The authorised processes list describes the processes licensed clinics can use to carry out the licensable activity. For example, clinics carrying out the licensed activity ‘Creation of embryos’ can use IVF or ICSI to do so.
The table below shows which processes are authorised for use in clinical practice. If a process is not listed it is prohibited for use in clinical practice.
Licensed clinics are only permitted to undertake authorised processes in accordance with the licence they hold.
All processes listed in the table below were approved prior to July 2024, when the authorised processes decision tree was reviewed. For more information, please refer to the March 2024 Authority papers.
| Licensed activity | Authorised processes |
|---|---|
| Procuring gametes | Egg collection Surgical sperm collection Ovarian tissue collection Testicular tissue collection |
| Keeping gametes | Culture of eggs Culture of sperm |
| Processing gametes | Semen preparation (including the use of reagents to increase sperm motility) Egg preparation Grading of gametes In vitro maturation Cryopreservation of gametes Thawing/re-warming gametes Polar body biopsy Egg activation using Calcium Ionophore (only in selected patients and in accordance with professional guidelines* - see below for further guidance) |
| Distribution of gametes | Transfer of sperm between centres Transfer of eggs between centres Supply of sperm from a licensed centre to unlicensed premises in thawed or thawing state for home insemination - this should only be done in exceptional circumstances as per the Code of Practice |
| Use of gametes | IUI GIFT IVF ICSI |
| Storage of gametes | Cryopreservation of eggs Cryopreservation of sperm Cryopreservation of testicular tissue (HTA licence may be required depending on the reasons for storage and intended use) Cryopreservation of ovarian tissue (HTA licence may be required depending on the reasons for storage and intended use) |
| Storage of embryos | Cryopreservation of embryos (including at the pronucleate and blastocyst stage) |
| Creation of embryos | IVF ICSI |
| Procuring embryos | Lavage |
| Keeping embryos | Culture system |
| Testing gametes | Genetic testing associated with polar body biopsy |
| Testing embryos | PGT-M PGT-A PGT-SR |
| Processing embryos | Culture Biopsy Assisted hatching Embryo grading (including non-invasive assessments, see T91 for limitations) Manipulation Thawing/re-warming of blastocysts and embryos Intrauterine culture of gametes and embryos (including insertion and removal of device, followed by transfer of embryo(s) to the same person) |
| Distribution of embryos | Transfer of embryos between centres |
| Placing permitted embryo in a woman | Embryo transfer |
| Using embryos in training | Embryo biopsy Blastocyst biopsy Cryopreservation and thawing/re-warming techniques Assisted hatching Embryo handling and manipulation Assessment of embryos |
*The HFEA’s Scientific and Clinical Advances Advisory Committee (SCAAC) considered the use of Calcium Ionophore as an egg activation technique and highlighted the theoretical risks relating to embryo viability (eg, premature activation and triploid embryos). Given the theoretical risks of Calcium Ionophore activation, centres using it are expected to do so only in selected patients, such as those with PLCz deficiency, or in accordance with professional guidelines. Centres are expected to document their rationale for using Calcium Ionophore for individual cases. As with all treatments and processes, centres should ensure that patients are fully informed about the efficacy and potential risks and that validation is carried out.
In August 2023, the Association of Reproductive and Clinical Scientists (ARCS) and the British Fertility Society (BFS) published ‘The use of ICSI in ART: Evidence for practice’ which includes guidelines on the best practice use of artificial egg activation.
Prohibited processes
If a process does not appear on the list above, it may have been considered by the SCAAC but determined to be inappropriate for use in clinical practice. This may be because the evidence indicating that the process renders the tissues or cells clinically ineffective or harmful to the recipient.
The table below shows which processes are prohibited for use in clinical practice.
| Licensed activity | Prohibited processes |
|---|---|
| Use of gametes | Use of immature sperm (e.g. spermatids) |
Suspended processes
Should evidence come to the attention of the SCAAC which indicates that an authorised process may render tissues or cells clinically ineffective or harmful to the recipient, the process will be suspended and taken to the SCAAC for further consideration. If a process is suspended it will be indicated on the authorised process list as follows:
Key
| Name of licensed activity | Suspended process |
For further information regarding suspended processes please contact your Clinic Inspector.
Applying to use a new process
If you wish to use a process, which does not appear either on the authorised or the prohibited processes lists, you will need to apply to the HFEA to seek permission to use it in clinical practice.
The application will be discussed by the SCAAC, who will consider evidence as to whether the process renders the tissues or cells clinically ineffective or harmful to the recipient and decide whether or not to add the process to the authorised processes list. If the process is approved, any clinic or laboratory may use the process, provided they are licensed to carry out the associated licensable activity and fulfil any additional requirements as specified by the SCAAC.
Should you wish to submit an application for a process which does not currently exist on the authorised processes list, please contact your Clinic Inspector.
To note: Authorised processes which have been recently approved by the SCAAC are subject to an enhanced reporting period. Any process subject to enhanced reporting will appear on the AP list but will be depicted as below:
Key
| Name of licensed activity | Fully authorised process |
Process subject to enhanced reporting  Authorised processes which have been recently approved by the SCAAC are subject to an enhanced reporting period. These will be indicated using this pop-up window. |
Rejected applications
Applications to authorise a new process may have been rejected at application due to insufficient evidence for the process to be authorised, for example, where there is not currently enough evidence to conclude that the process does not render the tissues or cells clinically ineffective or harmful to the recipient.