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09 February 1994

To: Directors of all IVF centres
HFEA Inspectors

 

Dear Director

DEVELOPING AND INTRODUCING NEW TECHNIQUES. INCLUDING INTRACYTOPLASMIC SPERM INJECTION (ICSI)

The Authority has received applications from centres to introduce Intracytoplasmic Sperm Injection (ICSI) into their treatment programmes. We have also received enquiries from others about how they might proceed in developing the necessary skills in order to apply in the future to perform ICSI.

The central problem for centres has been that while they recognise the need to demonstrate competence before proceeding to treatment, there can be difficulties in acquiring the necessary skills, given that a research licence cannot be given solely for this purpose.

The intention of this letter is to outline the Authority's position and to give advice on how centres might approach the development of ICSI locally. This can also be regarded as general advice about procedures for the introduction of other new techniques.

Background

In the first instance, while a technique is still in a pure research phase, the Authority would expect any new technique to be proven through licensed research before it would consider an application to introduce it into treatment. Similarly, once a new treatment is firmly established, the criteria for entry will have become clear and licence committees will have established what information is needed before approving treatment applications.

The difficult question is how a developing technique transfers from research into practice, and how a centre acquires the necessary skills to introduce a technique that has been developed elsewhere.

In looking at any new development, a licence committee will want to look at certain things in all cases, for example:

• whether the practice is safe;
• whether it is effective;
• whether it is necessary or desirable;
• what skills or competence are needed;
• whether the applicant has demonstrated that they have those skills.

ICSI and other new techniques

The Authority has discussed these matters on several occasions. Most recently, on 9 September, it looked specifically at the development of ICSI, and agreed that it would be usual for centres to be licensed to introduce ICSI clinically only following a period of research under a research licence. This research period need not necessarily be for more than three or six months, possibly even less. The research would be aimed at seeking new information, or adding to the body of knowledge about ICSI, but it would also provide an opportunity for the centre to identify criteria for measuring competence in ICSI and then to measure their actual performance against those criteria.

In reaching this decision the Authority took account of a number of points which it has established as matters of policy or through licence committee precedents:

I. a research project should not be used simply for practising a technique that has already been established elsewhere - it should have a clear research focus (for example, fertilisation rates with ICSI in oocytes that have failed to fertilise in IVF 24, 48 and 72 hours after insemination); however

II. licensed research need not always be entirely novel -it can be useful for one centre to repeat another centre's work to add to an existing body of research information;

III. development of skills and competence can therefore be a secondary, though important, part of the outcome of such a project;

IV. licensed research projects need not be long term, nor need they be aimed at publication;

V. many of the criteria that should be satisfied before proceeding to treatment could be demonstrated by non-licensable work, for example, with suitable animal models, or through manipulation of non-viable gametes.

While research would be the usual route towards licensing ICSI under a treatment licence, the Authority also accepts that there may be centres which could present an application for a treatment licence in which they might justify moving directly to a treatment licence without a prior period of licensed research. In these circumstances we would expect the centre to show other ways in which their competence has been measured, either through non-1icensable work (such as with animal gametes or with non-viable sperm and/or eggs) or through training courses or work in other centres, possibly abroad. For ICSI it is likely that such an application would also demonstrate significant experience in other micromanipulation techniques, such as SUZI, and the results of this should be detailed in the application. In any event, a licence committee must consider each application on its own merits.

For any new technique, the Authority recognises the need to consult those people working in the field who have direct or relevant experience. For ICSI, the Authority convened a meeting of experienced clinicians and scientists to discuss a number of issues. This was in order to understand fully the potential risks or benefits that are associated with it, and to attempt to identify the particular skills and competencies that are needed before the technique can be carried out successfully. The result of this meeting was considered by the Authority at its meeting on 9 September. We have also asked a number of specialists, including the Association of Clinical Embryologists, to assist in formulating a set of criteria which might be useful in establishing a competence threshold for ICSI.

Practice through "Diagnostic ICSI"

A further question has been raised by some centres about the possible use of "diagnostic ICSI" following failed fertilisation in standard IVF as a way of practising and developing skills prior to making a licence application. This would mean that unfertilised eggs would be injected with a single sperm to see whether that egg is capable of being fertilised by that sperm. This could inform future treatment for that patient, but any resulting embryo would not be used in treatment or research, or stored. It could also provide a means of assessing and developing competence in ICSI, prior to using ICSI in actual treatment.

Paragraph 7.7 of the Code of Practice is relevant to this question. This states that:

Attempts to produce embryos in vitro should not be made if there is no intention to store or use the resulting embryo(s), unless there is a specific reason why it is necessary to do so in connection with the provision of treatment services for a particular woman. On each such occasion, the reason should be explained to the woman, implications counselling should be offered and the written consent of each person providing the gametes must have been obtained.

"Diagnostic ICSI11 would therefore be acceptable in principle where the reason for carrying out the procedure is clearly to inform the treatment of the particular patient. The reasons for proceeding would have to be explained to the patient and be recorded in the treatment notes. In such cases it would clearly be useful to ensure normal embryo development before disposing of the embryos. Practice in ICSI procedures would not be the objective, but experience of the technique as a diagnostic tool could be cited in a subsequent application to add ICSI to a treatment licence.

However, using ICSI as a diagnostic technique in this way will only be of value if the practitioner has sufficient confidence in their ability in using the technique to be able to rely on the results for diagnostic purposes.

It is a condition of every treatment licence that a centre does not introduce a new technique without first applying to the Authority to be able to do so. The Authority considers ICSI to be such a technique even if it is only to be used for diagnostic purposes.  Centres should therefore seek authorization from a licence committee of the HFEA before proceeding with diagnostic ICSI.  The licence committee will be able to consider such an application in that context alone, and as a separate question to any subsequent application to introduce ICSI as a therapeutic technique.

This letter should be regarded as general advice about the Authority's approach to the licensing of new techniques. Centres may wish to consult the Authority before proceeding with an application, but no assurance can be given, prior to consideration by a licence committee, as to the outcome of any particular application, whether for research or for treatment.

If you have any further query about the content of this letter, please contact Hugh Whittall, or your centre's Inspector Coordinator, on 071 377 5077.

Yours sincerely

FLORA GOLDHILL
Chief Executive

Page last updated: 03 August 2012

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