In this session, Dr Uliana Dorofeyeva, Director of International Cooperations at IVMED, Ukraine, and a Medical Director at OVOGENE Egg Donor Bank, talked about IVF, egg donation and other treatments’ legislation in Ukraine.
In this webinar, Doctor Uliana Dorofeyeva talks about IVF legislation in Ukraine, which she considers very important because millions of people around the world are experiencing infertility. Part of them would start using their own oocytes and own sperm, which are treatment strategies widely available in the world. However, some regulations are changing.
You have probably heard about the historical moment of changes in France when it started to be allowed to treat married official couples as well as single men and women and unofficial couples. Legislation is changing, and opportunities are here, but before COVID-19, many patients from different destinations all over the globe needed to experience and learn about different countries and different regulations because of the limitations in their home countries, especially limitations for some kinds of treatments, such as egg donation and surrogacy.
If you cannot find an alternative or you’re not producing your oocytes and you need, for medical reasons, egg donation treatment and there’s no allowance in your country, you should look for opportunities elsewhere or other alternatives. This is the same for surrogacy if it’s indicated for medical reasons.
Something important to discuss is medical tourism for IVF. This is to reduce the cost for cross-border medical treatment to look for the same high-quality care and services in different destinations and, sometimes, it’s also combined with attractive destinations which is also nice.
I’m proud that Ukraine is one of those countries which has been receiving many patients from all over the globe, and I remember this like last year 2018-19 before COVID started, when we received over 500 patients from more than 30 countries during a year for different kind of IVF treatment, especially for egg donation, surrogacy, and some special alternatives which we call ‘experimental treatments. – says Uliana.
Dr Dorofeyeva has been practising IVF since 2008 and mostly works for international markets between clinics, partners, and also for international patients. She goes on to show a graph that involves Ukraine, Spain, the Czech Republic, North Cyprus, Greece, Russia, Poland, and more, from Egg Donation Friends’ website. Here you can see that from November 2020 until the end of the first quarter of 2021, there is post-COVID data that shows the number of registrations of patients who are looking for treatment in different destinations.
Moreover, Dr Dorofeyeva gives detailed information about Ukraine.
Oocyte donation is probably one of the most common treatments.
IVF in Ukraine is regulated by the Family Code of Ukraine, and the instructions of the procedures for the use of assisted reproductive technologies are approved by the order of the Ministry of Health. This law hasn’t changed since 2013.
According to Dr Dorofeyeva, regulations are quite strict from the beginning and they aren’t going to be changed.
In Ukraine, they’re working to have a reproductive law; however, it should be based on the order of the Ministry of Health. This states that:
Moreover, article 123 of the family code of Ukraine determines the origin of a child born as a result of the use of assisted reproductive technologies. This says the following:
It’s important to mention that the age limit for IVF treatments in Ukraine isn’t determined, so adults who have medical indications, both male and female, for the use of ART technologies can be treated by IVF techniques.
Moreover, the decision and procedure are established by each clinic independently taking into account ethical and moral forms. Generally, you will hear from the clinics that the age limit is probably 51, 54 or 56 years old; however, they would definitely consider the somatic status and the health status of the patient.
Genetic testing of the embryos is performed to reduce the risk of hereditary diseases, and they can increase the frequency of the pregnancy.
This treatment can also indicate the possibilities or the risks of giving birth to the child with mutations of any isolated gene or with chromosomal abnormalities which have been detected as a result of medical and genetic examination.
Moreover, PGD may be performed at the patient’s discretion in the presence of the application for the pre-implantation genetic testing in the form of an Annex from the order of the Ministry of Health.
Experimental treatments aren’t specifically regulated by the law. In Ukraine, these include the ovarian rejuvenation, mitochondrial donation, pronuclear transfer, IVIG treatment, which are performed in accordance to the medical evidence and practical experience of the physicians and the experts in the clinics. Nevertheless, this is done after having signed consent and after considering all medical risks for the patient.
This, article 48 of The Law of Ukraine, states the following:
Furthermore, by the Order of the Ministry of Health, there are different types of donations allowed:
The oocyte donor candidates should be:
Nevertheless, egg sharing or so called egg sharing for oocyte donation, isn’t as common as in another countries. The privilege of oocyte donation are anonymous or non-anonymous considered by law female donors who are donating for the need of the infertile patients.
The requirements, by law, for oocyte donors are the following:
Dr Dorofeyeva mentions the indications for IVF treatment with oocyte donation, which are:
The requirements to be a sperm donor are the following:
In addition to the regulations by law, clinics may also decide regarding the specific signs or, for example, in Dr Dorofeyeva’s practice, they don’t allow donors to be over 30 years old because of the presence aneuploidy of the oocytes and they also control the quality of the biological materials donated by donors. Also, other criteria could be additionally dedicated by the clinics.
In embryo donation, the donor may also be a patient of IVF programs who, after birth, has their cryopreserved embryos stored in the clinics. To donate those embryos, they should sign a consent form.
Moreover, donated embryos could be created from donor oocytes and donor sperm.
In addition, under the voluntary, informed, written consent of donors or patients, these embryos may be used for the treatment of infertile couples who are recipients, as well as female recipients or single women.
Embryo storage isn’t limited by law as it is in some countries in the world where there’s limitation for 5 or 10 years of the storage of the biological materials for the patients.
In Ukraine, you may store your materialsfor as long as you wish. There should be just a signed statement due to which there’s an agreement for the storage of the embryos in the specific medical institution for the certain period of time. However, this period may be prolonged.
Furthermore, the clinic may destroy patients’ embryos only after receiving voluntary consent, originally signed by the patients. Nevertheless, Ukrainian law doesn’t have any procedure which regulates this issue; if there’s no signed document from both sides. Also, this can happen when many of the clinics are storing a lot of embryos and patients, especially patients from abroad, aren’t communicating with them.
Therefore, you must make sure that if you haven’t provided written consent with two original signatures, your clinic shouldn’t destroy your embryos.
According to Dr Dorofeyeva, the transportation of biological materials across the Ukrainian border is happening; however, there is no specific law which regulates this transportation. She also mentions being the co-founder of the Association for medical transportation because there are some discrepancies and some questions which need to be answered.
What they recommend to patients, because a lot of the transportation of biological materials is happening from Ukraine to different destinations as well as from different destinations to Ukraine, patients should provide a statement and an act of transferring cryopreserved embryos. There’s a draft of this act which you will receive by the clinic as well as a letter that the biological materials are ready to be sent and that another clinic is going to receive them.
Moreover, for the transportation through the customs, there should be a special code received for those biological materials. For this reason, it’s better to use special companies who have experience in this and, preferably, to be performed as the hand carry because there’s no specific procedure and to avoid keeping these materials for the long time in the customs.
It’s also known that the special containers, where the transportation is performed, have a certain time once they keep these special conditions and safe conditions for the embryos. Therefore, this should be well controlled and by the dedicated people; however, it’s happening quite often.
If this is happening to the company, they will avoid X-rays. If the clinic provides the statement that the material shouldn’t be x-rayed, and according to Dr Dorofeyeva, who has been involved in many of those transportations, the big airports which formally know the procedure, don’t perform the x-ray for the biological materials.
Additionally, different IVF techniques and the procedures are allowed and performed successfully in Ukraine, such as IVF, ICSI, IUI, Assisted Hatching, Frozen Embryo Transfer, Oocyte Donation (both fresh and vitrified embryo donation/adoption), Social Freezing and Preservation, PGS/PGD, Experimental treatments, and Ovarian Tissue of Cryopreservation.
Dr Dorofeyeva mentions some of the reasons why people should choose Ukraine to undergo treatment.
In many countries, the procedures are very limited or not allowed, such as oocyte donation and surrogacy.
Most of the procedures are much less expensive than in some comparable countries with the same quality of care and treatment. The quality of care and treatment in Ukraine is extremely high and you need to be specific in terms of selecting the clinic because, as mentioned before by the doctor, there are over 60 clinics practicing in Ukraine.
I’ve been working since I started my practical experience in the clinic, which was second on the territory of Ukraine, and we’re joking that even our IVF specialists are all quite young, your professional experience and expertise are not according to your age, however to the number of the treatment cycles you performed. – says the doctor
Even right now during the COVID situation, there’s no quarantine. This is also important to mention because patients may go even during all the time of the quarantine for the medical treatment.
You just need to ask your clinic and your physician to provide this data and all good clinics have this very specific information due to the infertility related to the age of the patient. Therefore, they are very open to share this.
These clinics, which are busy and take care about their patients, have enough oocyte donors or use egg banks. They usually have enough surrogates to start treatments immediately.
Moreover, their donors have extraordinary beauty and the proven fertility. The clinic also follows the screenings according to the regulations, not only in Ukraine but also for international regulations. This involves extended genetic testing, psychological deep evaluation for the donors, including all infectious disease with the PCR testing that gives more certainty about the detection of the infection.
For donors, Dr Dorofeyeva mentions that in her bank, they check the quality and the previous results, so they may share this data and predict the result from this donation. They only use very successful donors with great results.
To select a clinic in Ukraine from the huge list would be:
This is very easy to get right now. Some clinics, out of this big list, are ISO certified. This means you can ask for the internal procedures, instructions, SOPs for the specific procedure and how it’s going to happen.
Specifically for international patients, this is important. You need to have a person who will be 24/7 in touch with you answering all questions providing very detailed information with regards everything, starting from the accommodation, cost, success rates, how long should you stay in Ukraine, and what will be happening during each stage of your treatment.
The doctor can do a lot and the clinic can evaluate your previous history. Very often, patients who go to the clinic for a second opinion, are those who have repetitive negative outcomes before and they’re doing a lot in terms of the evaluation of the medical history of looking for the specific reason for their infertility. However, without a successful and well-experienced team of embryologists, this would be just a half of the success.
We may say that our embryologists in our team are the best. – affirms the doctor.
They need to be by the international requirements which is easy to follow.
The clinic also knows what needs to be done additionally, and this is a comfort for the patient to do this all in one location with the same team.
Clinics are communicating very openly now and every patient who has experienced the treatment in that clinic will be happy to share his or her experience.
This is important because there should be clear agreements and clear guarantees. In good clinics, not even one lawyer is working; however, a legal team is also involved in explaining all the details in terms of, specifically, surrogacy which always comes with many of the questions as it’s really time consuming and not an easy procedure due to the regulative aspects.
Due to the COVID situation and even before, part of the activities in clinics as well as their responsibilities was to provide export of biological materials out of Ukraine and to help different clinics and their patients all over the globe to stay at their home country with the best comfort and avoid travelling as well as get the biological materials in their home country, if possible, and regulated by their law.
Therefore, they’re sending a lot of oocytes and embryos created in Ukraine to different destinations. You just need to share with the clinic where you are located, and this will be possible, as well to avoid travelling to Ukraine. Nevertheless, you should get some of the treatment done in your country under the agreements between the clinics.
Yes, of course. This is as I mentioned, these are not just the requirements of the law in Ukraine because there is a list of the tests which need to be performed for the donors. However, we do a lot more and this is according to our practical experience and just to confirm that we’re doing everything according to the good clinical practice recommendations and international recommendations. So, there’s a list of tests which are five drugs, nicotine and alcohol, which are performed during every stimulation for every donor and the results, by request of the patients, may be included in the list of other tests which are usually provided for the donors, such as Karyotyping and infection panel, consultations of the doctors, etc.
By law, we might treat individual patients who are single women and have medical indications for IVF, so quite often, we know there’s a donor, and there could be a known donor for the patient, so this is how this method could work. However, by law, we need to be sure that we are following the regulations and that there’s a woman who has a medical indication for oocyte donation or surrogacy. There could be another woman who is a known donor, so she could be a known donor in Ukraine, and she may produce her biological materials to be used by another patient. This is how this method can work, but I would say in my practical experience, we don’t have a lot of those patients asking for this, but probably now there will be a possibility to get more.
There’s still much information which we may not be sure about, specifically, x-ray is also in this list of those questions; however, it was my interest to make sure what the dosage of the different kinds of radiation during the transportation of biological materials and this is a published data regarding which the medical courier, who was performing a hand carry transportation, was measuring the level of the x-ray in mock transportation, so there were no materials inside, just an empty container, which was going through the x-ray and then during the flight for different destinations; the short destination, meaning a different level where the aeroplane was flying under the earth, and long destination flights. I should say that for the long destination flight, the level of irradiation they had special equipment to measure was almost the same as during the x-ray check in the airport, and it was much longer.
However, also in my experience, we had some long transportation after which we did the NGS testing of the embryos created from the oocytes, which were during this transportation, and these were companies, not our company, which we are considering now doing a hand carry, but it was cargo transportation. We were not sure that during this cargo transportation, x-ray was avoided, so the level of the mutations coming from those donor oocytes was extremely high, it was over 50%, and we considered that this could be an issue related to the x-ray. However, there is not much evidence about this, and different clinics could have different opinions, but our opinion is to avoid x-rays during any transportation and perform hand-carry transportation with the presence of the person who will take care of this all the way if this is possible.
Yes, in Ukraine, we perform gender selection as it was mentioned by law, so there should be a statement by the patient that she is requesting the gender selection. For medical indications, it is performed to avoid sexually transmitted diseases and mutations and also the family balance.
Yes, Canadians are performing IVF treatments in Ukraine, I would say quite many of them even though in Canada, surrogacy is allowed and performed, but I believe there’s a price difference, the reason why Canadians are coming here as well as the patients from the US. There is no need to fly the surrogate to Canada because it’s much easier in terms of the logistics and risks and also, right now, the issues with the visas and passports. For example, to get a surrogate who will easily enter Canada, it’s not that easy, and to request for Canadian or US visa right now they are issuing only essential visas, so it’s easier to bring embryos and to perform embryo transfer here for the surrogate and to follow all these procedures.
You would need to contact the clinic, you would need to get information about how all this happens. Clinics usually have a lot of information about every step of the treatment for the surrogate, ultrasound, and embryo transfer. Some coordinators are taking care of surrogates and communicating with the patients, so the best way would be to fly embryos to Ukraine in this situation.
In Ukraine, because surrogacy is allowed, we perform surrogacy for patients from different destinations. For those countries where surrogacy is also permitted, it is much easier, but for each process and before starting this surrogacy treatment, we always recommend each couple depending on which nationality they are and, specifically, who the father is, to consult with the lawyer to get all the clear information regarding the process and what needs to be done prior.
For some countries, there are some activities and actions, which need to be done before starting the IVF treatment, and then after they have a clear understanding of the process, we’re starting the medical process. Also, reading the agreements, signing all the agreements, understanding if there’s a need for DNA testing for the baby after delivery, etc., so many questions need to be solved in advance, but for Canadian patients, because they are written as a mother and father as I stated during the presentation, the married couple who used surrogacy they are in the birth certificate, they are already written as the mother and father, so together with all additional documents which will be in details providing this information by the lawyer, it is very easy to get to Canada together with the baby.
The process is a bit different for the countries where surrogacy isn’t permitted, and then there are some other recommendations; how this needs to be done in order, patients need to be here during the baby delivery, they need to communicate with the consulate before the program start to get additional permissions, so this is all communicated by the lawyer. This is a lot of situations, and better to discuss this before the program.
For single men, we cannot do surrogacy, but we can do egg donation, also just for a single woman. For single men, absolutely no treatment is allowed in Ukraine.
Yes, for single women, we can do double donations. However, the lady who is a mother is carrying the pregnancy and she delivers the baby, she is written on the birth certificate; however, we cannot do double donation and surrogacy, so at least one of the parents should be genetically dedicated to the baby, so we cannot do surrogacy for single woman and we cannot do surrogacy with the material which is absolutely like the donor egg and donor sperm. But for a single woman, a double donation and transferring embryos to her uterus may be done.
Yes, we are offering live birth guarantee packages. There are special indications for the sperm quality and we will be happy to share with you this specifically. This is a pharmacology, DNA test, Karyotyping being normal, etc., and for live birth guarantee we can do also for transferring embryos and for certain number of blastocysts. Also live births for surrogacy.
Yes, we do.
We’re working with the certified laboratory, we are not doing NGS24 in our laboratory, we are just doing the biopsy; however, the logistics is very easy and fast going so we are getting results within 10 to 14 days.
Ovarian Rejuvenation is a technique where once we inject platelet-rich plasma from the patient into her ovaries, and by injecting PRP plasma we make pre-antral follicles which are going to be ready for the accepting FSH and grow, normally, during 200 days, so they are getting faster, recruiting faster and this patient, if this is a patient in her advanced maternal age, she is responding with the nicely growing small antral follicles and, as soon as we may see her follicles, we are starting stimulation of such a patient. Usually, this is a procedure which is dedicated to those patients who would like to have a last trial of having an opportunity to produce their own eggs. After PRP injection, we usually see that FSH is going down, AMH is getting higher, and we may see nicely growing small antral follicles.
Mitochondrial donation and Pronuclear transfer are alternatives for oocyte donation. In these procedures, we use mitochondria from a donor, and we use a nucleus from the patient oocyte. Once exchanging nucleus and giving a potential of mitochondria from a donor to help this embryo to develop, the results are much better in terms of the blastulation, implantation, and the euploid rate of the embryos. Also, patients in their advanced maternal age have an opportunity to carry their own genes because genes come from the nucleus.
There is no difference. The biopsy is the mechanism which we do for the embryo in order to get a cell of the embryo to get it tested. The NGS24 is the method of how we are performing genetic testing of those cells coming through the biopsy from the embryo.
Every biological material which comes into our laboratory has a mark, and also the chips, all straws and vials. If this is a sperm, they are labelled with labels which are cryoprotective. They are not handwritten, they are printed and this is a set of labels which is printed for this patient and the same label is used for the medical documentation, for the dish where we are going to do the denudation, for the dish where we’re going to do ICSI, and for every straw independently how many straws this patient has.
Also, we have a system monitoring the storage, so we have a big map of all the storage which we have and there are canes and vessels. All these canes and vessels, including their colours and numbers, are in the system, so we know this comes from the machine with artificial intelligence and is also controlling this. We know in which vial the straw is located. The chip is read by the electronic witness procedure, so there is an embryologist who reads a label, and this is a specific label for the specific patient. There is also an electronic witness reader, which reads the same information from the system.
In the straw there is an information about the patient’s name and patient specific number, date of birth, date of the freezing of biological material, and type of the biological material which is frozen on this device.
No, there are just numbers on the straws, and these numbers are indicated in the system.
So far, the patients we got for blastocyst and embryo transfer were 47 years old.
We would recommend for patients who have at least 0.1. However, many of those patients have even less. Nevertheless, the critical factor for us to proceed with the pronuclear transfer is the number of oocytes received, and some patients are asking to combine oocytes from several treatments. For example, we got one oocyte from one treatment, another oocyte from another treatment, and then the third oocyte, and then only after that did we start the pronuclear transfer technique. We also had patients with AMH lower than 0.1; however, the most successful patient was in terms of her inclusion criteria, and the easiest and most successful was the treatment itself.
Yes, we do it in our clinic and it’s a quite simple technique. Patients need to come one hour and a half before the implant procedure. We draw about 20 millilitres of her blood, perform centrifugation, and then just take out the platelet-rich plasma. After it is ready, we do the injection immediately. It’s done under anaesthesia. If the patient has any negative feelings during this procedure and she stays over one hour in the clinic, then she may leave the clinic. The recommendations are to check the level of FSH and AMH and perform pelvic scans to check the efficiency of the procedure.
The costs please email me and I will dedicate you to our coordinators and they will be happy to provide you information regarding the costs, but it’s up to, I can be mistaken, 1000 euro per procedure including the tests which needs to be done prior to it, but we need to double-check.
