Ethical problems in medically assisted procreation
Abstract. The risks associated with the techniques of medically assisted procreation (MAP) rapidly became well-known, and in such a short space of time that no biomedical domain remained untouched by the great deal of thinking and the expression of a multitude of opinions it provoked. MAP is evolving between two poles: quality/misuse (even violation) and evidence/fantasy. The ethics will be evoked in the clinical reality from which they spring and where their justification lies. The three objects common to these ethics, the oocyte, the embryo and the child, are illustrated in this context. MAP has as its corollary access to the oocyte, the fertilization of which will take place in vitro. Access to the embryo, on the other hand, enables the clinician, for the purposes of diagnosis [preimplantation genetic diagnosis (PGD), predictive medicine], or even soon for therapeutic purposes (gene therapy) to draw close to a boundary, to trespass beyond which may be seen by humanity to threaten its very origins and integrity: the alienation of the human genome. For the infertile couple, the missing child may take on a dimension of which they would have been unaware, had they not been forced to express their desire. The burden of the imaginary child may, in this way, become a heavier load to bear when, after such desire, he comes into being. MAP puts the goal of normalisation within reach and, in doing so, accentuates the risk of the burden of the attributed representation of the child. On the one hand, MAP offers a tremendous diagnostic and therapeutic potential, while on the other it opens the door to excess and delirium.
In this melting pot, ethics, catalysed by this new source of problematics, has discovered a favourite area in which to define and redefine itself. We propose the intervention of ethics on three different levels. Before the elaboration of the law: on first reflection, ethics may influence the responsibilities of the legislator, by taking care that the law does not obscure the biomedical and socioeconomic contexts of MAP and, thereby, also include other related and complementary aspects dealing with the same subject. The secondary discussion of ethics should influence the application of legal protection, by taking into account the rapid technological and social development of MAP, there too, by discussing the whole, rather than the details which will obscure the object. The ethical reflection of the clinician, who is aware of these difficulties, is guided by elements that are specific to his position as a doctor. The cohesion of the team around the clinician and the ethics specialist enables us to develop consensual clinical ethics that are transmissible and therefore teachable. This complex role can, in our view, only be acted out directly in the clinical situation, where the constant, direct relationship with the object of the reflection and the treatment allows ethics to take into account the contingencies of medical practice: we invite the ethics specialist to take part in our clinical activity on a daily basis.
Key words: Infertility - Medically assisted procreation - Human fertilization Ethical consensus
The aim of medically assisted procreation (MAP) is to enable couples considered as infertile and untreatable by other methods to realize their "child project." This came about with in vitro fertilization (IVF) and the related therapeutic approaches, e.g. intracytoplasmic sperm injection (ICSI), etc. These techniques are relatively recent, as it was only 20 years ago that Edwards and Steptoe helped conceive the first living child, Louise Brown, born from IVF Female infertility due to problems of a tubal nature was solved where microsurgery had remained unsuccessful. Thereafter, during the 1980s, male infertility, which could no longer be ignored or denied, became the real challenge for research scientists. The most extreme cases could be treated by means of ICSI , and then by spermatid injection . Male infertility had almost been overcome. Obstacles once again presented themselves in female infertility, but in a different area this time, namely, the age of the oocyte. The only way this new problem could be solved was by using oocytes from a young donor. The first "natural cycle" of IVF had thus been completed (Fig. 1). The desire for a child had become accessible.
Much older methods of treatment, such as artificial insemination with the husband's sperm (AIH), the first case having been published in 1791, or artificial insemination with a donor's sperm (AID), as well as ovarian stimulation, were thereafter assimilated to MAP.
The risks associated with the techniques of MAP rapidly became recognised and no other medical domain has provoked such a great deal of thinking and the expression of a multitude of opinions in such a short space of time. In less than 20 years, over 22 000 publications, 11 national European laws and over 60 national and international biomedical societies have enabled doctors, biologists, legislators, humanists and clergymen to share, confront and ratify new ideas in a hitherto unequalled spirit of transparency.
Moreover, national registers, medical and biological guidelines, programmes of quality assurance, generated by the self-same practitioners of MAP anticipated the demands of the laws, which tend to be defensive, restrictive and sometimes arbitrary even to the extent of being a hindrance. Out of concern for transparency, MAP, more than any other medical breakthrough, is open to ethical discussion.
The following cries of outrage are heard :
"The field of the new reproductive techniques is an excellent example of the dangers inherent in having practice overtaking the evidence... Practice will become evidence only when clinicians refuse to experiment on their patients in an
Fig. 1. The natural cycle of in vitro fertilization (IVF). ICSI, intracytoplasmic sperm injection
uncontrolled way, and when they understand that real progress in medical care will always be slow and more plodding than not if we are to honour the first law of medical practice: first do no harm".
Those who base their findings on official statistics in order to better define the indications of MAP  are all the more worthy. The analysis of 36 961 cycles (70% of the cycles registered by the British Human Fertilization and Embryology Authority between 1991 and 1994), show that an average rate of 13.9 living children were obtained in 100 initiated cycles. The age of the mother, the duration of infertility and the number of times IVF has been attempted have a negative effect on the prognosis, while the fact that the infertility is secondary will improve chances of success. The probability of succeeding in producing a living child is not influenced by the medical indications. It can be evaluated by means of a model of multiple logistical regressions.
The necessity of evaluating the performances of MAP, which are rapidly developing, is becoming more and more urgent. It is in taking responsible steps that the specialists of MAP remain credible partners of those in charge of health. Ever increasing demands are being made on quality assurance (QA), which defines the global measures necessary to guarantee that one unit (structure, process) obtains the quantitative results foreseen. Quality management, for its part, systematically analyses the differences between what was initially sought after and the results obtained, identifies the reasons for these differences and the possibility of taking concrete measures to rectify them . The International Standardization Organization (ISO) defines quality in the field of health as the "capacity of treatment to meet the needs of the patients according to professional knowledge at the time and within the limits determined by the health authorities and those financing this".
Such steps taken by practitioners of MAP must result in an improvement of the information given to patients, in limiting the indication and in reducing the cost involved.
A list of the risks involved in MAP would hardly be exhaustive.
Table 1 recapitulates treatments available, defines their
indications and the potential risks involved. As we will see, MAP is evolving between two poles: quality/misuse (even violation)
The ethics will be evoked in the clinical reality from which they spring and where their justification lies. The three objects common to these ethics, the oocyte, the embryo and the child, are illustrated in this context.
Access to the oocyte
The new therapeutic approaches formerly described have as their corollary the access to the oocyte, the fertilization of which will take place in vitro. This action, charged with fantasies, enables us to view oocyte donation (OD) in a similar way, in some respects, to spermatozoa donation, now quite customary. The intangibility of the oocyte has thus been transgressed. The adage "mater semper certa est" is no longer true. The indication for donation is simple: it allows women who are of an age to procreate, who are in premature menopause, either naturally or iatrogenically (therapeutic or surgical castration), to be able to bear a child born of the in vitro fusion of a spermatozoon of the husband and a donated oocyte.
The extension of the indication for OD to women having reached the menopausal age of over 45-50 constitutes the most frequently evoked "misuse": it is true, this indication strays from the therapeutic mandate, the illness is not infertility but the refusal to mourn the passing of a physiological deadline. This possibility, however, is seen by some to be a new element in the equality of the sexes in terms of procreation.
Isn't the rational and logical justification for OD as an infertility treatment falsified by the excesses of the demands? This is heightened by the fact that the psychic representation of female gametes differs from that of male spermatozoa. A "magical" power is attributed to the oocyte as a source of life that is rare and exhaustible. The female gamete, haploid cell becomes the "potential child", indistinct from the mother's womb from which it has been torn.
The attribution of this fantasied power to the oocyte is at the heart of the disconcerting debate currently taking place in Switzerland on the subject of OD, during the parliamentary discussions on the execution of 24""~s Constitutional Article, already accepted by the people by referendum in May 1994 . The commentary of this bill states that: "In the case of OD, motherhood is split between the genetic mother on one hand and the biological mother on the other ... the relationship between the pregnant woman and the child which is forming inside her is fundamentally more intense and therefore more inclined to engender emotional struggles than the relationship between the social father and the child subsequently born, as in the case of sperm donation. The awareness of carrying a child to term, that is genetically foreign may already have negative consequences during the preg-. Nancy" . What power attributed to the oocyte! What a display of arbitrary and sexist protectionism, based on an unexplored fantasy and how conflicting such statements are with the demands made to specialists of MAP for controlled studies requested by the same law! These irrational mechanisms aim to ban the donation of oocytes under the pretext of protecting the child from this influence. The debate is not closed. The Conseil des Etats (Upper Chamber) has broadened the bill presented by the Swiss Federal Council by authorising OD on the same level as sperm donation, in a desire to adhere to the equality of the sexes. The commission of the Conseil National (Lower Chamber) advised the latter to refuse OD. The iniquity authorised by law would then become evident. It would reveal the mistrust towards heterologous treatments, which could only result in the prohibition of AID, now available on Internet. Furthermore, the wish to prevent seems already to be confirmed by the Federal Council's promulgation, in 1996, of an enactment regarding blood and organ donations, including sperm, the application of which might prevent AID: the cost of the controls of the donors and the procedural aspects of the controls, often performed arbitrarily and not scientifically justifiable, could become intolerable for the patient.
Surprisingly, while the motivation of the sperm donor has never been questioned, the female donor who wishes to give up her potential "quasi embryo" is closely scrutinized. Monique Bydlowski  describes well the fantasy of hypermaternity, the maternal omnipotence evoked by the donors: "They have children when they want, as many as they want. This declaration is accompanied by a feeling of depreciation for the recipient, alternating from pity to contempt for this poor womb, this infertility". These facts speak in favour of the protection of the anonymity of the female donor, required by law in both France  and Great Britain.
Access to the oocyte in MAP must be de-dramatised. Through it IVF is possible and OD, without being problem-free, would seem to remain possible in a context where the concern is ethical and not magical or fantasied. Equality of the sexes before the law is an obvious base for discussion. Equal treatment of AID and OD must be respected and the reflection that has been sparked off by OD must be extended to AlD. The questions of secrecy surrounding donation and the possibility of the loss of anonymity of the male or female donor raised by certain laws or bills (including those in Switzerland), require serious thought, and this thought, already applied to AID , should now be adapted to OD.
In reading the proposed text for the 24""~' Constitutional Article, it is clear that the Swiss constitution wishes to offer adequate protection both to the child and the donor. This legal structure provides a simple, transparent approach to AID and perhaps to OD, similar to that applicable to adoption. As clinicians, however, we wonder whether the desire for simplicity and transparency, which we share when it comes to adoption, is applicable in the same way when it comes to AID and OD. Is it in the interests of the child born of a donation to know the civil identity (name and address) of his biological father, should he so desire? Will attributing an identity to the sperm, in the case of AID or to the oocyte, in the case of OD, help the child in his search for an identity, when these are empty objects so totally different from the result of the donation: a much desired and loved child.
On the other hand, would this confusion of object not have the opposite effect to the spirit of protection sought after by the law? Is this not indiscriminately opening the door to a fantasy world to those searching for their identity? Will the child and the donors be better protected thereby than before the existence of the law? To what extent will the law make the secrecy surrounding donation, a social phenomenon, even more impenetrable, rather than unveiling it?
We wonder if these objectives would not be more easily attained, in the cases of AID and OD, if the definition of "data relative to lineage" were to preserve the civil anonymity of the sperm and the oocyte.
Once a certain line has been taken, we consider it essential that a national ethics commission discuss and propose directives concerning the choice of male and female donors: existing models, while they do not encourage access to AID or OD, do render these methods accessible to couples who have chosen them, once they are fully aware of all aspects involved .
Access to the embryo
Access to the embryo, on the other hand, enables us, for the purposes of diagnosis [preimplantation genetic diagnosis (PGD), predictive medicine], or even soon for therapeutic purposes (gene therapy), to draw close to a boundary, to trespass beyond which may be seen by humanity to threaten its very origins and integrity: the alienation of the human genome.
A consensus on the definition of the embryo has not yet been reached. At the European Council's 3rd symposium on bioethics (1996), Wieslaw Lang concluded that a reasoned practical consensus on the embryo is more urgent on a legal level than on a moral level. In a pluralist society, the philosophical uncertainty surrounding the moral status of the embryo will necessarily result in relatively flexible rules governing practices related to the embryo . On the contrary, we tend to agree with J. Testart , who encouragingly thinks "that it is urgent to talk about the status of the embryo as we did with the sex of angels, in order to realize what is at stake..the real threat is elsewhere, in the aim of the manoeuvre rather than in its means..new eugenics is about the ovum and it makes no difference whether it passes via the zygote or the pre-embryo".
Denis Müller  reminds us that "all too often, in bioethical discussions, the focus is on the legal rather than the ethical ... and that the ethical, taken as a reflection on morals and on the moral norms at stake, primarily questions the ultimate legitimations and therefore the founding and structuring prohibitions". He thinks that: "Only by making explicit reference to the category of a third party and therefore to a singular otherness, irreducible to ontology, biology and binary relationships, can the problematical status of the embryo be satisfactorily approached on the ethical and theological level. The embryo itself, as an exterior figure (like the foetus but also metaphorically like the child) represents a third party, a novum, a mystery in itself, indefinable and unavailable; it allows itself to be enclosed neither in the parental project nor in the desire for a child, nor in a technical or medical project, nor in the utilitarian logic of research at all cost".
In clinical work, our concrete concerns are centred on this "Third party novum", complicated by the forms it takes. They translate into our daily lives the potential requests of today and tomorrow. These requests are, in the great majority of cases, linked with suffering.
In the case of hereditary diseases which threaten the offspring, prenatal diagnosis (PND), already used, leads to pregnancy termination (PT). PGD enables the transfer in utero of embryos that do not carry the disease and thereby avoids PND and perhaps PT: the technique needs to be refined and its reliability improved, in order to avoid PND. This new indication for IVF would only apply to a small number of lethal hereditary diseases, detectable in the genetic material of biopsied embryonic cells that do not survive the diagnostic procedure. However, the collective imagination associates this biopsy with possibilities of cloning and selection: the aforementioned Swiss bill prohibits PGD, because, amongst other things, "it would no longer be possible to set a limit between prevention and the prohibited selection". A parliamentary debate still needs to rule on the definitive proposal that will be submitted for a referendum. Today, the Conseil des Etats (Upper Chamber) is not opposed to the Federal Council's proposal. The spectre of predictive medicine, of new eugenics, of using the sorting of ova haunts a debate which, to have some value, would have to have universal consensus.
The clinical objectives of research on the embryo include a better understanding of the ovular and embryonic causes of infertility, the improvement of IVF and PGD and the development of new methods of contraception (a vaccination?). It is necessary to clearly distinguish between the supernumerary embryos donated to research and those created for research. The duration of their development in vitro must also be limited: 14 days after fertilization seems to satisfy an Anglo-Saxon consensus: this moment corresponds to the stage of development of the embryo that allows us to consider it as an entity separate from extra-embryonic membranes. This research does not have any immediate implications on the clinical treatment of infertility. Hybridization, the creation of chimera, cloning and the alteration of the genome are unanimously prohibited.
On the one hand, MAP offers a tremendous diagnostic and therapeutic potential, on the other hand, it opens the door to excess and delirium.
Access to the child
For the infertile couple, the absent child takes on a dimension of which they would have been unaware, had they not been forced to express their desire, to reflect on it and even undergo complex treatment to realize it. The awareness of the value of this imaginary, and then real child makes it transcend the social norms attributed to a child. To reiterate the words of Monique Bydlowsky, "this conscious project is often infiltrated with unconscious meanings which will reappear in exactly the same way upon the arrival of this familiar-stranger: the child". The burden of the imaginary child may, in this way, become a heavier load to bear when, after such desire, he comes into being. MAP puts the goal of normalisation within reach, provides a salve to the narcissistic wound represented by infertility and, in doing so, accentuates the burden of the representation that is attributed to the child. The doctor, who is often unaware of his participation in the medical offer, will respond to this "archaic" suffering, which renders infertility intolerable, by encouraging the patient, in her repeated requests, to go forward with the liberating act. For Sylvie Faure-Pragier , "this suffering renders infertility intolerable. It is interpreted as a repetition of often major childhood traumas. It deepens the feeling of not being able to become an adult and is an intolerable regression to the dependence on the mother, which in reality is never overcome. Having a child would assert the magical possibility of self-management and infertility produces the desperate need to force the body to satisfy this illusion". This spiral is generated by the "want-to-be-mother" as described by M. Santiago Delefosse . Therefore, the desire for a child, if insufficiently perceived and, moreover, reinforced by misused MAP, is in danger of becoming "must-have-child", impossible child, evoked by the need of a must-be-mother".
The ethical question is to decide whether a doctor on his own, or an insufficiently trained team should be allowed to propose unjustified or even deleterious treatment without supervision. We think that a psychoanalytical reflection provides essential protection to the biomedical decision and to the ethical question. Let us quote F. Ansermet , who defines his psychoanalytical position: "Contrary to the doctor, the psycho-analyst intervenes from a radical standpoint of non-knowledge. His stake is not verification, but rather the understanding of what the subject constructs as an answer to reality... The foundations of the intervention of the analyst are built on an element of surprise and not on the control of knowledge". We be lieve that integrating psychoanalytical thought into clinical work could, among other things, rid clinicians of the continual risk of being tempted by the unknown, which fascinates them in their profession and which inevitably falsifies their attitudes.
In clinical work, ethical questions are raised in a field far wider than just the choice of treatment. PGD and OD only represent a minute part of the ethical thinking. The clinician is, however, continually confronted with requests, which he should under no circumstances answer alone. Ethical discussions belong to multidisciplinary discussions, which also involve the psycho-social sphere. For example, these questions cover, among others:
Even when the doctor has taken care to choose a team that enables the evaluation o the medical, biological, psycho-social and legal dimensions of such requests, he will still need the opinion of an ethical specialist to ensure global care for the Patient.
And ethics in MAM
In this melting pot, ethics, catalysed by this new source of problematics has discovered a favourite area in which to define and redefine itself. We propose an ethical intervention on three different levels.
The pre-law phase
First of all, bioethics has proved indispensable when concerned with thought be fore the elaboration of a law: the importance of the interrogations particular to the subject, the lack of knowledge encountered and the awareness of the total con tempt that certain intervening parties display in this respect, demand its intervention. Indeed, the practitioners of MAP are confronted with the evidence o their own powerlessness to hold the excesses of this new science at bay.
We have shown that the legal status of the embryo, defining its normative position in a legal system, seems to have found a consensus more easily than its ontological status (empirical and metaphysical) or moral status (normative position at the heart of an ethical system). Furthermore, "the legal status of the embryo inferior to that of living persons subjected to the law is confirmed by the clauses the penal code.
Only the murder of a living person constitutes homicide ... These declarations as declarations of the existing law are irrefutable" [9a]. We have seen that a relatively flexible ruling regarding the practices relating to the embryo is legally admissible. Ethical thought bears a quintessential responsibility in this area. in clinical work, the thoughts must be centered on the child, even if we are actually working with the potential parents. Ethical thought must not lose sight of this object that the law is aiming to protect. It is here that we situate the clinicians in the discussions. The role of the law is to prevent excess, but not to hinder clinical work in its research. The role is concrete; excessive restrictions do not, in the long term, prevent abuse, but they do encourage parallel practices (in form or location).
Even on this level, the human dimension of the intervening parties is confirmed each time by the amplification of questions raised by the threat. The values approached, as well as the fundamental aspects of the subjects unveiled by these modern treatments, explain the fantasied answers that alone pacify. The responsibility of ethics is huge.
Ethical reflection on a secondary level continues once the law has been promulgated; it has to moderate its application. The swiftness of changes, as well as social broadcasting of the innovations, may tend towards new excesses or towards banalisation. Victor Scardighi  names the three successive steps of this broadcasting: firstly the "fantasies of miracles and catastrophes" that characterise the research-development phase. The implementation phase brings a more concrete form to the research and to the social impact of the innovation. The assimilation often brings approval or rejection, but above all makes the innovation more commonplace. Isn't it the role of the vigilance of ethics to act as a conscience for society? The clinician has his place in this discussion. Again, the child, the concrete element of the request, remains at the centre of the discussion. Only the study of the child that is born, his development and what becomes of him, will enable ethical discussions to evolve with time. The ethics specialist needs the clinician to bring concrete elements to the discussion. Is this second role of ethics not to channel the collective fantasies and delusions which hinder without protecting, by intervening at all times in social broadcasting and innovation? It falls once again to the clinician, who answers to the patient, in close collaboration with his partner, the ethics specialist, to restore peace.
The ethical reflection of the clinician, who is aware of these difficulties, is guided by elements that are specific to his position as a doctor. The absent child generates suffering. The clinician's duty is to respect the object of the request, after having evaluated the respective importance of each of its facets: in the end, does the child still have the same place, or further, does he still have his place in the request? The clinical answer depends on the place attributed to this child, this question having been openly discussed prior to treatment. The aim of treatment is to palliate this cruel deficiency, sometimes even in renouncing the "impossible child" . In practice, we have developed the necessary tools to be better in line with clinical ethics.
Those attending patients must carefully weigh up the possibilities of treatment, as well as the couple's ability to follow this treatment, before responding to the request of a couple: should and/or can the imaginary sought after child become the real child? A study undertaken by the autonomous divisions of psycho-social medicine of the CHUV, together with the unit for reproductive medicine, enabled us to determine the fact that two thirds of the patients studied needed an evaluation of their resources in the face of the requested treatment. The final third, instant partners, were able to benefit from simple information provided on the treatment and on the possibility of available support.
This "whole patient" is more competent in his relationship with the medic care-giver. This partnership avoids the instrumentalization of the patient and the doctor also feels freer in his choices and decisions.
The three-fold goal of "the proposed counselling" is:
The doctor-patient relationship, made accessible and liberated by counseling may also answer the question which will inevitably evolve with time: Is the child still at the centre of the request?
In our opinion, the ethics specialist's place is essential in this approach. 0ur thinking needs the concrete help of "clinical bioethics".
The manifold questions raised by MAP are an almost unexplored minefield of clinical and ethical research. Are we asking the right questions? Shouldn't other area, of debate be opened? Is MAP treating the right patient? Isn't the child more at risk in certain therapeutic situations than the adult? Is the training of the medical team adequate? Who can claim to be a MAP specialist? We believe that these are the primary and secondary ethical questions involved.
In its primary reflection, ethics may moderate the responsibilities of the legislator, by taking care that the law does not obscure the biomedical and socioeconomic contexts of MAP, thereby also including other related and complement aspects dealing with the same subject, such as pregnancy termination, adoption and contraception.
The secondary discussion of ethics should moderate the application of legal protection, by taking into account the rapid technological and social development MAP, there too, by discussing the whole, rather than the details, which will obscure the object. In ethical reflection, the doctor is to the ethics specialist what t latter is to the clinical ethical discussion: a counselling partner. It is imperative that in their debates, they both avoid alienation and fantasy and thereby ask the legislator, society, and the patient the underlying questions and assuage their fears. On the other hand, this complementary reflection, enriched and refined by constant contact with the medical team situates ethical discussion equidistant between the poles of quality/misuse (even violation) and evidence/fantasy. On the other hand, the cohesion of the team around the clinician and the ethics specialist enables us to develop consensual clinical ethics that are transmissible and therefore teachable. This complex role can, in our view, only be acted out directly in the clinical situation, where the constant, direct relationship with the object of the reflection and the treatment allows ethics to take into account the contingencies of medical practice. Thus, again, we extend an invitation to the ethics specialist to take part in our clinical activity on a daily basis.
Acknowledgements. The author would like to thank his collaborators at the Reproductive Medicine Unit of the Department of Obstetrics and Gynecology at the CHUV (Prof. Pierre De Grandi), especially Dr. Alfred Senn and Mrs. Marie-Dominique B6ran, for the constant, evolutionary discussions which have enabled him to formulate the concepts described here. He expresses his gratitude to the patients whose concerns and suffering are at the heart of his thinking, He is grateful to Vivien Büchi (MA Oxon) and to Dr. Michèle Davidson, who have translated the French text into English. He also thanks Professor François Ansermet for providing him with the article referred to in this paper.
Dr. M. Germond, PD, MER