The question of in vitro fertilisation

The studies in this publication were submitted by the Society for the Protection of Unborn Children as evidence to the government inquiry into human fertilisation and embryology (sometimes referred to as the Warnock committee). They set out the objections to in vitro fertilisation, on medical, humanitarian and social grounds

Evidence to the government inquiry into human fertilisation and embryology from the Society for the Protection of Unborn Children

  • Professor Jérôme Lejeune, MD, PhD
  • Professor Paul Ramsey
  • Gerard Wright, QC
© 1984, the SPUC Educational Research Trust

Contents


HTML editor's note: The appendices, which provide the context of the SPUC submission, are included on this page of the HTML version of this publication. Please note that besides its opposition to in vitro fertilisation in principle, SPUC does not necessarily endorse the assumptions, definitions, language and reasoning in these documents.

Background documents


Government circular giving guidelines to all organisations wishing to submit evidence to the Warnock Committee

1 November 1982
Dear ..............., GOVERNMENT INQUIRY INTO HUMAN FERTILIZATION AND EMBRYOLOGY As you know, the Government has established a Committee of Inquiry into Human Fertilization and Embryology, under the chairmanship of Mrs Mary Warnock. The Inquiry's terms of reference are:
"to consider recent and potential developments in medicine and science related to human fertilization and embryology; to consider what policies and safeguards should be applied, including consideration of the social, ethical and legal implications of their developments and to make recommendations."
At its first meeting on 14 October the Inquiry decided that it should seek the views of a wide range of interested bodies on all aspects of its work. I am therefore writing to you to invite you to submit written evidence to the Inquiry. The Inquiry will be interested in views on any part of its work, but there are a number of subjects on which evidence, whether of a factual nature describing current activities and problems or concerned with implications of these activities, would be especially welcome. These are:
a. therapeutic, that is, concerned with the therapeutic aspects of recent developments for the treatment of infertility and the prevention of inherited disease.

b. scientific and research, the potential use of new techniques for the advancement of knowledge of human physiology and pathology. In this context the Inquiry recognises there may be no clear distinction between the terms "medical" and "scientific", while the former may imply a direct therapeutic purpose, the latter may include an advance in knowledge whose end product is not immediately therapeutic, although it may in combination with other factors become so.

c. legal, this area would include questions (if legal liability, the rights of" the individual (both the parents and child and, in the case of artificial insemination, the donor), legitimacy, incest. inheritance and the rights of surrogate mothers.

d. social, including the implications for society example the ability to choose the sex of a child in advance. While the Inquiry finds it difficult to determine specifically social issues, it feels strongly that developments in an area as fundamental as human reproduction are bound to have effects on the way people regard children, parenthood and the family in general, and are anxious to have the views of those with an interest in how attitudes are likely to change.

e. moral and ethical, any consideration of the above involves making moral and ethical judgements, for example, in the acceptability of certain techniques, and the Inquiry hopes that those submitting evidence will highlight those issues which they believe to pose the greatest moral or ethical questions.

The Inquiry is aware that many organisations may not have a detailed knowledge of the range of techniques which have given rise to concern. The enclosed note has been written to assist those preparing evidence by giving examples of the types of issue that the Inquiry will be considering. It must be stressed that the note is only illustrative of the issues, some of which are highly controversial. The note in no sense reflects the thinking of the Inquiry or implies that any conclusions have been reached. Indeed the Inquiry is anxious to promote a wide-ranging debate on all these issues. However, I think I should point out that in considering the scope of their work, the Inquiry decided that its terms of reference include sex selection and artificial insemination, but not abortion and contraception. The Inquiry would not wish to receive evidence on the latter subjects.

A number of bodies have already asked whether they could give oral evidence as well as make submissions in writing. The Inquiry may well wish to explore certain points in detail in this way, but do not wish to make any final decisions on this until they have had an opportunity to assess written evidence. It is however likely that the taking of oral evidence will be the exception rather than the rule and bodies preparing evidence should view their written submission as their sole opportunity to state their position.

The Inquiry is anxious to make progress with its task but appreciates that it takes time to prepare evidence. It has therefore decided to allow a period of three months for the submission of evidence. Evidence should be sent to the Secretary to the Inquiry at the following address, to arrive not later than 1st March 1983:

The Secretary, Inquiry into Human Fertilization and Embryology, Room B1202, Department of Health and Social Security, Alexander Fleming House, Elephant and Castle, LONDON SE1 6BY

Any queries, either about the Inquiry and its scope, or the submission evidence, should also be made to the Secretariat.

Yours sincerely,
Mrs, J.C. Croft
Secretary to the Inquiry into Human Fertilization

Medical and Scientific Developments Relevant to Human Fertilization


Introduction
1. This paper describes the techniques that have been used or that may be developed in the near future to modify the earliest stages of human fertilization and embryology . The circumstances in which these might be used are mentioned but the paper does not consider their legal, ethical or social implications.

Background
2. About one couple in ten are infertile. Most of the techniques described in this paper have been developed to overcome particular types of infertility in either husband or wife. Some of the later paragraphs describe procedures that will not lead directly to the birth of a child, but would increase knowledge and understanding of the physiology and pathology of hum an reproduction.

In Vitro Fertilization and Embryo Transfer (IVF)
3. In Vitro Fertilization and Embryo Transfer became a human reality when the first "test tube baby" was delivered by Mr Patrick Steptoe at Oldham General Hospital in June 1978. This birth was the culmination of more than a decade of research by Mr Steptoe and Dr Robert Edwards of Cambridge. Their programme at Oldham resulted in two further IVF births.

The IVF Technique
4. In Vitro Fertilization and Embryo Transfer is used primarily to overcome female infertility due to the absence or gross disease of the Fallopian Tubes, down which the egg. has to pass to reach the uterus. . The concept of IVF is simple; a ripe human egg is extracted from the ovary shortly before it would have been released by nature, Next, the egg is mixed with the semen of the husband or partner, so that fertilization can occur. The fertilized egg is then transferred back to the mother's uterus, once it has started to divide. In practice the technique for recovery of the eggs for fertilization, their culture outside the mother's body, and the retransfer of the developing embryo to the uterus, have to be carried out under very carefully controlled conditions.

5. An alternative method that does not involve fertilization outside the mother's body has also been used. In this the egg and semen are immediately transferred back so that fertilization takes place in the uterus. By either method once a fertilized egg has implanted in its mother's uterus subsequent development should proceed in the same way as a normally conceived pregnancy.

IVF in the UK
6. In 1980 Mr Steptoe and Dr Edwards opened a private clinic at Bourn Hall, Cambridge, where IVF is now available to UK residents and to couples from overseas. It was reported recently that there have been more than 140 pregnancies conceived at Bourn Hall, representing a 20-25 per cent success rate among women to whom embryos have been transferred. The only other successful pregnancies have been at the Royal Free Hospital, where the first pair of "test tube twins" born in the UK were delivered. Other IVF programmes at the Hammersmith Hospital, St Mary's Hospital, Manchester and elsewhere have yet to achieve a viable pregnancy.

IVF in other Countries
7. In Australia there is a successful IVF programme in Melbourne, and there have also been IVF births in France, USA, Sweden and Denmark. The technique is now being used in many more centres worldwide.

Developments of IVF
8. "Surrogate Mothers, Womb Leasing and Egg Donation"
In veterinary practice it is now possible for an embryo, conceived in vitro, to be transferred to the uterus of a cow, pig or sheep that is not its natural mother. There are reports that in the USA and Australia similar methods have been used to transfer IVF embryos to women who are not genetically related. The term "surrogate mother" has been used to describe this situation, which has also been described as "egg donation". In the UK there are as yet no reports of a successful pregnancy in which a woman has borne a child of which she was not the genetic mother.
9. It has been suggested that human egg. donation might be used:

a. Where a woman has or may be the carrier of an hereditary disease. She might receive a donated egg, which after fertilization by her husband's sperm in vitro would then be transferred to her uterus. In this way the woman would carry her husband's child to term and thus be the child's physiological mother, without the risk that she might pass on her disease to the child.

b. When a woman cannot herself bear a child. She could donate an egg which would be fertilized by her husband's sperm in vitro and then transferred to the uterus of another woman. The surrogate mother would then carry the pregnancy but return the child to its genetic parents after delivery. This sequence of events has been called "womb leasing" in some publications, if the mother is to be paid to carry the pregnancy.

Womb Leasing for Artificial Insemination by Donor (AID)
10. There is, however, a clear distinction between surrogate motherhood, as described above, and recent UK press reports of another type of "womb leasing" resulting from AID (see para 20). In this case a married couple who could not have children made an agreement with another woman that she would bear a child fathered by the husband. Following the birth, the mother was to give the baby to the couple. The child was conceived by AID, but when the baby was born the mother decided to keep the child herself. Although the reports referred to this arrangement as "womb leasing" the pregnancy was, in effect, no different from other AID pregnancies.

Cloning
11. In certain amphibian species such as frogs, and more recently in some mammals, for example sheep, it has become possible as an experimental procedure to divide a fertilized embryo when it was at a very early stage of development and contains two or four cells. The result is that each of these cells develops into a separate individual (clone) but with identical characteristics and genetic constitution to its siblings derived from the same embryo. Human identical twins are the result of natural cloning when a two-cell human embryo separates to become two separate embryos.

12. The possibility exists that cloning could be used to investigate the chromosomal normality of human embryos conceived by a couple who have a high chance of procreating an abnormal child. For example, a young mother who has already given birth to an infant with Down's Syndrome and analysis of her chromosomes shows that she has a high chance of a similarly affected child in a subsequent pregnancy, might choose to have her next embryo conceived in vitro. The embryo would then be allowed to develop to the two or four cell stage where it would be cloned. One of the clones would be allowed to continue development while the remaining clones would be deep frozen (see para 13). Development of the unfrozen clone would continue for some further divisions until it was possible to determine by cytogenetic techniques whether the embryo had the normal chromosomal complement or the extra chromosome that is diagnostic of Down's Syndrome. If the embryo had a chromosome abnormality the frozen clones would not be transferred to the mother. If on the other hand the embryo had a normal chromosomal make-up, one or more of the clones could be unfrozen and transferred to the mother's uterus.

There are no reports of a successful human pregnancy following cloning of the embryo. A postulated use for human cloning. would be to produce identical twins deliberately.

Freezing of Human Embryos
13. Human semen can be successfully frozen for many months or years. The same techniques could be applied to early human embryos which might be deep frozen for subsequent use, as is now possible in veterinary practice. Before discussing the freezing of embryos further the induction of super-ovulation should be mentioned, although this technique is often used entirely separately from IVF.

Induction of Super-Ovulation
14. Normally one egg is released during. each human menstrual cycle. Some women do not release an egg regularly and for them certain drugs, such as chorionic gonadotrophin may be used to stimulate ovulation, as this can cause the release of several eggs in a single cycle (super-ovulation). As the recovery of an egg for IVF involves a surgical operation and an anaesthetic, drugs that cause super-ovulation can be used so that more than one egg can be recovered from a single operation. However these drugs may also disorganise the normal hormonal cycle so that after IVF the transfer of the embryo to the mother's uterus is less likely to succeed.

15. To avoid multiple operations to collect a single egg each time, super-ovulation can be induced by drugs and the eggs collected and fertilized. The resulting. embryos could then be deep frozen until the optimum time for transfer back to the mother's uterus in a subsequent cycle.

16. Other suggested reasons for freezing embryos are:
a. To enable women to have an IVF pregnancy months or years after they or their partners have been sterilised, or even after their husband's death. This would be similar to the posthumous use of frozen semen for Artificial Insemination by Husband (AIH).

b. The use of cloning and freezing techniques to ensure that an embryo with a chromosomal abnormality is not transferred to the mother was discussed in paragraph 12.

c. Storage of embryos for experimental purposes is described in paragraph 27.

17. Researchers in various parts of the world are attempting to store human embryos by deep freezing. techniques. There is a recent Australian report that a human embryo has been successfully unfrozen and continued its in vitro development, but no report that an unfrozen embryo has been transferred back to its mother and resulted in a successful pregnancy.

Artificial Insemination
18. Historically, artificial insemination was the first technique applied to modify human reproduction almost 100 years ago . [here are two types of artificial insemination - Artificial Insemination by Husband (AIH) and Artificial Insemination by Donor (AID). Both are now widely used.

AIH
19. This technique is used for some couples who cannot otherwise conceive and, if for example, it is felt that the chances of pregnancy would be increased by concentrating the husband's semen or by inserting it directly into the uterus. Other reasons for AIH occur:
i. When the husband cannot ejaculate but instead passes his semen into the bladder (retrograde ejaculation).
ii. For some couples where the husband is severely physically handicapped and AIH offers the only possibility for him to father a child.
iii . If a man is to undergo surgery or radiotherapy that may result in sterility, his semen may be stored by deep freezing and used at a late date for AIH . More recently semen has been similarly stored by some men before they undergo vasectomy as a means of permanent contraception.
iv. Less commonly, AIH may be used to overcome a particular type of female infertility where antibodies which kill the sperm are found in the cervical mucus. In such cases AIH may be successful when the semen is injected into the uterus.

AID
20. Artificial Insemination by Donor is used when investigations have shown the husband to be infertile or to have significantly reduced fertility. For AID, semen is donated by another man. AID has also been used when a fertile husband stiffens from, or may be the carrier of, a serious hereditary condition for example, Huntington's Chorea; and the couple decide that they will not risk passing on the husband's condition to the next generation.

21. Both AIH and AID may be carried out using fresh or frozen semen. . There have been many successful pregnancies using frozen semen , although the proportion of successful inseminations is not as high as if is with fresh semen. For AIH and AID the semen may either be placed in the upper portion of the vagina next to the cervix or injected into the uterus through a fine catheter.

The Use of AID in the UK
22. It is known that in 1979 more than 1800 women began treatment in the UK, and in the same year there were over 800 pregnancies from AID.

Choosing the Sex of Human Offspring
23. There are at present two techniques available that can identify the foetal sex as early as 16-18 weeks gestation, namely ultrasound, or amniocentesis followed by chromosomal analysis. Either method is now used to identify the foetal gender when there is a risk of a sex linked hereditary disease, but both techniques can only be used at a relatively late stage of pregnancy. If a foetus of the affected gender is identified, a late abortion may be carried out under section 1.1.B of the Abortion Act.

24. It has been suggested that IVF, cloning and freezing techniques could be used to determine the sex of an embryo prior to its transfer to the mother's uterus, thereby avoiding the situation where a late abortion might otherwise be performed on account of an inherited sex linked disorder such as haemophilia. It has also been suggested the techniques might be used more widely by couples who particularly wanted a child of a given sex.

25. In future, the development of a technique to separate male and female bearing. sperm would also allow couples to choose the sex of their offspring using. AIH after the sperm had been separated. Techniques to separate male and female bearing sperm do not exist at present.

Trans-species Fertilization
26. It has been found that trans-species fertilization studies using human sperm and hamster eggs can differentiate between cases of unexplained male human infertility, usually where the man has a very low sperm count. Studies show that men whose sperm will not fertilize a specially treated hamster egg. have little prospect of fertility, whereas those whose sperm will do so, may father a pregnancy if they try for long enough. The hamster-human hybrid will, however, not develop beyond the two cell stage. It has been suggested that this test may become a routine and important test in the investigation of male subfertility.

Experimental use of Human Embryos
27. Tests for teratogenicity in animals cannot be relied on as an absolute guide to drug safety in human pregnancy. Once a drug or other substance has passed the full range of animal studies, a more scientific way to test for human teratogenicity might be to carry out tests on human embryos cultured in vitro. Other experiments using human IVF embryos could be used to investigate the causes of major abnormalities such as spina bifida, cleft palate and hare lip. The protagonists of the use of human embryos for experimental purposes argue that the best species for human experimentation is man, and claim that many uncertainties of human embryology and genetics could be resolved by experiments of this kind.

Ongoing Development of the Human Embryo and Foetus In Vitro (Ectogenesis)
28. In the current state of knowledge it is not possible to maintain development of a human (or other primate) embryo in vitro beyond a comparatively early stage but development of current techniques is likely to result in embryos being maintained for progressively longer periods so that embryonic and foetal development can be studied. Once these are available it may be suggested that studies should be specifically carried out using human embryos to document in detail the normal and abnormal stages of human embryonic and foetal development. In the foreseeable future it is improbable that a human embryo could be maintained indefinitely by purely in vitro methods (ectogenesis). However, it may become possible to maintain such embryos for considerably longer periods than can now be achieved.

Genetic Manipulation of Human Embryos
29. Within the next 10-20 years advances in molecular biology may make it possible for defective genes in a very early human embryo to be identified and selectively removed or replaced by normal genes. Such manipulations are not possible in the present stage of knowledge but there is already speculation that techniques of this kind might be used by a couple who are at risk of pro-creating a child with an inherited condition due to a single gene, for example cystic fibrosis. If it became possible to identify and replace the cystic fibrosis gene in a IVF embryo, the mother could be assured that the embryo being transferred to her uterus would not suffer from this abnormality. There are a number of other inherited conditions such as Thalassaemia and Tay-Sachs disease, which are also due to single genes, that might be amenable to this type of genetic manipulation. It has been suggested that in the distant future whole chromosomes might be replaced by similar methods.

The use of Cloned IVF Tissues and Organs for Transplantation
30. It has been suggested that in the long term it may become possible to use IVF and cloning techniques to produce embryonic and foetal organs of an exact tissue type for transplantation purposes. Such organs could be matched to correspond in every detail with the immunological characteristics of the intended recipient of the transplant . Problems of tissue rejection would thereby be overcome, and it has been suggested these techniques could overcome the shortage of organs that are available for transplantation.

Conclusion
31. This note is not intended as a comprehensive description of all the techniques that might in future be rinsed to modify human fertilization and embryology. The purpose of the paper has been to outline existing techniques and future developments that will be discussed by the Inquiry into Human Fertilization and Embryology..

Statement by the Medical Research Council

Research related to Human Fertilization and Embryology

This statement was also published in the British Medical Journal 1982 Vol 285 p 1480

Introduction
The purpose of this statement is to set out the guidelines which the Medical Research Council believe should guide those whose research involves the use of in vitro fertilization with human gametes. The council's intention is that the guidance should be followed by workers supported by the council, but the principles are believed to be generally valid for all such research.

Background
In 1978 the council set up an advisory group to review policy on research related to in vitro fertilization and embryo transfer in humans. The group decided to concern itself only with the ethics of such work and did not examine specific scientific aspects. The group advised the council that scientifically sound research involving in vitro fertilization - where there was no intent to transfer the embryo to the uterus - should be allowed to proceed if its aim were clearly defined and acceptable; and concluded that, in the context of female infertility due to tubal occlusion, in vitro fertilization with subsequent embryo transfer should be regarded as a therapeutic procedure covered by the normal ethics of the doctor/patient relationship. The council endorsed these views.

In May 1982 the advisory group way reconvened with an expanded membership* and terms of reference as follows:

"to consider recent and potential developments in research related to human fertilization and embryology, and to advise the council on these and on the ethical grounds they should take into account in considering research proposals in these areas.

The group's further conclusions have been accepted by the council as an appropriate basis for MRC policy.

Guidelines for research related to human fertilization and embryology
i. Scientifically sound research involving. experiments on the processes and products of in vitro fertilization between human gametes is ethically acceptable and should be allowed to proceed on condition both that there is no intent to transfer to the uterus any embryo resulting from or used in such experiments and also that the aim of the research is clearly defined and directly relevant to clinical problems such as contraception or the differential diagnosis and treatment of infertility and inherited diseases.

ii. Informed consent to research involving human ova or sperm should be obtained in every case from the donor(s); sperm from sperm banks should not be used unless collected and preserved specifically for a research purpose. Approval for each experiment should be obtained from the appropriate scientific and local ethical committees.

iii. When human ova have been obtained and fertilized in vitro for a therapeutic purpose and are no longer required for that purpose it would be ethical to use them for soundly based research provided that the informed consent of both donors was obtained.

iv. Human ova fertilized with human sperm should not be cultured in vitro beyond the implantation stage; and should not be stored for unspecified research use.

v. Although it is not always possible to extrapolate results from animal work to the human situation, studies of animal gametes and embryos are useful to elucidate the potential risks of in vitro fertilization and embryo transfer. Tests of animal embryos in appropriate animal models are necessary before it can be assumed that freezing and storage of the embryo does not cause harm to the conceptus.

vi. Studies on interspecies fertilization are valuable in providing information on the penetration capacity and chromosome complement of sperm from subfertile males, and should be supported. The fertilized ova should not be allowed to develop beyond the early cleavage stage.

Stumble It Stumble It Digg this Digg This Add to del.icio.us Add to del.icio.us

© SPUC 2010