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30 April 2000

Dear Colleague,

The Storage and Use of Frozen Eggs

As you may know, storage and use of frozen eggs have become licensable activities. However, the Authority is aware that these are still new procedures., and is concerned to ensure that any patient wishing to freeze and later use their frozen eggs in treatment is fully informed of the risks involved and the chances of success. The HFEA has therefore prepared the attached patient information leaflet which clinics may wish to use. This leaflet will shortly also be available on the HFEA's website.

Also enclosed is a new consent form, HFEA (00)7, with accompanying guidelines. This form replaces the current consent form 96(7) for those centres freezing and/or using frozen eggs, and highlights the experimental nature of these techniques. Those centres currently licensed for the storage and use of frozen eggs will shortly be sent a pad of these new forms for immediate use. Eventually form (00)7 will replace form 96(7) for all centres once stocks of the latter form have been exhausted.

Finally, the HFEA has agreed standard conditions that should be applied whenever a centre is licensed for the storage and/or use of frozen eggs. These conditions are as follows:

• The use of cryopreserved oocytes in treatment services shall be restricted to oocytes frozen at the preovulatory stage;
• Before a woman gives consent to the storage and/or use of cryopreserved oocytes in treatment services she must be given an oral explanation supported by relevant written material:

a)   of all risks associated with the cryopreservation and thawing of oocytes; and

b)   that counselling is available.

 

• Donors of cryopreserved oocytes shall be subject to the existing screening requirements as set out in the Code of Practice; and
• The centre shall not mix in the same treatment cycle:

a)   Fresh oocytes with oocytes that have been cryopreserved;

b)   Embryos that have been created using cryopreserved oocytes with embryos created using fresh oocytes; or

c)   Cryopreserved embryos that have been created using cryopreserved oocytes with cryopreserved embryos that have been created using fresh oocytes.

 

I hope that you find this letter and enclosed material helpful. Please contact your centre's inspector co-ordinator if you have any questions.

Yours sincerely,

Ruth Deech
Chairman

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GUIDELINES FOR CONSENT TO THE STORAGE AND USE OF EGGS AND EMBRYOS HFEA (00)7

Introduction

The Human Fertilisation and Embryology Act 1990 requires the effective consent of individuals for the storage and use of their gametes or embryos. These consents must, by law, specify the purpose for which the patient's genetic material is intended.

Completion of this HFEA consent form will ensure that women providing eggs have given the necessary consents. Any women producing eggs to be stored, used in the treatment of another woman, used in research or to be fertilised in vitro to produce embryos which may be stored and subsequently used in treatment or research, must complete and sign the consent form.

A woman providing eggs(s) should be informed that one consent will be assumed to cover all the egg(s) she provides at that centre unless she specifies otherwise on the form. In the exceptional case of a woman providing egg(s) at more than one centre, each centre must obtain a separate consent.

A woman may withdraw or vary a consent that she has given by notice given to the person keeping the egg(s) or embryo(s). In this case, it is advisable that a new consent form is completed. Patients should be asked to inform the clinic of any changes that may affect the consent that they have given. The terms of any consent to the use of any egg or embryo cannot be varied, and such consent cannot be withdrawn once the genetic material has been used in providing treatment services or for the purposes of a project of research.

Couples undertaking treatment together should be reminded that their consents to the storage and use of embryos developed in vitro using their gametes must be compatible, otherwise their consents will be invalid and the future use of their embryos will be affected.

Before completing the consent form, the woman must be given a suitable opportunity to receive proper counselling about the implications of the proposed steps and must be provided with all the relevant information. Centres may wish to make reference to the Code of Practice where this requirement is explained.

The forms are WHITE pads. No carbon is required to make a duplicate copy. Centres must retain the top copy for their own records and give a duplicate to the woman providing the egg(s). Guidance notes are provided here. The form should be completed in ball point pen, or typed.

Guidelines:

The sections below relate to the corresponding sections of the consent form for the storage of eggs and embryos.

NAME
The full name of the woman concerned should be entered in this section together with any other name by which she has been known.

PART I - CONSENT FOR USE OF EGGS AND EMBRYOS

Ia.  This section enables the woman concerned to consent to the use of her eggs for a specific purpose.

i.  The woman concerned may consent to the use of her eggs in her own treatment. This is only consent to treatment that does not involve the creation of an embryo in vitro and the woman must be aware that this clause is insufficient for treatment using IVF and ICSI. In order to have treatment that involves the creation of an embryo section Ib must be completed.

ii.  The woman concerned may indicate that she wishes to donate eggs for the treatment of others. In this case, she must be screened accordingly. This section only provides for donation and not the creation of an embryo in vitro. If the woman concerned wishes to allow the creation of embryos from her eggs for the treatment of others, she must give her consent in section Ib.

iii.  The woman may indicate that she wishes to donate her eggs to a project of research. She must have received all relevant information pertaining to the nature of the research that might be carried out. This section only provides for the donation of eggs for the purpose of research. If the woman concerned wishes to allow the creation of embryos from her eggs to be used in research, she must give her consent in section Ib.

The woman concerned may indicate any particular conditions that she wishes to place on the use of her eggs.

Ib.  This section enables the woman to the consent to the use of her eggs for the creation of an embryo in vitro.

i.  This section must be completed in order for any treatment involving the creation of the embryo in vitro to take place, including ICSI. If the woman is having treatment together with a partner, he must be named in full on the consent form.

ii.  The woman may consent here to the use of her eggs for the creation of an embryo in vitro for the treatment of others. In this case, she must be screened accordingly.

iii.  The woman may consent here to the use of her eggs for the creation of an embryo in vitro for a project of research. She must have received all relevant information pertaining to the nature of the research that might be carried out. The woman concerned may indicate any particular conditions that she wishes to place on the use of her eggs. This section of the form must be signed and dated.

PART II - CONSENT FOR THE STORAGE OF EGGS AND EMBRYOS

IIa.  This section enables the woman concerned to specify a length of time for which her eggs are to remain in storage. In the event that she is eligible to store her eggs for longer than ten years, a form for consent to the long term storage of eggs should be completed.

IIb.  This section enables the woman concerned to specify a length of time for which embryos created using her eggs may remain in storage. If she is eligible to store her embryos for longer than five years, this form should be accompanied by a completed HFEA (96)8 for the extension of the statutory storage period of embryos.

In order for the recipient of donor eggs or embryos to extend the storage period of her embryos, the consent of the woman who has provided the eggs must be given. For this reason, centres may wish to advise women who donate their eggs to indicate a storage period for embryos of longer than ten years to prevent subsequent complications.

IIc.  This section provides for what should happen to the eggs and embryos in the event of death or mental incapacity of the person concerned. It must be completed in all circumstances.

i.  This option indicates that the eggs and/or embryos of the patient be allowed to perish in the event of her death or mental incapacity.

ii.  The woman may indicate that, in the event of her death or mental incapacity, her eggs and/or embryos may continue in storage for the purposes to which she consented in sections Ia and Ib, however it is important to note this is only valid for Ia ii and iii and Ib ii and iii, i.e. for donation to others or research.

If a woman wishes for her eggs and/or embryos to be donated for the treatment of others after her death, she must have been screened at the time of storage and preferably have been tested again after six months storage. Therefore, even if donation is not the primary intention a woman can only donate posthumously if such screening has been carried out.

iii.  The woman concerned may indicate here any other conditions of storage. She may, for example, choose to distinguish between eggs or embryos intended for her own treatment and those intended for donation.

If the woman wishes for her eggs and/or embryos to be carried by another woman (a surrogate for example) for her partner she should specify this clearly in the space provided. Again the woman will need to have been screened at the time of storage and preferably have been tested again after six months storage. Eggs or embryos can only be used posthumously if such screening has been carried out.

IId.  The woman concerned may indicate any particular conditions that she wishes to place on the use of her eggs. This section of the form must be signed and dated.

IIe.  The woman concerned must be reminded of the statutory storage period of embryos and the centre's obligation to allow these embryos to perish once they reach the end of their storage period.

This form must be signed and dated by the woman concerned.

Page last updated: 14 April 2009

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