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30 November 2007

 

Dear Colleague

Use of in vitro matured eggs in treatment services

The Authority’s Regulation Committee has looked again at the use of in vitro matured eggs in treatment (IVM). I am writing to clarify the position:

i) IVM is not a separate licensable activity; centres that are already licensed to provide IVF/ICSI do not need to submit a further application if they wish to offer IVM;

ii) What centres are required to do is

• to notify their HFEA Inspector of their intention (licence condition A.13.1);
• provide patient and consent information for approval by the Inspector before commencing use of IVM in clinical treatment;
• ensure that laboratory procedures used meet the need of patients, ensure the safety and quality of gametes and embryos and are appropriate to the treatment plan concerned.

Guidance on issues that patient information should address has been added to the Code of Practice (G.5.14), along with the updates outlined in letter CH(07)03 b. Centres may also find it useful to refer to the HFEA information for patients regarding IVM, which can be found under ‘For patients’ on this website.
 
As IVM is a new technique there is insufficient evidence to be absolutely certain of its safety as the number of children born is very few (~400 worldwide) and those that have been born are still very young. In order to monitor the long term safety of the technique centres are asked to report which treatment cycles have involved the use of in vitro matured eggs. A new category will be added to treatment forms within the next 6 months.
 
This letter supersedes and revokes previous communication to centres regarding licensing of IVM (letters CE(00)05 and CH(07)01).

Yours faithfully

Walter Merricks
Interim Chair

Page last updated: 23 August 2012

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