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Fertility Treatments Help Cancer and Rare Diseases

23 July 2008

Media Release

Fertility Treatments Help Cancer and Rare Diseases


Two proposed changes to fertility treatment practices could help infertile cancer sufferers to still have babies and also to help treat some very rare diseases, according to two discussion papers released today.

The first proposal would allow women who have frozen their own eggs before undergoing cancer treatment to now use the eggs to create embryos and, if successful, ultimately give birth.

The other allows women to screen their embryos so that once the baby is born, umbilical cord stem cells can be used to treat non-inherited disease in close family members.

The discussion papers were released publicly today for comment by the Advisory Committee set up under the Human Assisted Reproductive Technology Act.

Committee Spokesperson Gareth Jones says both practices are not currently allowed in New Zealand, though they are allowed in some countries.

To date, there has been a tight restriction on the use of frozen eggs to create babies while a track record of cases has built up to assure safety.  This has now occurred and the expert committee providing guidance in this area now believes it is safe to proceed.

Only a very small number of women currently freeze eggs in New Zealand – thought to number 20 to 25.  However, because of existing restrictions, this is likely to significantly under-represent demand.

Similarly, using cord blood from babies conceived from screened embryos to help treat very rare diseases is expected to help only a very small number of people.

This treatment is currently approved for families with genetic disorders where the treatment would help a brother or sister.  This is now to be extended for some rare non-genetic diseases such as leukemia for close family members.

Professor Jones says the advisory committee responsible for providing advice to the Minister of Health is now seeking public views on its proposals before it finalises them.

Anyone interested in providing their view has until 5 September 2008 to do so. The discussion papers can be downloaded from the website of the Advisory Committee on Assisted Reproductive Technology: http://www.acart.health.govtnz/moh.nsf/indexcm/acart-consultation-home

For more information, contact:

ACART Spokesperson
Professor Gareth Jones
03 479 8303
(Prof Jones will be available for interviews only after 1:30PM today.)


Ministry of Health
Luz Baguioro, Media Advisor
04 496 2349, 021 802 622


Questions and Answers


Advisory Committee on Assisted Reproductive Technology

What is ACART?
ACART is an Advisory Committee set up under the Human Assisted Reproductive Technology Act 2004 (HART Act) to advise the Minister on assisted reproductive procedures and human reproductive research. It has 12 members.

ACART must include:
·        one or more members with expertise in assisted reproductive procedures
·        one or more members with expertise in human reproductive research
·        one or more members with expertise in ethics
·        one or more Māori members with expertise in Māori customary values and practice and the ability to articulate issues from a Māori perspective
·        one or more members with the ability to articulate issues from a consumer perspective
·        one or more members with expertise in relevant areas of the law
·        one or more members with the ability to articulate the interests of children. Any person appointed under this requirement must be the Commissioner for Children, or a representative or employee of the person who holds that office.

At least half the members of ACART must be lay persons.

ACART is a diverse committee that has been composed to represent a wide cross-section of New Zealand society.

What is the HART Act?

The Human Assisted Reproductive Technology Act 2004 provides the legislative framework that prohibits or allows some procedures, and requires that others be subject to ethical review on a case-by-case basis before going ahead. The Act identifies where further advice is required on areas of treatment or research, as well as procedures for developing this advice.

Use of frozen eggs in fertility treatment

This is a consultation on ACART’s draft advice to the Minister of Health on whether women should be allowed to use frozen eggs in fertility treatment. ACART will consider submissions before finalising its advice to the Minister. The Minister will make the final decision.

What is an egg?

At birth, the female ovary contains all the eggs for that female’s reproductive life. The majority of these eggs lie dormant in a very immature state. Each menstrual cycle, a few of these eggs start to develop and, in most cases, one will continue to develop and be released (ovulated) each month. By the time it is released, the egg is over 3 times its original size and is ready for fertilization. It is now referred to as a mature egg.  

IVF drugs can be used to allow more than one of these mature eggs to be produced in a single cycle. Eggs produced in this way can immediately be combined with sperm to create embryos for use in fertility treatment. These eggs can, however, also be frozen for possible use in fertility treatment at a later date.

Why freeze eggs?

The main benefit is likely to be where a young single woman needs treatment for cancer which could leave her infertile. By freezing her eggs prior to treatment, she may be able to preserve her fertility. Later, her frozen eggs could be used to form IVF embryos so she could have children that were genetically her own.

Another reason for freezing eggs is as an alternative to freezing embryos, as some people – usually for religious or spiritual reasons – consider it unacceptable to freeze embryos. Often in IVF treatment, more embryos are formed and frozen than can be used. This leaves women or couples with the difficult decision of what to do with any embryos they will not themselves use as frozen embryos (and sperm and eggs) may be stored for only 10 years (although this may be extended with the approval of the Ethics Committee on Assisted Reproductive Technology (ECART)). At present, options available in New Zealand for the use of any ‘surplus’ frozen embryos are donating them to others for reproductive purposes or allowing them to thaw and perish.

Some women may believe egg freezing is an option to preserve their fertility so that they can, for example, focus first on their career, or wait until they find a partner with whom they wish to have children.  Current evidence would not support such a belief, as the birth rate from the use of frozen eggs is relatively low.

How many women have frozen eggs stored in New Zealand fertility clinics?

We do not know exact numbers as this information isn’t centrally collected. However, we believe it is 20 - 25. This may not, however, be an accurate reflection of the number of women who potentially may wish to freeze their eggs, as the use of frozen eggs in fertility is not allowed at present.

Why can’t frozen eggs be used in fertility treatment now?

In 2005, when the freezing and subsequent use of eggs was last reviewed, an expert group considered that it was such a new technology that there was not enough information to assess the risks associated with the use of frozen eggs.

ACART has reviewed recent evidence (see appendix one of the discussion document) and considers that it is safe to use frozen eggs. Babies born from frozen eggs appear to be at no more risk of health problems than babies born from IVF generally. All babies born from frozen eggs are, however, still very young, and it will be important for ACART to monitor outcomes over time to be certain of the safety of the use of frozen eggs.

Guidelines for PGD with HLA tissue typing

This is a consultation on draft guidelines for ECART to use when considering applications to use PGD with HLA tissue typing.

What is PGD?

Preimplantation Genetic Diagnosis (PGD) is a procedure for genetically testing embryos for specific conditions or chromosomal abnormalities prior to implanting the embryos into a woman’s uterus. The main purpose is to select embryos that do not have a disorder or disease present in the family.

What diseases can it be used for?

PGD is used for a range of genetic disorders, such as Huntington disease, cystic fibrosis, spinal muscular atrophy, beta-thalassaemia and Fragile X syndrome.

It can also be used to identify carrier status embryos. Carriers of disease are usually unaffected by it, but may pass the disease on to their children.

In addition, it can be used to select against disorders that confer a susceptibility to develop disease later in life, for example, some forms of breast cancer, ovarian cancer and colorectal cancer.

These uses do not require the approval of ECART.

What is HLA (Human Leukocyte Antigen) tissue typing?

Some disorders can be treated using a stem cell transplant. HLA tissue typing is performed so that the transplant isn’t rejected by the recipient’s immune system. The immune system recognises proteins on cells as foreign or self. If certain proteins are recognised by the immune system (mistakenly) as self, then the transplant will not be rejected. HLA proteins are the major proteins identified as foreign and self.

PGD can be used with HLA tissue typing to select an embryo that will result in a child whose tissue is compatible for donation to an existing individual suffering from a disease. In this situation, stem cells are harvested from the cord blood (or bone marrow) of the resulting child to treat the existing individual. As an example, the first use of PGD with HLA tissue typing was for Fanconi Anaemia in 2000 in the United States.

How common are these procedures?

Data is combined for Australia and New Zealand. In 2005, PGD was performed in 991 (2.4%) IVF cycles in which embryos were created or thawed.

PGD with HLA tissue typing has not yet been used in New Zealand.

Why do we need guidelines?

The HART Act divides PGD into two categories – those uses that can proceed as with any medical treatment and those that require approval from the Ethics Committee on Assisted Reproductive Technology (ECART). PGD on its own is able to proceed without approval, but each use of PGD with HLA tissue typing must have ECART approval. ECART requires guidelines against which to determine whether to approve each application for its use.

How do these guidelines differ from the existing guidelines?

The existing guidelines restrict the use of PGD with HLA tissue typing to situations where the disease is genetic. The new guidelines lift this restriction so that it may be used, with ECART approval, for diseases which are not genetic in nature.

In addition, the existing guidelines restrict the use of PGD with HLA tissue typing to benefit a sibling. The new guidelines lift this restriction so that, with ECART approval, it could be used to benefit a close relative. ECART will consider whether the relationships between the parties involved are appropriate. ACART considers, however, that its use is most likely to be sought in the case of a sibling.


How does this relate to the Bioethics Council’s recent report “Who Get’s born?”

There is no formal relationship between ACART’s role and the Bioethics Council’s work on PGD. ACART has the statutory function of providing advice and guidelines on assisted reproductive technology, including PGD. The Bioethics Council chose to also do work on PGD as part of its pre-birth testing project. As part of ACART’s consultation in 2007, the Bioethics Council made a substantive submission. ACART took this into account, along with the other submissions, in determining its advice to the Minister, which preceded consultation on these draft guidelines for PGD with HLA tissue typing.

Did ACART consider the use of PGD for sex selection?

No. It is an offence under the HART Act to use PGD for sex selection and anyone convicted of this offence would be liable to imprisonment for a term not exceeding one year or a fine not exceeding $100,000 or both. ACART was not asked by its Minister to revisit this issue.

Consultation

Why is ACART consulting the public?
ACART is consulting the public because human assisted reproductive technology is an important issue for our society. People have a range of views based on their values which can give rise to significant ethical and moral debate.  For this reason, the HART Act requires ACART to consult the public before giving advice to the Minister of Health or issuing guidelines to the Ethics Committee on Assisted Reproductive Technology.

How will ACART formulate its advice to the Minister of Health?
ACART has included its proposed advice to the Minister in this discussion paper to give the public the opportunity to comment specifically on ACART’s current thinking. ACART is, however, open to changing its views and its final advice to the Minister will be informed by the submissions arising from this consultation.

The Government will make the final decision about New Zealand’s policy on the use of frozen eggs in fertility treatment.

 How is ACART conducting public consultation?
ACART has released a discussion document that outlines its draft advice to the Minister – people are encouraged to make written submissions.

When do submissions close?
Submissions close at 5 pm on Friday, 5 September 2008.

Who do I send my submission to?
Send your submission to the ACART Secretariat:

acart@moh.govt.nz

ACART Secretariat
P O Box 5013
Wellington

Ends

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