• Directions
• Chair's letters
• Chief Executive's letters
  • 2013
  • 2012
  • 2011
  • 2010
  • 2009
  • 2005-2008
  • 2001-2004
  • 1997-2000
  • 1993-1996
• Multiple Births Minimisation Strategy: achievements and compliance
• Frequently used guidance
• Inspecting surgical procedures
• Retrieval of storage of gametes where patients are unable to consent
• Surrogacy and legal parenthood – changes from 1 October 2013

18 July 1995

To: All  Persons Responsible at Treatment Centres

Dear Colleague

LICENSING INTRACYTOPLASMIC SPERM INJECTION (ICSI)
I wrote to you on behalf of the Authority last year regarding the development and introduction of new techniques, including ICSI. Since then, the Authority has set up a Working Group on Developments in Reproductive Technology to advise it on all aspects of the introduction and use of new clinical and scientific techniques. One of the Working Group's first tasks was to review the licensing of ICSI. As a result, the Authority has decided to introduce additional standard licence conditions for ICSI treatment licences.

This letter explains the additional standard conditions and sets out how they will affect new and renewal ICSI licence applications, as well as current licences.

I.  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.

ICSI is recognised to be a significant new development in IVF techniques. The Authority believes it should be possible to monitor its outcome in licensed treatment. It is essential that the Authority collects information which distinguishes ICSI procedures. The Authority has therefore 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 in out in the Appendices to this letter (reference CE(95)1). (An ICSI practitioner is defined as the person who injects the spermatozoon into the egg.)

The Authority will require details about patient selection criteria, the information about ICSI provided for patients, consent forms, protocols, procedures and results as set out in Appendices 1-3 to this letter. In recognition of the important role played by the ICSI practitioner, the Authority will also require detailed information on the performance of each ICSI practitioner at the centre.

Condition 3

That oocytes which have failed to fertilise after 24 hours are not thereafter to be subjected to ICSI procedures, except for diagnostic purposes.

There is insufficient evidence of the safety of the ICSI procedure using ageing eggs, which may have chromosomal damage. Current HFEA policy is therefore that 24 hour failed-to-fertilise oocytes should not be used in ICSI treatment. The only exception to this is ICSI for diagnostic purposes as specified in section 7 of the Code of Practice.

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 Appendix 3 of this letter (reference CE(95)1).

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

II.  Information to be Submitted with an Application for an ICSI Licence

In future, for both initial and renewal applications for a licence to practise ICSI, two distinct sets of information will be required. One relates to the centre and the other to the individual ICSI practitioner(s). Details of the information required for initial applications are given in Appendix 1 and those for renewal applications in Appendix 2.

A centre may propose that a person be recognised as a competent ICSI practitioner at any time. The information to be supplied in support of such a proposal is detailed under Case 2 in Appendix 1.

If the information submitted to the HFEA does not show that a proposed practitioner has suitable experience of clinical ICSI, the Authority will arrange for one of its ICSI inspectors to assess the person's competence in practice at the licensed centre. The inspector's report on the proposed practitioner's competence will be submitted to a licence committee.

III.  Current ICSI Licences

All centres currently holding ICSI licences will shortly be asked to accept and will be required to comply with the new licence conditions. The practice of identifying individual ICSI practitioners in conditions attached to a licence will cease.

IV.  Change of ICSI Practitioner

The Authority recognises that ICSI practitioners may move between centres, that new practitioners enter the field and that some practitioners will leave. Where a recognised ICSI practitioner will be leaving a centre, or where a new practitioner will be joining a centre, the person responsible should notify the Authority in advance and at the earliest opportunity. Where information submitted to the HFEA indicates a significant break in the proposed practitioner's practice of clinical ICSI, the Authority may require re-examination of the person's competence with ICSI.

V.  Other Developments Involving ICSI

Current ICSI treatment licences allow the transfer into a woman of embryos produced by injecting mature sperm individually into mature oocytes. The ICSI technique may enable further new procedures to be devised. In considering the use of ICSI in new ways, the person responsible is reminded of the requirement of paragraph 7.5 of the Code of Practice. This states that:

"Treatment centres should satisfy the Authority that sufficient scientific evidence is available to establish that any procedures used do not prejudice the development potential of the gametes or embryos".

The Authority expects centres to obtain its approval before attempting to use ICSI in new ways. The Authority must decide whether new developments are necessary or desirable for treatment purposes.

If you have any queries regarding the licensing of ICSI at your centre, please contact your inspector coordinator.

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

Yours sincerely,

Flora Goldhill
Chief Executive

---

Appendix 1

Information to be submitted by a centre in support of an initial application to perform ICSI

A. Centre Information

• patient selection criteria for ICSI treatment;
• information for patients about ICSI;
• consent forms for ICSI treatment; and
• laboratory protocols and procedures for ICSI.

B. Practitioner Information

The ICSI practitioner information required will vary according to whether each proposed practitioner has already been recognised by the Authority as competent to perform clinical ICSI:

Case 1:  Competence already recognised by the Authority

• a detailed CV with special reference to experience in human embryology, and
• a record of practice, as set out in Appendix 3, of clinical ICSI performed at a named licensed centre(s) over the past 12 months.

Case 2: Competence not previously recognised by the Authority

• a detailed CV with special reference to experience in human embryology, and
• an ICSI training record to include:

1. results of a short research project under a research licence; and/or
2. work with relevant animal models; and/or
3. work using non-viable sperm/oocytes; and/or
4. practice of micro injection skills with latex beads/air bubbles; and/or work at another licensed centre(s); and/or
5. attendance at relevant training courses; and/or
6. experience of clinical ICSI gained outside the UK.

---

Appendix 2

Information to be submitted by a centre in support of renewal licence to perform ICSI

A. Centre Information

• patient selection criteria for ICSI treatment;
• information for patients about ICSI;
• consent forms for ICSI treatment;
• laboratory protocols and procedures for ICSI.

B. Practitioner Information

The following information will be required for each competent practitioner:

• detailed CV with special reference to experience in human embryology; and
• record of practice of clinical ICSI for each competent practitioner, as set out in Appendix 3, performed at the centre(s) over the past 12 months.

---

Appendix 3

Record of Practice of Clinical ICSI

A.   Information about the performance of ICSI must be supplied in the following circumstances:

• with an initial ICSI licence application, in respect of the previous 12 months practice of each competent ICSI practitioner;
• 3 months after a new practitioner has been recognised as competent, in respect of the ICSI procedures they have carried out in that time;
• at licence renewal, in respect of the practice over the previous 12 months (or other appropriate period) of each ICSI practitioner covered by the licence.

B.   The following information must be supplied:

The following information is required in respect of each ICSI practitioner at a licensed centre:

• number of oocytes on which ICSI has been attempted, number  of  oocytes  damaged  by  procedure,  number surviving injection;
• number of pronuclei observed in surviving injected oocytes: 0 ,1,2 , > 2;
• number of 2-pronucleate eggs that cleaved;
• number of embryos replaced fresh, number stored frozen, any other outcomes; and
• available information on the incidence of pregnancy or other outcome.

Page last updated: 03 August 2012

• Send to a friend