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21 April 2006

To all Persons Responsible

Dear Colleague,

Important information on the use of embryos where donors have reached the '10 family' limit ? new transitional arrangements for frozen embryos

Following the HFEA's review of Sperm, Egg and Embryo Donation (SEED Review) a new limit on the use of gametes from an individual donor came into effect on April 1.  As a result of licensed treatment, gametes (or embryos produced using gametes) from an individual donor should not be used to produce children for more than 10 families ? see Chair's letter CH (06) 01.  This limit of ´10 families' replaced the previous limit of '10 live birth events' (HFEA Code of Practice, 6th ed., para.8.30).
 
The Authority is aware that a number of patients currently have embryos in storage that were created with gametes from donors who have now reached the '10 family' limit.  In the interests of the individuals concerned, it has been decided that a new transitional arrangement should apply to embryos in this situation.  This arrangement is as follows:

Where: 

• embryos were created before 1 April 2006 and
• the embryos were created using gametes from a donor together with gametes from the woman to be treated or her partner and
• the transfer of the embryos could result in children being produced for more than 10 families as a result of licensed treatment

Centres may take into account exceptional reasons for exceeding the 10 families limit and, if exceptional reasons exist, transfer the embryos. 

The effect of this arrangement is to allow the rules that applied under the previous ´10 live birth events' guidance to continue to apply to embryos that were in storage when the new ´10 families' guidance came into effect.  This transitional arrangement only applies to embryos that were in storage on 1st April 2006; it does not apply to gametes.

As with the previous guidance, the HFEA expects to be notified whenever the permitted limit is exceeded (Code of Practice, 6th ed., para.8.31).  The notification should be sent to the centre's HFEA Inspector and should set out the exceptional reasons for providing the treatment which resulted in the limit being exceeded and the process by which the decision to treat was reached. 
 
In the interests of all patients centres are reminded that before they begin a treatment cycle they should consider very carefully whether there exist any reasons that might prevent the treatment being completed (including transfer of any embryos created in the course of the treatment).

If you have any questions or require any further information please contact the HFEA Inspector for your centre.

Yours sincerely,

Dame Suzi Leather, DBE
Chair, HFEA

Page last updated: 23 August 2012

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