The Leeds Teaching Hospitals NHS Trust


Sperm Storage for Patients prior to Chemo or Radiotherapy


Unfortunately chemotherapy, radiotherapy and surgery affect fertility at least on a temporary basis but can do so for many years and even permanently. Sperm and possibly testicular tissue banking can enable boys/men who may not have completed (or even started) their families to achieve pregnancies after treatment. Although we have discussed the subject of testicular 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.

Regulation of Sperm 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 gametes 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 sperm.
  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 sperm 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 sperm must give their consent in writing prior to the storage.

NB Testicular 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 int 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 sperm have to be discarded if the patient does not survive.

Consent

The consent must specify one or more of the following:

  1. whether the treatment is provided for themselves, or themselves and a named partner.
  2. whether the treatment is provided for others.
  3. whether any sperm or testicular tissue obtained can be used for research.

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

4. the maximum period of storage is 10 years .There is at present no time limit for the storage of testicular tissue for young boys 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 sperm/testicular 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 testicular recovery to take place, we often also arrange a sperm analysis 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 sperm:A difficult situation can arise when recently bereaved partners or relatives return to the unit requesting the use of these gametes. The HFEA consent forms are NOT a last will and testament. The person storing the sperm 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 sperm:

  • 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 sperm cannot be regarded legally as the child of the individual to whom the sperm 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 sperm storage.
  • Counselling is available prior to undergoing the screening test.
  • The sperm sample is 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)

Sperm storage 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, take HFEA and LTHT consents for storage of sperm and arrange then for the embryologist to see you. This may occur in the same visit.

6. The embryologist will take you to the appropriate private rooms where after appropriate instruction you will provide your first sperm sample for storage.

7. Time permitting we would like to take a second sample from you after 3 days of abstinence for storage. The embryologist will book that appointment with them also before you leave.

8. The sperm sample will be stored in small aliquots (portions) in the suitable container for long term storage.

9. 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 sperm surviving after freezing and thaw.

10. You will then receive annual letters from us which ensure that you keep us informed of your intentions regarding the stored sperm.

11. Once the fertility is no longer desired, you would be expected to advise the trust to discard the sperm.

12. 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.

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

14. 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.

Some of these steps are discussed in further detail below:

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.
  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.

Semen sample and storage

The patient will usually be seen by an embryologist immediately after consultation with the doctor, and will provide a sample by masturbation. The sample will be subjected to basic semen analysis to establish the volume, concentration and motility of the sperm prior to freezing. Therefore further appointments will be made on alternate days or after 3 days (to allow accumulation of 2-3 days abstinence) for additional samples until commencement of cancer therapy. Ideally at least 2-3 samples should be stored to provide a reasonable store for future use.

How long can my sperm be stored?

Although the statutory length of time for which sperm can be stored is normally ten years, in cases where medical treatment after the date of storage is likely to affect your fertility, the maximum storage period can be extended to 39 years, or the date of your 55th birthday, whichever is the earlier.

What are the prospects of using frozen sperm?

The success of using samples depends on the quality and quantity of the sperm, which was stored. Men who have been very ill systemically e.g. with persistent fever, weight loss, loss of appetite etc. generally have very poor sperm samples and sometimes may have even switched off their sperm production completely. Therefore the quality of sperm samples obtained is very variable between patients and depends on individual circumstances.

Cancers that affect the whole body e.g. leukaemias may have a more profound effect as compared to localised tumours with a malignant potential. We will always offer you the chance than make judgements ourselves.

The samples are diluted with a preservative when they are frozen to protect the sperm against damage during the freezing process. However this does not guarantee the sample will survive the freeze-thaw process, and even if it does, there is usually a reduction in the motility of the sperm. As previously stated the chances of success in achieving a pregnancy depend on many factors including the method chosen for their use. If sufficient numbers of sperm of adequate quality have been frozen then we would expect you to have a reasonable chance of achieving a pregnancy BUT this cannot be guaranteed.

What is Testicular 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 testicular 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 Research work in animals has shown that it may be possible to repopulate the testicular tubes with parent sperm (stem cells) after sterilising doses of chemotherapy or radiotherapy. However no such attempts in the human have been undertaken as yet.

2. 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 sperm or the testicular 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.

3. 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 such tissue can be stored even if that was for experimental purposes only.
Technique for testicular tissue storage: Testicular tissue is removed surgically by making a small cut into your scrotum following a local or a light general anaesthetic. A small part of the testis is removed and strips of tissue are preserved for future use.

4. How could this tissue be used?

  • The preserved testicular tissue could be potentially transferred back to the testis, at the appropriate time, by a grafting procedure or an injection process and this, as stated above may result in the re-population of testis with cells that in turn produce mature sperm cells. The length of reproductive span then is uncertain and we also do not know the likely outcomes from this.
  • In order to optimise the use of the sperm 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' might 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. Men who have been severely ill are more likely than those in relatively good health to have fewer and poorer quality sperm that may or may not survive the freeze-thaw process. Other relevant factors include the number of samples frozen, and whether the patient's partner with whom the treatment may be conducted in future has any contributory fertility problems herself. If she has any problems affecting her fertility the chance of success will be lower. Different techniques have different success rates. 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 these sperm /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 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 sperm for anybody else other than the patient and his named partner. This is an extremely important factor that you, your relatives and your partner must consider before signing consents and storing sperm.

Other factors:

It is impossible to predict what will be possible with the technology of the future and this makes it difficult to define limits below where it will not be possible to preserve sperm or testicular tissue. However if the laboratory staff feel that the prospects of sperm survival are negligible in the current state of medicine, then it is not advisable to proceed with storage. Each case is judged on its own merits and there may be variations. Sperm that has been exposed to procedures, which might prejudice their normal developmental potential, cannot be used for treatment; therefore generally we only freeze samples BEFORE you have started chemotherapy or radiotherapy.

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 testicular function. It is also not certain the effect chemotherapy would already have had on sperm 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 testicular tissue/sperm preservation would have most certainly and irreparably damaged the primary spermatogonia (parent sperm cells).

Follow up

  1. Every twelve months, The Centre will write to you to ask if continued storage is required.
  2. If you wish the samples to be destroyed, the unit will require a written confirmation of this request, preferably in the patient's or legal guardian's own hand. The unit will then reply giving written confirmation that the patient's wishes have been carried out.
  3. We would be grateful if we are kept informed of any change in address if continued storage is expected. Failure to keep regular yearly contact with the unit may result in the samples being discarded.
  4. In the event of the patient's death we will destroy all samples stored in our facility.
  5. The unit operates a bring forward system, which will alert the centre in good time that particular gametes are about to reach the end of the statutory or agreed period of storage.

What costs are involved?

  1. The testicular tissue will be frozen and stored in The Leeds Centre of Reproductive Medicine at Seacroft hospital which is part of the Leeds Teaching Hospitals NHS Trust.
  2. At the present time there are no charges made for this facility.
  3. Many infertility treatments are not NHS funded and are usually funded by the patients themselves.
  4. We do not envisage that any change would occur from our current position in the near future. However we cannot guarantee any future change in this situation.

We hope that this provides you with all of the information needed. Specialist counselling can be arranged when needed.