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02 January 1996

To: Persons Responsible at Licensed Centres; HFEA Inspectors

Dear Colleague

Proposed changes to HFEA forms 91(1), 91 (2) and 91(3)

The HFEA is currently reviewing the forms used by centres to report IVF and donor insemination treatments and pregnancy outcomes and has concluded that forms (91)1, (91)2 and 91(3) respectively need to be revised. I am writing to give you some information about the changes which are proposed.

The aim of the review is to ensure that the register of information continues to record data that are up to date, allow effective monitoring of licensed treatments and provide information that will be of interest to patients and practitioners. To achieve this, the revised IVF treatment form, (96)1, will collect new information about micromanipulation, type of ovarian stimulation and reason for abandoning the treatment cycle. The revised donor insemination form, (96)2, has been extended to record type of insemination and type of ovarian stimulation. The outcome form, (96)3, now additionally records embryo reduction.

The new forms are to be piloted in a number of centres during January and the final versions will be sent to centres in early March, for use by all centres from 1 April 1996. Copies are attached, together with the instructions for completing them. We would welcome any comments you have on the content, layout and wording of the forms and also on the instructions. Please let Joanna Thompson at the Authority have these by 31 January 1996.

We look forward to hearing from you.

Yours sincerely

Flora Goldhill
Chief Executive

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GUIDANCE NOTES ON COMPLETING HFEA FORMS

IVF TREATMENT CYCLE FORM (HFEA Register (96)1)

Introduction

The Human Fertilisation and Embryology Authority is required by law to keep information on its register about IVF treatment of individual patients. An IVF treatment cycle form must be completed for each IVF treatment cycle for each woman whether or not the cycle is abandoned at any stage before embryo transfer.

A treatment cycle begins:

• if fresh embryos are to be used, with the administration of drugs for the purpose of superovulation, or if no such drugs are used, with the collection of egg(s) or any attempt to collect them;
• if stored embryos are used when they are taken out of storage to be replaced.

A treatment cycle ends when it is established whether or not a clinical pregnancy has resulted. A clinical pregnancy is defined for these purposes as a fetal heart on ultrasound.

A copy of the form must be sent to the HFEA no later than 8 weeks after the date of transfer of the embryo(s) to the woman, or if the cycle was abandoned before then, no later than one week after the cycle was abandoned. Centres must keep a duplicate copy for their own records.

The forms are supplied in orange pads requiring no carbon. Guidance notes are provided below to assist centres in completing the IVF treatment cycle form. The forms should be completed in ball point pen, or typed. The numbers in the guidance notes correspond to items on the form.

Guidance Notes.

1(a). HFEA centre reference number. This is the unique number issued to each centre by the HFEA as soon as it receives their initial licence application. This number must be included on all forms returned to the HFEA.

1(b). Patient's clinic record number. This is the number used in centres1 own records and is required by the HFEA to link outcome forms with the correct treatment cycle forms. Each patient should have one unique record number which should be quoted in all correspondence with the HFEA.

1(c). Name of centre where treatment started, if different. This is the HFEA centre number of the centre in which treatment started in cases where the IVF procedure took place at a different centre, i.e. the centre number of the satellite centre in Transport IVF. If the centre is not a licensed centre please fill in the centre's name.

2. Full name of patient. Maiden name or any other name by which she is/ has been known etc. The Act requires that the Authority keeps identifying information about patients (See note on confidentiality). The other name may be a previous married surname, for example.

2(e). UK postcode. If the patient is a UK resident, the first three characters only of the postcode should be recorded as part of the identifying information about patients.

3. Name of Husband/male partner. This is required to help establish the legal father of a resulting child.

Note. A husband is assumed in law to be the legal father of a child born following treatment unless he can prove that he did not consent to his wife's treatment. A male partner who is not married to the woman receiving treatment is the legal father of a child born following treatment sendees provided for him and a woman treated together (section 28 of the Human Fertilisation and Embryology Act 1990).

3(d). If a male partner is named at 3a These details about a male partner who is not married to the woman receiving treatment are to help establish that the couple were treated together (See note at 3 above).

4. Sperm/egg/embryo donor's clinic reference code (if applicable). The IVF treatment may involve donated sperm, eggs or embryos. These details are required in order to establish the genetic parents of any resulting child, and make any necessary links with donor information. The donor's clinic reference code is that given to the donor when he/she provides gametes at a treatment centre or sperm bank. If the treatment involves donated embryos the clinic reference codes of the man providing the sperm and the woman providing the eggs must be complete in section 4a and 4b respectively.

4(d). Donor's centre reference numbers). If the donor gametes or embryos used in this cycle were supplied to the treatment centre by a sperm bank or other licensed centre, give the HFEA reference code of the centre where the donations were made.

5. Infertility. Each part of the question must be completed. Tick the appropriate boxes.

Female
 1°  Primary infertility is defined as never having been pregnant.
 2°  Secondary infertility is defined as where the woman has previously been pregnant, irrespective of the outcome.

Male
 1°  Primary infertility is defined as never having made a woman pregnant.
 2°  Secondary infertility is defined as having previously made a woman pregnant.

Couple
 1°  Primary infertility is when a pregnancy has not been started by the couple together.
 2°  Secondary infertility is where the couple have previously started a pregnancy together.

Example If the woman has had a previous pregnancy, her infertility is secondary; if the man has not made a woman pregnant his infertility is primary. The couple therefore have primary infertility because they have not started a pregnancy together.

6. Female and male factors for infertility: Other(describe). Please describe any other reasons for treatment here.

8. Duration of infertility. If the male or female partner has had unprotected intercourse for 10 years without achieving a live birth but had achieved pregnancy 2 years ago by assisted conception, total infertility will be 120 months and infertility since last pregnancy will be 2 years for that partner. The duration of infertility may be different for each partner if either have achieved a pregnancy with a different partner If the IVF treatment is given because of a genetic disorder in a partner or the treatment is a surrogacy cycle, this question will not apply.

9(a). Number of previous IVF cycles: in total. Record here the total number of IW treatment cycles undertaken by the male and the female partner at this and any other centre before the current cycle. This may be different for each partner if either have had treatment with a different partner.

9(b). Number of previous IVF cycles at this clinic. This is the total number of IW treatment cycles undertaken by the male or female partner at this centre before the current cycle This may be different for each partner if either have had treatment with a different partner.

10. Type of treatment. Record here the type of treatment undertaken. More than one box may be ticked if for example it was a frozen embryo replacement (FER) using embryos created by intra cytoplasmic sperm injection (ICSI) or transport IVF involving ICSI.

10(b). Clinical trial. If the treatment cycle is part of a clinical trial this should be recorded in this section.

11. Type of stimulation. If no stimulation was used because it was a natural cycle or a frozen embryo replacement please tick the box 'Natural cycle.' If ovarian stimulation drugs had been used in this treatment cycle, please tick the appropriate box or write the name of the type of stimulation, not specific product names, in 'other'.

12. Number of embryos developed. Fertilisation is achieved when there is visible evidence in the eggs of pronuclei or cleavage. Give the total number, including those to be stored or donated.

13. Treatment cycle abandoned. If the treatment cycle is abandoned, the form must be completed as far as possible and returned to the HFEA.

14. Reason for abandoning the treatment cycle. Please specify the reason the cycle was abandoned by ticking one of the boxes or writing an explanation under 'other'.

15. Date of embryo transfer or date when cycle abandoned. Give the date the embryo(s) were placed in the woman or the date on which treatment was abandoned.

16. Number of embryo replaced. Please fill in the number of embryos replaced against the correct description of the type of embryo. It may be necessary to fill in more than one box in this section. For example if 2 embryos were replaced that were frozen/thawed ICSI embryos then fill in '2' under 'Frozen thawed' and '2' under 'Developed from ICSI.

Embryos replaced in a woman in a single treatment cycle must be produced either from husband/partner's sperm or from a donor's sperm, but not from both. This is essential in order to establish the genetic father of a resulting child, and make any necessary links with donor information. In addition embryos created by micromanipulation must not be replaced with any other embryos in the same treatment cycle. (See the directions in the letter Ref: CE(95)1 from the Chief Executive on 18 July 1995).

18. Clinical Pregnancy. Tick 'yes' if a fetal heart is present. If yes an HFEA outcome form must be completed.

Ectopic pregnancy, blighted ovum and missed abortion should be recorded here according to the following definitions:

Ectopic pregnancy  A pregnancy in which implantation of the blastocyst and subsequent development occur outside the uterine cavity.

Blighted Ovum  A small fluid filled sac in which the foetus is completely absent or with small amounts of amorphous tissue where the fetes is usually located.

Missed Abortion  Prolonged retention of the products of conception after the fetus has died in utero.

If these outcomes are recorded on the treatment form it is not necessary to complete an HFEA outcome form.

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DI/DONOR GAMETE TREATMENT CYCLE FORM (HFEA Register (96)2)

Introduction

The Human Fertilisation and Embryology Authority is required by law to keep information on its register about any treatment services in which donor gametes are used. Donor insemination or GIFT using donated eggs or sperm must be recorded on this form. For centres' convenience, space is provided to record information about up to three DI or GIFT cycles. The three cycles recorded should not cover a period of more than four months. This means that if patients leave a gap of more than one month in a series of treatments, a new form should be started. Centres must return the top copy of the form to the HFEA within 8 weeks of the end of the last treatment cycle recorded on the form and keep a duplicate copy for their own records. The forms are supplied in green pads requiring no carbon. Guidance notes are provided below to assist centres in completing the DI treatment cycle form. The forms should be completed in ball point pen or typed. Numbers in the guidance notes correspond to items on the form.

Guidance Notes

1. HFEA centre reference number. This is the unique number issued to each licensed centre by the HFEA. This number must be included on all forms returned to the HFEA.

2. Patient's clinic record number. This is the number used in centres' own records and is required by the HFEA to link outcome forms with thecorrect treatment cycle forms. Each patient should have one unique record number which should be quoted in all correspondence with the HFEA.

2(e). UK postcode. If the patient is a UK resident, the first three characters only of the postcode should be recorded as part of the identifying information about patients.

3(a). Full name of patient. Maiden name or any other name by which she is/ has been known etc. The Act requires that the Authority keeps identifying information about patients (See note on confidentiality). The other name may be the woman's surname from a previous marriage.

(b). Name of Husband/male partner. This is required to help establish the legal father of a resulting child.

Note. A husband is assumed in law to be the legal father of a child born following treatment unless he can prove that he did not consent to his wife's treatment. A male partner who is not married to the woman receiving treatment is the legal father of a child born following treatment services provided for him and a woman treated together (section 28 of the Human Fertilisation and Embryology Act 1990).
 
4. If a male partner is named at 3...... These details about a male partner who is not married to the woman receiving treatment are to help establish that the couple were treated together (See note at 3(b) above).

6. Male factor for infertility: Other(describe). Please describe any other reasons for treatment here.

8. Duration of infertility. If the male or female partner has had unprotected intercourse for 10 years without achieving a live birth but had achieved pregnancy 2 years ago by assisted conception, total infertility will be 120 months and infertility since last pregnancy will be 2 years for that partner. The duration of infertility may be different for each partner if either have achieved a pregnancy with a different partner If the DI treatment is given because of a genetic disorder in a partner this question will not apply.

Note. Items 1-8 are fixed information about the patient. Space is provided at items 9-13 to record details of up to 3 successive DI treatment cycles. These should not cover a period of more than 4 months.

9(a). Number of previous DI cycles: in total. Record here the total number of DI treatment cycles undertaken at this and any other centre before the current cycle.

Number of previous DI cycles at this clinic. This is the total number of DI treatment cycles undertaken at this centre before the current cycle.

10. Donor's clinic reference code. This is the reference code given to the donor when he or she makes a donation at a treatment centre or sperm bank.

11. Donor's centre reference number(s). If the donor gametes used in this cycle were supplied to the treatment centre by a sperm bank or storage centre, give the HFEA reference code of the centre where the donations were made.

12. Type of treatment. Tick the box that describes the method of insemination or describe any other type of treatment.

13. Type of Ovulation Induction. If no stimulation was used please tick 'Natural cycle.' If ovarian stimulation drugs have been used please tick the appropriate box or write the name of the type of stimulation, not specific product names, in 'other'.

18. Clinical Pregnancy. Tick 'yes' if a fetal heart is present. If yes an HFEA outcome form must be completed.

Ectopic pregnancy, blighted ovum and missed abortion should be recorded here according to the following definitions:

Ectopic pregnancy   A pregnancy in which implantation of the blastocyst and subsequent development occur outside the uterine cavity.

Blighted Ovum   A small fluid filled sac in which the foetus is completely absent or with small amounts of amorphous tissue where the fetes is usually located.

Missed Abortion   Prolonged retention of the products of conception after the fetus has died in utero.

If these outcomes are recorded on the treatment form it is not necessary to complete an HFEA outcome form.

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OUTCOME FORM (HFEA Register (96)3)

Introduction

The Human Fertilisation and Embryology Authority is required by law to keep information on its register about the outcomes of treatment services given to individual patients. The outcome of every clinical pregnancy achieved through IW or other treatment using donor gametes must be recorded on an outcome form. Centres must return the top copy of completed outcome forms to the HFEA on the 15th day of every month. If the 15th falls on a weekend, the forms should be returned on the following Monday. Centres must keep a duplicate copy for their own records. The forms are supplied in purple pads requiring no carbon. Guidance notes are provided below to assist centres in completing the outcome form. The forms should be completed in ball point pen, or typed. The numbers in the guidance notes correspond to items on the form.

Guidance Notes

l(a). HFEA centre reference number. This number will be issued to centres by the HFEA as soon as it receives their initial licence application. This number must be included on all forms returned to the HFEA.

l(b). Patient's clinic record number. This is the number used in centres1 own records and is required by the HFEA to link outcome forms with the correct treatment cycle forms. Each patient should have one unique record number which should be quoted in all correspondence with the HFEA.

2(a). Full name of patient. Maiden name or any other name by which she is/ has been known etc. The Act requires that the Authority keeps identifying information about patients. Other names may be surnames from previous marriages.

3. Name of Husband/male partner. This is required to help establish the legal father of a resulting child.

Note. A husband is assumed in law to be the legal father of a child born following treatment unless he can prove that he did not consent to his wife's treatment. A male partner who is not married to the woman receiving treatment is the legal father of a child bom following treatment services provided for him and a woman treated together (section 28 of the Human Fertilisation and Embryology Act 1990).

4(a). Donor's clinic reference code. This is the reference code given to the donor when he makes a donation at a treatment centre or sperm bank.

4(b). Donor's centre reference number(s). If the donor gametes used in this cycle were supplied to the treatment centre by a sperm bank or storage centre, give the HFEA reference code of the centre where the donations were made.

5. Date of embryo transfer or dates of donor insemination treatment. The date of any embryo transfer, transfer of donor gametes or insemination using donor sperm should be given here. In the case of donor insemination, more than one date may be recorded in one treatment cycle. Give all dates.

6. Number of gestational sacs. Please fill in the number of gestational sacs in which a fetal heart beat has been detected.

7. Pregnancy outcomes. Tick the appropriate pregnancy outcome for each of the gestational sacs.

8. Babies born. Please complete each section to provide information about each baby.

9. Congenital abnormalities. If any congenital abnormality is present, please describe.

Page last updated: 24 August 2012

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