Fertility preservation provision in the NHS in Scotland: guidance

Patients to be considered for NHS fertility preservation

a) Patients newly diagnosed with cancer, at pre-treatment stage.

b) Patients undergoing medical or surgical treatment or having a medical condition that is likely to compromise fertility – this includes cytotoxic agents for patients with rheumatological conditions, haematological conditions where treatment involves risk to fertility (e.g. haematopoietic stem cell transplant for haemoglobinopathy), inflammatory bowel disease, those with genetic conditions such as FMR1 mutations, Turner syndrome and related chromosomal abnormalities, some metabolic diseases and potentially some differences of sexual development. For some patients facing ovarian surgery for advanced endometriosis with bilateral endometriomas or with BRCA mutations, consideration of fertility preservation may be appropriate although it is not appropriate for patients undergoing unilateral oophorectomy (e.g. for borderline ovarian tumours).^[6]

c) Transgender individuals. ‘Transgender’, or ‘trans’ is an umbrella term describing a diverse range of people whose gender identity does not fully correspond with the sex they were assigned at birth. This includes but is not limited to trans men, trans women, and non-binary people.

d) People who have previously had treatment for cancer (or comparable serious medical disorder) where further treatment has become necessary. This will commonly be conditioning chemotherapy prior to stem cell transplantation following relapse/incomplete remission of their disease, or endocrine treatment for breast cancer. Where previous treatment may have compromised ovarian function in some of these cases, they should be discussed with local multidisciplinary groups and/or peer review process prior to proceeding with fertility preservation procedures.

e) Front-line armed forces personnel are an appropriate group when facing deployment to a combat zone. The numbers of patients in this category are low and armed forces personnel based in Scotland who meet this criterion will be eligible for fertility preservation treatment.

f) This list is not exhaustive, and special consideration is likely to be necessary on a case by case basis to cover the whole range of possible conditions and scenarios that could arise. Clinicians should use their local multidisciplinary groups and/or peer review process to facilitate rapid and equitable decision-making.

Specific considerations for the above groups (refer to points (a) to (d))

Patients with cancer

The number of new cancer diagnoses in Scotland in relevant age groups in 2022 are given in Annex B. Overall, 419 men and 766 women were diagnosed with cancer between the ages of 15 to 39, with 258 men and 512 women diagnosed with the main conditions relevant to fertility preservation. This gives an estimate of maximum possible annual referral rates for patients with cancer.

1. For new cancer diagnoses, the prospects for fertility vary greatly depending on age and intended treatment. It was agreed that those at low risk of compromised fertility (where it is clinically judged that the risk is less than 30% of loss of fertility after treatment) would not be eligible.

2. In order for a patient to be eligible for fertility preservation, the proposed cancer treatment should be with the intention of cure or long-term survival. There may be individuals where it is considered that gamete storage is appropriate despite the prognosis being poor. In such cases there should be a clear intent for posthumous use in an established relationship, with appropriate discussion and consent for use as required under legislation.

3. For patients previously treated for cancer but now facing further cancer treatment, if prospects for successful oocyte/embryo storage are good (e.g. no evidence of premature ovarian insufficiency, even if ovarian reserve reduced, as per current assisted reproduction access criteria) then they may be eligible but should be discussed with local multidisciplinary groups and/or peer review process prior to proceeding with fertility preservation procedures. There is no minimum limit of Anti Mullerian Hormone (AMH) required for treatment, though it is a helpful indicator when discussing likely response to treatment.

4. Some patients will be advised to take long-term endocrine treatment, most commonly for breast cancer after chemotherapy, and this treatment should be included in the initial assessment of risk. Recent research indicates the safety of interrupting such endocrine treatment for pregnancy.^[7] In most cases fertility preservation will have been offered prior to chemotherapy and this will only apply to a small number of patients. Where there is evidence of a remaining good ovarian reserve at that point, reassurance to patient regarding long-term ovarian function may also be appropriate. Current evidence is that after two to three years of endocrine therapy, pregnancy does not increase the risk of relapse, thus patients would have the option of a treatment break at that time to achieve a pregnancy. If oocytes/embryos have been stored that would be an opportunity for their use, to minimise time off endocrine treatment although attempting natural conception would also be an option.

5. For males facing gonadotoxic treatment, cryopreservation of semen is the preferred option for fertility preservation. However, for some patients and groups (e.g. adolescent males), sample collection by masturbation may not be appropriate and/or possible. In these cases, more invasive methods including surgical intervention may be considered and where clinically appropriate offered to obtain sperm for storage.

6. Surgical interventions to attempt sperm retrieval may rarely be considered in certain situations including adolescents, gender dysphoria or sexual assault in addition to its use in specific medical conditions e.g. Klinefelter syndrome.^[8] Surgical retrieval carries a higher risk to the patient and should only be considered where a patient cannot produce a sample by masturbation (for whatever reason) and if necessary, these can be discussed as set out in point (d) on page 7.

Other medical conditions (refer to point (b) above)

1. Current experience in Scotland shows that non-oncology patients make up approximately 20% of fertility preservation referrals.

2. Similar assessment to that for new referrals with cancer will be appropriate, i.e. a significant risk of loss of fertility, consideration of future use of gametes.

3. Similar considerations to those with cancer also apply to patients who have already received some potentially gonadotoxic therapy, or whose ovarian reserve may be reduced by the nature of their underlying condition.

Transgender and non-binary people

1. Referral pathways: only patients who have been assessed and referred as eligible to access treatment under the Gender Identity Healthcare Protocol^[9] will be considered. Initial discussion of fertility preservation will be provided by the Gender Identity Service prior to referral, when early information provision about the effect of gender reassignment on fertility and fertility options will be provided. The Human Fertilisation and Embryology Authority (HFEA) has published specific information for trans and non-binary people seeking fertility treatment. Information for trans and non-binary people seeking fertility treatment | Human Fertilisation and Embryology Authority (hfea.gov.uk)

2. An appointment with the fertility clinic counsellor should initially be offered.

3. The effect of trans-endocrine treatment on fertility is considered reversible; however, patients should be advised that treatment would need to be paused for several months. Guidance on the appropriate pathway for people already taking gender-affirming hormone treatment is given in Annex D of this document.

4. Patients need to be made aware that transvaginal egg recovery, conducted under sedation, is a central part of the process.

5. Surgical interventions (to recover either eggs or sperm) may be considered in certain situations, including gender dysphoria or sexual assault. Transabdominal egg recovery carries a higher risk to the patient and should only be considered where clinically appropriate or the patient cannot go through a transvaginal recovery. Similarly, surgical sperm retrieval may be considered where a patient cannot produce a sample by masturbation (for whatever reason). These rare cases can be discussed as set out in point (d) on page 7.

6. Clinics should provide an environment which is sensitive to the needs of all people and ensure that the means of obtaining gametes for fertility preservation considers individual needs.

7. Some people may later choose or require surrogacy. This may not be known at the time of gamete storage and has issues for whether subsequent use will count as ‘donation’ and thus what clinical activities/tests are required. Please see Annex E of this document for details of how to approach this.