Extension of Embryos Storage

Overview

Embryo freezing (cryopreservation) is the process of freezing and storing fertilized eggs for later use. It is frequently employed in reproductive procedures that result in embryos, such as in vitro fertilization (IVF). It can also help people maintain their fertility and become pregnant in the future. People undergoing cancer treatment or undergoing gender transition are two examples.

People in the United Kingdom are increasingly opting to freeze their gametes (eggs and sperm) and embryos. There are several causes for this, including: not being ready for a family but wanting to preserve fertility, cancer treatment that may affect fertility or because they are planning to transition or undergo gender re-assignment surgery.

According to the Human Fertilisation and Embryology Authority (HFEA), 37% of patients freezing their eggs in the UK in 2019 were under the age of 35, 53% were 35 to 40, and 12% were beyond 40.

The present embryo storage extension restrictions frequently limit women to two options. To freeze their most viable eggs in their 20s and utilize them to start a family in their 30s even if they are not ready; or to freeze their significantly less viable eggs in their 30s to create a family later in life, when treatments have a lower success rate. Some people opt to store their things abroad, which is expensive and, depending on the region, may lack regulatory controls.

 

Why Would You Store Your Embryo?

Embryo freezing is frequently performed following fertility procedures. In vitro fertilization (IVF) and intracytoplasmic sperm injection(ICSI) are two examples.

These procedures fertilize eggs with sperm and can result in additional embryos. If you have surplus embryos, you can freeze them and use them later if you:

• Postpone or cancel implantation into your uterus after an egg is already fertilized.
• Want to delay IVF to a later date.
• Want an option in case early attempts at fertility treatment fail.
• Choose to donate unused embryos to other people trying to get pregnant or to researchers rather than destroy them.

Embryo freezing is also utilized to preserve fertility. A woman or person designated female at birth (DFAB) with cancer, for example, may desire to store fertilized eggs before beginning chemotherapy or radiation therapy if the treatment may harm their capacity to get pregnant. A transgender man (transitioning to male) may also preserve eggs or embryos before beginning hormone therapy or undergoing gender affirmation surgery.

 

Advantages of Embryo Freezing & Storage

Embryo freezing can help people get pregnant later in life if they are facing current barriers, such as:

• Advancing age.
• Gender transition.
• Infertility issues.
• Social/personal reasons like if you’re pursuing higher level education or have professional demands and plan to delay pregnancy for several years.
• Treatment that may damage fertility (for example, chemotherapy or pelvic radiation therapy for cancer).
• Upcoming military deployment.
• Women without a partner may be concerned about advancing age and choose to either freeze eggs or embryos that they create with donor sperm.

 

Risks or Complications of This Procedure

Embryo storage does not increase the likelihood of congenital defects or health issues in subsequent pregnancies. In reality, frozen-thawed embryo outcomes study shows decreased rates of preterm delivery, low birth weight, growth limitation, and perinatal death.

The main risks associated with embryo cryopreservation are:

• Damage to embryos during the freezing process.
• Embryos that are not viable for freezing.
• Failure to get pregnant after embryos are thawed and implanted.
• Increased rates of medical issues in pregnancy like preeclampsia and placenta accrete spectrum.
• Multiple births if more than one embryo is implanted (twins or triplets).

 

Ethical Considerations Of Embryos Storage Issues

There are very complicated ethical and psychological concerns linked with embryo storage, donating, and allowing embryos to die. Many people, for example, have diverse ideas about when human existence starts. For some, life begins at conception, whereas for others, it begins at implantation or during fetal brain development. Some individuals believe that human life begins at birth, reflecting the belief that legal rights begin with the birth of a child.

These multiple views, as well as their fertility treatment experiences and outcomes, will influence how individuals approach end-of-life storage decisions.

Council is aware that many persons find it difficult to make a final decision about their stored embryos: some participants naturally believe that they have the right to choose how their embryos are managed. While Council respects and understands this viewpoint, storing embryos forever is not considered suitable by the legislature or Council.

The 2007 NHMRC Ethical Guidelines suggest that it is not preferable to retain embryos in storage permanently, and that licensees must have clear procedures limiting the period of embryo storage. Furthermore, the HRT Act requires that the future welfare of any child born as a consequence of an IVF or ART operation be adequately considered.

This has an impact on policy, such as the on-donation of embryos made using donor gametes. In on-donation, the possibility for genetic misunderstanding and the emotional impact on children born after donation must be evaluated against the possible gift that a donor embryo may represent. This, and many other considerations, underpin law, policy, and decision-making regarding end-of-life storage difficulties for embryos.

The primary legal and ethical principles underpinning the Embryo Storage Policy follow:

• In WA an embryo must not be stored for more than ten years except where this has been approved by Council.
• An embryo storage extension beyond a ten-year period may be granted by
• Council only if it considers there are special reasons for doing so in a
• particular case.
• The primary purpose of storage of an embryo must relate either to its probable future implantation or its probable future use under an NHMRC licence.
• Where storage is for probable future implantation, compliance with the IVF eligibility requirements of the HRT will be taken into consideration.
• The options for embryos in storage include:
• future use by the participants;
• donation to other eligible participants;
• donation to research as an excess ART embryo; and
• being allowed to succumb.
• Any extension to storage must only be in accordance with consent given by those with a right to consent.
• To facilitate participant decision-making about their embryos, ongoing communication between licensees and participants during the initial storage period outlining options and responsibilities will be important. Licensees will be required to undertake this communication, and ensure clinic policies incorporate counselling on embryo storage.

How Long Can Embryos Be Stored for? 

In the first instance, ten years. You can extend the storage duration if you have renewed your agreement to allow us to do so. There is no documented decline in the embryo's health over time.

Will the embryos survive the thawing process? As previously indicated, around 85% of the embryos will survive, and doctors will not know if they will survive until they are thawed.

How long does it take to thaw the embryo? Only a few minutes. Typically, embryos are removed from storage just a brief time before being replaced. After freezing, doctors may grow the embryos for a day or two to see whether they can develop further. This will be especially true if the embryos were fewer than four cells old when they were frozen.

How many embryos will be thawed? The single largest health risk connected with reproductive therapy is multiple births. Multiple births pose threats to both the mother's health and the health of the unborn babies. Twins and triplets are more likely to be born prematurely and with a lower birth weight. As a result, in the vast majority of situations, doctors will thaw a single embryo and examine its viability first (i.e. the number of cells which have survived from the original embryo). If the initial embryo does not survive the thaw, we will thaw more embryos. Some patients may be candidates for a second thaw and transfer during their FET cycle. In all cases, the number of embryos to be thawed will be discussed with you at the time of planning your treatment.

 

Time – Line For Licensee Information For Initial Storage Period

During an approved embryo storage term, licensees may transmit extra information to participants; for example, some licensees send biannual storage invoices. In this scenario, the suggested reminder letter below may be included at a convenient time for clinic practice. Clinics might choose to send these or create their own. Reminders should emphasize the necessity of participants supplying up-to-date contact information.

Information on embryos storage matters to be provided with initial IVF counselling. Storage payment fee letters should include reminders about responsibility to update contact details for both participants.

 

9 years of storage - reminder letter should be sent

This is intended to motivate people who are nearing the end of their ART therapy to evaluate all possibilities for their embryos. Those who may find it difficult to let any unused embryos die might consider donating them to other qualified participants or as extra ART embryos for research, so that the donation procedure can begin before the first storage time expires. Counselling may be useful for those who are unsure about their planned activities. Council has created an Embryo Storage Brochure to aid in the dissemination of relevant details.

 

9 3/4 years storage or 3 months prior to expiry - Notice to be sent.

Three months before the expiry of the authorised storage period, the licensee must take reasonable steps to notify participants of the impending expiry. This action is required by legislation, and aims to notify participants:

• of the impending expiry of the authorised storage period.
• that further instructions are being sought from the participants on how the embryo/s is to be dealt with.
• that the licensee is unable to keep an embryo for a period longer than the authorised storage period.
• where the authorised storage period was less than ten years, that effective consent to continue storage will be required.
• where the authorised storage period was for ten years and it is a 9 ¾ year notice, that participants are aware that they may apply to Council for an extension.
• that the licensee is required to provide assistance 
• that an extension to an embryo storage period may be granted where Council considers there are special reasons for doing so
• that supporting documentation (such as the inclusion of signed consent forms to donate) will assist Council in determining that the basis for approval.
• that Council is unable to approve an extension to the storage period once the authorised storage period has expired
• that if approval for a storage extension by Council is not received, it is a legislative requirement that the embryos be allowed to succumb.

An End of Storage Information Sheet (to be prepared by Council) is intended to aid participants who are unable to utilize, or do not plan to use or donate their embryos, but find it difficult to let their embryos die. It will outline choices for the process of allowing embryos to die, such as when a ceremony may be beneficial to participants. It will also urge people to seek counseling.

 

What Happens if I Do Not Renew My Consent to Storage at the Appropriate Time?

If you do not renew your storage consent, your embryos will be taken from storage and disposed of when they can no longer be stored legally.

You can withdraw your consent to storage if you do not want to renew your consent to storage or continue preserving your embryos. You must contact your clinic and complete the appropriate withdrawal of consent form. At this stage, you might want to think about giving the embryos you don't want to use for your own treatment for training or for use in someone else's treatment. You would need to discuss this with your clinic and get any necessary extra consents.

You can also consider donating your embryos for use in research, helping to increase knowledge about diseases and serious illnesses and potentially develop new treatments. Your clinic will need to give you more information about this and advise you whether this is an option for you.

 

What If I Change My Mind About Using or Donating Embryos?

Before the embryos are utilized in treatment or research, you, your partner, or the donor(s) (if applicable) can change or withdraw your permission at any time. If your partner withdraws their permission, your embryos will be unable to be utilized in therapy.

If one individual withdraws permission (either the egg donor or the sperm donor), there may be a 'cooling-off' period of up to a year. If your partner or the donor(s) do not want the embryos to be utilized beyond this period, they will be withdrawn from storage and allowed to die.

 

What Happens When I Want to Use Them?

The precise technique for utilizing your stored embryos differs according on your unique circumstances and the clinic.

The first steps are determined by whether or not you ovulate on a regular basis. If your periods are normal, your doctor may recommend that the embryo be transplanted to your womb without the use of fertility medicines. Ultrasound scans may be utilized in this scenario to examine the lining of your womb. Urine or blood tests may be done to determine whether you are ovulating (releasing an egg), indicating that the lining of your womb is ready to receive the embryo.

If your periods aren’t regular, or you don’t have them at all, your doctor may suggest using drugs to suppress your natural cycle and trigger a ‘false’ period. You are then given medication to help prepare the womb lining for an embryo.

When the timing’s right, the clinic’s embryologist (embryo specialist) will thaw your embryos and usually transfer one embryo to your womb (three embryos can be transferred in exceptional circumstances if you’re over 40).

 

Conclusion

Using cryopreservation, or embryo freezing, physicians can freeze and store unwanted embryos (fertilized eggs) developed through IVF, which may involve intracytoplasmic sperm injection (ICSI). The initial step in embryo storage is to freeze the embryos.

The frozen embryos are then preserved and thawed as needed for future use in IVF. This permits patients who are already undergoing IVF to save time and money on future cycles because a woman will not need to undergo multiple egg retrievals or take as many drugs.

If your embryos are not immediately utilized in therapy, you may want to keep them so that they can be used in the future. Embryos that will be kept are frozen. You must consider how long in the future you might desire or be able to use preserved embryos, as well as the possible expenses of storage. You should speak with your clinic about this.

You should be aware that embryos can only be stored with the permission of both you and the egg or sperm source. This might be your partner or a donor (if donor sperm or eggs have been used in your treatment).