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22 October 1996

Dear Colleague

This is the fourth in a series of letters that are intended to keep you and your colleagues informed of current HFEA policy. This letter contains new information on issues that have recently been considered by the Authority and clarification of issues that may have given clinics difficulties over the last few months.

The issues covered in the Annexes to this letter are:

1. The definition of non-viable gametes
2. Restrictions on the use of failed to fertilise oocytes
3. Late inspection papers
4. Collection of data for the HFEA Register
5. Benefits in kind

I hope that you find this information 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

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1. The definition of non-viable gametes

Flora Goldhill's letter of 18 July 1995 (copy attached) set out the additional standard licence conditions for ICSI [Ref: CE(95)1]. In appendix 1 of that letter reference is made to the use of non-viable gametes in the training of ICSI practitioners. Clinics have requested that the definition of 'non-viable' gametes be clarified, and, in response to these requests, the following definitions have been agreed:

Damaged oocytes - In the context of ICSI practice, an oocyte has been damaged where cytoplasmic leakage has occurred or where the cytoplasm has become diffuse and non-translucent owing to breakdown of the vitelline membrane.

Non-viable oocytes - An oocyte 'damaged' as defined above would be non-viable, as also would be a 48-hour-old-failed-to-fertilise egg which had no visible evidence of a pro-nucleus or of a second polar body.(see below).

Non-viable sperm - Sperm would be non-viable if, by chemical or other treatment, they had been rendered incapable of initiating fertilisation. Clinics would be required to provide information on the method used and would be responsible for ensuring that their method was effective.

Although non-viable gametes may be used to practice ICSI technique, it is the clinic's responsibility to ensure that fertilisation is not initiated. If a centre is in any doubt about whether or not fertilisation would be initiated when injecting sperm into an oocyte, then they should apply for a research licence.

2. Restrictions on the use of failed to fertilise oocytes

Section 1 (l)(b) of the Human Fertilisation and Embryology Act 1990 states that "references to an embryo [in the Act] include an egg in the process of fertilisation". This means that, where an oocyte is in the process of fertilisation, any manipulation of that oocyte would have to be licensed under the Act. Therefore, failed to fertilise oocytes can only be manipulated without a research licence, for example, to train ICSI practitioners, where clinics can be sure that the occyte is not in the process of fertilisation.
 
Failed to fertilise oocytes need not be regarded as an embryo under the terms of the Act if it can be established that the process of fertilisation has permanently halted. The HFEA has agreed that this can be established when a failed to fertilise oocyte is at least 48 hours old and there is no visible evidence of a pro-nucleus or of a second polar body.

Therefore manipulation of failed to fertilise oocytes should only be carried out:

• under a research licence; or
• where the failed to fertilise oocytes are at least 48 hours old and there is no visible evidence of a pro-nucleus or of a second polar body.

3. Late inspection papers

The late submission of inspection papers by licensed clinics disrupts the Authority's work, interferes with the smooth processing of licence applications from other clinics and may unduly delay papers being sent to inspectors prior to inspection of the clinic concerned. Clinics are strongly requested to submit licence applications by the required deadline.

4. Collection of data for the HFEA Register

All clinics should now be using the revised treatment forms HFEA (96) 1, 96 (2), and 96 (3) to report on licensed treatments and their outcomes. The Authority is required to collect the information provided on the treatment forms in an accurate and timely fashion. In the coming year, alongside the introduction of audits of clinics' records, the Authority will be looking at the adoption of measures to ensure that:

(a) treatment forms are completed accurately, so that they do not have to be returned for correction (a costly and time consuming exercise for both the Authority and clinic): and

(b) forms (96)1 and (96)2 are returned no later than 8 weeks after the treatment takes place (as specified on pages 100 and 105 of the Manual for Centres) and (96)3 forms are returned on the 15th day of each month (page 108, Manual for Centres).
 
5. Benefits in kind

My letter of 22 July 1996 (copy attached) explained the Authority's decision to remove payments to donors in the future including all benefits in kind that may currently be offered to donors. A date and programme for implementing the Authority's decision is under discussion, but one reason for an early announcement of this decision was to give clinics as much time as possible to prepare for the changes. The Authority hopes that clinics will use this transitional period to put into place strategies for recruiting unpaid donors.

Page last updated: 17 August 2012

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