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09 July 1997

To: All Persons Responsible at Treatment Centres

Dear Colleague

LICENSING INTRACYTOPLASMIC SPERM INJECTION (ICSI)

Flora Goldhill wrote to you on 18 July 1995 (Reference: CE(95)1) introducing the additional standard licence conditions for ICSI treatment licences. Since then the Authority has acknowledged that the current system has led to inconsistencies with respect to the licensing of practitioners and facilities. To that end, the HFEA's licensing and fees Committee commissioned a specially constituted Working Group to address these inconsistencies by revising and developing a set of procedures and criteria for the assessment of this area of clinical biology. The HFEA subsequently approved the procedures and criteria.

The attached procedures supersede those contained in Mrs Goldhill's earlier letter. Having said that, these revised licensing requirements for ICSI retain the additional standard licence conditions which were introduced in July 1995. These are reinforced in Annex A.

The revised guidelines and accompanying documentation which centres are asked to consider are highlighted at Annex B. While these guidelines do not alter the previous ones significantly, they aim to provide more detail regarding the specific licensing requirements of centres with respect to ICSI, and they describe the information to be submitted to support a centre's application for an ICSI licence. The principal points to note are:

1.   Centres will now be required to complete a logbook proforma, to be signed off by the Person Responsible and made available to the HFEA for inspection. The proforma is appended with the revised guidelines attached;

2.   A centre should not apply for an ICSI licence unless the potential practitioner has achieved a damage rate of less than 25% in respect of 50 consecutive human eggs.

3.   Candidates will be expected to demonstrate that they are cognisant of the HFEA's requirements in relation to ICSI, as detailed in the additional conditions and guidelines attached; and

4.   The 3-month progress report which centres are required to submit once a practitioner has been licensed has been formalised into a proforma. This is also appended.

Current ICSI Licences

All centres currently holding ICSI licences will shortly be asked by the Authority to accept and comply with the revised licence conditions.

This letter and its appendices should be retained until further notice and inserted in the Manual for Centres after page 14 in section 1.

Please contact your Inspector Co-ordinator if you have any queries regarding the licensing of ICSI at your centre.

Yours sincerely

Suzanne McCarthy
Chief Executive

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Annex A

Additional Standard Licence Conditions
The additional standard licence conditions for ICSI are as follows:

Condition 1

That embryos produced using ICSI are not replaced with any other embryos in the same treatment cycle

The Authority takes the view that it should be possible to monitor the outcome of ICSI in licensed centres. It is essential that the Authority collects information which distinguishes ICSI procedures. The Authority has decided that ICSI embryos must not be replaced in the same cycle as any other IVF embryos.

Condition 2

That when applying for an ICSI licence the Person Responsible provides the Authority with the information set out in Annex B of this letter (reference CE (97) [4]). (An ICSI practitioner is defined as the person who injects the spermatozoon into the egg.)

The Authority will continue to require details regarding patient selection criteria, the information about ICSI provided for patients, consent forms, protocols, procedures and results as set out in Annex B of this letter. In recognition of the important role played by the ICSI practitioner, the Authority will also require detailed information regarding the performance of each ICSI practitioner at the centre.

Condition 3

That oocytes which have failed after 24 hours to fertilise by normal IVF procedure are not to be used in ICSI treatment.

The Authority takes the view that there is insufficient evidence supporting the safety of the ICSI using ageing eggs which may have chromosomal damage.

Condition 4

That clinical ICSI is carried out only by trained competent staff recognised as such by the Authority.

Condition 5

That the Person Responsible at a centre notifies the Authority before clinical ICSI procedures are first carried out by a particular practitioner at that centre.

Condition 6

That 3 months after a new ICSI practitioner has been recognised as competent, the Person Responsible provides the Authority with the information set out in the proforma attached to Annex B of this letter (reference CE(97)[4]).

Conditions 4, 5 and 6 reinforce that clinical ICSI is to be carried out by suitably trained competent staff only. The Authority recognises that there are various ways in which centres can train their embryologists to perform ICSI.

NB You are asked to note that the changes to the original conditions of 18 July 1995 are limited to the references in Condition 2 and Condition 6. In all other respects, these conditions are identical.

Page last updated: 03 August 2012

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