The Leeds Teaching Hospitals NHS Trust


Mature Egg Storage


Unfortunately chemotherapy, radiotherapy and surgery affect fertility at least on a temporary basis but can do so for many years and even permanently. Eggs and possibly ovarian tissue banking can enable girls/women who may not have completed (or even started) their families to achieve pregnancies after treatment. Although we have discussed the subject of ovarian tissue banking at the end of this booklet, this is only in an effort to be comprehensive. Please note that this is not a service that is currently available in Leeds and the reasons for this are also described below.

Please note that it is neither possible to guarantee success nor to give you a pregnancy rate as there are many other factors that cannot be determined at the present time and which would affect success rate.

It is extremely important that you recognise this storage as an experiment that may or may not prove to be useful in future and regarding which no short or long term information can be given at present.

Regulation of Egg or Embryo Storage

Human Fertilisation & Embryology Act, 1990

The storage of gametes is regulated by the Human Fertilisation and Embryology Act of 1990 (HFEA) and there are a number of guidelines and requirements that must be met before eggs can be stored. It is important that all those involved i.e. the patient, the referring clinician and the unit staff fully understands and complies with the law.

Storage of Mature Sperm for Your Own Use

The following information is for your guidance. For further information please refer to the HUMAN FERTILISATION ACT, 1990.

  1. From August 1991 a licence is required to store mature human eggs or embryos.
  2. The patient's right to confidentiality in this act prohibits the normal exchange of information between clinicians with out specific written consent unless it is deemed necessary for your continuing medical care.
  3. Before consenting to the storage of your eggs or embryos you will receive all information and may wish to receive further counselling regarding the implications of taking the proposed steps. This would include an oral explanation supported by relevant written material such as this booklet.
  4. Any one consenting to storage of their eggs or embryos must give their consent in writing prior to the storage.

NB Ovarian Tissue preferably must not be taken from anyone not capable of giving their consent. However a person under 18 can, in exceptional circumstances, give consent if it is the intention to use the tissue solely for their own treatment and in their life time. It is not essential to obtain the consent of his parent or guardian under these circumstances although we always endeavour to do so. The eggs or ovarian tissue will have to be discarded if the patient does not survive.

Consent

The consent must specify one or more of the following:

  1. whether the intended treatment is for themselves with a named partner. This is relevant in case of storage of embryos and not eggs (Embryos are eggs that have fertilised and have started to grow).
  2. whether the treatment is to be provided for others
  3. whether any ovarian tissue obtained can be used for research

(It is not normal for patients undergoing chemo or radiotherapy to store eggs or ovarian tissue for purposes other than their own use or research. The medical disorder would preclude the use of their eggs for anyone else.)

4. the maximum period of storage is 10 years. There is at present no time limit for the storage of ovarian tissue for young girls but if these sperm were to be matured outside the body or embryos were formed then similar regulations as those stated in the HFEA Act at the time would apply.

5. what is to be done with the ovarian tissue in the event of individual's death or becoming incapable of varying or revoking his/her consent. This is a legal requirement.

Notes from the HFEA Code of Practice:

  1. "Eggs or sperm which have been exposed to procedures which might prejudice their developmental potential, and embryos created from them, should not be used for treatment."
  2. Audit: Centres HAVE TO carry out a periodic review of the status of stored gametes. This is to reconcile the centre's records with the genetic material in storage. It is also to review the purpose and duration of storage and to identify any action that may need to be taken.
  3. Counselling: Counselling for patients who are having or are about to undergo chemotherapy or radiotherapy is an important issue. It is acknowledged that in many cases there is insufficient time to properly inform patients and for them to understand and digest the implications of the HFEA consent form.
  • We tend to review you again after the first year in storage by when we hope that you are better and have had sometime since the completion of your treatment. We can then discus the nature of sample stored o your behalf the legal and treatment related issues and our mutual responsibilities.
  • As there would have been sometime for ovarian recovery to take place, we often also arrange a hormone assessment and /or a scan for you on this day, so that at review we can give you an early indication of whether or not your treatment has had an impact on your fertility.
  • It is also recognised that some patients may require specialist counselling. This can be easily arranged upon request for you and your partner.

4. Re Posthumous use of eggs: A difficult situation can arise when recently bereaved partners or relatives return to the unit requesting the use of the stored gametes. The HFEA consent forms are NOT a last will and testament. The person storing the eggs has to provide directions as to what they wish should happen in this unfortunate event.

5. Legal Parenthood in the event of posthumous use of eggs:

  • Whenever gametes are used posthumously, the man or the woman to whom the egg or the sperm belongs must have consented in writing for the stated purpose beforehand.
  • The unit will and must legally consider the rights of the unborn children in deciding whether or not to conduct treatment.
  • Any child born with the posthumous use of the eggs cannot be regarded legally as the child of the individual to whom the eggs belonged without the prior completion of birth registration details on the HFEA form.

6. HIV, Hepatitis B,C & Syphilis Screening:

  • It is our policy to screen all patients, donors and recipients for HIV, Hepatitis B, C and Syphilis prior to egg or embryo storage.
  • Counselling is available prior to undergoing the screening tests.
  • The eggs are stored in containers that have other similarly screened and negative samples.
  • There is a very small theoretical risk of cross-infection when unscreened samples are stored in the same containers. It is however important to note that such an incident has never been reported in the past.
  • At the present time we are unable to offer treatment services to individuals who test positive to HIV, Hepatitis B or C.
  • By ensuring that we are aware of the HIV and Hepatitis status of our patients we can provide a safe environment for your sperm whilst in storage.

What Happens?

Referral to The Leeds Centre for Reproductive Medicine (The Centre)

Storage of mature eggs can be considered soon after a decision to proceed with Chemotherapy or Radiotherapy has been taken or before radical surgery is performed. The steps are as follows:

  1. After discussion with the oncologist or the oncology nurse specialist, the patient is given this written information booklet.
  2. Obviously you and your physician/surgeon in charge of your treatment will decide if this is desirable and if it is possible to delay your therapy without endangering your future health and success of your treatment.
  3. If considered appropriate your oncologist/oncology nurse specialist will:
  • Arrange the hepatitis B, C and HIV screening
  • Contact The Centre during the working hours (see front page for details) for an urgent appointment.

4. An urgent consultation appointment will be given with the doctor in The Centre.

5. The doctor will discuss options, check results and if there is an agreement to progress, arrange for you to see the nurse specialist for HFEA and LTHT consents for storage of mature eggs or embryos.

6. You will under go an IVF cycle effectively in order to develop the mature eggs for collection and storage. Please read the IVF-ICSI booklet for all details in relation to the IVF cycle.

7. You will be sent an annual review appointment for discussion regarding this sample, your current fertility at that time and any issues that have arisen since diagnosis and treatment. You will also be advised regarding the probable chances of your eggs surviving after freezing and thaw. Further treatments as necessary after thaw such as ICSI for mature eggs will also be discussed.

8. You will then receive annual letters from us which ensure that you keep us informed of your intentions regarding the stored eggs/embryos.

9. Once the fertility is no longer desired, you would be expected to advise the trust to discard the eggs/embryos.

  • 10. The trust after discussion with your oncologist may also advise discarding the sperm in the following circumstances:
  • You have completed your family
  • You do not have a compromise in your fertility from your cancer treatment
  • You have been cured of your cancer, the risk of recurrence is very small and your fertility has not been compromised.

11. If it is felt that the there is no clinical indication for continued storage of eggs / embryos, you may continue storage irrespective but there may be a cost involved as per trust procedures for voluntary egg /embryo storage. We can provide you with the current annual cost at the time.

12. Currently there is no cost for storage but there may be a cost in treatment when the sperm is utilised. We will advise you of your PCT criteria for eligibility for sub-fertility treatment at the time treatment is intended.

Storage of mature eggs

Some of the important points regarding an IVF cycle for storage of mature eggs or embryos are discussed in further detail:

Initial Consultation in The Centre

  1. A doctor specialising in assisted conception, will take a medical history and explain the implications and conditions regarding storage.
  2. You will be requested to complete a consent form after due consideration of the implications with the nurse specialist.
  3. The consent form is completed on the understanding that the terms of consent can be changed or varied at any time in accordance with the law of the land and the NHS regulations.
  4. Written consent is also required to enable the unit to contact the referring clinician should this be necessary in the future.
  5. Contact with persons not covered by a HFEA treatment licence is normally prohibited under the terms of the HFEA Act unless the patient has given written consent specifying the persons who can be contacted.
  6. It will however be important to understand that NHS funding may not be available when the samples are to be put to use and that you may have to self fund your treatment such as in-vitro fertilisation of eggs, intra-cytoplasmic sperm injection, embryo replacement and other related procedures which may be required.

Technique of Mature Egg or Embryo Freezing

This in brief includes:

  1. You undergoing an IVF cycle as any other IVF patient does up to the time of egg recovery. This requires several stages of treatment which are detailed in the specific IVF and ICSI booklet.
  2. After thaw when the eggs are to be used in order to optimise the fertilisation process direct injection of the sperm into the egg outside one's body i.e. ICSI will be necessary. This does not guarantee that all eggs will survive thaw, the injection procedure or fertilise. ICSI is an experimental procedure. We will be pleased to give you a detailed ICSI booklet now or at a later date whenever you feel more information would be desirable regarding this technique and its risks as this is a technique under observation and is considered experimental. Information regarding the risks of ICSI in frozen-thawed eggs is further limited to virtually unavailable and must be considered entirely experimental at this stage.
  3. For couples I stable relationships, mature eggs may be fertilised to form embryos before freezing. However storage and use of these embryos is only possible in the long term with the continuing consent of both partners. If any one partner withdraws consent the embryos will be allowed to perish and cannot be used even if the female or the male partner is now sterile.

We will provide you with a specific IVF-ICSI booklet that you are advised to read carefully regarding the treatment procedure, use of drugs, their side effects and risks in treatment. You are advised to read it carefully and are also invited to attend the New Patient Seminar which is held regularly with in the unit and for which no appointment is necessary.

What is Ovarian Tissue preservation?

This is not a service that we can offer currently in Leeds. This subject is primarily being discussed for comprehensiveness and to explain why we do not provide this service at present.

  1. State of ART: The current technology for preservation of ovarian tissue is experimental and although some success has been achieved in other species such as mice, lamb and sheep, no human work fit for clinical service has yet been conducted.

In two patents pregnancies have occurred after the ovarian tissue has been returned to the body.

Research work in animals has shown that it is also possible to develop the immature eggs in the laboratory, fertilised with ICSI procedure using partner perm for creation of embryos and their subsequent transfer to the womb. Many pregnancies have been achieved in animals but the offspring have many health issues. Therefore no such attempts in the human have been undertaken as yet.

The science is evolving and it is envisaged that changes in protocols and methods will take place as development occurs. We at this stage cannot say whether the current methods are the best in terms of preservation of the eggs or the ovarian tissue and what would be the likelihood of success in returning fertility in the coming years. We also cannot state whether our current methods will have the same or a higher risk of chromosomal abnormalities, genetic disease or malformations when compared to the normal population.

2. European Tissue Directive: There are very strict conditions in which human tissue for clinical purposes can be stored. As the science is not sufficiently developed, there are also no centres where ovarian tissue can be stored even if that was for experimental purposes only.

3. Technique for ovarian tissue storage: Ovarian tissue is removed surgically via a laparoscope or by making a small cut in your tummy (mini-laparotomy) under general anaesthesia. A small part of the ovary is removed and strips of tissue are preserved for future use.

4. How could this tissue be used?

  • The preserved ovarian tissue could be potentially transferred back to its normal location (auto-transplantation), at the appropriate time, by a grafting procedure. The length of reproductive span then is uncertain and we also do not know the likely outcomes from this as only 2 women have so far been successful in the world.
  • In order to optimise the use of the eggs and to give you the best chance of success procedures such as the 'test baby method /IVF' and 'direct injection of the sperm into the egg outside one's body i.e. ICSI' will be recommended.
  • It is extremely important that you recognise this storage as an experiment that may or may not prove to be useful in future and regarding which no short or long term information can be given at present.

5. Risk of Recurrence: There is a risk of preserving malignant cells and then at a later date transferring them back through the grafting process.

Success rate:

The likelihood of achieving the pregnancy depends upon a number of factors. Women who are severely ill are more likely than those in relatively good health to have fewer and poorer quality eggs that may or may not survive the freeze-thaw process. Other relevant factors include the number of eggs or embryos frozen, and freeze thaw outcomes, survival after ICSI and continued development after transfer. If the person receiving the embryos has continuing health issues and if the uterus has been irradiated, the chance of success will be lower. Each PCT has its own eligibility criteria for funding treatments according to which treatments are dispensed by the trust. Some couples may not be found eligible for NHS funded treatment when this is intended whilst others may receive some help. We will advise you on this at the time and as per regulations at that time.

Ethical Issues:

  1. In the interest of your future health and that of your children we shall not use the stored eggs, embryos or the ovarian testicular tissue for reproduction until such time that a clinical cure has been achieved from your disease.
  2. Unfortunately we will have to decline treatment if after consultation with your oncologist or other care providers (GP, social worker and specialists) there is:

a continuing concern regarding your current / future health

  • your life expectancy
  • risk of recurrence of the primary problem
  • the health of your future children
  • or your ability to provide for the maternal and parental nurturing for the child.

3. The transportation of stored tissue to another HFEA (Human Fertilisation and Embryology Authority) licensed or unlicensed centre will be at the discretion of HFEA and the staff at The Centre.

4. We believe that with modern methods you will make a complete recovery and in that event we would like to help you lead a full life including that of having your own children. The options for using this tissue are likely to be much greater in the future as research is progressing rapidly.

5. The Centre also cannot use your eggs or embryos for anybody else other than the patient from whom the eggs were retrieved. This is an extremely important factor that you, your relatives and your partner must consider before signing consents and storing eggs or embryos.

Confidentiality

You should be assured that all information regarding your treatment will be kept strictly confidential between you and the team. You also have the legal right to keep the record of your treatment confidential from your own general practitioner. We however advise you to keep your GP informed. They are your primary carers, are usually very helpful and will also be equally committed to confidentiality. You can request them to keep information regarding assisted conception separate from your main GP notes so that this information is not freely available in their surgery.

We believe that the current law will be the one that will govern you and your children's lives forever. 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 and your child's legal position.

Welfare of Future Children

One of the conditions of treatment as per the HFEAct is that 'a woman shall not be provided with treatment services unless account has been taken of the welfare of any child who may be born as a result of the treatment (including the need of that child for a father), and of any other child (other children in the household or the family) who may be affected by the birth'. This applies to every woman whether or not she is 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 potential child and that of any other child who may be affected. Factors considered in assessment include the couple's commitment to having and bringing up a child, ability to provide a stable and supportive environment for the child/children, couple's medical history and that of their families, health and consequent future ability including their ages to look after or provide for a child's needs, ability to meet the needs of the children in the event of a multiple birth, risk of harm e.g. that of inherited disorders, transmissible disease or abuse and effect of a new born on the existing child in the family. The HFEA also advises that views of all those who have been involved with the prospective parents should be taken into account when deciding whether or not to offer treatment. We have a protocol that has been approved by our local ethics committee and under specific circumstances we may obtain reports from your other carers e.g. general practitioner, medical specialists and social workers for consideration by the members of the Assisted Conception Unit or by the ethics committee.

Please note that fair and unprejudiced counselling services are available to everybody prior to, during or after the assessment process irrespective of the outcome of such an assessment.

Effect of past Radiotherapy or Chemotherapy

The effect of past chemotherapy is uncertain and depends on the agents used, their duration of use, and the number of courses that may have been employed. Usually we believe this effect to be low as many patients recover their menstrual and reproductive function. It is also not certain the effect chemotherapy would have had on egg viability and its ability to form a normal embryo. There is no evidence for an increase in the incidence of congenital abnormalities in the births that have been reported to date in those patients where reproductive function has returned after chemotherapy.

Radiotherapy prior to ovarian tissue preservation would have most certainly and irreparably damaged the eggs. In those patients where radiotherapy has been given after ovarian biopsy, there may be a degree of permanent and irreversible damage to the uterus also which in turn may interfere with the future chance of a pregnancy.

Counselling

Free counselling service with a trained counsellor is routinely available to all upon request. It is carried out by HFEA licensed counsellor/s, 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.

What costs is involved?

The oocytes will be frozen and stored in the Assisted Conception Unit at St James's. At the present time there are no charges made for this facility.

However, a lot of infertility treatments are not NHS funded and are usually funded by the patients themselves. I do not envisage that any change would occur from our current position in the near future but this is possible. It is possible that in future a cost may be charged to you by the trust for oocyte storage.