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n/a
Document type
Clinical policy
Place
Hertfordshire and West Essex ICB
Output type
Clinical Policies & Evidence-based Interventions
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Gamete Storage

v1.2

Condition or Intervention 

Cryopreservation is the process of freezing and storing of egg, sperm or embryo for future use for fertility preservation. A gamete is defined as a mature sexual reproductive cell, as a sperm or egg, that unites with another cell to form an embryo.

This policy covers cryopreservation of gametes (sperms/eggs) for individuals about commence a treatment that is likely to lead to permanent infertility and would like to have their gametes preserved for future use.  The process of gamete retrieval and cryopreservation generally involve collection and storage of multiple gametes available at the time of procedure.  

Formation of embryos and their cryopreservation is covered under a separate policy- Fertility treatment and referral criteria for tertiary level assisted conception. https://www.hweclinicalguidance.nhs.uk/clinical-policies

The funding of gamete retrieval and cryopreservation does not commit the ICB to funding for Assisted Conception services. Local fertility policies and criteria for eligibility in place in the commissioning area in which the patient is living at the time of application will apply.

Recommendation 

NHS-funded gamete storage and cryopreservation will be funded under the following circumstances:

Patients are about to commence treatment deemed likely to cause permanent infertility. It should be noted that following some treatments fertility may recur, in which case ongoing gamete preservation will be reassessed. Conditions considered appropriate for gamete cryopreservation are:

  • Medical conditions requiring treatment with cytotoxic drugs (including malignancies)

OR

  • Conditions requiring total body irradiation or radiotherapy that may affect an individual’s reproductive organs

OR

Conditions requiring male urological or female gynaecological surgery, which are likely to lead to permanent infertility (including gender reassignment surgery). When requested under gender reassignment surgery, the patient should be undergoing treatment at a nationally accredited clinic.

OR

  • Hormone therapy causing permanent infertility secondary to the inability to produce gametes

The following conditions must also be met:

  • After thorough counselling and a discussion regarding risks and implications of the procedure the patient would like to have gamete storage (shared decision making)

AND

  • The patient is aware that funding for gamete retrieval and cryopreservation of material does not guarantee future funding of assisted conception or fertility treatment. 

AND

Female patients must be of reproductive age up to 43 years old.

AND

  • The patient has not undergone previous sterilisation, even if the procedure has been reversed.

AND

  • Registered with a GP 

Note:  Gamete storage will be funded for a maximum of 10 years. If exceptional to policy, requests to extend this can be applied for via individual funding request.  

Treatment should not be delayed whilst seeking funding for gamete storage.

Patients who have undergone NHS-funded cryopreservation but no longer meet eligibility criteria may choose to self-fund ongoing cryopreservation of their stored material. 

Number of attempts at gamete extraction

It is anticipated that in majority of the patient’s extraction of gametes would be undertaken by their respective MDT they are part-of (for example cancer MDT).  For patients who require a gamete extraction and are not part of an MDT, up-to two attempts from an accredited provider would be funded through individual funding request process. 

Exclusion Criteria

The following circumstances will not be eligible for funding:

  • Gamete harvesting and cryopreservation in pre-pubertal patients.
  • Cryopreservation of gametes requested for social reasons.
  • Cryopreservation of ovarian and testicular tissue
  • Infertility that has arisen secondary to a congenital disorder

Rationale

Cryopreservation Services Funded

When considering and using cryopreservation for people before starting chemotherapy or radiotherapy that is likely to affect their fertility, follow recommendations in ‘The effects of cancer treatment on reproductive functions’ (2007)

When using cryopreservation to preserve fertility, use sperm, oocytes. 

Women of reproductive age (including adolescent girls) should be offered oocyte cryopreservation if they meet all the following criteria:

  • They are well enough to undergo ovarian stimulation and egg collection. 
  • The procedure will not worsen their condition.
  • Enough time is available before the start of their treatment.

Offer sperm cryopreservation to men and adolescent boys who are preparing for the treatments outlined above that are likely to make them permanently infertile. Local protocols should exist to ensure that health professionals are aware of the values of semen cryopreservation in these circumstances, so that they deal with the situation sensitively and effectively.

There is no lower age limit applied in this policy however all patients, including those aged under 16 years must be able to understand the procedure being carried out and considered competent to give informed consent.

Human Embryo and Fertility Act 1990 

Cryopreservation of gametes must meet the current legislative standards. 

The provider of the service must ensure the patient receives appropriate counselling and provides full consent. 

The provider of the service must ensure patients are aware of legal issues on posthumous use of gametes should they wish a partner to be able to use these should their treatment not be successful. 

Patients will need to provide annual consent for continued storage. The patient will be responsible for ensuring the storage provider has up to date contact details. Failure to provide on-going consent may result in the destruction of stored materials. 

The provider must ensure appropriate consent to storage is in place and that the patient understands the need for on-going consent.

NOTE:

This policy will be reviewed in the light of new evidence or new national guidance, eg, from NICE.

References: 

1. National Institute of Health and Clinical Excellence (NICE), October 2014. Fertility Problems Quality Standard [QS73], London: NICE.

2. National Institute of Health and Clinical Excellence (NICE), September 2017. Fertility problems: assessment and treatment. Clinical Guidance [CG156], London: NICE.

3. NHS England, 2013. Interim Gender Dysphoria Protocol and Service Guideline 2013/14, London: NHS England.

4. Royal College of Physicians, The Royal College of Radiologists, Royal, November 2007. The Effects of Cancer Treatment on Reproductive Functions - Guidance on Management, Report of a Working Party, London: RCP.

5. Yasmin, E., Balachandren, N., Davies, M. C., Jones, G. L., Lane, S., Mathur, R., Webber, L., Anderson, R. A., & British Fertility Society (2018). Fertility preservation for medical reasons in girls and women: British fertility society policy and practice guideline. Human fertility (Cambridge, England), 21(1), 3–26.


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