CH(95)04
27 November 1995
Dear Colleague
POLICY UPDATE
This is the third in the series of letters to keep you and your colleagues in licensed clinics in touch with current HFEA policy. It contains new information as well as guidance on matters which have caused difficulties in recent months. It also contains preliminary advice to clinics about providing information to people who will be affected by the decision on whether to change the current maximum statutory storage period for embryos.
The issues covered in the Annexes to this letter are:
1. Data to be Provided about Clinics' Recent Results
2. Restrictions on the Use of 24 Hour Old Oocytes in Treatment
3. Surrogacy and the Commissioning Couple as Donors
4. Import and Export of Gametes and Embryos
5. Consent to the Use of Sperm after Death
6. Statutory Storage Period
7. Information about Abandoned IVF Cycles
8. Information about GIFT Cycles
9. Payments to Egg Donors
I hope you find this advice helpful. Please contact the inspector co-ordinator for your clinic or Carol Perkins or Bea Heales if you have any queries about this letter.
Yours faithfully
Mrs Ruth Deech
Chairman
1. Data to be Provided about Clinics' Recent Results
The Patients' Guide says that clinics will be able to give more recent information about their treatments and outcomes than those in the Guide. Clinics should give this in a standard format to ensure consistency for patients. The HFEA has prepared a pro-forma for this purpose, attached at annex A, which clinics should use. The Authority would welcome comments on the pro- forma, particularly on the reactions of patients, before it makes decisions about the final version which will be included in the Code of Practice in due course. The use of the pro-forma does not preclude clinics from giving people other information which they ask for or which would be helpful to them.
2. Restrictions on the Use of 24 Hour Old Oocytes in Treatment
The restriction on the use of 24 hour old oocytes mentioned in Flora Goldhill's letter of 18 July 1995 applies only in connection with ICSI. This is because of the increased risk with ICSI of dispersing the chromosomes, which have become more centrally located after 24 hours. It does not apply when other forms of micromanipulation or IW are used. The HFEA will review this policy as it gets more information about the safety and efficacy of the practice.
3.Surrogacy and the Commissioning Couple as Donors
In surrogacy cases, the surrogate parents (birth mother and her partner/husband) are the legal parents of a child born through a surrogacy arrangement until parental responsibility is legally and formally transferred to the commissioning couple. Where the commissioning couple's gametes are used in the treatment of the surrogate mother, clinics should consider the commissioning couple as donors. The commissioning couple should therefore be screened and their gametes or embryos only used after they have been quarantined in accordance with Code of Practice guidelines.
CH(95)4
4. Import and Export of Gametes and Embryos
Clinics are reminded that the export of gametes is covered by a general HFEA direction (D.I991/8) and does not require a specific application to the Authority. However, the export of embryos and the import of gametes and embryos are authorised only by a special direction. A special direction means that an application must be made to the Authority for each import or export and this must be approved before it can proceed.
The directions which govern import and export can be found at pages 103 to 112 of the Manual for Centres. Some of the steps that clinics should take in making the arrangements are as follows.
The provider(s) of sperm and of the gametes that were used to make an embryo must have given written consent to the import/export and the purpose for which they are to be imported/exported.; The consent must be obtained in writing and must not have been withdrawn before the import/export takes place.; The gametes or embryos must not be used for any purpose other than that specified in the consent.
In the case of export, before giving consent, the person(s) must have been given a written notice saying that the law governing the use of gametes and the parentage of any resulting child may not be the same abroad as it is in the United Kingdom.
Gametes and embryos may not be exported if they could not legally be used in the United Kingdom. If donated sperm or embryos produced using donated gametes are imported, the appropriate donor information form(s) must be completed and a copy sent to the Authority within one week of the date on which they are imported.
When gametes are exported in accordance with the general direction, D1991/8, the HFEA must be informed of the date on which they were sent, the person to whom they were sent and the purpose for which they were sent, within 2 working days of their export.;; When gametes or embryos are imported, the Authority must be informed within 2 working days of their arrival in the United Kingdom.
CH(95)4
5. Consent to the Use of Sperm after Death
A number of cases have recently been drawn to the HFEA's attention concerning consent to the use of frozen sperm after a person has become unable to vary their consent or has died. The cases have involved the partners of the men concerned, who want to use the sperm in their own treatment. Problems have arisen when form HFEA 91(6), consent to the use and storage of sperm and embryos, has not been completed by the man. The following information is to help remind clinics of the position in respect of sperm stored before 1 August 1991 and of sperm stored after that date.
Sperm stored before 1 August 1991
Where sperm was stored before 1 August 1991, the written consent of the person whose sperm is
stored is not required for the sperm to continue to be stored.
In order for such stored sperm to be used in licensed treatment, consent for its use from the person who provided it must exist. If the consent was given before 1 August 1991 it need not be on form (91)6, but it must be in writing and must not have been subsequently withdrawn.
Sperm stored on or after 1 August 1991
If sperm was stored on or after 1 August 1991, the consent of the person who provided it must be obtained in writing and must not subsequently have been withdrawn. It must satisfy the provisions of Schedule 3 of the Human Fertilisation and Embryology Act (1990), and must state what the individual wishes to happen to his sperm in the event that he dies or is unable, because of incapacity, to vary the terms of the consent or to revoke it. HFEA direction D1991/7 requires that the consent should be recorded on form HFEA(91)6.
Clinics should ensure that they have effective consents for all sperm and embryos in storage. Consent forms HFEA(91)6, for the storage and use of sperm and embryos, and HFEA(91)7, for the storage and use of eggs and embryos, satisfy the provisions of the Act and constitute effective consent. It is possible that other forms of written consent may be satisfactory. However, this is a complex area and, if there are any doubts, clinics should seek their own legal advice before accepting any other form of consent.
CH(95)4
6. Statutory Storage Period
As you will be aware, the statutory storage period for embryos is currently under review. The HFEA has prepared a report on the matter for the Department of Health and it is for the Department and, ultimately, Parliament to decide whether or not the 5 year period should be changed. The decision on whether to extend the limit or not is particularly significant for those people who had embryos placed in storage on or before 1 August 1991. These embryos reach the end of their current maximum storage period on 31 July 1996. It is therefore important that clinics have systems in place for contacting and informing patients affected, so that they may be made aware of the position and begin to consider what they wish to do with their embryos, whatever Parliament decides. Clinics should do everything in their power to contact all the people affected and should make a written note of the steps they have taken in each case to do this.
The standard information that should be given to patients and donors whose embryos are approaching the end of their current maximum storage period should include:
- a reminder of the date on which embryos using their gametes were stored;
- the current legal position in respect of the maximum storage period for embryos;
- that the matter is under review and that it is for the Department of Health and Parliament to change or affirm it;
- that they will wish to make decisions about the use of their embryos for implementation before the expiry of the 5 year period, if it is not altered; and
- that the clinic will provide any information or counselling needed by patients to help them in the decision making process.
As soon as I have any more information on this matter, I will write to you again.
7. Information about Abandoned IVF Cycles
Under the Human Fertilisation & Embryology Authority Act (1990) all IVF treatments started, whatever the outcome, must be notified to the Authority. An F/F treatment cycle starts with:
a. the administration of drugs for the purpose of superovulation, or;
b. if no drugs are used, with the attempt to collect eggs, or;
c. if frozen-thawed embryos are used, with the removal of the stored embryos in order for them to be thawed and then transferred.
If the current treatment cycle is stopped at anytime subsequent to the start of the cycle as defined in a), b) or c) above, it should be recorded as an abandoned cycle and reported to the Authority on form HFEA(91)1. Currently, this includes circumstances where:
i. egg collection is not carried out and there is no further treatment; or
ii. egg collection is not carried out, but the patient continues to have drug treatment preparatory to another treatment being carried out, or
ii. egg collection is successful but no embryos are created; or
iv. all embryos are cryopreserved for a subsequent treatment cycle with frozen embryo transfer.
The definition of an abandoned cycle will be reviewed during the preparation of the next Patients1 Guide.
CH(95)4
8. Information about GIFT Cycles
Under the Human Fertilisation & Embryology Authority Act (1990), GIFT is not a licensable treatment unless donated gametes are used. Where donated sperm or eggs are used, clinics should notify the HFEA using the pink form HFEA(91)2, with the word "GIFT" written prominently in capital letters at the top of the form.
Where embryos are produced from spare eggs following GIFT, solely for cryopreservation or donation, clinics should use form HFEA(91)5 to notify the HFEA. The yellow IVF form HFEA(91)1 should not be used.
9. Payments to Egg Donors
HFEA direction D1991/2 makes clear to clinics that they may not pay to egg donors, in money or money's worth, more than £15 plus reasonable expenses. (Benefits in the form of treatment services or sterilisation may also be offered.) In addition, the Authority advised clinics in a letter of 28 April 1994 (CE(94)3) that they should not make payments to any agency or other intermediary in respect of the supply of egg donors.
The Authority has recently considered a further situation in which an egg donor might receive payment directly from the recipient or from an unlicensed agency or intermediary. Clinics are now advised that they should not use donors whom they know or believe to have been paid, or are likely to be paid, in cash or in kind through an agency or intermediary any sum in excess of that presently allowed by directions. The Authority will be issuing revised directions to this effect. Guidance will also be issued on the kind of enquiries that clinics should make of prospective donors so that they may satisfy themselves that no financial arrangement of this sort is taking place.
Form CH(95)4
IN VITRO FERTILISATION
CLINIC: [name to be inserted by clinic]
IVF treatments and results for the twelve month period ending: [date to be inserted by clinic]
[All numbers to be inserted by clinic]
Overall Totals
Patients treated
Treatment cycles started
Clinical pregnancies*
Clinical pregnancy rate* %
Results by fresh and frozen embryo replacement for cycles started Using fresh embryos Using frozen embryos
Patients treated;
Treatment cycles started;
Clinical pregnancies*;
Clinical pregnancy rate** % %
Where Intra Cytoplasmic Sperm Injection (ICSI) treatments were performed these figures are included in the table above, but separate totals are also provided below:
ICSI treatments
Patients treated
Treatment cycles started
Clinical pregnancies*
Clinical pregnancy rate** %
*;; A clinical pregnancy is defined as the presence of a foetal heart on ultra-sound
** The clinical pregnancy rate is expressed as a percentage of treatment cycles started
Form CH(95) 4
DONOR INSEMINATION
CLINIC: [name to be inserted by clinic]
DI treatments and results for the twelve month period ending: [date to be inserted byclinic]
[All numbers to be inserted by clinic]
Overall Totals;
Patients treated;
Treatment cycles started;
Clinical pregnancies*;
Clinical pregnancy rate**; %
Results for stimulated and unstimulated DI; Stimulated; Unstimulated
Patients treated;;
Treatment cycles started;;
Clinical pregnancies*;;
Clinical pregnancy rate**; %; %
* A clinical pregnancy is defined as the presence of a foetal heart on ultra-sound
** The clinical pregnancy rate is expressed as a percentage of treatment cycles started
Page last updated: 17 August 2012