Ethical dilemmas posed by surplus frozen embryos in Argentinean fertility centers

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Authors:

Natacha Salome Lima, A. Gustavo Martínez

Consejo Nacional de Investigaciones Cientificas y Tecnicas
Buenos Aires, Argentina

Abstract:

In Argentina, access to ART treatments has been regulated since 2013, but the law fails to define a number of important issues, including embryo disposition decisions (EDD) and national registries. Disputes regarding the legal status of cryopreserved embryos are a multifactorial problem that, in Latin-American countries, is also associated with the influence of the Catholic tradition on policy makers, and a clear resolution of embryo disposition remains a difficult topic. Also, improvements in IVF laboratory procedures, such as single embryo transfer (eSET), preimplantation genetic testing (PGT), and the freeze-all strategy, have led to an increase in the number of frozen embryos being stored. Yet, little is known of how these enhanced procedures might influence EDD. To collect data on storage content, an online survey was sent to all reproductive facilities, during 2017 and 2020. Based on the survey results, we found a tendency that shows an exponential increase in the number of frozen embryos being stored (by 68.5%). This is a consequence of the improvements in cryopreservation techniques (vitrification) and the development of more efficient ovarian stimulation protocols that have facilitated a rise in elective single embryo transfer (eSET). This paper focuses on three strategies that could be implemented to facilitate EDD under this particular setting. First, counseling sessions at different treatment stages should be encouraged and would be conducted by trained mental health professionals. Second, once storage content is labeled, aneuploid embryos and embryos which were cryopreserved more than 10 years ago, could form part of a national bank for research purposes. Third, promote effective regulation that includes EDD and explicit storage limits.

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Introduction

During the last 10 years, improvements in ART procedures have led to higher rates of pregnancy (1). The international committee that monitors progress in assisted reproduction reports that well over 8 million babies have been born by medical interventions worldwide and the number of ART babies is steadily growing (2). Considering that 25% of these children have been born from frozen embryo transfers, it might be estimated that between 2 and 3 million babies have been born through IVF procedures worldwide (3). The recent advances in clinical and laboratory procedures have decreased various risks. For instance, milder ovarian stimulation has reduced the risk of ovarian hyperstimulation syndrome; better culture media composition and adjustment of the duration of embryo culture has improved pregnancy rates; freezing and thawing techniques, as well as an increase in the strategy of elective single embryo transfer (eSET) have significantly lowered the risk associated with multiple pregnancies and reduced those encountered in perinatal and obstetrics (4).  

Despite contributing to higher rates of pregnancy and live births, one consequence of such modifications is an increase in frozen embryos. Embryo disposition decisions (EDD) is a complex phenomenon associated with clinical, ethical and legal challenges. Regulations regarding EDD vary among countries. Some European countries, such as Germany, Italy and Switzerland, have stricter regulations protecting embryos. In the case of Italy, the influence of the Catholic religion has had an interference in many assisted reproductive processes (5). In 2009, the Constitutional Court ruled that the obligation to generate a maximum of three embryos to be transferred simultaneously and the ban on cryopreservation was unconstitutional (6). At present, the norm is that only a strict, necessary number of embryos must be produced, in accordance with medical advice. In the Asian context, countries such as India store cryopreserved embryos for a maximum period of 5 years, and do not allow embryo donation to other couples, due to existing regulatory restrictions (7). While Japan has adopted a similar prohibition on embryo donation for reproduction, the Japanese Society of Obstetrics and Gynecology (JSOG) has regulated the storage limit to be until the end of the woman’s reproductive life (8).  

Latin America faces the problem of embryo disposition decision at a regulatory level, with Brazil being the first country in the Region where the discard of cryopreserved embryos has been regulated (9-11). New Resolution of the Brazilian Federal Council of Medicine (CFM) defines that cryopreserved embryos can be discarded after three or more years, should it be the expressed will of the patients and, for the first time, it states that this applies to abandoned embryos as well. The CFM define that abandoned embryos are those from the owners who failed to comply with the pre-established contract and those patients were not able to be contacted by the clinic that performed the procedure (11). In Argentina, the lack of an adequate regulatory framework regarding embryo disposition is mainly associated with the influence of the Catholic tradition on policy makers. This trend has only recently begun to be changed with the regulation of the access to the Voluntary Termination of Pregnancy (Law No. 27,610/2020), introduced last December. However, the debate about the legal status of cryopreserved embryos is still pending and should be part of a different discussion.

The legal status of the embryo has been the subject of a strong debate since the Civil and Commercial Code was enacted in 2015 in Argentina. At that time, a distinction between the stages of conception and implantation after IVF was incorporated in the draft of the Civil and Commercial Code. This difference is important because conception and implantation, in the context of IVF, are two different moments that can be separated by years. Due to pressure on the legislators from the Catholic Church, this distinction was removed and the definitive text establishes that the existence of the human person begins with conception. What is understood by conception in the field of IVF is a legal dispute that separates the waters between those who consider that the embryo is a human person and those who do not. If we take into account that Argentine legislation allows cryopreservation and donation of embryos for reproductive purposes, it is understood that it would not be appropriate to treat an embryo as a person. It should also be noted that the Civil Code includes the need to enact a law that determines the protection of cryopreserved embryos. However, since 2015, after presenting various legislative projects, that law has still not been enacted.

On a different note, cultural values towards the embryo can be associated with discomfort, guilt, or psychological burden. In many cases, once patients achieve pregnancy and fulfill their child-wish, they need to come to a decision about the fate of their remaining frozen embryos. Previous research suggests that many people find embryo disposition decisions (EDD) difficult and emotionally distressing (12). Patients arrive at this decision privately and often without the involvement of the medical staff (13). Although many patients choose to donate their remaining embryos to other people or couples as an initial preferred disposal option, this wish is often simply contemplated rather than performed (14). Studies suggest that patients often feel that they are unable to make satisfactory decisions when presented with the current embryo disposition options: store for reproduction; thaw and discard; donate to others; or donate to research — or they do not provide updated instructions, after leaving their reaming embryos in an unclear situation for a period of time (15).

It is common to face ambivalence during the decision-making process, which could lead to embryo abandonment. In a Japanese study (8) this ambivalence is framed under the term Mottainai, which is an expression of sadness and guilt over the disrespectful and wasteful treatment of valuable entities. According to the Ethics Committee of the American Society for Reproductive Medicine (16), in cases where no written disposition nor contact with the patient or couple is possible, the embryo is considered as abandoned and the facility may dispose of it. In some cases, other ‘solutions’ such as the request for nonreproductive transfer appears and raises ethical questions and concerns. Recently, the ASRM (17) analyzed the concept of compassionate transfer, which means a patient requests the transfer of existing cryopreserved embryos into her body, with the intent not to get pregnant, but rather to dispose of the embryos. The analysis revealed that in rare but clinically and ethically significant cases, some patients prefer methods of disposition which are less “sterile” or more “natural” and are different to the existing options.

We wondered if the difficulties associated with EDD may be greater when having more available frozen embryos. Therefore, we conducted an online survey to get an overview of the local situation. Most fertility clinics in Argentina are private entities, as there are very few public providers. Access to ART treatments has been regulated since 2013, but the law fails to define a number of important issues, including EDD and national registries. An online survey was sent to all reproductive facilities to collect data on storage content and the results were complemented with data from the Latin American Register (RedLara) and the Argentine Registry of Assisted Fertilization. In the following section a comparison of survey results from the Argentinean context will be presented.

Results

The Latin American Register of Assisted Reproduction (RLA) collects the results of ART procedures reported by the centers, annually. Over the last decade, cryopreserved embryo transfers have increased substantially and this rise now exceeds the follicular aspirations performed in the same period (18). During 2017, a preliminary study was conducted that showed that there were approximately 54,432 frozen embryos stored in 46 Argentinean fertility centers. Almost 40% of them were cryopreserved before 2007 with slow freezing techniques (19). Such slow freezing techniques have depicted a low success rate when compared with vitrification, as declared by Rienzi and colleagues (20).

 In 2020, the total amount of frozen embryos reached 91,724 stored in 54 centers. Despite the number of treatment cycles (IVF + OD) being constant between 2017 and 2020 (with a slight increase of 8%), the number of frozen embryos has increased exponentially (by 68.5%).

Table 1: Evolution of storage content in Argentinean fertility centers between 2017 and 2020

 

2017 

2020 

Fertility centers surveyed  

57 

64 

Response rate 

46 (81%) 

54 (84%) 

Total number of cryopreserved embryos 

54,432 

91,724 

Total number of cases with cryopreserved embryos

21,773 

36,690 

Cryopreserved embryos ≥ 10 years *

21,684 (39.8%) 

23,671 (25.8%) 

Total number of cases with cryopreserved embryos ≥ 10 years 

8674

9468

*More than 70% were cryopreserved using slow freezing techniques

Since 2017, the normative background has not changed, but we noticed that some developments in the IVF laboratory procedures might lead to an increase in frozen embryos. Therefore, we conducted a second survey to analyze how these improvements in IVF laboratory procedures have affected the number of frozen embryos in Argentinean fertility centers. This time, 54 fertility centers participated with a higher response rate (84%). (Table 1)

Table 2. Total treatment cycle in the different laboratory procedures between 2017 and 2020

2017

2020

IVF + oocyte donation (OD)

18,786

20,308

PGT

587 (2.9%)

1268 (6.2%)

eSET

5281 (26.4%)

7614 (37.5%)

Day 2-3 embryo transfer

8761 (43.8%)

6819 (33.6%)

Day 5 embryo transfer

5116 (25.6%)

6523 (32.1%)

Freeze all

2163 (10.8%)

4765 (23.5%)

 

Data from the Latin American Register of Assisted Reproduction (RedLara) (18) and the Argentine Registry of Assisted Fertilization (RAFA) shows that there was an increase in single embryo transfer (eSET) of 11.1%. PGT and freeze all procedures have also grown (Table 2).

Discussion

How have these improvements in IVF technologies affected daily practice?

The increase in cryopreserved embryos is associated with the changes of IVF laboratory procedures, such as moving towards single embryo transfer, blastocyst versus cleavage-stage embryo culture and greater access to PGT. Indeed, improvements in cryopreservation techniques (such as vitrification) and the development of more efficient ovarian stimulation protocols have facilitated new strategies, such as elective single embryo transfer (eSET) and freeze-all strategies that have emerged as accepted and valuable alternatives to fresh embryo transfer, delaying the treatment cycle and avoiding ovarian hyperstimulation syndrome (21).

When comparing the reports for the years 2017 and 2020, it has been observed that the eSET increased by 11%. In general, eSET is performed using blastocyst stage embryos (Day 5), thus decreasing Day 2 and Day 3 transfers and when performing eSET, the remaining embryos are cryopreserved. PGT technology has become an integral part of ART procedures and is developing steadily. Embryo biopsies are performed to select the embryo with the highest expected success, avoiding monogenic diseases and aneuploidies (22).

Furthermore, the use of freeze-all strategy has also grown since 2017. This implies that the entire cohort of embryos is cryopreserved in order to be transferred in unstimulated cycles when the uterine environment is regarded as more receptive. This helps avoid supraphysiological hormonal conditions that adversely affects endometrial development and function (23). In the next sections, some insights related to the increase of frozen embryos will be addressed, considering the problems associated with embryo abandonment and the difficulties perceived in embryo dispositions decisions. 

Do the improvements in IVF laboratories contribute to an increase in embryo abandonment?

IVF laboratory procedures contribute to an increase in cryopreserved embryos but this does not relate to more embryo abandonment. After analyzing storage content, it was found that 1 in 4 embryos have been cryopreserved for more than 10 years (25.8%). Although, it is a dynamic process in which new embryos are daily cryopreserved and others are transferred or discarded, the problem of remaining embryos, especially those cryopreserved more than 10 years ago, still persists. Considering the total number of cases with cryopreserved embryos (21,773 in 2017 and 36,690 in 2020 – see Table 1) compared with the number of embryos cryopreserved more than 10 years ago (21,684 in 2017 and 23,671 in 2020), the growth was not significant.

The problem of abandoned embryos has already been discussed and, as Cattapan and Baylis stated (24), fertility clinics are now in the precarious position of either discarding them in an unclear regulatory environment, or storing them in perpetuity. Also, while regulatory context varies in different countries, most face the challenge of adapting regulations to the problems of clinical practice. In some cases, there is a time limit for embryo cryopreservation. For example, in India, the current guidelines suggest a maximum storage period for cryopreserved embryos of 5 years, but embryo donation to others is not allowed, even though many subfertile couples preferred to donate their embryos to others, rather than discontinue storage (7). Having achieved pregnancy and the time elapsed to achieve it through IVF, there are two variables that influence decision-making about the remaining frozen embryos. In some cases, people are unable to make a decision, because existing options do not seem satisfactory to them and delaying the decision is a way to avoid making a decision. Studies have shown that patients prefer to store their embryos for future attempts and that they are emotionally attached to their embryos and conflicted about their disposition (15, 25).

Continuing embryo storage without clear guidance and limitations presents problems for both patients and clinics and it is a shared responsibility between the clinic and the patients to keep cryopreserved embryos. As having children is a vital project that is limited in time, it would contribute to the problem to define a time limit for embryo cryopreservation, which several countries have established as being between 5 and 10 years.

What are the main reasons for difficulties with the embryo disposition decision?

Changes in clinical practices lead to an increase in good quality embryos, but the numbers are not the critical issue. These numbers reflect the problem that the Argentinean culture has when it has to define the status of preimplantation embryos.  The legal gap and the doubts that patients have faced during treatments have shown that what is at stake is the symbolic embryo representation (26), which means the way patients perceive and refer to their frozen embryos. This is a key factor to predict decision-making problems, but it might change during reproductive treatments. The nature of the links between embryo representation— i.e. the meanings and value attached to the embryo, which may vary throughout the reproductive journey and the decision to donate or discard, remains unclear. In many cases, patients refer to their embryo as a child and choose the discard option; others feel that their embryos are a symbol of their relationship (27), reporting feelings of grief and a more affective attitude towards the embryos. In the same way, patients’ views regarding the moral status of their embryos are the strongest (negative) predictor of embryo donation. It seems that couples undergoing fertility treatments find it difficult to donate embryos to other couples when they, themselves, are not guaranteed to have children of their own and many prefer to continue storage indefinitely (15). In couples who have fulfilled their child-wish, some research suggests that donors continue to see themselves as having a degree of parental responsibility. At least for a proportion of donors, their willingness to donate may be affected by enabling donation under certain conditions, such as the selection and assessment of recipients, openness about genetic heritage, and future contact (28).

Three strategies to prevent embryo abandonment

In conclusion, we propose three strategies that might prevent embryo abandonment in the Latin American context. First, counseling sessions at different treatment stages should be encouraged. It is difficult to establish a suitable plan for all patients, since some will need more sessions and others less. What follows is an outline that would be the basis for thinking about a successful embryo donation program. The first counselling session should be before the IVF treatment starts and the person or couple would usually need to sign a consent form of embryo disposition, before they actually obtain the embryos. Thus, it is important to discuss the options, but keeping in mind that their anticipated preferences may change. If the treatment was successful and the person or couple fulfilled their child-wish, but their frozen embryos are still stored at the clinic, a second counselling session is encouraged to discuss the possible options. If the person or couple do not achieve pregnancy, the second session will be devoted to working on feelings of grief and loss, and future expectations together, with an evaluation of the next steps. The third session can occur when family planning is over and it will depend on the reproductive results of the person or couple. This session is dedicated to help them to make a decision in accordance with their moral values. These sessions should be conducted by trained mental health professionals because they are prepared to deal with patient’s insecurities and frustrations; they are also usually available to offer a space, in addition to the medical consultation, where patients can address and discuss their preferences, fears and insecurities. Mental health professionals trained in assisted human reproduction are prepared to accompany patients from an integral health perspective, giving a place for the emotional burden generated by decision-making, during assisted reproduction treatments and different studies highlighted the importance of this support (15, 25, 28, 29, 30). Considering the great emotional burden that embryo disposition decisions generate, the need to arrange follow up contact with patients with frozen embryos should be part of patient´s follow up, to find out about their preferences (29).

While there is a trend that supports the embryo disposition decision to be part of a patient’s reproductive autonomy, there is also a need to support a patient’s indecisiveness, which means listening to the reasons that hinder the decision to find the best course of action in each case. It is necessary to give clear guidance along the process and to create an environment in which embryo disposition is discussed during different treatment stages (30). As a result, healthcare professionals could empower couples to decide what is best for them, as opposed to "letting things happen," which is the current situation. Unfortunately, the lack of adequate legislation, starting from knowing what the problems are that assisted reproductive patients face when deciding what to do with their remaining frozen embryos, does not contribute to the patients being able to make a "closure" on the matter. This is shown in the survey results, considering that 1 in 4 embryos are "abandoned". Our survey results show that IVF procedures and strategies are moving towards generating more good quality frozen embryos. Thus, a second strategy could be to create a national bank, for research purposes, containing the embryos that are going to be discarded. This strategy is in line with the latest studies in the Latin American population that suggest that patients prefer to donate their embryos for research purposes: the majority for stem cell treatment and the rest for ART research, and for general scientific research (31). As in Argentina patients must sign a consent before each embryo transfer, they should also sign it when they decide to give their embryos for research purposes.   

Third, promote effective regulation that includes EDD and explicit storage limits. Starting to regulate some practical aspects, such as storage periods, might be helpful initially. However, there is still a need to address a patient’s psychological burdens, which is reported in many and different contexts.

At the beginning of this paper, we wondered if the evolution of IVF laboratory procedures would lead to an adjustment in counseling ART users with frozen embryos. Embryo abandonment is an ongoing problem that could be reduced by establishing appropriate storage limits, regulating embryo disposition, and providing clear guidance and timely information to patients. The survey results revealed that IVF centers in Argentina will face an increase in euploid, aneuploid and untested frozen embryos, due to the changes registered in laboratory procedures. This tendency shows the need to discuss EDD with patients from the beginning of fertility treatment, through to their conclusions. A comprehensive approach to the issue that we have discussed in this article requires considering different levels of approach and different potential strategies. From the perspective of the embryology laboratory, selective and non-massive cryopreservation is proposed. From the field of psychological orientation, it is expected that patients can be hosted, which means providing them with sufficient and appropriate information, enabling them the time to reflect on written information before the treatment starts, and respecting their reproductive autonomy. From the state level, it is expected that clear and coherent regulations for embryo disposal, in line with the challenges of clinical practice, are enacted, drawing special attention to the promotion of embryo donation programs acknowledging cultural values on parenthood and family building.

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