What is embryo cryopreservation?
Successfully fertilised eggs are referred to as embryo(s). As a result of IVF, multiple eggs may be recovered and fertilised. In terms of the law, the number of fresh embryo(s) that may be transferred is limited to a maximum of three (3) embryo(s). If multiple fertilised eggs (embryo(s)) are produced during an IVF cycle, some of these embryo(s) may be frozen and stored. This reduces the risk of multiple births while creating opportunities for future pregnancy by transfer of frozen/thawed embryo(s), sometimes avoiding additional egg retrieval procedures.
To be stored, embryo(s) are frozen or ‘vitrified’ and stored on the clinic’s premises in a Cryotech freezing device, which can hold a maximum of 2 embryo(s) per device. Standard practice in the laboratory is to freeze two (2) embryo(s) per device to minimise device costs. However, you can elect to freeze embryo(s) individually (1 per device) to facilitate future single embryo transfer and the thawing of one embryo at a time.
Who should fill in a consent to cryopreservation?
Patients must fill in this form when they are having fertility treatment using embryo(s) created outside of the body (in vitro), this may be in vitro fertilisation (IVF) or intra-cytoplasmic sperm injection (ICSI) regardless of whether you are using your partner’s gametes/ a known donor/ anonymous donor, and you want any excess embryo(s) after treatment cryopreserved and stored at the clinic for later use.
Why do I/we have to fill in this form? Do I/we need to provide our written consent to cryopreservation?
In terms of regulation 10 of the Regulations: Artificial Fertilisation of Persons (GNR. 175 of 2 March 2012), should you and your partner (if any) not provide your written consent, your doctor is obligated to destroy any embryo(s) that are left over after your procedure, if you conceive a child or you decide not to proceed with the embryo transfer. As such, you and your partner (if any) need to give your written consent to the clinic and/or lab freezing any excess embryo(s) for a further period.
Any frozen embryo(s) are subject to you and your partner’s (if any) joint disposition and therefore all decisions about their disposal must be made in writing and made jointly (if you have a partner).
Both you and/or your partner must provide your written consent to cryopreservation and this consent can be withdrawn at any time, by either of you. Should this be the case, you and/or your partner will be required to provide the clinic and your doctor with a formal written withdrawal of your consent to the continued storage.
Who decides whether to freeze any excess embryo(s)?
The decision, as to whether to freeze or not, is made by the laboratory staff (embryologist) and is only made on day 5 or 6 of embryo culture and will be communicated to you on the day. The laboratory will only freeze excess embryo(s) from the treatment cycle if the embryo(s) are of suitable quality for cryopreservation. There is no guarantee that embryo(s) will be of suitable quality and/or that freezing will take place in an IVF cycle.
Who owns the frozen embryo(s)?
Any excess embryo(s) will be stored in your name, together with that of your partner (if any) and will therefore require your joint written consent to use. Specifics relating to ownership in and disposition of the stored embryo(s) should be recorded in an Embryo Disposition Agreement.
How long can the embryo(s) be stored?
When considering how long to store for, you may want to think about how far in the future you might want to be able to use your stored embryo(s) and the costs of storing them. Should you decide to freeze and store your embryo(s), you need to be aware that should your embryo(s) remain unclaimed for a period of 10 years, your doctor and/or clinic is obligated to destroy them. Storage fees are ordinarily paid annually in advance. These storage fees will be amended annually, and the clinic will communicate this to you.
Do I/we have any guarantee that the freezing process will be a success?
There is no guarantee, and the clinic accordingly does not warrant, that the embryo(s) will survive the freezing/thawing process or that a successful/viable pregnancy will occur thereafter.
What are the practicalities of cryopreservation?
The practicalities of storage are specified in this document, specifically those issues such as:
- you and your partner’s (if any) contact details;
- marital status;
- the number of embryo(s) per storage device;
- period of storage and any extension thereof;
- processes, procedures and equipment; and
- embryo disposition.
You must consider them carefully and make sure you are aware of what the consequences of your choices are.
Can I speak to someone about this procedure?
Should you wish to be provided with an opportunity to have counselling, in relation to your treatment and storage of your excess embryo(s), then please request the details of a psychologist, who specialises in fertility counselling, from the clinic.
What is an Embryo Disposition Agreement?
An Embryo Disposition Agreement is a written agreement and declaration, entered into between you and your partner, or just you (if single), which specifically regulates and records issues relating to ownership and disposition of your embryo(s). In particular, the agreement and declaration will record what you would like to happen to your embryo(s) if:
- you or your partner were to pass away;
- you and your partner were to get divorced/ separated;
- you or your partner withdraw your consent to be part of the IVF program;
- you fail to renew your storage agreement or fail to make payment of your storage fees;
- you (recipient) reach the age of 55 years old (SASREG National Guide Limits); or
- you or your partner become incapacitated (mentally / physically) and lose the ability to decide for yourself.
It is advised that your wishes, with regards to the future use of the frozen embryo(s), are recorded in an Embryo Disposition Agreement. The reason for this is that in circumstances where you do not have an Embryo Disposition Agreement in place, and you or your partner are no longer able to provide your consent, you and/or your partner will NOT be able to use or have the embryo(s) transferred prior to a court order being obtained.
The clinic will continue to store the embryo(s) until such time as a court order, or suitable settlement agreement, is provided to the clinic. Until the clinic receives the Court Order/ Agreement you both will be equally liable for the storage costs.
While this is perhaps not something you have considered, you and your partner (if any) need to record your wishes on how your embryo(s) are to be used. This must be recorded in a formal written agreement signed by you and your partner (if any). It is therefore recommended that this additional legal step be taken and that you enter into an Embryo Disposition Agreement. You can think of this as an ‘ante-nuptial’ contract for artificial fertilisation.
What if I/we want to donate my/our embryo(s)?
Unused embryo(s) can also be donated to a specific person or an unspecified person (anonymous donation), other than your partner. You can also donate your unused embryo(s) to the clinic for research purposes, therefore helping to increase knowledge about diseases and serious illnesses and potential development of new treatments. Any donation that you would like to make will be recorded in your Embryo Disposition Agreement.
Who will assist me with an Embryo Disposition Agreement?
Should you wish to enter into an Embryo Disposition Agreement, an attorney specialising in Fertility Law, will assist you with the drafting and finalisation thereof. The details of such an attorney can be obtained from the clinic.
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