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ART POLICY GUIDELINES Laboratory Guidelines for 2008 (1st edition) Table of Contents Definitions Standards Liability Storage and Handling of Gametes and Embryos Research
People Involved in an Egg Sharing Arrangement
People Providing Gametes and Embryos for Donation
Preimplantation Intra-Cytoplasmic Sperm Injection (ICSI) Conceptus References 1. Definitions
ART encompasses a variety of clinical treatments and laboratory procedures which include the
handling of human oocytes, sperm, or embryos, with the intent of establishing a pregnancy. This
includes, but is not limited to, in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT),
zygote intrafallopian transfer (ZIFT), embryo biopsy, preimplantation genetic diagnosis (PGD),
embryo cryopreservation, oocyte or embryo donation, and gestational surrogacy.
2. General Standards 2.1 Personnel
High standards of integrity are required from those responsible for ART accredited activities – and
from those taking part in those activities – in order to:
• Protect the interests and privacy of people seeking treatment • Protect the interests and privacy of people considering donations • Guard against the misuse of gametes and embryos • Protect the welfare of couples and potential children born as a result of treatment and any
other children who may be affected by the birth.
There should be a backup system in place for all personnel essential to a program. A single
individual may fulfil the requirement for expertise in one or more areas. An ART program must
• A designated overall practice director, medical director, and laboratory director. One
individual may fulfil more than one of these positions, but the medical director must be a
registered sub-specialist in Reproductive Medicine (with HPCSA).
• An individual who is a sub-specialist in Reproductive Medicine with training and
experience in reproductive endocrinology, particularly in the use of ovulation-inducing
agents and hormonal control of the menstrual cycle.
• An individual with experience in oocyte retrieval techniques. • An individual with specialized training and experience in gynaecologic sonography who
provides the monitoring of follicular development.
• An individual experienced in male reproduction (andrology) with special competence in
• An embryology laboratory director with personal experience in the organization and
maintenance of a clinical embryology laboratory and in tissue culture techniques.
• Access to a mental health professional with expertise in reproductive issues. • An individual with specialized training and experience in gamete and embryo
cryopreservation techniques, when gamete and/or embryo cryopreservation is offered.
• An individual with specialized training in gamete biology and micro-operative techniques
or access to such an individual, if oocyte and/or embryo micro-operative techniques are
• Appropriate personnel to perform hormonal assays. An outside laboratory that has
demonstrated adequate competence, quality control, and service, may be used for rapid
assays of all the necessary reproductive hormones (including estradiol and
progesterone). Such hormone assays should be performed by a laboratory that meets
• An individual or consultant with specialized expertise in genetics or genetic counselling.
Where formal qualifications are insufficient, it is recommended that centres arrange for staff to
take part in scientific, clinical, nursing or counselling training.
The Person Responsible (i.e. the Medical Director) must ensure that proper equipment and
suitable practices are used in all service provision and support to patients.
If a centre decides to use outside facilities, the Person Responsible is expected to be satisfied
that those facilities are duly accredited.
Centres are expected to be fully aware of the microbiological hazards of handling gametes and
embryos and comply with regulations regarding waste disposal and infection control.
The location used for egg collection for in vitro fertilisation is expected to be as close as is
practical to the laboratory where fertilisation is to take place. The procedure room where
conscious sedation is used should have adequate monitoring and resuscitation equipment.
Facilities for the cryopreservation of gametes and embryos are expected to be:
• Customised, secure and dedicated; and • Adequate for the volume and types of activities to be carried out.
Appropriate emergency procedures are expected to be in place in all centres to respond to
damage to storage vessels, embryo incubators etc.
Written procedures are expected to provide for the safe use of straws and to minimise the risk of
Centres are expected to have written standard itemised operating procedures as follows:
• Freezing and thawing procedures • Location and duration of storage • Handling of contaminated samples.
Centres are expected to also take steps to minimise risks arising from the transfer of material
Centres with storage facilities are expected to provide secure, controlled access to gametes and
Maintaining and Improving Standards
Centres are expected to establish an effective system for monitoring and assessing laboratory
Centres are expected to establish procedures for improving and updating laboratory practice.
Centres may wish to circulate information about the variety of treatments they offer. Publicity
materials are expected to conform to the guidelines of the HPCSA. Publicity materials are
expected to also be designed and written with regard to the particularly sensitive issues involved
Liability / Errors 3.1 Conscientious Objection
Prospective employees at an accredited centre are expected to be provided with full descriptions
3.2 Adverse Incidents
Each treatment centre is expected to have a written policy and procedure for dealing with adverse
Adverse incidents are defined as any event, circumstance, activity or action which has caused, or
has been identified as potentially causing harm, loss or damage to patients, their embryos and/or
gametes, or to staff of an accredited centre.
Where an adverse incident has occurred, centres are expected to:
• Review relevant procedures in order to minimise the risk of any reoccurrence of the
Storage and Handling of Gametes and Embryos 4.1 General Obligations
Treatment centres are expected to ensure that the highest possible standards are maintained in
the storage and handling of gametes and embryos.
All patients placing gametes, embryos and ovarian or testicular tissue in storage are expected to
be screened for Hepatitis B, Hepatitis C and HIV.
It is expected that screened samples will be kept in a separate cryostore from unscreened
• Any samples stored before comprehensive screening of all patients was introduced; and • Any samples in temporary storage while the results of screening test are obtained.
It is expected that gametes and embryos will be stored in a designated security area with
The Medical Director is expected to permit access to the designated security area only to the
treatment centre’s named individuals for whom access is essential in the course of their work. No
other people are expected to have access to gametes and embryos.
In order to minimise the amount of handling required in retrieving gametes and embryos, their
storage location is expected to be recorded in detail. Each and every occasion when gametes or
embryos are handled is expected to be recorded.
There is expected to be an effective monitoring system to ensure high standards of security
wherever gametes and embryos are handled or stored.
The sources of gametes and embryo are expected to be accurately recorded and labelled in a
way that is not susceptible to unauthorised or undetectable alteration.
Records are expected to enable authorised staff to trace what happens to an individual embryo,
egg or sperm sample from the date of collection. This also applies to fresh embryos and frozen
Storage centres are expected to carry out reviews, at least annually, of the status of stored
gametes and embryos. The purposes of these reviews are expected to be:
• To reconcile the centre’s records with the genetic material stored; and • To review the purpose and duration of storage; and • To identify action that needs to be taken.
Storage centres are expected to endeavour to maintain contact with the providers of stored
gametes and embryos to inform them when the terminal storage date for their gametes and
embryos is approaching as agreed by mutual consensus. Centres are expected to inform
providers of the importance of keeping the centres informed of a change in contact details.
It is expected that gametes and embryos intended for treatment will not be placed in close
proximity to radioactive material or any known potential source of infection, chemical or
Transfer of Gametes and Embryos
Where gametes or embryos are transferred between sites, adequate arrangements are expected
to be made to protect their quality and security. All storage, treatment and research centres are
expected to operate a fail-safe mechanism to ensure that correct gametes and embryos are
5. Research 5.1 General Standards
Research projects in ART should be approved by the relevant bona fide Research Ethics
Committee and in accordance with the National Health Act.
6. Records 6.2 Confidentiality
Centres must ensure that information provided in confidence is kept confidential and only
disclosed in the circumstances permitted by law. It is expected that patients will not have access
to any other person’s records (including those of a patient’s spouse or partner) without that other
Access to Health Records
Centres are expected to establish written procedures for considering applications for access to
Centres are expected to allow all donors and clients who provide information about themselves to
the centre access to the record of that information and an opportunity to correct it.
Certain points are yet to be debated and finalized in these guidelines. Areas with question marks
will be finalized once opinions are heard from SASRSS members”
Use of Gametes and Embryos Obtaining Gametes and Embryos
Centres may only import and export gametes and embryos in accordance with the regulations in
It is expected that eggs, sperm or embryos created from the patient/s will not be used for
treatment where there are reasonable grounds for believing that procedures to which the eggs or
sperm have been subject carry an actual, or reasonable theoretical risk of harm to their
Similarly, it is expected that embryos will not be used for treatment where there are reasonable
grounds for believing that procedures to which the embryos themselves have been subject carry
an actual or a reasonable theoretical risk of harm to their development, or a theoretical risk of
It is expected that attempts to produce embryos in vitro will not be made unless there is an
intention to store or use the resulting embryos(s) or unless there is a specific reason why it is
necessary to do so in connection with the provision of treatment services for a particular woman.
• It is expected that the reason will be explained to the woman • It is expected that counselling relating to the implications of the treatment is offered to her • The written consent of each person providing the gametes must have been obtained.
Frozen embryo transfer is a regulated activity. Where a woman has had an embryo stored and
subsequently wishes to have treatment transferring the embryos to her, the treatment centre
• Consider her for treatment in the usual manner • Check that the treatment is in accordance with the terms of the consent given by both
It is expected that gametes or embryos that have been exposed to a material risk of
contamination and which might cause harm to recipients or to resulting children will not to be
used for treatment. If in any doubt about these risks, treatment centres are expected to seek
• ??Select the sex of embryos for social reasons (to be debated or discussed further by
Termination and Disposal
Where consent to continued storage has been withdrawn by only one gamete provider, centres
are expected to take steps to ensure that the other gamete provider (unless that person is a
donor) is informed of the centre’s obligation to dispose of the embryos. Where the
women/partner to be treated is not one of the gamete providers, the centre is expected to take
similar steps to ensure that she is informed of the obligation to dispose of the embryos.
People Seeking Treatment
It is recommended that sperm is produced at the accredited facility. In the event that the sperm
sample is produced outside of the facility, this should be documented as such.
Transfer of Eggs and Embryos
It is recommended that women will not be treated with gametes, or with embryos derived from
gametes, of more than one man or woman during any treatment cycle.
In all cases it is expected that the appropriate number of eggs or embryos to be transferred, and
the reasons for this (Including the risks of multiple pregnancy) will be assessed and discussed
with the woman and her partner and her consent placed in the medical records.
Use of patient’s own egg or embryos (fresh or frozen) 7.6 Donor Insemination
Before commencing treatment by donor insemination, the treatment centre is expected to discuss
with the patient the number of treatment cycles to be attempted in the event of failure to conceive,
before further investigation takes place and thereafter, and review this situation at regular
People Providing Gametes and Embryos for Donation
If embryo donation is being considered where an embryo has been created using partner sperm
produced at home, the treatment centre must take that fact into consideration.
Where a donor of gametes or embryos has, as a result of such donations achieved the maximum
limit of live births as prescribed by the National Health Act, it is expected that the donor’s gametes
or embryos will not be used on a subsequent occasion (for deliberation by SASRSS).
A ‘live birth event’ is the birth of a live child or children. This means that the birth of twins or
triplets is expected to be considered a single ‘live birth event’ (for deliberation by SASRSS).
- Issues of siblings, and frozen embryos (for deliberation by SASRSS)
Gametes from donors who have reached the maximum number of live birth events should not be
exported. The export of gametes should be done in accordance with the regulations of the
Insemination of a woman at an accredited treatment centre using her late husband or partner’s
sperm is regulated under the National Health Act.
Intra-Cytoplasmic Sperm Injection (ICSI) 9.2 Definitions
ICSI is the type of IVF treatment that involves the injection of a single sperm straight into an egg.
The ICSI practitioner is defined as the person who injects the spermatozoon into the egg. An ICSI
practitioner should fulfil the requirements as per the SASRSS accreditation guidelines.
Compilation of these guidelines
These guidelines were modelled on the “HFEA. Code of Practice. 6th Edition” and adapted for
South African practitioners in the Sub-Speciality of Reproductive Medicine.
Certain points are yet to be debated and finalized in these guidelines. Areas with question marks
will be finalized once opinions are heard from SASRSS members
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