Journal of Assisted Reproduction and Genetics, Vol. 9, No. 5, 1992
NEWS AND VIEWS REPRODUCTIVE HEALTH CARE POLICIES AROUND THE WORLD
Ovum Donation: Ethical and Legal Aspects
procedure, during laparoscopy for investigation of the donor's own infertility and at the time of therapeutic surgery on women of reproductive age. The ovum may be retrieved when the elective procedure is performed at the suspected preovulatory period or from patients who agree to undergo ovarian stimulation before the surgical procedure. In the latter group, the risk of superovulation should be taken into consideration. Oocytes can be obtained from women from whom an excess of oocytes was recovered while they were participating in IVF or other assisted reproductive programs. Women who participated in IVF and GIFT and donated oocytes are usually infertile. There may be cases in which the recipient conceived and gives birth to a child, while the donor does not conceive. This situation raises an ethical problem. This may be a source of particular distress to the infertile female who serves as an oocyte donor. Therefore, proper counseling of a couple before they agree to donate oocytes should be undertaken (4). With the establishment of cryopreservation programs, the process has reduced the number of donated "spare" oocytes. Most of the couples undergoing IVF prefer to freeze preembryos for potential additional transfer in case the cycle of treatment is unsuccessful. The donors in some programs have been volunteers, anonymous friends, or family members. Special concern over the medical risk to the volunteer donors will certainly arise. The risk would be associated with the induction of ovulation, with the use of anesthesia and with the surgical procedure of laparoscopy or even ultrasonographic oocyte recruitment procedures (8). The transvaginal ultrasound follicular aspiration
Until recently, women with primary and premature ovarian failure suffering from primary or secondary amenorrhea, hypergonadotrophism, and hypoestrinism were considered incurably sterile. Since the introduction of oocyte donation in in vitro fertilization (IVF) and embryo transfer (ET) programs, pregnancies and births have been reported in patients with premature ovarian failure who have conceived after induction of endometrial maturation and surrogate embryo transfer (1-6). Recently there is a tendency of donation of ova by women in reproductive age to be used by older menopausal females in order to achieve fertility. This tendency makes childbearing possible without limitation of age. Procreation of oocyte donation technology also greatly appeals to couples who are carriers of autosomal recessive disorders. The risk to reduce these genetic disorders can be achieved either by using donor sperm or by oocyte donation. Oocyte donation is preferred by the couple, since the donated oocyte is fertilized by the husband's sperm and then implanted into the gestational mother, so that the offspring belongs to both of them and neither parent feels excluded. The donation of oocyte for treatment of infertility raises ethical, legal, social, and religious debates that will be presented.
DONORS OF OOCYTE (7) Oocytes may be obtained from donation under the following circumstances: during a sterilization The opinions presented in this column are those of its author(s) and do not necessarily reflect those of the journal and its editors, publisher, and advertisers.
4 11
1058-0468/92/1000.0411506.50/0 © 1992 Plenum Publishing Corporation
412
has proven to be safe. However, in sporadic cases, complications have been reported such as injuries to viscera and pelvic inflammation. Ovum donation may be made by friends or relatives. A survey of attitudes regarding the use of siblings for gamete donation revealed that the acceptability of using a sister for gamete donation is high among couples desiring ovum donation. However, this is contrary to couples undergoing AID, who rejected the concept of using the husband's brother as a known donor (9,10). It is known that some tribes have a custom that the brother of an infertile man provides sperm in secrecy to his sister-in-law. In cases that the donor is the sister of the recipient, the child's aunt will be his/her genetic mother. The options of oocyte donation in the close family are as follows: between sisters, mother to daughter, daughter to mother, and even from the granddaughter to her grandmother. In such circumstances it is believed that some considerable confusion of relationship within the family will occur. It is possible to predict areas where conflicts in the family will arise that will negatively influence the child. Even when the matter of donation is kept secret, there is the probability for potential conflict within the family when some members are part of the secret while others are not.
SELECTION OF DONORS The selection of oocyte donors is of critical importance to the prospective parents and the resulting child. It should be based not only on medical reasons, but also on social and psychological considerations. The donor should be a healthy female, as determined by medical examination and psychological evaluation. She should be less than 35 years old (in order to prevent trisomy), preferably with previous proof of infertility, for reasons noted above and she should have been screened for sexually transmitted diseases and hereditary disorders. The guidelines for minimal genetic screening and screening for sexually transmitted diseases were recently published by several ethical committees in different countries and is included in legislation where it exists (11,12). In cases of voluntary donation, the donor and the recipient can appropriately be matched, the maximum number of oocytes can be retrieved and the cycle of the donor and the recipient can be syn-
SCHENKER
chronized. The most common stated motivation of the volunteers to donate oocytes is to help infertile couples. In 30% of the cases, the donation has been noted to have financial incentive (9).
SELECTION AND SCREENING OF RECIPIENTS The only contraindications to ovum donation are medical or psychological conditions of the recipient under which pregnancy is ill-advised. A primary diagnostic workup is indicated before the infertile couple is treated by means of ovum donation. The following examinations should be performed: a physical examination of the female partner, hysterosalpingography for evaluation of the adequacy of the uterine cavity, a patent fallopian tube for the "GIFT" method is suggested for transfer of preembryos, a cardiopulmonary workup is recommended, especially in women with dysgenesis of ovaries and in older candidates. In addition to a routine sperm evaluation, the male partner should submit a sperm sample for the hamster zona-free sperm penetration assay (SPA), which has been proven to have a good correlation with in vitro fertilization of human oocytes (13). The couple should undergo psychiatric and social evaluation, serological examination for blood groups, rubella antibodies, VDRL and HIV, and other tests according to individual indications. In the case of POF, physical examination and various laboratory tests should be performed on the female partner in order to rule out autoimmune disorders, which can make conception inadvisable. An association of autoimmune disorders with other disturbances of autoimmunity is present in 30-50% of the patients with POF (7,14). Endocrine testing should be carried out in order to rule out adrenal, parathyroid, and thyroid dysfunction. Serum should be tested for the presence of circulating antibodies to ovarian tissue or to other endocrine glands. Chromosome analysis is useful in patients with POF in order to identify the role of chromosomal abnormalities in the pathology of the entity. Some patients with POF and chromosomal aberration may be mentally affected. It is of primary importance to identify women with POF who are osteopenic and thus at greater risk for later osteoporotic fractures. At present there are a number of techniques available for noninvasive mass bone analysis. The couple should give a written consent. AcJournal of Assisted Reproduction and Genetics, Vol. 9, No. 5, 1992
OVUM DONATION
cording to the legislation in the State of Israel, they should apply to the District Court with a request for adoption following delivery of the child (15). WHO ARE THE PARENTS? Prior to the development of OD programs there was never any question who the mother was, since she was always both the genetic and the gestational one. Only the identity of the father was uncertain, and this uncertainty was clarified by social evidence to presume the paternity to the mother's husband. In case of ovum donation we may have to distinguish between the genetic and the gestational mother. The current international legal presumption is that the gestational mother is the legal mother. This gives the child and society certainty of identification at the time of birth, thus protecting both mother and child. The recipient is the legal mother and the female donor oocyte has no legal rights or responsibilities concerning the offspring. THE ANONYMITY OF THE DONOR The oocyte donors can be either anonymous or known to the couple. Most of the ethical committees in various countries recommend that if ovum donation is practiced, the anonymity of the donor should be preserved (11,12,16). It seems that the reason to use an anonymous oocyte donor was influenced by the experience with the practice of sperm donation. The practice of sperm donation has always been in secrecy, for a number of reasons: 1. Sperm donation was not accepted as a social and marital norm. The child conceived by the clinical procedure of artificial donor insemination (AID) was considered illegitimate resulting from adulterous relations. In the case of ovum donation, the conception results after applying assisted reproductive technology and is therefore not considered as arising from an adulterous relationship. 2. In sperm donation, secrecy is also in the husband's interest, since it protects him in the society from the supposed stigma of infertility, which in many societies is synonymous with impotence. Since female infertility is more acceptable and well documented in the different traditional writings, this is not the case in ovum donation. Journal of Assisted Reproduction and Genetics, Vol. 9, No. 5, 1992
413
3. Children born following gamete donation may have a social stigma, as well as suffer from psychological and emotional trauma. 4. There is a need to protect the donor. The promise of anonymity to the semen donor was originally introduced due to the concerns in the following areas: (a) Donors fear that they could be considered legally liable for the maintenance of the children resulting from the gamete donation. (b) The children may be able to claim inheritance rights. For this reasons the husband of a married donor would have a material interest in refusing consent to his wife's donation of an oocyte and so would the children of the oocyte donor. (c) If the donor of oocyte is not anonymous and if the child born resulting from ovum donation is defective, the oocyte donation donor may be charged with negligence, if she failed to give a full medical and family history. (d) Access to identifying information could lead to unwanted invasion of the donor's normal future family life by gamete donation children seeking their genetic mother. Since in case of ovum donation the mother who gives birth currently, according to the international laws, is recognized as the legal mother, this may release the ovum donor from all legal liability and inheritance. It is reasonable for the ovum donor to expect that her anonymity be preserved in the future, since in cases of ovum donation the recipient is the biological and the social mother. The above arguments point out that if the donors were not anonymous, many would be reHuctant to donate their oocyte.
ARGUMENTS AGAINST ANONYMITY OF DONORS 1. Truth should be always told. 2. It is accepted by the international community that each individual has the right to know his/ her biological origin. Therefore, offsprings conceived by ovum donation have the right to explore his/her origin when such information is restricted. Otherwise, offspring conceived following ovum donation have lesser rights than children naturally conceived. 3. An ovum donation child, when ill, may be
414
harmed by not knowing his genetic constitution and family medical history of the donor. 4. Practice with anonymous ovum donation will lead to distrust in the family. As seen from the adoption experience, the child may accidently discover data regarding of his/her conception. This may be also achieved by blood testing and tissue typing that would be able to prove that the child is not genetically related to his gestational mother. In such cases, the family interrelationships can be harmed. Disclosure of the ovum donation process of conception may intensify the psychological needs of the offspring to explore his/her genetic origin. This need may be less in cases of ovum donation as compared to those of semen donation, since the parents, both the father and the mother are the biological parents. A recent survey of 67 centers in the United States performing oocyte donation revealed that 31% of the centers accept both anonymous and nonanonymous donors. Twenty-nine percent of the centers accepted oocyte donation only from anonymous donors, while 18% provided the service with nonanonymous donors. The experience of some centers is that the infertile couples prefer to select their own donors. A number of limited surveys of ovum donation have suggested that at present the donors are less concerned with anonymity that was previously reported with sperm donors (17).
MEDICAL RECORD KEEPING There is consensus among medical professionals that keeping accurate medical records is essential. Record keeping has always been an important part of both medical practice and of quality assurance. In cases of ovum donation it is also crucial for the follow up of the parties involved. It raises particularly difficult ethical and legal questions with regard to medical confidentiality and familiar privacy. The right to privacy is a fundamental human right. In the context of medical information that is personal and intimate, the concern for respect for privacy of the participants is paramount. Truthtelling and candidness are values to be respected in the communication between the physician and the patient and in case of ovum donation, it may be considered in the relationsh!p between the physician, donor, and recipient. Candidness with the family
SCHENKER
after the birth of a child as to the method of his conception or later as to the identity of the donor is of a different nature. Society's (state) intervention in the privacy and intimacy of the familiar relationship in order to force a greater openness could be an invasion of the freedom of procreation decision making that extends beyond the legitimate concern for the quality of services and for the proper followup of the offspring. Registration and regulations in different countries where ovum donation is practiced, consider the nature of information to be maintained about the parties involved in the ovum donation program (12). A distinction has been drawn between non-identifying and identifying information. The non-identifying information includes: (a) detailed description of physical characteristics, ethnic origin etc., (b) medical history and genetic background. It is feasible to provide offsprings with non-nominative, genetically identifying information, by storing DNA extracts from donor's white blood cells taken at the time of oocyte donation, and (c) social characteristics: education, profession, habits, interests, etc. When identifying information is required, it will include full names, addresses, date and place of birth, I.D. of the patients involved. The responsibility for collection of information should lie with the physician performing each stage of the ovum donation procedures. There are different opinions regarding the storage of information: Where should they be kept? Who should have access to them? What kind of information should be released to the parties involved in the program? In most countries where ovum donation is practiced, the records of identifying and non-identifying information are kept and maintained by the physician or medical institution according to the regulations of that particular country. In some countries, ethical committees have suggested that the identifying information of the parties involved should be stored with the central governmental registry body (18). In South Africa, for example, a National Data Bank exists. The advantages of central state registry are: (1) The information can be safely kept for long periods. (2) There is a protected central control for release of information. (3) Information can be updated and more readily accessed than when stored in medical institutions or in individual clinics. (4) A central computerized national register may provide control over the number of donations made by each donor. Journal of Assisted Reproduction and Genetics, Vol. 9, No. 5, 1992
415
OVUM DONATION
Considering the sensitive nature of this information, safeguards should be devised where documentation is kept. It is of importance to restrict to a minimum the personnel that have access to this information. In most instances, the records may be released with non-identifying information. Persons with a legitimate interest to obtain non-identifying information are: (1) all parties involved in the ovum donation program: the donor, the parents and the offspring; in the case of offspring who have not yet reached the age of maturity, the right of access could be exercised by the parents, (2) authorized persons in the course of their duty: medical personnel where the procedure has taken place, personnel who are authorized to store the information, (3) persons appointed by the courts. Identifying material may be released in extreme situations according to the legislation of a specific country. The legislation should not be retrospective on current or past participants in the program. The identifying information can be released only if the parties involved have given their consent to it prior to the procedure. In case the donor is looking for information about the recipient or the offspring, the parents have the right to refuse to release that information even if the offspring reached the age of majority, since there is a possibility that the parents did not disclose to the offspring the details concerning his conception. Conflicts of interest may arise between the parties involved: ovum donor, offspring, and parents regarding disclosure or access to information. The recipient couple has the right to have access to information concerning the donor, which is the genetic parent. This is of importance not only for the benefit of the recipient couple, but also the benefit of the offspring for medical or other reasons. In case of offspring who have not yet reached the age of majority, the right of access should be exercised by the parents. The parents have a right to privacy concerning the circumstances of conception of the offspring. This may be also true in cases of ovum donation. The parents, as guardians of their children are responsible for the welfare of their offspring under the age of majority. The parents have a right and duty as parents to judge the appropriate manner and time to inform their offspring of the circumstances of their conception, if at all. Therefore, the parents have the choice of whether or not to inform an offspring conceived by ovum donation of the circumstances of his birth, and the rights of the parties to Journal of Assisted Reproduction and Genetics, Vol. 9, No. 5, t992
autonomy, information, and privacy should be respected. In case of conflict between the interests of the parents and those of the offspring, when they are of equivalent weight, the rights and the interests of the offspring should prevail. Similar situations exist in adoption laws. 'The present tendency is that in counseling the parents in cases of ovum donation the information should be given to the offspring on the circumstances of their conception should be given.
COMPENSATION FOR DONATION According to most ethical committees' statements, oocyte donors should not be reimbursed for their donation. Some centers in the United States found a solution to this ethical problem by giving compensation for the time and expenses associated with undergoing IVF treatment cycles. The donors receive $50 daily for the preparation of the cycle while receiving drugs for induction of ovulation, $100 for each day that they have ultrasound examination and $350 for the day of aspiration. The payment to donors for a cycle of treatment is between $500-2000 per aspiration. This amount is around 20% of the total cost of a retrieval cycle, which is paid directly or indirectly by the recipient (17). The interim licensing authority (ILA) in the U.K. (19) has decided to allow centers to offer a free sterilization in return for donated eggs, provided that: 1. The discussion of egg donation must be separate from the decision concerning the management and clinical care of the patient who is going to undergo sterilization or other operations. Only when those decisions have been made may the question of egg donation be raised. 2. Willingness to donate eggs should not influence the medical staff to perform the operation earlier. Some centers offer a free IVF or GIFT cycle treatment as compensation for excess egg donation, in such cases, the payment of the recipient may be in the range of $15,000-20,000 per cycle of treatment (17).
AGE OF RECIPIENT It has been shown that ovum donation may potentially be applied to menopausal women and not
416
only in cases of premature ovarian failure. The endometrium of menopausal women retains its ability to respond to sex steroid hormones and provides a receptive environment for implantation and pregnancy nearly similar to that of endometrium in the reproductive age (20,21). In all races, a remarkable increase in maternal mortality rate is reported with advancing age (22,23). The maternal mortality rate is about 80: 100,000 at age 40, as compared to 20:100,000 at age 30. The etiology of this increased maternal mortality may be attributed to the higher incidence of hypertension, diabetes mellitus, and thromboembolic conditions at the age of above 40 and above. Two phenomena occur with aging: a physiological decline and an increase in diseases. In healthy middle age adults, many physiological functions are maintained in the basal resting state. However, decrements in function occur in most organ systems and homostatic mechanisms when the system is challenged or stressed. Pregnancy and delivery are challenging and stressful situations. Therefore, because of medical concern there should be a serious reservation about any attempt to produce pregnancy beyond the accepted childbearing age. It should be mentioned that mortality curves are exponential after the age of 30, with cardiovascular and neoplastic diseases being the common cause of death. This data should be taken into consideration when one treats menopausal women with OD. A case of maternal death following ovum donation in advanced age of a female was recently reported (24). An increased incidence of congenital anomalies in the offspring of older women in general is reported. This may be due to either the older gametes or to the endometrial environment. Chromosomal aberrations (mainly Down syndrome) can be prevented by using oocyte donors of age below 35. Since recipient females of advanced age are usually married to older male partners, a paternal partner may contribute to congenital malformations in the offspring of women in menopausal age undergoing OD. Paternal age does not appear to be an important risk factor for Down syndrome, however, the age of the father does play a role in the development of autosomal dominant genetic diseases. The relative frequency of new autosomal dominant mutations in offspring increases logarithmically with the increase in paternal age (25). There is an increase in the incidence of hydatid-
SCHENKER
iform mole toward the end of the childbearing period. The most pronounced effect of age is observed in women older than 45 when the relative frequency of this lesion is more than ten times higher than at age 20 (26). Pregnancy beyond the ordinary childbearing age raises familial and social problems. Surveys in the United States have shown that 31% of clinics providing OD exclude recipient over the age of 40. On the other hand, 27% of the centers indicated that they have no upper age limit for recipients. The average age of recipients, according to the United States registry is 35-55 (t 7). Recently, the media reported that a nearly 60-yearold woman gave birth after ovum donation. Even though gestation can be obtained by QD at menopausal age, it should be restricted for medical, social, and familial reasons. LEGAL CONTROL OF OVUM DONATION There is an ongoing debate in society, especially among the members of the medical profession, as to the necessity of LEGAL regulations and public control concerning assisted reproductive practices. At present, many countries, even in the Western hemisphere, have not yet established legislation pertaining to the various aspects of assisted reproductive technologies, such as sperm, oocyte, and preembryo donation, freezing of preembryos, and research on preembryos. We assume that this is because of the fact that the law tends to lag behind social changes and scientific achievements (12,27). Regulations through process of law come from two sources: statutes and judge-made laws. Statutes are decided by legislators, while judgemade laws develop either where the courts are called upon to interpret and apply written law, or where such law does not exist--by analogy or otherwise. Legislation may resolve the following problems: a relation between biological and social parents, safeguarding of the interests of the offspring, regulation of medical performance including quality control, record keeping and development of a national data bank for oocyte donors. Development of a national data bank for oocyte donors may have an advantage, in that the number of donated oocytes from any one person could be limited. This could avoid the problem created when a single donor (more frequent in semen donation than in ovum donation) is used to initiate a large
Journal of Assisted Reproduction and Genetics, Vol. 9, No. 5, 1992
OVUM DONATION
number of pregnancies, introducing some risks of unintended consanguinity among future marriage partners. Data on consanguinity risk of ovum donation is not available, but it may be presumed that the risk would be much lower with anonymous ovum donation than with semen donation, since OD is unlikely to result in multiple offspring from one oocyte donor. At present, legislation exists only in few countries (27). In some countries, assisted reproduction is practiced according to regulations drawn up by professional bodies. In some, such bodies are appointed by the government or by medical associations. In other countries spread over the continents, reproductive scientific centers impose their own ethical standards, whereby standing committees decide on a case-by-case basis. Some practicing groups have determined their own standards. In some countries, where the procedure is controlled by governmental or professional societies, the practicing units have to be authorized by those bodies. Most medical centers involved in the practice of assisted reproduction prefer public control by ethical committees. Our survey (27) indicates that mainly two factors have influenced the practice of assisted reproduction: religious attitude and the feminist movement. The religious influence prevails in the countries where religious parties are in potential power and when the government is influenced by the religious attitudes (28). Control of various aspects of ovum donation practice as determined by parliamentary legislation is less desirable. Nevertheless, ovum donation should be controlled by some legal framework that will protect the legal relationship of the parties involved. The medical and social issues, such as selection of oocyte donors, limitation of the overuse of donors, and the licensing and quality control of medical performance, can be teft to the judgment and supervision of professional bodies. It has been argued that the legal and social issues involved in the practice of gamete donation are similar to those of adoption. If this is the case, the same legal and social framework can be applied to both. However, there are major differences between adoption and the use of gamete donation. The practice of adoption is child-centered, a solution for an abused or an unwanted child, while the reason for the use of oocyte donation is to solve the interest of the recipient couple.
Journal of Assisted Reproduction and Genetics, VoL 9, No. 5, I992
417
SUMMARY The newer technologies of assisted reproduction offer the infertile couple a wide spectrum of choices according to their specific problem. A relatively newer technique is that of ovum donation, whose technology is now well established. However, as with other newer technologies, it has given rise to new dimensions of ethical and legal issues which have to date not been fully appraised. It is very difficult to find a legal consensus under international umbrella to the specific issues involved in ovum donation. This is due to the different cultural, religious, and time influence atmosphere prevailing in the various parts of the world. Each society should develop its own statutes on ovum donation. A frame of ethical guidelines should be established by international organizations that may help each society issue its own regulations.
REFERENCES 1. Lutjen P, Trounson A, Leeton J, Wood C, Penoa P: The establishment and maintenance of pregnancy using in vitro fertilization and embryo donation in a patient with primary ovarian failure. Natu re 1984;307:174 2. Navot D, Laufer N, Kopolovic J, Rabinowitz R, Lewin A, Granat M, Margalioth E, Schenker JG: Artificially induced endometdal cycles and establishment of pregnancies in the absence of ovaries. N Eng J Med 1986;314:806 3. Schenker JG: Pregnancies in cases of premature menopause. In Advances in Gynecological Endocrinology, AR Genazzani, R Petraglia, A Voope, F Facchinetti (eds). Lancaster, Parthenon Publishing Group, 1989, p 621 4. Schenker JG: Ovum donation: The state of art. Ann NY Acad Sci t988;541:742 5. Rosenwaks Z: Donor eggs: Their application in modern reproductive technologies. Fertil Steril 1987;47:895 6. Serhal PF, Craft IL: Qocyte donation in 61 patients. Lancet 1989;1:1185 7. Schenker JG: The therapeutic approach to infertility in cases of ovarian failure. Ann NY Acad Sci 1991;626:414 8. Schenker JG: Pregnancies in women with gonadal dysgenesis. In The Fetus as a Patient, K Maeda (ed). Amsterdam, Excerpta Medica, 1987, p 31 9. Sauer MV, Rodi M, Scrooc M, Bustillo M, Buster JE: Survey of attitudes regarding the use of siblings for gamete donation. Fertit Steril I988;49:721 I0. Rosenberg SM, East JM, Wood SC: Ovum donations by sisters in ovarian failure: Simplified priming and early withdrawal of exogenous support. J IVF/ET 1989;6:228 11. The Ethics Committee of the American Fertility Society: Ethical considerations of the new reproductive technologies; donor eggs in in vitro fertilization. Fertil Steril 1990;53:48S
418 12. Schenker JG, Frenkel D: Medico-legal aspects of in vitro fertilization and embryo transfer practice. Obstet Gynecol Survey 1987;42:405 13. Margalioth E, Navot D, Laufer N, Lewin A, Rabinowitz R, Schenker JG. Correlation between the zona-free hamster egg sperm penetration assay and human in vitro fertilization. Fertil Steril 1986;45:665 14. Alper M, Peter R, Garner M: Premature failure: its relationship to autoimmune diseases. Obstet Gynecol 1985;66:27 15. Schenker JG: In vitro fertilization (IVF), embryo transfer (ET) and assisted reproduction in the State of Israel. Hum Reprod 1987;2:755 16. Templeton A: Gamete donation and anonymity (comment). Br J Obstet Gynaecol 1991;98:343 17. Sauer MV, Paulson RJ: Understanding the current status of oocyte donation in the United States: What's really going on out there? Fertil Steril 1992;58:16 18. New South Wales Law Reform Commission: Artificial conception report. 1988, p 92 19. Department of Health and Social Security: Human fertilization and embryology: A framework for legislation. London, 1987 20. Navot D, Scott RT, Droesch K, Veeck LL, Liu HC, Rosenwaks Z: The window of embryo transfer and the efficiency of human conception in vitro. Fertil Steril 1991 ;55:114 21. Navot D, Bergh PA, Williams MA, Garrisi GJ, Guzman I, Sandier B, Grufeld D: Poor oocyte quality rather than implantation failure as a cause of age-related decline in female fertility. Lancet 1991 ;337:1375
LOTAN AND SEIDMAN 22. Harrison EE: Who do pregnant women die? Dallas Med J 1982;(Sept-Oct):242 23. Schenker JG, Mot Yoseph S: Maternal Mortality in Israel. Presented at the 13th World Congress of FIGO. Singapore (in press) 24. Bewley S, Wright GT: Maternal death associated with ovum donation twin pregnancy. Hum Reprod 1991;6:898 25. Frieman JM: Genetic disease in the offspring of older fathers. Obstet Gynecol 1981 ;57:475 26. Jequier AM, Winterton WR: Diagnostic problems of trophoblast disease in women age 50 or more. Qbstet Gynecol 1975;423:378 27. Schenker JG: Assisted reproduction: Formation of laws and regulations. In New Concepts in Reproduction, Y Boutaleb, A Gzouli (eds). Lancaster, The Parthenon Publishing Group, 1991, p 149 28. Schenker JG: Health care politics around the world: Religious views regarding treatment of infertility by assisted reproductive technologies. J Assist Reprod and Genet 1992; 9:1
Joseph G. Schenker Department of Obstetrics and Gynecology Hadassah University Hospital Jerusalem, Israel
In Vitro Fertilization and Embryo Transfer in Israel: Results from a National Survey I
INTRODUCTION The first in vitro fertilization (IVF) and embryo transfer program was established in Israel in December 1981. At that time only a few IVF programs were 1 Members of the professional committee appointed by the Ministry of Health to evaluate the function of IVF clinics licensed in Israel: Shlomo Mashiach, MD (Chairman), Department of Obstetrics and Gynecology, Sheba Medical Center, TelHashomer; Vaslav Insler, MD, Department of Obstetrics and Gynecology, Kaplan Hospital, Rehovot; Gedalia Paz, MD, Institute for the Study of Fertility, Serlin Maternity Hospital, Hakirya, Souraski Medical Center, TeI-Aviv; and Yoram Lotan, MD, Ministry of Health, Jerusalem.
operating worldwide, following the birth of the first child, as a result of IVF by Steptoe and Edwards in England, 3 years earlier (1). Israel was thus one of the first countries to adopt this new technique for assisted conception. During the next 8 years, 15 additional IVF programs were established in Israel. In order to assess the outcome and needs of advanced reproductive technology procedures in Israel, in 1989 the Ministry of Health appointed a professional committee to evaluate all of the IVF units licensed in Israel. The present study reports the results of this survey, the first to encompass the entire IVF program in Israel since its establishment. Journal of Assisted Reproduction and Genetics, Vol. 9, No. 5, 1992
NEWS AND VIEWS REPRODUCTIVE HEALTH CARE POLICIES AROUND THE WORLD
Ovum Donation: Ethical and Legal Aspects
procedure, during laparoscopy for investigation of the donor's own infertility and at the time of therapeutic surgery on women of reproductive age. The ovum may be retrieved when the elective procedure is performed at the suspected preovulatory period or from patients who agree to undergo ovarian stimulation before the surgical procedure. In the latter group, the risk of superovulation should be taken into consideration. Oocytes can be obtained from women from whom an excess of oocytes was recovered while they were participating in IVF or other assisted reproductive programs. Women who participated in IVF and GIFT and donated oocytes are usually infertile. There may be cases in which the recipient conceived and gives birth to a child, while the donor does not conceive. This situation raises an ethical problem. This may be a source of particular distress to the infertile female who serves as an oocyte donor. Therefore, proper counseling of a couple before they agree to donate oocytes should be undertaken (4). With the establishment of cryopreservation programs, the process has reduced the number of donated "spare" oocytes. Most of the couples undergoing IVF prefer to freeze preembryos for potential additional transfer in case the cycle of treatment is unsuccessful. The donors in some programs have been volunteers, anonymous friends, or family members. Special concern over the medical risk to the volunteer donors will certainly arise. The risk would be associated with the induction of ovulation, with the use of anesthesia and with the surgical procedure of laparoscopy or even ultrasonographic oocyte recruitment procedures (8). The transvaginal ultrasound follicular aspiration
Until recently, women with primary and premature ovarian failure suffering from primary or secondary amenorrhea, hypergonadotrophism, and hypoestrinism were considered incurably sterile. Since the introduction of oocyte donation in in vitro fertilization (IVF) and embryo transfer (ET) programs, pregnancies and births have been reported in patients with premature ovarian failure who have conceived after induction of endometrial maturation and surrogate embryo transfer (1-6). Recently there is a tendency of donation of ova by women in reproductive age to be used by older menopausal females in order to achieve fertility. This tendency makes childbearing possible without limitation of age. Procreation of oocyte donation technology also greatly appeals to couples who are carriers of autosomal recessive disorders. The risk to reduce these genetic disorders can be achieved either by using donor sperm or by oocyte donation. Oocyte donation is preferred by the couple, since the donated oocyte is fertilized by the husband's sperm and then implanted into the gestational mother, so that the offspring belongs to both of them and neither parent feels excluded. The donation of oocyte for treatment of infertility raises ethical, legal, social, and religious debates that will be presented.
DONORS OF OOCYTE (7) Oocytes may be obtained from donation under the following circumstances: during a sterilization The opinions presented in this column are those of its author(s) and do not necessarily reflect those of the journal and its editors, publisher, and advertisers.
4 11
1058-0468/92/1000.0411506.50/0 © 1992 Plenum Publishing Corporation
412
has proven to be safe. However, in sporadic cases, complications have been reported such as injuries to viscera and pelvic inflammation. Ovum donation may be made by friends or relatives. A survey of attitudes regarding the use of siblings for gamete donation revealed that the acceptability of using a sister for gamete donation is high among couples desiring ovum donation. However, this is contrary to couples undergoing AID, who rejected the concept of using the husband's brother as a known donor (9,10). It is known that some tribes have a custom that the brother of an infertile man provides sperm in secrecy to his sister-in-law. In cases that the donor is the sister of the recipient, the child's aunt will be his/her genetic mother. The options of oocyte donation in the close family are as follows: between sisters, mother to daughter, daughter to mother, and even from the granddaughter to her grandmother. In such circumstances it is believed that some considerable confusion of relationship within the family will occur. It is possible to predict areas where conflicts in the family will arise that will negatively influence the child. Even when the matter of donation is kept secret, there is the probability for potential conflict within the family when some members are part of the secret while others are not.
SELECTION OF DONORS The selection of oocyte donors is of critical importance to the prospective parents and the resulting child. It should be based not only on medical reasons, but also on social and psychological considerations. The donor should be a healthy female, as determined by medical examination and psychological evaluation. She should be less than 35 years old (in order to prevent trisomy), preferably with previous proof of infertility, for reasons noted above and she should have been screened for sexually transmitted diseases and hereditary disorders. The guidelines for minimal genetic screening and screening for sexually transmitted diseases were recently published by several ethical committees in different countries and is included in legislation where it exists (11,12). In cases of voluntary donation, the donor and the recipient can appropriately be matched, the maximum number of oocytes can be retrieved and the cycle of the donor and the recipient can be syn-
SCHENKER
chronized. The most common stated motivation of the volunteers to donate oocytes is to help infertile couples. In 30% of the cases, the donation has been noted to have financial incentive (9).
SELECTION AND SCREENING OF RECIPIENTS The only contraindications to ovum donation are medical or psychological conditions of the recipient under which pregnancy is ill-advised. A primary diagnostic workup is indicated before the infertile couple is treated by means of ovum donation. The following examinations should be performed: a physical examination of the female partner, hysterosalpingography for evaluation of the adequacy of the uterine cavity, a patent fallopian tube for the "GIFT" method is suggested for transfer of preembryos, a cardiopulmonary workup is recommended, especially in women with dysgenesis of ovaries and in older candidates. In addition to a routine sperm evaluation, the male partner should submit a sperm sample for the hamster zona-free sperm penetration assay (SPA), which has been proven to have a good correlation with in vitro fertilization of human oocytes (13). The couple should undergo psychiatric and social evaluation, serological examination for blood groups, rubella antibodies, VDRL and HIV, and other tests according to individual indications. In the case of POF, physical examination and various laboratory tests should be performed on the female partner in order to rule out autoimmune disorders, which can make conception inadvisable. An association of autoimmune disorders with other disturbances of autoimmunity is present in 30-50% of the patients with POF (7,14). Endocrine testing should be carried out in order to rule out adrenal, parathyroid, and thyroid dysfunction. Serum should be tested for the presence of circulating antibodies to ovarian tissue or to other endocrine glands. Chromosome analysis is useful in patients with POF in order to identify the role of chromosomal abnormalities in the pathology of the entity. Some patients with POF and chromosomal aberration may be mentally affected. It is of primary importance to identify women with POF who are osteopenic and thus at greater risk for later osteoporotic fractures. At present there are a number of techniques available for noninvasive mass bone analysis. The couple should give a written consent. AcJournal of Assisted Reproduction and Genetics, Vol. 9, No. 5, 1992
OVUM DONATION
cording to the legislation in the State of Israel, they should apply to the District Court with a request for adoption following delivery of the child (15). WHO ARE THE PARENTS? Prior to the development of OD programs there was never any question who the mother was, since she was always both the genetic and the gestational one. Only the identity of the father was uncertain, and this uncertainty was clarified by social evidence to presume the paternity to the mother's husband. In case of ovum donation we may have to distinguish between the genetic and the gestational mother. The current international legal presumption is that the gestational mother is the legal mother. This gives the child and society certainty of identification at the time of birth, thus protecting both mother and child. The recipient is the legal mother and the female donor oocyte has no legal rights or responsibilities concerning the offspring. THE ANONYMITY OF THE DONOR The oocyte donors can be either anonymous or known to the couple. Most of the ethical committees in various countries recommend that if ovum donation is practiced, the anonymity of the donor should be preserved (11,12,16). It seems that the reason to use an anonymous oocyte donor was influenced by the experience with the practice of sperm donation. The practice of sperm donation has always been in secrecy, for a number of reasons: 1. Sperm donation was not accepted as a social and marital norm. The child conceived by the clinical procedure of artificial donor insemination (AID) was considered illegitimate resulting from adulterous relations. In the case of ovum donation, the conception results after applying assisted reproductive technology and is therefore not considered as arising from an adulterous relationship. 2. In sperm donation, secrecy is also in the husband's interest, since it protects him in the society from the supposed stigma of infertility, which in many societies is synonymous with impotence. Since female infertility is more acceptable and well documented in the different traditional writings, this is not the case in ovum donation. Journal of Assisted Reproduction and Genetics, Vol. 9, No. 5, 1992
413
3. Children born following gamete donation may have a social stigma, as well as suffer from psychological and emotional trauma. 4. There is a need to protect the donor. The promise of anonymity to the semen donor was originally introduced due to the concerns in the following areas: (a) Donors fear that they could be considered legally liable for the maintenance of the children resulting from the gamete donation. (b) The children may be able to claim inheritance rights. For this reasons the husband of a married donor would have a material interest in refusing consent to his wife's donation of an oocyte and so would the children of the oocyte donor. (c) If the donor of oocyte is not anonymous and if the child born resulting from ovum donation is defective, the oocyte donation donor may be charged with negligence, if she failed to give a full medical and family history. (d) Access to identifying information could lead to unwanted invasion of the donor's normal future family life by gamete donation children seeking their genetic mother. Since in case of ovum donation the mother who gives birth currently, according to the international laws, is recognized as the legal mother, this may release the ovum donor from all legal liability and inheritance. It is reasonable for the ovum donor to expect that her anonymity be preserved in the future, since in cases of ovum donation the recipient is the biological and the social mother. The above arguments point out that if the donors were not anonymous, many would be reHuctant to donate their oocyte.
ARGUMENTS AGAINST ANONYMITY OF DONORS 1. Truth should be always told. 2. It is accepted by the international community that each individual has the right to know his/ her biological origin. Therefore, offsprings conceived by ovum donation have the right to explore his/her origin when such information is restricted. Otherwise, offspring conceived following ovum donation have lesser rights than children naturally conceived. 3. An ovum donation child, when ill, may be
414
harmed by not knowing his genetic constitution and family medical history of the donor. 4. Practice with anonymous ovum donation will lead to distrust in the family. As seen from the adoption experience, the child may accidently discover data regarding of his/her conception. This may be also achieved by blood testing and tissue typing that would be able to prove that the child is not genetically related to his gestational mother. In such cases, the family interrelationships can be harmed. Disclosure of the ovum donation process of conception may intensify the psychological needs of the offspring to explore his/her genetic origin. This need may be less in cases of ovum donation as compared to those of semen donation, since the parents, both the father and the mother are the biological parents. A recent survey of 67 centers in the United States performing oocyte donation revealed that 31% of the centers accept both anonymous and nonanonymous donors. Twenty-nine percent of the centers accepted oocyte donation only from anonymous donors, while 18% provided the service with nonanonymous donors. The experience of some centers is that the infertile couples prefer to select their own donors. A number of limited surveys of ovum donation have suggested that at present the donors are less concerned with anonymity that was previously reported with sperm donors (17).
MEDICAL RECORD KEEPING There is consensus among medical professionals that keeping accurate medical records is essential. Record keeping has always been an important part of both medical practice and of quality assurance. In cases of ovum donation it is also crucial for the follow up of the parties involved. It raises particularly difficult ethical and legal questions with regard to medical confidentiality and familiar privacy. The right to privacy is a fundamental human right. In the context of medical information that is personal and intimate, the concern for respect for privacy of the participants is paramount. Truthtelling and candidness are values to be respected in the communication between the physician and the patient and in case of ovum donation, it may be considered in the relationsh!p between the physician, donor, and recipient. Candidness with the family
SCHENKER
after the birth of a child as to the method of his conception or later as to the identity of the donor is of a different nature. Society's (state) intervention in the privacy and intimacy of the familiar relationship in order to force a greater openness could be an invasion of the freedom of procreation decision making that extends beyond the legitimate concern for the quality of services and for the proper followup of the offspring. Registration and regulations in different countries where ovum donation is practiced, consider the nature of information to be maintained about the parties involved in the ovum donation program (12). A distinction has been drawn between non-identifying and identifying information. The non-identifying information includes: (a) detailed description of physical characteristics, ethnic origin etc., (b) medical history and genetic background. It is feasible to provide offsprings with non-nominative, genetically identifying information, by storing DNA extracts from donor's white blood cells taken at the time of oocyte donation, and (c) social characteristics: education, profession, habits, interests, etc. When identifying information is required, it will include full names, addresses, date and place of birth, I.D. of the patients involved. The responsibility for collection of information should lie with the physician performing each stage of the ovum donation procedures. There are different opinions regarding the storage of information: Where should they be kept? Who should have access to them? What kind of information should be released to the parties involved in the program? In most countries where ovum donation is practiced, the records of identifying and non-identifying information are kept and maintained by the physician or medical institution according to the regulations of that particular country. In some countries, ethical committees have suggested that the identifying information of the parties involved should be stored with the central governmental registry body (18). In South Africa, for example, a National Data Bank exists. The advantages of central state registry are: (1) The information can be safely kept for long periods. (2) There is a protected central control for release of information. (3) Information can be updated and more readily accessed than when stored in medical institutions or in individual clinics. (4) A central computerized national register may provide control over the number of donations made by each donor. Journal of Assisted Reproduction and Genetics, Vol. 9, No. 5, 1992
415
OVUM DONATION
Considering the sensitive nature of this information, safeguards should be devised where documentation is kept. It is of importance to restrict to a minimum the personnel that have access to this information. In most instances, the records may be released with non-identifying information. Persons with a legitimate interest to obtain non-identifying information are: (1) all parties involved in the ovum donation program: the donor, the parents and the offspring; in the case of offspring who have not yet reached the age of maturity, the right of access could be exercised by the parents, (2) authorized persons in the course of their duty: medical personnel where the procedure has taken place, personnel who are authorized to store the information, (3) persons appointed by the courts. Identifying material may be released in extreme situations according to the legislation of a specific country. The legislation should not be retrospective on current or past participants in the program. The identifying information can be released only if the parties involved have given their consent to it prior to the procedure. In case the donor is looking for information about the recipient or the offspring, the parents have the right to refuse to release that information even if the offspring reached the age of majority, since there is a possibility that the parents did not disclose to the offspring the details concerning his conception. Conflicts of interest may arise between the parties involved: ovum donor, offspring, and parents regarding disclosure or access to information. The recipient couple has the right to have access to information concerning the donor, which is the genetic parent. This is of importance not only for the benefit of the recipient couple, but also the benefit of the offspring for medical or other reasons. In case of offspring who have not yet reached the age of majority, the right of access should be exercised by the parents. The parents have a right to privacy concerning the circumstances of conception of the offspring. This may be also true in cases of ovum donation. The parents, as guardians of their children are responsible for the welfare of their offspring under the age of majority. The parents have a right and duty as parents to judge the appropriate manner and time to inform their offspring of the circumstances of their conception, if at all. Therefore, the parents have the choice of whether or not to inform an offspring conceived by ovum donation of the circumstances of his birth, and the rights of the parties to Journal of Assisted Reproduction and Genetics, Vol. 9, No. 5, t992
autonomy, information, and privacy should be respected. In case of conflict between the interests of the parents and those of the offspring, when they are of equivalent weight, the rights and the interests of the offspring should prevail. Similar situations exist in adoption laws. 'The present tendency is that in counseling the parents in cases of ovum donation the information should be given to the offspring on the circumstances of their conception should be given.
COMPENSATION FOR DONATION According to most ethical committees' statements, oocyte donors should not be reimbursed for their donation. Some centers in the United States found a solution to this ethical problem by giving compensation for the time and expenses associated with undergoing IVF treatment cycles. The donors receive $50 daily for the preparation of the cycle while receiving drugs for induction of ovulation, $100 for each day that they have ultrasound examination and $350 for the day of aspiration. The payment to donors for a cycle of treatment is between $500-2000 per aspiration. This amount is around 20% of the total cost of a retrieval cycle, which is paid directly or indirectly by the recipient (17). The interim licensing authority (ILA) in the U.K. (19) has decided to allow centers to offer a free sterilization in return for donated eggs, provided that: 1. The discussion of egg donation must be separate from the decision concerning the management and clinical care of the patient who is going to undergo sterilization or other operations. Only when those decisions have been made may the question of egg donation be raised. 2. Willingness to donate eggs should not influence the medical staff to perform the operation earlier. Some centers offer a free IVF or GIFT cycle treatment as compensation for excess egg donation, in such cases, the payment of the recipient may be in the range of $15,000-20,000 per cycle of treatment (17).
AGE OF RECIPIENT It has been shown that ovum donation may potentially be applied to menopausal women and not
416
only in cases of premature ovarian failure. The endometrium of menopausal women retains its ability to respond to sex steroid hormones and provides a receptive environment for implantation and pregnancy nearly similar to that of endometrium in the reproductive age (20,21). In all races, a remarkable increase in maternal mortality rate is reported with advancing age (22,23). The maternal mortality rate is about 80: 100,000 at age 40, as compared to 20:100,000 at age 30. The etiology of this increased maternal mortality may be attributed to the higher incidence of hypertension, diabetes mellitus, and thromboembolic conditions at the age of above 40 and above. Two phenomena occur with aging: a physiological decline and an increase in diseases. In healthy middle age adults, many physiological functions are maintained in the basal resting state. However, decrements in function occur in most organ systems and homostatic mechanisms when the system is challenged or stressed. Pregnancy and delivery are challenging and stressful situations. Therefore, because of medical concern there should be a serious reservation about any attempt to produce pregnancy beyond the accepted childbearing age. It should be mentioned that mortality curves are exponential after the age of 30, with cardiovascular and neoplastic diseases being the common cause of death. This data should be taken into consideration when one treats menopausal women with OD. A case of maternal death following ovum donation in advanced age of a female was recently reported (24). An increased incidence of congenital anomalies in the offspring of older women in general is reported. This may be due to either the older gametes or to the endometrial environment. Chromosomal aberrations (mainly Down syndrome) can be prevented by using oocyte donors of age below 35. Since recipient females of advanced age are usually married to older male partners, a paternal partner may contribute to congenital malformations in the offspring of women in menopausal age undergoing OD. Paternal age does not appear to be an important risk factor for Down syndrome, however, the age of the father does play a role in the development of autosomal dominant genetic diseases. The relative frequency of new autosomal dominant mutations in offspring increases logarithmically with the increase in paternal age (25). There is an increase in the incidence of hydatid-
SCHENKER
iform mole toward the end of the childbearing period. The most pronounced effect of age is observed in women older than 45 when the relative frequency of this lesion is more than ten times higher than at age 20 (26). Pregnancy beyond the ordinary childbearing age raises familial and social problems. Surveys in the United States have shown that 31% of clinics providing OD exclude recipient over the age of 40. On the other hand, 27% of the centers indicated that they have no upper age limit for recipients. The average age of recipients, according to the United States registry is 35-55 (t 7). Recently, the media reported that a nearly 60-yearold woman gave birth after ovum donation. Even though gestation can be obtained by QD at menopausal age, it should be restricted for medical, social, and familial reasons. LEGAL CONTROL OF OVUM DONATION There is an ongoing debate in society, especially among the members of the medical profession, as to the necessity of LEGAL regulations and public control concerning assisted reproductive practices. At present, many countries, even in the Western hemisphere, have not yet established legislation pertaining to the various aspects of assisted reproductive technologies, such as sperm, oocyte, and preembryo donation, freezing of preembryos, and research on preembryos. We assume that this is because of the fact that the law tends to lag behind social changes and scientific achievements (12,27). Regulations through process of law come from two sources: statutes and judge-made laws. Statutes are decided by legislators, while judgemade laws develop either where the courts are called upon to interpret and apply written law, or where such law does not exist--by analogy or otherwise. Legislation may resolve the following problems: a relation between biological and social parents, safeguarding of the interests of the offspring, regulation of medical performance including quality control, record keeping and development of a national data bank for oocyte donors. Development of a national data bank for oocyte donors may have an advantage, in that the number of donated oocytes from any one person could be limited. This could avoid the problem created when a single donor (more frequent in semen donation than in ovum donation) is used to initiate a large
Journal of Assisted Reproduction and Genetics, Vol. 9, No. 5, 1992
OVUM DONATION
number of pregnancies, introducing some risks of unintended consanguinity among future marriage partners. Data on consanguinity risk of ovum donation is not available, but it may be presumed that the risk would be much lower with anonymous ovum donation than with semen donation, since OD is unlikely to result in multiple offspring from one oocyte donor. At present, legislation exists only in few countries (27). In some countries, assisted reproduction is practiced according to regulations drawn up by professional bodies. In some, such bodies are appointed by the government or by medical associations. In other countries spread over the continents, reproductive scientific centers impose their own ethical standards, whereby standing committees decide on a case-by-case basis. Some practicing groups have determined their own standards. In some countries, where the procedure is controlled by governmental or professional societies, the practicing units have to be authorized by those bodies. Most medical centers involved in the practice of assisted reproduction prefer public control by ethical committees. Our survey (27) indicates that mainly two factors have influenced the practice of assisted reproduction: religious attitude and the feminist movement. The religious influence prevails in the countries where religious parties are in potential power and when the government is influenced by the religious attitudes (28). Control of various aspects of ovum donation practice as determined by parliamentary legislation is less desirable. Nevertheless, ovum donation should be controlled by some legal framework that will protect the legal relationship of the parties involved. The medical and social issues, such as selection of oocyte donors, limitation of the overuse of donors, and the licensing and quality control of medical performance, can be teft to the judgment and supervision of professional bodies. It has been argued that the legal and social issues involved in the practice of gamete donation are similar to those of adoption. If this is the case, the same legal and social framework can be applied to both. However, there are major differences between adoption and the use of gamete donation. The practice of adoption is child-centered, a solution for an abused or an unwanted child, while the reason for the use of oocyte donation is to solve the interest of the recipient couple.
Journal of Assisted Reproduction and Genetics, VoL 9, No. 5, I992
417
SUMMARY The newer technologies of assisted reproduction offer the infertile couple a wide spectrum of choices according to their specific problem. A relatively newer technique is that of ovum donation, whose technology is now well established. However, as with other newer technologies, it has given rise to new dimensions of ethical and legal issues which have to date not been fully appraised. It is very difficult to find a legal consensus under international umbrella to the specific issues involved in ovum donation. This is due to the different cultural, religious, and time influence atmosphere prevailing in the various parts of the world. Each society should develop its own statutes on ovum donation. A frame of ethical guidelines should be established by international organizations that may help each society issue its own regulations.
REFERENCES 1. Lutjen P, Trounson A, Leeton J, Wood C, Penoa P: The establishment and maintenance of pregnancy using in vitro fertilization and embryo donation in a patient with primary ovarian failure. Natu re 1984;307:174 2. Navot D, Laufer N, Kopolovic J, Rabinowitz R, Lewin A, Granat M, Margalioth E, Schenker JG: Artificially induced endometdal cycles and establishment of pregnancies in the absence of ovaries. N Eng J Med 1986;314:806 3. Schenker JG: Pregnancies in cases of premature menopause. In Advances in Gynecological Endocrinology, AR Genazzani, R Petraglia, A Voope, F Facchinetti (eds). Lancaster, Parthenon Publishing Group, 1989, p 621 4. Schenker JG: Ovum donation: The state of art. Ann NY Acad Sci t988;541:742 5. Rosenwaks Z: Donor eggs: Their application in modern reproductive technologies. Fertil Steril 1987;47:895 6. Serhal PF, Craft IL: Qocyte donation in 61 patients. Lancet 1989;1:1185 7. Schenker JG: The therapeutic approach to infertility in cases of ovarian failure. Ann NY Acad Sci 1991;626:414 8. Schenker JG: Pregnancies in women with gonadal dysgenesis. In The Fetus as a Patient, K Maeda (ed). Amsterdam, Excerpta Medica, 1987, p 31 9. Sauer MV, Rodi M, Scrooc M, Bustillo M, Buster JE: Survey of attitudes regarding the use of siblings for gamete donation. Fertit Steril I988;49:721 I0. Rosenberg SM, East JM, Wood SC: Ovum donations by sisters in ovarian failure: Simplified priming and early withdrawal of exogenous support. J IVF/ET 1989;6:228 11. The Ethics Committee of the American Fertility Society: Ethical considerations of the new reproductive technologies; donor eggs in in vitro fertilization. Fertil Steril 1990;53:48S
418 12. Schenker JG, Frenkel D: Medico-legal aspects of in vitro fertilization and embryo transfer practice. Obstet Gynecol Survey 1987;42:405 13. Margalioth E, Navot D, Laufer N, Lewin A, Rabinowitz R, Schenker JG. Correlation between the zona-free hamster egg sperm penetration assay and human in vitro fertilization. Fertil Steril 1986;45:665 14. Alper M, Peter R, Garner M: Premature failure: its relationship to autoimmune diseases. Obstet Gynecol 1985;66:27 15. Schenker JG: In vitro fertilization (IVF), embryo transfer (ET) and assisted reproduction in the State of Israel. Hum Reprod 1987;2:755 16. Templeton A: Gamete donation and anonymity (comment). Br J Obstet Gynaecol 1991;98:343 17. Sauer MV, Paulson RJ: Understanding the current status of oocyte donation in the United States: What's really going on out there? Fertil Steril 1992;58:16 18. New South Wales Law Reform Commission: Artificial conception report. 1988, p 92 19. Department of Health and Social Security: Human fertilization and embryology: A framework for legislation. London, 1987 20. Navot D, Scott RT, Droesch K, Veeck LL, Liu HC, Rosenwaks Z: The window of embryo transfer and the efficiency of human conception in vitro. Fertil Steril 1991 ;55:114 21. Navot D, Bergh PA, Williams MA, Garrisi GJ, Guzman I, Sandier B, Grufeld D: Poor oocyte quality rather than implantation failure as a cause of age-related decline in female fertility. Lancet 1991 ;337:1375
LOTAN AND SEIDMAN 22. Harrison EE: Who do pregnant women die? Dallas Med J 1982;(Sept-Oct):242 23. Schenker JG, Mot Yoseph S: Maternal Mortality in Israel. Presented at the 13th World Congress of FIGO. Singapore (in press) 24. Bewley S, Wright GT: Maternal death associated with ovum donation twin pregnancy. Hum Reprod 1991;6:898 25. Frieman JM: Genetic disease in the offspring of older fathers. Obstet Gynecol 1981 ;57:475 26. Jequier AM, Winterton WR: Diagnostic problems of trophoblast disease in women age 50 or more. Qbstet Gynecol 1975;423:378 27. Schenker JG: Assisted reproduction: Formation of laws and regulations. In New Concepts in Reproduction, Y Boutaleb, A Gzouli (eds). Lancaster, The Parthenon Publishing Group, 1991, p 149 28. Schenker JG: Health care politics around the world: Religious views regarding treatment of infertility by assisted reproductive technologies. J Assist Reprod and Genet 1992; 9:1
Joseph G. Schenker Department of Obstetrics and Gynecology Hadassah University Hospital Jerusalem, Israel
In Vitro Fertilization and Embryo Transfer in Israel: Results from a National Survey I
INTRODUCTION The first in vitro fertilization (IVF) and embryo transfer program was established in Israel in December 1981. At that time only a few IVF programs were 1 Members of the professional committee appointed by the Ministry of Health to evaluate the function of IVF clinics licensed in Israel: Shlomo Mashiach, MD (Chairman), Department of Obstetrics and Gynecology, Sheba Medical Center, TelHashomer; Vaslav Insler, MD, Department of Obstetrics and Gynecology, Kaplan Hospital, Rehovot; Gedalia Paz, MD, Institute for the Study of Fertility, Serlin Maternity Hospital, Hakirya, Souraski Medical Center, TeI-Aviv; and Yoram Lotan, MD, Ministry of Health, Jerusalem.
operating worldwide, following the birth of the first child, as a result of IVF by Steptoe and Edwards in England, 3 years earlier (1). Israel was thus one of the first countries to adopt this new technique for assisted conception. During the next 8 years, 15 additional IVF programs were established in Israel. In order to assess the outcome and needs of advanced reproductive technology procedures in Israel, in 1989 the Ministry of Health appointed a professional committee to evaluate all of the IVF units licensed in Israel. The present study reports the results of this survey, the first to encompass the entire IVF program in Israel since its establishment. Journal of Assisted Reproduction and Genetics, Vol. 9, No. 5, 1992
