IFFS Sur Veillance 98: Preface

LEGISLATION AND GUIDELINES (SURVEILLANCE): Surveillance of ART is best accomplished by the adoption of rules and procedures by legislative action, i.e., the adoption of regulations. The creation of a licensing agency and the issuance of a license for various ART procedures, i.e., both clinical and laboratory, after fulfillment of requirements seems to work well. Because of the inertia of the legislative process, it is recommended that any bill to adopt regulations in the clinical or laboratory area or to revise them contain a strong provision for informed medical and scientific input to assure medical and scientific accuracy of the regulations and that the bill also provide a simple mechanism for the update of the regulations in order to conform to medical and scientific developments and to social changes. States now operating under regulations might well consider legislation to facilitate prompt modification of regulations to accommodate medical, scientific, and social needs. The licensing body should be truly independent of governments and should be publicly accountable. The regulatory framework proposed should allow the maximum responsible expression of creativity for doctors and scientists and of responsible choice and self-determination for patients. Inherent in the licensing concept is the potential to suspend or withdraw a license to an individual or a program for violation of any rule or procedure promulgated by the licensing authority. MARITAL STATUS IN ART: In the majority of countries having legislation, ART is only applied to heterosexual couples (married or in a stable relationship). However, others such as single women have gained access to ART. Follow-up studies in these alternative groups are scant and further studies are expected. ART: THE NUMBER TO TRANSFER: Higher-order multiple pregnancies are undesirable. To avoid this, many countries limit by legislation the number of embryos to be transferred (2-4). Other countries have no such limitation. Some countries recommend that the number transferred should not result in a triplet birth rate exceeding 2%. There appears to be a worldwide trend to replace fewer embryos. CRYOPRESERVATION: The general consensus was in support of the availability of cryopreservation (gametes and embryos) for ART. Recommendation: Where regulations exist, it was noted that the individual(s) consent and understanding of his (their) responsible - legal and otherwise - was mandatory for such practice and needed to conform to other existing legislation. Most respondents reported that it was preferable to set limits on the duration of storage of cryopreserved gametes and embryos. Although a 5-year limit is commonly used, the age of the female partner should bear strong consideration. DONATION OF GAMETES AND EMBRYOS: The donation of gametes and embryos has worked well. From a strictly medical point of view, what matters first in gamete and embryo donation is the safety of the recipients and the prospective child. There is concern regarding the risk of sexually transmitted diseases, that could occasion, for example, a quarantine period to test for HIV. This is desirable in all cases and is easily achieved for sperm and embryos. In many countries this is not practiced in the case of oocyte donation where the cryopreservation of embryos from donated eggs prejudices the chances of the recipient. The risk is minimal. A choice between fresh and frozen delayed transfer, with audit of the results, would minimize the risks taken. Screening for serious diseases that would be a serious threat to the child's health is encouraged. The risks entailed if the screening is not performed should be pointed out. The consequences of the lack of transparent, though confidential, records from the point of view of personal and public health should be delineated. The difference in practice concerning sperm and oocyte donation, the latter forbidden by several legislations, is unequal access to the reproductive goal for each parent. When gamete or embryo donation is not allowed at all or in the context of IVF, couples are prevented from achieving their reproductive goal. Consideration should be given to an increased genetic risk in the event of use of donated gametes within families, and an appropriate limit placed on the number of donations or offspring. MICROMANIPULATION: ICSI has been widely used in ART and should be available to those who require it. At the present time, follow-up studies of children born from ICSI show no increase over controls in congenital anomalies diagnosable at birth. There is special concern about the reproductive potential of male offspring after ICSI. There are known risks (e.g., cystic fibrosis and microdeletions in the Y- chromosome) but there may be others. Centers offering ICSI have an obligation to inform and obtain consent about transmittable risks from prospective parents. ICSI with sperm in various stages of differentiation from sources other than the ejaculate seems to work but must still be regarded as experimental and patients so informed. The role of hatching remains uncertain and no summary statement on this procedure is possible at this time. WELFARE OF THE CHILD: In general, consent to treatment legally gives an assurance of responsibility to the future children from both parents, whatever their future matrimonial situation. If treatment were to be performed without consent or after withdrawal of consent, the welfare of the child would be prejudiced by future uncertainties as to who would be responsible for their care. EMBRYO REDUCTION: Embryo reduction has been established as a means for enhancing the welfare of the mother and the remaining vital fetuses. Its use implies informed consent about the immediate risks and absence of long-term follow-up of children born after this procedure. PREIMPLANTATION GENETIC DIAGNOSIS: Preimplantation genetic diagnosis is a useful procedure and is available to detect many diseases. It requires a moral distinction between termination of an affected fetus and the discarding of a similarly affected nontransferred embryo. Many persons are prepared to make such a distinction. The procedure is still under evaluation. IVF SURROGACY: IVF surrogacy has an application where parentering partners are prevented from reproduction by the absence of a functioning uterus. It must be clearly distinguished from surrogacy in which the surrogate supplies the female genetic component as well as the uterus. IVF surrogacy, although less problematic than complete surrogacy, still encounters difficulties in gaining worldwide recognition. EMBRYO RESEARCH: Medical science has progressed to date by a reasoned process of development involving research on gametes, embryos, and infertile couples. Research cannot be confined to experimental animals and reproductive services need to be properly assessed before introduction. CLONING: As judged by this survey, worldwide reaction to human reproductive cloning has been negative. On the other hand, rapid favorable developments, are occurring in animal experiments and in the application of cloning in the field of animal husbandry. It would, therefore, seem wise not to impede research that might lead to applications that could be beneficial to human health.