The Leeds Teaching Hospitals NHS Trust


Embryo Donation


Why do some infertile couples need embryo donation?

Some couples can only achieve pregnancy by using embryos donated by another couple.

  • Both the woman and the man have undergone infertility treatment but have failed due to the profound effects of age (for example women >43 years in age) on the developmental competence of their eggs or sperm. This is by far the largest group of patients who could receive donated embryos.
  • Woman or the man has become sterile after surgery, radiotherapy or chemotherapy when the spouse may have other reasons for failing to produce eggs or sperm.
  • Some couples may be carriers of genetic diseases that can be passed on to their offspring. Mostly only egg or sperm donation will be required in this group but very occasionally embryo donation would be appropriate, for example when the male partner is the carrier and the female partner is above the age of 43 years.

For these couples, embryo donation may be their only realistic chance of having a child.

Treatment for same sex couples and single women is considered on an individual basis after careful consideration of the Welfare of the Future Child/Children.

Who donates embryos?

Couples with frozen embryos are offered the chance to donate their spare embryos to other couples if they have completed their family or concluded their treatment. All donating couples do so voluntarily and for altruistic reasons. The HFEA provides guidance on financial reimbursements to the donor, which covers expenses for travel and loss of earnings (SEED REVIEW: details can be accessed from the Centre staff and the HFEA website). No financial incentives are involved.

Regulation of embryo donation

We suggest that you visit the website of the Human Fertilisation & Embryology Authority (www.hfea.gov.uk ) and read the section titled "What you need to know about donating sperm, eggs or embryos”.

Human Fertilisation and Embryology Act

The Human Fertilisation and Embryology Act were passed by the Parliament in 1990 and became law on 1st August 1991. Simultaneously the Department of Health established The Human Fertilisation and Embryology Authority (HFEA) for the regulation of all treatments and research pertaining to human eggs, sperm and embryos. This authority licenses centres, its staff and regularly inspects the centres for compliance with the law and the HFEA Code of Practice. By law every HFEA licensed centre is required to report every treatment cycle and its outcome to the HFEA. This information is analysed periodically and published on the HFEA website (www.hfea.gov.uk).

HFEA register

The Authority keeps a confidential register of identifying information on all patients and their treatments, donors and outcomes of their donation, recipients of egg/sperm/embryo donation and children born after HFEA licensed treatments. This register was set up on 1st August 1991 and contains above information from that date onwards.

Identifying information regarding the Donors

A recent change in the law has established that the child has a right to know his/her genetic origin. Children born following treatment taking place after 1st April 2005, have the right to know their origins at the age of 18 years or at 16 years, if contemplating marriage.

This means

  • People who donated before 1st April 2005 on an anonymous basis, and whose donations have either been used in treatment or remain in storage, may choose to become identifiable.
  • Donors registering after 1st April 2005 have to provide identifying information which the HFEA may release, on request, to people aged 18 years or more and who have been conceived with gamete or embryo donation.
  • Donations made before April 2005 can only be accepted if the donor has waived their right of anonymity.
  • An exception to above is where donation was made before 1st April 2005 on an anonymous basis and samples are stored for a sibling pregnancy. In this case sperm, eggs or embryos may still be used up to the maximum legally permitted storage period.

Identifying information about donors is held on the HFEA Register and may be given to any child born from a donation once they are 18 years old (if the donor is registered as identifiable). All donors have to waive their right of anonymity since the Only HFEA s empowered to release identifying information about the donors to the child.

A donor-conceived person aged 16 and over, is entitled to apply to the HFEA and access non-identifying information that the HFEA hold about the donor. At the age of 16 years, persons conceived with donated gametes or embryos can submit a joint application to establish whether they are genetically related to their partner before entering an intimate physical relationship.

From the 1st October 2009 the HFEA permits centres to release non-identifying information to recipient couples about their donors. This includes information about the screening tests performed before donation and their results as well as personal non-identifying information such as hobbies, likes/dislikes/ professional qualifications and a personal message written by the donor.

We encourage couples to tell the child/children if donated gametes have been used. This should be done at an appropriate time in their lives. Information, support and implications counselling is available within the clinic to help guide you through this process. External support is also available- see useful addresses.

All couples and donors are advised to explore the implications of these regulations. Counselling services are available to all donors and recipient couples to assist in the process of consideration. When in doubt, please seek independent legal advice.

Legal Parenthood

The law defines the legal mother as the woman who gives birth and her partner as the father irrespective of the source of embryos created unless the husband/partner can prove that he did not consent to treatment. As an embryo donor you have no parental rights or responsibilities.

Both partners of a recipient couple must provide written consent to the use of donated embryos in the treatment of their partner.

Under the current law, there is no need for the recipient couple to disclose the use of donor embryos to the Registrar of Births. Therefore you will not expect to be named at any stage.

Welfare of Future Children

The HFEAct states that a treatment centre MUST take account of the welfare of any child who may be born as a result of the treatment (including the need of that child for supportive parenting), and of any other child (other children in the household or the family) who may be affected by the birth'.

This applies to every couple whether or not they are resident in or a citizen of the United Kingdom. It is the statutory duty of every centre to have a written procedure for assessing the Welfare of the Future Child and that of any other existing child who may be affected by treatment.

It is our statutory duty to identify the person/s who will have the parental responsibility and who will be responsible for the raising of the child. Where necessary, we obtain reports from the general practitioner, other medical specialists, authorities and agencies e.g. social workers, police etc for information to ensure that the child would not be at risk. When treating single women or those in a single sex relationship we ask the couple to identify a father figure to ensure that the child’s/children’s right for both paternal and maternal nurturing will be met.

Donors’ rights

Embryo donors have the right to change their mind up to the point the embryos have been placed into the recipient woman. Donor has no rights once embryos have been transferred to the recipient.

Embryos created using donated eggs can only be stored for a patient with the consent of the egg donor and not the couple who had these embryos created in the first place.
You may ask the centre, at any time, how many children have been born as a result of your donation, their sex and year of their birth.

If you have any concerns at all about the implications of donating embryos you are advised to seek independent legal advice before consenting.

Limitation to the number of pregnancies with each donor

Legally in the UK, eggs/sperm or embryos from any one donor can be used to produce a maximum of TEN children or TEN families. In reality, this possibility is extremely unlikely for embryo donors. However, donors may set a lower limit should they wish to do so.

Consents

As stated above, we can only advise you with respect to the current law and the changes that we can envisage. You are advised to seek more specific and independent legal advice if you are concerned about how a retrospective change in the law might affect your legal position.

All donors and recipients are asked to sign appropriate consent forms after they have read the information booklets, have discussed the medical/ ethical issues with the doctors/nurses/counsellor, and are satisfied that their questions have been answered fully. Consents are obtained prior to donation.

Your consent advises us of your informed choice. You always reserve the right to change your mind until but not after the embryos have been transferred to the recipient. It is however important that all issues are thoroughly considered beforehand so that sudden and unexpected changes that you may later regret are avoided.

Confidentiality

All information regarding your treatment and donation is strictly confidential and subject to both the HFEAct and the Data Protection Act. We may communicate with your general practitioner, referring consultant and other carers only with your written consent.

Once the information has been disclosed to unlicensed individuals it can no longer be controlled by the HFE Act although it will still be under the Data Protection Act and General Law of Confidentiality. At your GP’s practice, information will be accessible to other GPs and staff. When changing GPs, your medical records will be transferred to your new GP practice without our involvement or written named consent from you.

From time to time your notes may be inspected by HFEA members for audit, by Commission of Health Improvements (CHI), individuals working for Patient Safety Agency (PSA) and National Care Standards Commission.

You have a right to decline consent to communicate with specific people or agencies, in which we may need to consider the reasons for your refusal to consent in our assessments.
From the 1st October 2009 the HFEA requires your permission to disclose either your identifying or non-identifying information to named researchers who approach the HFEA and have their research approved by the authority. Your consent will be requested when you are registered with the HFEA.
We advise you to keep your G.P. informed. They are your primary carers, will also be committed to confidentiality. Sometimes patients request their GP to keep written information regarding egg, sperm and embryo donation separate from the practice notes so that this information is not freely available to all the staff in their surgery. You may request them but they may not be obliged to do so.

Implication counselling

Implication counselling is advised for embryo donors and required for embryo recipients.
In addition to this:

Free counselling service with a trained counsellor is routinely available to all upon request. It is carried out by HFEA licensed counsellor/s, either on or away from the unit in the Department of Clinical Psychology which you may find less stressful. Appointments can be made directly by yourselves or via the Centre. If you require an interpreter, you are advised to give sufficient notice for an independent interpreter to be arranged.

The counselling is entirely confidential and private between you and the counsellor and will not be judgmental or prejudicial. The counsellor is also HFEA licensed and has a statutory duty to give essential information that may affect the Welfare of future or existing children to the team. This is exceptional.

The effect of embryo donation on the donors and any existing children is carefully discussed with donors. If the children of the donors are of an appropriate age they are also asked to discuss the matter with their children.

Screening of Donors

Donors, by law, have to be at least 18 years of age and the woman must not exceed 35 years in age, and the man cannot be more than 40 years of age. They have to be of normal intelligence, in good health and with no past or family history of severe physical, mental or genetic disease. All donors are required to submit details about their personal, medical and family history.

Please be advised that it is possible that a donor-conceived person if disabled as a result of an inherited disorder may be able to sue the donor for damages if he/she can prove that the donor knowingly did not disclose the inheritable disorder or reasonably ought to have known about the disorder.

All donors are carefully screened according to current guidelines and best practice.

Which screening tests are performed?

Genetic Testing

All prospective embryo donors (both female and male) have an analysis performed of their chromosomes.

In addition, we routinely test for cystic fibrosis. The screening will be performed for only the 12 commonest gene mutations in the Caucasian and Northern European populations. These mutations account for 85% of all varieties known to medicine to date. Exclusion of these mutations reduces the risk of being a carrier for cystic fibrosis to about 1% for these populations. In other population's e.g. Asians, the incidence of cystic fibrosis is much lower than that among Caucasians. Whilst all 12 mutations known to be common in the Caucasian and Northern European populations are excluded, the risk of being a carrier among the Asian donors cannot be accurately determined.

In addition, wherever appropriate additional screening tests may be applied. For example:

  1. East European, South Asian and Middle Eastern donors are screened for Thalassaemia.
  2. Donors with African descent are screened for Sickle cell disease.
  3. Jewish donors are screened for Tay Sach’s disease.

It is very important for the recipient couples to understand that not all known gene mutations are or can be possibly screened for and even after screening of some, there may be others for the same disease that are either uncommon or are not yet known. Hence the likelihood of developing these illnesses can be minimised with this screening but cannot be completely eliminated.

Screening for infections

  • All embryo donors are screened for HIV, hepatitis B and C.
  • Syphilis: All embryo donors are screened for syphilis
  • Cytomegalovirus (CMV): This virus commonly infects people and in normal circumstances gives a minor flu like illness. However it can become activated in pregnancy and can harm the baby. It is a very common infection in the normal population and many of us are exposed to it during our lifetime. We screen all donors and use CMV negative donors only for CMV negative recipients. On the other hand, CMV positive recipients can have gametes from both negative and positive donors.

What is the risk of a congenital abnormality?

The risk of a congenital abnormality after treatment using donor embryos is believed to be the same as for natural conception in a normal couple that is approximately 1 - 2%. The risk of having a child with Down’s syndrome and other similar abnormalities, miscarriage or a still birth as a result etc is that in the female donor’s age group in the normal population. GP's and those responsible for the obstetric care (obstetricians and midwives) routinely advise the recipient couples about prenatal diagnostic tests as appropriate.

How are the Donors matched to the Recipients?

Physical characteristics such as height, weight, body build, hair colour, complexion, eye colour, race and blood group etc are recorded. We try to provide an acceptable match. There are fewer donors and detailed matching for physical characteristics can prove difficult.Matching for ethnic origin and rhesus blood group is always performed. Exceptions are always discussed with the recipient couple in advance.