it if it is indicated. It is the endometrial receptivity test to check if there is any kind of alteration in the receptivity of the endometrium when we are getting ready for the embryo transfer – regardless of the fact if it’s with own embryos or embryos from an egg donor. It is usually recommended for all these patients who have had implantation failures. It means that they have already had several transfers with variable quality embryos (hopefully those embryos that have already been tested for PGT) and they did not get any implantation. When, while doing scans, we see that the thickness of the endometrium and everything is fine and there aren’t any other reasons why the embryos might not be implanting, then we usually recommend the ERA test. We have to make sure that the window of implantation is not displaced and we need to know how many days of progesterone we need – if, according to the result of the test, there is a displacement.
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