This page highlights some of the questions and concerns which have been raised over the years. Where there is updated information this will be added as "Editorial Comment" from time tit time. The original concerns are left as they were at the time because they illustrate the way in which concerns raised in the past have shaped our thinking today.
SCROLL down this page to explore the various sections
A new website, (http://www.ronsangels.com), recently opened and claimed
to be auctioning off the eggs of models and actresses at prices up to $150,000.
The ASRM Board of Directors, Ethics Committee finds the 'Ron's Angels' website,
www.ronsangels.com, both offensive and unethical. Infertility is a serious
disease affecting 6.1 million American women and their partners. In 1996 alone,
more than 3,768 cycles of assisted reproductive technology (ART) were attempted
with donor eggs resulting in 1,849 babies, 8% of total 1996 ART cycles. Donor
egg programs exist to help this nation's infertile couples have the children
they very much want to have - even if it means using another woman's eggs to do
so.
The ASRM Ethics Committee states that reasonable compensation is
justified for the time and trouble of both sperm and egg donors. Compensation
should not vary based on attributes that a child may have. The 'Ron's Angel's'
website is essentially a donor egg 'auction' to sell human eggs to the highest
bidder in the hopes of providing potential parents with more attractive - and
therefore desirable - children. We believe that the 'Ron's Angels' website
violates the ethical principles outlined by the Committee, promotes unrealistic
expectations to potential parents, commercializes what is otherwise a voluntary
donation process, offers undue enticement to potential donors, and has great
potential to exploit highly vulnerable people.
ASRM Bulletin, Volume 1 Number 23, October 26 1999
Two gay men named as parents in surrogacy case Top
Tow men have won a court case to allow them to be named as the fathers of two children carried by a surrogate mother. The surrogate had embryos each of which had been created as a result of fertilisation of donated eggs with the sperm from the two men. A twin pregnancy has resulted and when the children are born both men will be named as 'fathers' the surrogate, presumably, being named as the mother. The two men come from Chelmsford in the United Kingdom and the surrogacy arrangement and IVF treatment was carried out in California, USA.
Although single sex relationships are not recognized in the UK the registration details will be respected by the social services in that country because they were agreed under the laws of another country. The social services have indicated that they will not treat these children any differently from others.
Aspen & Darren were born December 9th 1999.
January 3rd 2000
Barrie Dewitt and Tony Barlow, who were
named on the birth certificate as "parent one" and "parent 2" while no mother's
name was mentioned, faced further battles to define the nationality of the
children. Immigration officials at Heathrow Airport, London, did not accept
that the two men were the babies legal parents and that they did not have an
automatic right to live in Britain - they were granted temporary residency for
one month, but their US passports were confiscated pending a review by the Home
Office (The Government Department in Britain responsible for immigration etc.).
The children's homosexual parents have been advised to apply for British
residency for the children. Mr. Drewitt will ask for a meeting with Mr. Jack
Straw (UK Home Secretary) about the issue which appears to be a case of
discrmination against the children of gay couples.
Editorial comment: We await further news and will update this page as and when decisions are taken.
Source: Daily Telegraph January 3rd 2000.
17 year old girl seeks IVF Top
In the UK a 17 year old girl has been seeking IVF treatment on the National Health Service - she has complained that she has been trying to get pregnant by her 17 year old boy friends and failed. In the UK fertility treatment on the 'free' state health service is free but only spasmodically available in certain areas of the country. Private fertility treatment is available but treatment and drugs must be paid for.
Sex Selection and Preimplantation Genetic Diagnosis Top
(Reuters Health October 15 1999) - Using preimplantation genetic diagnosis to determine the sex of an embryo conceived by IVF is ethically acceptable, but only if the aim is to avoid the transmission of genetic disorders, according to the ethics committee of the American Society for Reproductive Medicine. This is the only reason for choosing the sex of children that avoids the potential of "gender bias," the panel says in the October issue of Fertility and Sterility. The panel's report focuses on the use of preimplantation genetic diagnosis for sex selection. Although the practice is rare, they note "...the increasing attractiveness of pre-pregnancy sex selection..." to some individuals compared with other methods of sex selection, such as abortion. According to a press release from the American Society for Reproductive Medicine, "this Ethics Committee Statement supports the use of [preimplantation genetic diagnosis] and sex selection to prevent the transmission of genetic diseases and discourages use of this technology for nonmedical family balancing or family planning purposes." Fertil Steril 1999;72:595-598.
Sex Selection of Sperm Top
The human embryo contains 46 chromosome 22 + X from the woman and 22 + X or Y from the man. - whether the sperm has the X or the Y chromosome determines the sex of the embryo - only those containing the Y chromsosme will be boys.
There have been several attempts to select the sperm containing either the X or Y chromosome and in some animals this works very well - but not so well in humans. A recent report in New Scientist (December 4th 1999) describes a technique from Colorado State University. The key to the method is to dye the sperm in such a way that there is a colour difference between those containing the X or Y chromosomes. The dyed sperm are given a charge and 'blown' across a laser beam which can detect the colour differences: An electrostatic plate then deflects the X sperm in one direction and the Y another. It claims that bovine sperm can be sorted at a rate of a thousand per second or more and it is also claimed that the technique can be applied to humans. Time will tell whether this is an sufficiently accurate method to offer prospective parents.
Health of children after IVF Top
There has been concern that the health of the children born as a result
of fertility treatment might be impaired.
A study of 5856 babies born from
all the fertility clinics in Sweden between 1982 and 1995 were compared with a
similar number in the general population in the same period. The authors
investigated the incidence of childhood cancers through the Swedish Cancer
Register related to maternal age, parity, previous subfertility, year of birth,
and multiple pregnancies.
There was a very significant increase in the
multiple pregnancy rate (27%) compared with 1% in the control group. This meant
that more children were born preterm (<37 wks) than in the controls (30.3%
vs 6.3%) and more had low birth weights (<2500g - 27.4% vs 4.6%).
Malformations occurred in 5.4% of all the babies born in the in vitro
fertilisation group and the rates of neural tube defects and oesophageal
atresia were higher than in those of the control groups. The was no
increase in childhood cancer in the IVF group.
The authors conclude that
the frequency of multiple births and maternal characteristics were the main
cause of adverse outcomes and not IVF itself.
They felt that there was
a continuing need to decrease the occurrence of prematurity after IVF, that
there was a continuing trend in reducing the number of embryos transferred
(generally only 2 in Sweden) - in about 20% of the cases only 1 embryo was
transferred.
There is a conflict of interest between higher success
rates associated with more embryos transferred and the long term disadvantages
of increased risk of multiple births and the associated abnormalities. They
conclude that further research is needed to enable clinicians to select one
viable embryo for insertion to enable the effectiveness of treatment to be
maintained while substantially lowering the medical risks to the children
born.
T.Bergh et al Lancet 1999;354;1579-85
Risk of cancer after fertility drugs in IVF Top
Ten Australian IVF clinics provided data for women treated before
January 1994. The frequencies of breast, ovarian, and uterine cancers was
assessed. The observed number was compared the expected number in the general
population. 29,700 women were assessed - 20,656 were exposed to fertility drugs
and 9044 were not. For breast and ovarian cancer the incidence was no greater
than expected. The incidence of uterine cancer was no greater in the exposed
group but was significantly higher in the unexposed group. Women with
unexplained infertility had significantly more cancers of the ovary and uterus
than expected. However women who have been exposed to fertility drugs with IVF
did seem to have a transient increase of having breast and ovarian cancer
diagnosed in the first year after treatment, though the incidence was no
greater overall. They suggested two possible explanation to the increase
diagnosis of breast cancers in the first year. One possibility was that an
early diagnosis was made in the course of the clinical management for fertility
or related health problems. The other possibility was that the fertility drugs
used for superovulation promoted the development of cancers which already
existed.
There was no obvious explanation for the increased in
diagnosis of ovarian and uterine cancer in the 'unexplained group, and the
authors urge further investigations.
Alison Venn et al Lancet
1999;354: 1586-90
Ethics of Embryo biopsy and Preimplantation Genetic Diagnosis Top
The technology of embryo biopsy and Pre Implantation Genetic (PIGD) is becoming well established and is in use in many fertility clinics around the world. Only a handful of disorders can be screened at the time (Cystic Fibrosis, Duchene Muscular Dystrophy, Huntington's Chorea, Aneuploidy - chromosome numbers, Tay Sach's etc., ) as well as the sex of the embryo (see separate new item sex selection). Many people are concerned about the extent that this technology could be taken in the future - selection for minor disorders - and some people have expressed concern that the worth of disabled people is being diminished. For those parents with known genetic disorders or, who already have a severely disabled child/children risk having further children being severely disabled children, the new technology offers an option of deciding whether to choose which embryos should be transferred in IVF, and then decide what should be the fate of those embryos which are defective. A high proportion of human embryos suffer from aneuploidy, where the chromosome complement is abnormal. Some clinicians have suggested that all embryos should be screened by PGD and only those without defects or aneuploidy transferred - this might significantly increase success rates but would probably be too expensive or impracticable bearing in mind the large number of IVF cycles which take place.
(Editorial comment November 16 1999)
Public involvement?
Top
In the United Kingdom the public are
to be asked for their views. At the moment four clinics offer PGD and only
about 200 PGD 'treatments' each year. The Human Fertilisation and Embryology
Authority (HFEA), which licenses all fertility clinics in the UK which practice
IVF or donor assisted treatment, has published a consultation document (Nov 16
1999). "Advances in medical science and increasing public interest made the
process necessary" say The Authority. "But", they say "it was not in in favour
of genetic selection to allow a couple to choose the sex of their child or
selection for intelligence or any other attribute".
Ruth Deech, the HFEA
chairman, said "The authority decided it would be unacceptable to allow
preimplantation genetic diagnosis to be use for any social, physical or
psychological characteristics or any other conditions not associated with life
threatening medical disorders.
New scientific and medical advances,
especially in the field of genetics, often cause public unease and present us
with complex, social, ethical and regulatory question. We feel it's time the
publica had a say."
Source: Press report in the Daily Telegraph Nov.16 1999
Editorial comment: The United Kingdom is one of the few countries where legislation exists and which can therefore take note of public awareness and views of emerging technologies. Previous soundings of public views have already taken place and the HFEA acted on the majority consensus view - e.g. whether oocytes from aborted fetus or cadavers could be used in fertility treatment - the view from over 15,000 responses was that such clinical procedures should not for the moment be sanctioned but that research using such material could be submitted for approval by the HFEA in the usual way (all research involving human embryos in the UK must be approved by local ethics committees and the HFEA).
Number of embryos transferred in IVF can be limited Top
Dr. Laura Schieve has retrospectively looked at 35,5554 IVF transfer procedures that took place in 300 clinics in the USA. 9,873 resulted in live births (27.8%). When two embryos were transferred in women between the ages of 20 and 29 or between 30 and 34 the live birth rate was 43% and 36% respectively. Women aged over 35 achieved the maximum live-birth rates when more than 2 embryos were transferred.
If three embryos were transferred the multiple birth rate was as high as 45.7% for the 20-29 age group and 39,8% for the 30-34 group. The rate was less than 25% for women age 40-44 even if 5 embryos were transferred. When the number of embryos transferred was reduced to 2 the multiple birth rate declined to 22.7% for the 20-29 group and 10.8% for the women 40-44.
The American Society for Reproductive Medicine (ASRM) have issued new guidelines and recommends that no more than 2 high quality embryos be transferred in the 'most favourable' prognosis - the number of embryos considered acceptable for transfer increases as the prognosis worsens.
Source JAMA 1999;282:1832-1838 and Reuters Medical News
Editorial comment November 17 1999: In the UK the law does not permit the number of embryos transferred in IVF to be more than 3. In GIFT however, so long as no donor gametes are concerned the number of eggs placed in the fallopian tube can be any number because GIFT, per se, does not come under the HFE Act (1990).
Since 2003 the UK regulations specify the number of embryos which can be transferred has been reduced to 2 and there is pressure to reduce this still further to 1. In some Scandinavian countries the number of embryos transferred must be 1 particularly if state funded treatment is accepted.
Can motility of sperm be increased
?
Top
The ability of the sperm to swim actively
towards the egg is an important fact in conception through intercourse- The
sperm has to swim quite along distance and through many hazards before it
reaches the egg. In many men the motility of the sperm is either reduced or
barely exists. In IVF (in vitro fertilisation) the egg and sperm are put
together in a dish or tube and the distance a sperm has to travel to find the
egg is just a few centimeters - the effectiveness of the swimming action
however is necessary to initiate the fertilisation process although the actual
penetration of the sperm through the zona pellucida is aided by
enzymes.
There have been many attempts to boost the motility of sperm -
pentoxifyline (a derivative of caffeine) can be effective in some cases over a
short period of time. More recently L-Carnitine, a naturally occurring
substance similar to an amino acid has shown some promise - in one Italian
trial the motility was boosted from 22 to 38% and five of the 20 women taking
part in the trial became pregnant. It is interesting to note that the effect of
L-Carnitine seems to be short lived and if the dosage is removed the poor
motility return.
A more complete trial is under way under Dr.
Jon.L.Pryor of the University of Minnesota. L Carnitine is present in the
epididymis where it is present in significantly higher concentration than in
the blood. Clinical trials to prove its effectiveness will be submitted to the
Federal Drug Administration and it is hoped that further studies will prove or
disprove its use in boosting motility in those men who motility falls below
acceptable standards.
Many Clinicians have expressed the view that
any therapy designed to boost sperm numbers or motility have little chance of
success - time will tell.
Use of sperm after death of 'donor' Top
There have been several cases where the use of sperm after the death of the man who provided the sperm was questioned.
It is perfectly possible to use the sperm of a man after his death provided that proper consent has been obtained prior to his death, A man with diagnosed cancer may want to store sperm by Cryopreservation so that the harmful effects of chemo or radiotherapy on sperm production in the testis can be mitigated. In these cases it is wise to provide proper consent forms particularly if the prognosis of the cancer is uncertain or poor. Proper consent requires the man to state specifically how the sperm can be used (e.g. solely for his wife/partner or for anyone) - where there is a wife/partner that should be clearly specified on the consent and it would be wise to add the comments of the wife/partner. In any case the signatures must be properly witnessed and dated.
Questions have been raised in several cases in the UK. In one (referred to as the Diane Blood case - 1998/99) sperm was taken after a sudden death of her husband and she and the family maintained that if he had been able to give his consent he would have done and would have wanted his wife to be able to use the sperm to have a child. The UK HFE Authority which controls the use of donated gametes ruled that she could not use the sperm because although there was implied consent there was no actual consent. Mrs. Blood asked that the sperm be transferred to another country, but this too was rejected by the HFEA. She took the matter to court and to appeal. The Law Lords ruled that unless the HFEA could show real reason why the welfare of a child born in such circumstances they were 'minded to allow the appeal'. The HFEA did not show such circumstances and Mrs. Blood was eventually able to take the sperm to Belgium where, after and IVF/ICSI procedure she was successful in her pregnancy.
There have been other cases through the courts with the emphasis on determining whether proper written consent was given by the man before his death. The grieving process has often been helped by the knowledge that a 'husband's' sperm can still be used.
Two grandparents (MR. and Mrs. Smith) who want to use their dead son's frozen sperm to have a grandchild. They are both in their 60s and would have to show that they had considered the welfare of the child given their age and the fact it would have no parents. The HFEA have insisted that proper consent had been obtained before the death of their son Lance was killed in a car crash - the sperm was extracted 24 hours after his death. There would be no problem if the sperm was used for his girl friend - but she no longer wishes that to be the case. The grandparents are seeking to use the sperm with donated eggs and a surrogate mother. That use was not specified in the consent provided although it is now claimed another consent has been found - typed. The Smiths plan to take the case to the high court to order the clinic in Birmingham to comply with their wishes. The Smiths now to take their case to the High Court. They say that allowing the sperm to die would be like losing their son all over again. "You must understand, if this sperm is destroyed it is as if he is dying again to us,'' Barry Smith told a Sunday newspaper. Before his death, Lance Smith, 36 and his fiance agreed his sperm should be extracted and stored in the event of his death so that they could still have a child -- but she no longer wants to have a baby. The Smiths say their son wrote a letter requesting that "a quantity of sperm'' be frozen in the event of his death. Informed consent must clearly specify the way in which the sperm can be used - that does not seem to be the case. Neither can the Smiths take the sperm out of the country without the authority of HFEA and that they are unlikely to give bearing in mind the proposed use for that sperm.
Time will tell and the outcome will be reported later as the case unfolds. No doubt too that other cases have arisen around the world - please let the webmaster know for future inclusion.
December 21 1999.
Eggs frozen before cancer treatment must stay in storage. Top
See also editorial comment at the end of this section.
A Northern Ireland woman whose eggs were frozen before she had cancer treatment is attempting to overturn a ruling that says she cannot use them to have a baby. Ms Carolyn Neill (34) had the eggs stored after being told earlier this year that radiotherapy could leave her infertile. However, the Human Fertilisation and Embryology Authority, a British government health watchdog, says she cannot have the eggs thawed because of the risks of abnormalities to the baby. The authority has also ruled that Ms Neill cannot take her eggs abroad now that her cancer treatment has been completed successfully.
It believes that not enough research has been carried out to ensure that frozen unfertilised eggs could result in a healthy baby. The authority is due to review the issue of frozen eggs next month. British clinics have been freezing embryos for years but have not been allowed to use a frozen unfertilised egg to achieve conception.
The Assisted Reproduction and Gynaecology Centre in London, where Ms Neill's eggs are being stored, is seeking a judicial review. Ms Neill believes the authority's ruling is unfair and the decision should be left to herself and her doctor. She said she had decided to freeze her eggs with the full agreement of the HFEA. "When I was told the eggs couldn't be defrosted I felt it had all been a waste of time and that hope had disappeared."
Ms Ruth Deech, of the authority, said there were real concerns about the procedure. "We are concerned about genetic abnormalities that might show up in later life. We all remember the thalidomide episodes years ago. We must never have something like that again. "We must value safety above all else, and as soon as we have enough independent scientific evidence to convince us that it is reasonably safe to go ahead and use those eggs in treatment, then of course we will permit it."
However, the medical director of Ms Neill's fertility clinic in London, Dr. Mohamed Taranissi, said: "It is very sad to find out that this technique is now being provided successfully in the US and various parts of Europe and the Far East but is banned in the UK, which brought IVF to the world some 20 years ago."
By Suzanne Breen, in Belfast, The Irish Times, December 17th 1999.
Editorial comment: Eggs have been successfully frozen in
Bologna (Italy) and in other parts of the world- but many people feel that the
dangers of disrupting the delicate processes by which the chromosome separate
after fertilization may be too severe. Dr. Eleanora Porcu has combined freezing
eggs with fertilisation using ICSI (microinjection) - this she says overcomes
the fertilisation and chromosomal problems and has resulted in healthy births.
The Human Fertilisation and Embryology Authority in the UK is renowned for its
ultra-cautious approach. Over 40 babies have been born around the world from
frozen eggs. In time the doubts over these procedures will be
answered.
It seems illogical that a regulatory authority can give
permission for the freezing of eggs - although that permission is not strictly
necessary - without considering the likely request to use the frozen eggs at a
later stage. If they had doubts about the freezing of those eggs they should
have considered whether they would also give permission for the thawing and use
of the eggs - not to have done so has dashed the hopes of a woman who was
already distressed at having to cope with a diagnosis of cancer. Perhaps the
lines of communication between patient, clinic and licensing authority need
clarification and one hopes that, in the not too distant future, such matters
can be resolved in a more humane manner.
Many clinics are now offering to freeze eggs and the number of children born world wide from frozen eggs, whilst small in comparison with those born from frozen embryos continues to grow/
Scottish sperm survey - By post ! Top
Britain's first postal sperm census will begin this week. Men taking part in the survey will receive special packs which will allow them to post their samples to researchers. A specially developed culture medium will allow the sperm to stay alive for 48 hours - usually sperm counts which are not completed within one to two hours are ineffective since the sperm cells die if not separated from the seminal fluid.
1,000 randomly selected Scotsmen are to take part in the Government funded study - at a cost of £450,000. They will post their samples to the Medical Research Councils's Reproductive Biology Unit in Edinburgh. Dr. Stewart Irvine, head of the project said: "The first postal sperm census is a good way to describe it. As far as I am aware it is the first time a national sperm census like this has been done. We have no idea where we stand with semen quality in Scotland. It is an incredibly important issue when you consider how devastated couples can be when they have reproductive problems. This survey will allow us to see where we are now, and perhaps repeat the exercise in 10 years time to see whether or not the semen quality is changing."
Men between 20 and 30 were asked to join the census after being chosen at random from GP's lists in Scotland. Dr. Irvine has been impressed by the willingness of men to take part in the census, He pointed out that ten years ago it would have been unacceptable to go out into the general population and ask for a semen sample. As well as providing the sample the men will answer a 27 page questionnaire asking about their medical history, life style and even their choice of underwear. Their mothers will be asked to fill in a questionnaire to test theories about whether sperm counts can be affected early in a child's life - even possibly during development in their mothers womb.
It is hoped the census will be published before the end of the year.
Source: The Sunday Telegraph, June 2, 2000.
GIFT success rates continue to rise - more than with IVF. Top
There have been many suggestions that GIFT has a higher success rate than IVF - many argue that the presence of secretions (and perhaps other cells) within the fallopian tubes is a more natural environment for fertilization and early embryo development.
A new report fro Boston, USA, suggests that this might be true - more importantly it suggests that the overall quality of ART practice accounts for gradual improvements in both IVF and GIFT.
Delivery rates from assisted reproductive technologies (ART) now approach those from natural fecundity, with recent improvements coming from advances in ovulation induction regimens, according to a report in the January issue of Obstetrics and Gynecology.
Dr. Daniel W. Cramer from Brigham and Women's Hospital in Boston, Massachusetts, and colleagues evaluated detailed information on 1,244 couples accepted for IVF or gamete intrafallopian transfer (GIFT) between 1994 and 1998 at three greater Boston fertility clinics. Among the couples, there were 2,598 IVF and 297 GIFT cycles, the authors report, which yielded "...overall clinical pregnancy and delivery rates [of] 19.9% and 18.9% for IVF and 24.6% and 22.6% for GIFT, respectively."
IVF delivery rates (1994-1995 and 1997-1998) per cycle improved from 14.9% to 22.5%: GIFT delivery rates per cycle improved from 20.6% to 28.0%. These improvements occurred without a concomitant increase in the number of twin or triplet births, the investigators note, and no quadruplet or higher-order births occurred. Over this brief interval, there was a shift in the ovulation induction regimen. Fewer women received a short "flare" GnRH agonist treatment course and more received a long course. Also, the use of urinary FSH declined from 80% down to 25% while the use of recombinant FSH increased to 62%.
The multivariate analysis indicates that "...the decreasing use of flare GnRH agonist regimens and the increasing use of the highly purified urinary FSH preparation, Fertinex, significantly influenced ART success during the 4 years of our study."
Among other changes, intracytoplasmic sperm injection (ICSI) use increased to 27.5% of IVF cycles from 14.9%, and the percentage of day 3 embryo transfers increased significantly during the observation period. Neither of these trends, however, had a significant effect on IVF success, according to the analysis. "We found significant improvements in IVF and GIFT rates at the participating clinics...which appear to correlate with qualitative changes in aspects of IVF treatment during the same period," the authors conclude. The investigators suggest, "because our data suggest that the use of highly purified forms of urinary gonadotropins and recombinant forms of gonadotropins might be superior to previous gonadotropin preparations."
Source: Obstet Gynecol 2000;95:61-66
Developing a Public Policy (USA) on Assisted Reproductive Technologies (ART) Top
Whether ART should be controlled by legislation or through professional societies is a long running debate. The United Kingdom, some other European countries, some states in Australia, and Canada, have opted for legislation. Other countries have no regulations but comply with a consensus opinion whilst in the USA there has been strong resistance to the interference of politicians.
A recent article in Fertility and Sterility (Vol 73, No 1, January 2000: Accepted for publication July 30th) by Carl Coleman and Barbara DeBuono, reflects on the work of the New York State Task Force on Life and the Law who have released a 474 page report on the clinical, legal, and ethical issues raised by ART.
The 24 members of the Task Force include leaders drawn from health care professional, law, bioethics, patient advocates, and religious communities. Seven of the recommendations of the Task Force have been enacted into law in the State of New York.
Amongst the issues addressed was the question of multiple gestations. They recognised the need of practitioners to maximise the pregnancy rates with an increasing acceptance of selective embryo reduction as a 'justification' for transferring multiple embryos. The Task force recognised that for patients a high order multiple pregnancy is a better outcome than no pregnancy at all.
The Task force considered recommending legislation but concluded that legislation in general was inappropriate. Instead the the report calls on professional societies to take the lead in changing the standard of practice. Professional societies, they argue, have the expertise to consider the complex clinical variables involved - legislators do not necessarily have that expertise. The Task Force urged the American Society for Reproductive Medicine (ASRM) to revise its guidelines.
For some areas the Task Force did recommend legislation. It recommended that legislation establish minimum standards for obtaining informed consent. Legislation would require practitioners to provide patients with written information about the benefits, risks and alternative treatments including information about the likelihood and consequences of multiple pregnancies.
On the question of frozen embryos they agreed that irrespective of whether embryos are persons (some religious bodies would consider that was so) they should be afforded status as a "potent symbol of life". Therefore embryos should be bought or sold and that they should not be created "on speculation" - in other words there should be a particular patient who intends to use them for their own treatment.
All but one of the Task Force agreed that no embryo should be transferred, used for research, or destroyed without the mutual consent of the the couple who created that/those embryos.
Editorial Comment: Before the passage of the Human Fertilisation and Embryology Act (1990) through the UK Parliament many health care professional urged the government to consider a combination of legislation and control through professional societies. They argued that legislation was often too cumbersome and ill informed to be able to respond to particular needs or advances in technology. However the public response to, and the reaction of members of Parliament to such sensitive issues resulted in extensive legislation which has had to be modified over time. Many would argue that a licensing authority, while needed, should be able to respond quickly to clinical needs and not be shackled by legislation which could be, and has occasional proved to be, ill informed or at its best difficult to interpret.
Elsewhere where strict legislation has for example prevented research on human embryos (e.g. in the State of Victoria, Australia) important research has had to be carried out in neighbouring States which have notprohibited research (e.g. the State of Queensland).
Cryopreserved embryos need parents Top
A Florida couple have a dilemma. In 1989 Ron and Donna were successful after IVF treatment - four embryos were transferred to the uterus and the remaining embryos stored by Cryopreservation - two of the embryos were not viable and three were destroyed accidentally. This left 6 embryos still frozen.
Because of a difficult pregnancy Donna decided not to have any further children and decided they would rather donate the embryos to another couple for 'adoption' by a good "Christian couple".
The doctors have discouraged potential recipients because of the age of the embryos - frozen for more than ten years. They still hope that someone will be able to give them a life. "I want to do the responsible thing" said Donna. If the matter cannot be resolved soon the couple may soon let them be thawed and have a memorial service.
Source: Newsweek January 24th 2000
Editorial Comment: There is no evidence that embryos stored by cryopreservation deteriorate with time - stored in liquid nitrogen at -196 C means that all life processes are held in suspended animation - physicist feel that the only damage likely to occur would be through cosmic radiation and that would take thousands of years. The truth is that we do not really know - thousands of healthy children have been born as a result of Cryopreservation - some for several years.
Some countries do restrict the time embryos can be stored by cryopreservation although those laws may not be based on scientific evidence. In the UK the storage limit was set at 5 years. After the first 5 year interval had expired (after the implementation of the Human Fertilisation and Embryology Act in August 1990) many couples failed to contact the clinic about their wishes for those embryos - they had the choice for donating to another couple, donating for research, or allowing them to die. Failure of those 'parents' to contact the clinics meant that several thousand embryos had to be destroyed since there was no consent to other possibilities. The Act was revised so that the storage interval could be extended to 10 years in some circumstances. They could be used for the purposes of the the couple from whom those embryos came but not if any donation or surrogacy was concerned.
Other countries have either no regulations or similar ones to the UK or even Stricter ones - one country limiting the storage to one year.
Is there any hope then? Although frozen embryos can be transferred from one country to another the treatment in the receiving country can only proceed if the regulations for that country are complied with. Therefore the UK authorities would not sanction donation of Donna and Ron's embryos because the five years had expired. Other countries with no specific time restrictions might be more accommodating.
Some people would describe these embryos as person - others would certainly agree that they are living entities which deserve respect. Many other couples around the world would want their spare embryos to be given an opportunity of life and embryo donation gives another couple the only chance to have a child. Let us hope that cautious common sense can help Ron and Donna.
New Jersey Governor vetoes infertility care mandate in New Jersey. Top
A bill which would mandate infertility care in New Jersey had cleared the legislature and needed only the approval of the State Governor Christine Todd Whitman.
A statement from the American Society for Reproductive Medicine (ASRM) expressed extreme disappointment that the governor had chosen to bow to the needs of the wealthy insurance lobby and ignore the serious medical problem of an estimated 353,600 New Jersey residents who suffer from infertility. The family Building Act had passed in both the state Senate and Assembly. Infertility affects 6.1 million American each year. Currently only a quarter of the health care plans with at least 10 employees provide coverage for infertility services. If the veto had not been applied New Jersey would have been the fourteenth state to mandate some form of infertility.
Source: ASRM Bulletin Vol 2 Number 3, January 19 2000
Canadians Try New Infertility Method Top
A team of Canadian doctors have described an alternative to IVF where the woman is stimulated to produce several eggs. In "in vitro maturation," or IVM — allows a woman's egg to mature outside her body (in culture) before it is fertilized and re-implanted in her womb. At a press conference this week, doctors at the McGill University of Health in Montreal said a baby girl conceived by the IVM method was recently born there. Four other women have reportedly had babies by the same method. According to wire reports, Dr. Siang Lin Tan of McGill told reporters he believed the new procedure was safer and cheaper than the more traditional IVF because it negated the need to use costly drugs to stimulate the ovaries of women who have difficulty conceiving. "It avoids the potential side effects that drugs may occasionally cause," he said.
Source "Daily Briefings" November 19 1999
Editorial comment: This is a technique which the world of Assisted Reproductive Medicine has been waiting - a cautious welcome has be given to this announcement with a warning that (as far as is known) it is not yet available elsewhere. No doubt this is the method of the future and we all look forward to further developments in this field.
Couples look to success rates to decide on treatment centre Top
A new report issued by the Centers for Disease Control and Prevention (CDC) reports the success rates of 335 fertility clinics across the United States. The report, based on data collected for 1997, reports information gathered from centers that offer advanced reproductive technology (ART) procedures used to treat infertility. "While these ratings may be useful, there are many other factors that infertile couples should also consider," according to Pamela Madsen, the executive director of the American Infertility Association (AIA).
"For instance, depending upon a patient's age, success rates can vary greatly from center to center. Some centers may have better success rates using donor egg. Simple statistics cannot tell the whole story," added Ms. Madsen. "Caution must be exercised when interpreting published success rates, as they do not accurately reflect the inclusion or exclusion of the most challenging IVF patients, for example: women older than 41-42 years, those with diminished ovarian function at any age (high FSH, low response), or those with multiple prior IVF failures," said Dr. Zev Rosenwaks, director of the Center for Reproductive Medicine and Infertility, and professor of obstetrics and gynecology at Weill Medical College of Cornell University.
Since 1981, when assisted reproductive technology was first used in the United States, advanced treatments have greatly increased the ability to treat the more severe causes of infertility. In addition to success rates, the AIA suggests that patients also learn about the following important issues when choosing a fertility center:
Find out how many patients a center has treated who are your age.
"All couples should realize that selecting a fertility specialist based solely on the CDC's published success rates could cause patients to choose a center that is not best suited to meet their needs," said Ms. Madsen.
Source 'Medscape Wire' January 25, 2000
Editorial Comment: The same trend applies in the United Kingdom, where the HFE publishes the results from all licensed clinics. It is not meant to be a 'league table' say the HFEA but that is what the patients consider it to be.
FSH improves fertility rates in men with severe sperm dysfunction Top
Prolonged administration of follicle-stimulating hormone (FSH) to men with oligoteratoasthenozoospermia (OATS) before in vitro fertilization can improve fertility rates.
"This effect may be related to improvements in subcellular components of the sperm," a team of researchers, led by Dr. Zion Ben-Rafael, of Rabin Medical Center, in Petah Tikva, Israel, speculates in the January issue of Fertility and Sterility.
The researchers examined the effects of prolonged treatment with FSH on sperm microstructure and fertilization rates. Each of the affected men had at least one previous failed in vitro fertilization attempt, and was treated with daily injections of 75 IU or 150 IU of FSH for 60 days or longer. A control group of men received no treatment, and all underwent an additional in vitro fertilization cycle after at least 60 days.
Treatment with FSH improved fertilization rates fourfold, from 5.8% in controls to 19.7% in men treated with 75 IU of FSH and 20.5% in men treated with 150 IU of FSH. Moreover, "Electron microscopy detected a significant reduction in the rate of abnormal acrosomes, nuclei and axonemes," the investigators say. The authors suspect that the improvement in fertilization potential after treatment with FSH is likely a result of this "...normalization of sperm subcellular organelles, mainly the acrosome." However, they believe that further studies are needed to confirm these observations.
Source: Fertil Steril 2000;73:24-30.
Tansplantion of ovarian tissue in to a women raises hope for cancer patients. Top
A surgeon at New York Methodist Hospital transplanted ovarian tissue -- which had been previously removed from the patient and frozen -- back into the patient. The procedure was performed on Thursday, February 18, 1999, by Kutluk Oktay, M.D., director of reproductive endocrinology and infertility in the Department of Obstetrics & Gynecology at New York Methodist. The patient, a 29-year-old Arizona resident, flew to New York for the procedure. On the seat next to her was a container that held the cryogenically preserved (frozen) ovary which she had had surgically removed last year in Arizona to treat a benign medical condition. It was the patient's second ovary to be removed; the first was excised when she was 17 years old because of a cyst. The actual procedure began in the Hospital's cytogenetics laboratory at 7 a.m. Dr. Oktay thawed 60 of the 72 segments of ovarian tissue, washed them in special solutions and stitched them together to form a chain of tissue, a process that took four hours. Then, with the patient ready in the operating room, Dr. Oktay transplanted the tissue into the patient's pelvic wall, very near to the ovary's original location.
The surgery was done laparoscopically, using tiny instruments to avoid a large incision and decrease recovery time. Not all of the segments of tissue were used, so that if the transplant does not take, surgeons can try again (perhaps transplanting the tissue in a different location), or if the ovarian functions diminish after a number of years, there will be more tissue available to transplant. While the transplant went smoothly, it will be six to nine months until physcians can determine if the ovarian tissue is fully functional and producing hormones. "Ovarian tissue banking and transplantation will find many more applications in the future," said Dr. Oktay. "With this technology, women who need chemotherapy or radiation therapy for cancer treatment and want to preserve their fertility, will be able to bank their ovarian tissue and have it transplanted when their cancer treatment is complete," he said. "It will also enable patients to prolong their reproductive life span, as banked ovarian tissue does not 'age,'" said Dr. Oktay.
Dr. Oktay's colleague in Leeds (Professor Roger Gosden" had pioneered ovarian autotransplantation using animals. In 1996, a sheep, which had an ovary removed, frozen and reimplanted, subsequently gave birth to a healthy lamb. Dr. Oktay conducted a study in Leeds in which he transplanted human ovarian tissue in immunodeficient mice, resulting in the development of mature eggs.
Source 'Latest News' February 22nd 1999
Research on mice may bring hope to men with severe male factor problems Top
Scientists have come up with a new infertility procedure that could one day reverse the effects of sterility in men and change sperm banking as we know it. Researchers from the University of Pennsylvania were able to make an infertile mouse fertile, through a technique called germ cell transplantation.
"It's part of a continuing research effort to utilize the male stem cells that reside in the testes," said Dr. Ralph Brinster, professor of reproductive physiology at the university's School of Veterinary Medicine. "We've shown that you can transplant germ cells from one animal to another and they would colonize the testes." Successful sperm development requires healthy germ, or immature cells, and the correct environment within the testes. By transplanting germ cells from an infertile mouse into the testes of a mouse with a healthy testicular environment, Brinster and his team were able to restore fertility and produce offspring that carried the genetic makeup of the infertile donor male. According to the study, published in the current issue of Nature Medicine, nearly 50 percent of all human infertility can be traced to male defects. And 70 to 90 percent of those defects are caused by impaired sperm development.
The findings could pave the way for the advances in sterility treatments for both humans and animals, Brinster said. That's especially good news for young cancer patients who are often subjected to treatments that cause infertility, he said. Adult males often have their sperm frozen and stored for future use before cancer treatment begins. But for patients who develop cancer before the onset of puberty, there is currently no method to insure their ability to reproduce later in life.
The new findings suggest that freezing testicular stem or sperm cells could be a far more effective solution -- for a variety of species -- than freezing sperm ever was. "We showed you could freeze these cells and they can be maintained indefinitely," Brinster said. "It's difficult to freeze sperm because you have to develop different techniques for different species. But with stem cells, they're very easy to freeze and use similar techniques for all species." The technique is beneficial in more ways than one. "When you freeze spermatozoa, it's just one possible combination of a male's genetic makeup," Brinster said. "When you freeze a stem cell, you can immortalize that male's genetic makeup." In other words, freezing the stem cell is a way to preserve the biological "factory" that manufactures sperm, rather than just a specimen itself.
The technique could also be used to aid in the preservation of endangered species, Brinster said. "It took less than one percent of the [mouse] stem cells to make the testes fertile. When you combine that with the possibility of freezing testes cells from endangered species, in later years you'd still have the diversity of that species. "If a valuable animal died before it produced sperm, scientists might be able to harvest and preserve the testes cells and transplant them," he said. Brinster estimates that within five years, the technique could be available for use with animals. But human applications would likely take much, much longer.
"There are a lot of ethical questions to examine," said Dr. Brinster.
Source ' Med-Tech' - Lindsay Arent, January 5th 2000
ICSI is not superior to IVF for women with tubal factor infertility. Top
Intracytoplasmic sperm injection (ICSI) does not appear to offer any advantages over in vitro fertilization (IVF) for the treatment of infertility when the sole cause is a tubal factor, Turkish investigators report in the January 2000 issue of Fertility and Sterility.
Dr. Orhan Bukulmez and colleagues from Hacettepe University, in Ankara, randomized 76 patients with tuboperitoneal factor infertility to either ICSI or IVF. The median age in both groups was 34 years and the mean duration of infertility was similar. "A comparable number of oocytes and embryos were obtained in the ICSI and IVF groups," the investigators report.
The individual implantation rate was 38.75% in women who underwent ICSI and 34.58% in women who underwent IVF. Of the 38 women treated with ICSI, eight became pregnant and seven successfully completed the pregnancy and gave birth. An identical number of women became pregnant following IVF, the authors note, and six of them gave birth.
ICSI is both "more expensive and time-consuming" than IVF, the group notes. It also "...requires special equipment and skill," and the long-term effects of ICSI on infants born as a result of the procedure are still unknown. For these reasons, Dr. Bukulmez's team concludes that "...IVF should be the initial treatment of choice..." for treatment of infertility due to a tuboperitoneal factor alone. .
Source: Fertil Steril 2000;73:38-42
No significant difference in efficacy between Folitropin-alpha and Folitropin-beta Top
The recombinant human follicle-stimulating hormone preparations follitropin-alpha and follitropin-beta are equally efficacious in patients undergoing in vitro fertilization and embryo transfer (IVF-ET), British researchers report.
The incidence of adverse events with the two preparations is comparable, they say, although injection-site reactions are significantly more common and more severe with follitropin-beta.
Dr. Peter Brinsden, of Bourn Hall Clinic in Cambridge, United Kingdom, and colleagues assigned 44 infertile women undergoing IVF-ET to receive either follitropin-alpha or follitropin-beta 150 IU per day for 6 days. Doses thereafter were adjusted according to each woman's ovarian response.
Reporting their results in the January issue of Fertility and Sterility, the researchers observe that there were "no statistically significant differences" in efficacy between the two treatments.
Specifically, a mean of 12.1 oocytes were retrieved in women given follitropin-alpha, compared with 12.3 in women given follitropin-beta. Women given follitropin-alpha had a mean fertilization rate of 52.9%, compared with a mean of 53.5% among women in the follitropin-beta group. Ultimately, 7% of women in the follitropin-alpha group became pregnant compared with 6% of women in the follitropin-beta group.
Neither treatment preparation elicited serious adverse events, according to the authors, although three women given follitropin-beta experienced a severe local reaction. There were no severe local reactions reported among women in the follitropin-alpha group.
"The first direct comparison of the two available [recombinant human follicle-stimulating hormone] preparations demonstrated their equivalent efficacy, with no statistically significant differences in any of the measured outcomes," Dr. Brinsden's team concludes.
"This study also further confirmed the previously documented high efficacy of [recombinant human follicle-stimulating hormones] as indicated by the low cumulative dose of [follicle-stimulating hormone] and the large number of oocytes retrieved."
Fertil Steril 2000;73:114-116.