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Dear Colleagues

We would like to know your comments or practice regarding the preservation service year (storage period) of cryo-embryos. To my knowledge, most of IVF centers would provide storage service for very long time if the patients would like to pay for it. While in our center, we have been used 56 MVE tanks for embryo preservation from the year of 2006. The place is so limited. So we plan to set the maximum time limit, 5 years for example, of the preservation service (exceptions special needs for some patients).

I will appreciate hearing any comments or publications as a reference for informed consent preparation.

Thank you very much in advance.

Xue Song guo
Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University School of Medicine.

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Answer by Norbert Gleicher

Space for cryopreservation is, indeed, becoming a problem for many IVF programs. The biggest problem in the U.S. are, however, "abandoned" embryos, which we, by consent, are entitled to discard, but are hesitant to discard anyhow. This does not appear to be the problem in China. I would, therefore, recommend to let the market place take care of the problem, and would only increase storage fees to create incentive for patients to either use their embryos or have them in other ways "resolved." For example, storage fees could be only increased after 3 years or 5 years.
The problem with absolute deadlines is that many patients will ignore them, and what to do then?
Best regards,

Norbert Gleicher, MD

Medical Director and Chief Scientist, The CHR
President, Foundation for Reproductive Medicine

Answer by Michael Alper

I think that 5-years is arbitrary since some patients need their embryos stored longer.

So, if Dr Xue Song Guo limits the time to 5 years then the patient or the IVF Center needs to find another institution to accept the embryos for patients who want longer storage. In the USA there are some companies that accept embryos for storage from IVF Centers but I am not sure if these options exist in China. If not, this would be a problem since it would be improper to discard embryos without a plan and the consent of the patient.

My question is that why does the IVF Center get more storage tanks to accommodate patients. There should not be a financial problem with this since patients typically would pay for the extended storage.

Michael Alper
Boston IVF

Answer by Ilan Tur-Kaspa

Couples or individuals with cryopreserved embryos express considerable concerns about the fate of their embryos. Most patients (65-87%) are likely to use frozen stored embryos for reproduction within 1-5 years, but some may do so up to 20 years later. A recent multi-institutional U.S. survey demonstrated that a large proportion of those certain they did not want a baby were very unlikely to choose the available options of thaw and discard (43%), reproductive donation (53%), freezing forever (64%), compassionate transfer (70%), or a disposal ceremony (60%).
Should we set a time limit for storage of cryopreserved embryos? Programs should create and enforce written policies on the designation, retention, and disposal of embryos. Xue Song Guo, from Shanghai Ninth People's Hospital, affiliated to Shanghai Jiao Tong University School of Medicine, is raising the question whether to set a maximum time limit, 5 years for example, for the embryos' preservation service. Since space is limited, then it seems reasonably, except for special cases, that once a couple has completed their family, within several years of trying, then all stored embryos would be disposed according to patients' instructions and the Center's policy. This was the logic of many IVF centers worldwide when they started to offer embryo freezing over 2 decades ago. During the years however, many programs did not dispose the stored embryos just because of the expired time limit, and some has embryos stored now for over 20 years. Part of the reason for it was the lack of specific written consents and directions by patients for disposition of the embryos, and due to legal uncertainty, most programs preferred to continue storage indefinitely. If a Center has written policies on the designation, retention, and disposal of embryos, then the risk of liability may to be low and acceptable, and disposal of embryos may be performed.
As long as patients continue their contact with the IVF center where their frozen embryos are stored, and continue paying for storage, then the Center has no ethical dilemma. Still, the practical dilemma of limited storage space exists. The most difficult situation is what to do with abandoned embryos. The Ethics Committee of the American Society for Reproductive Medicine (ASRM) has published in June 2013 a revised Opinion on this question. Again, they emphasized the importance of having program-specific policies. When in doubt, "embryos may ethically be consider to have been abandoned if: at least 5 years have passed since contact with an individual or couple, diligent efforts have been made to contact the individual or couple, and no written instruction from the couple exists concerning disposition". The ASRM Ethics Committee concluded that if a program reasonably determines under these standards that embryos have been abandoned, it is ethically acceptable to dispose these embryos by removal from storage and thawing without transfer. It is not ethically acceptable to use abandoned embryos for research or transfer them to another couple without prior written consent.

It seems that specific written consents and directions by patients for disposition of the embryos are needed. Professional societies are encouraged to set up national guidelines and detailed consents to ease the burden for all IVF centers offering embryo cryopreservation to patients undergoing modern ART treatment.

References
1. 1. Ethics Committee of the American Society for Reproductive Medicine. Disposition of abandoned embryos. A committee opinion. Fertil Steril 2013;99(7):1848-49.
2. 2. Lyerly AD, et al. Fertility patients' views about frozen embryo disposition: results of a multi-institutional U.S. survey. Fertil Steril 2010;93:499-509.
3. 3. Klock SC, Sheinin S, Kazer RR. The disposition of unused frozen embryos. N Engl J Med. 2001;345:69–70.
4. 4. Saunders DM, Bowman MC, Grierson A, Garner F. Frozen embryos: too cold to touch? The dilemma ten years on. Hum Reprod. 1995;10:3081–82.

Ilan Tur-Kaspa, MD
Founder and Medical Director,
Institute for Human Reproduction (IHR),
Professor, Dept. of Ob/Gyn, The University of Chicago,

Answer by Alain Chanson

In Switzerland, the medically assisted reproduction is regulated by a law:

http://www.admin.ch/opc/en/classified-compilation/20001938/index.html

It is forbidden to freeze embryos and only zygotes (at J1) can be cryopreserved.
A maximum of 3 embryos can be cultured and transferred.
Consequently, we freeze a lot of zygotes (a mean of 4 to 6 per OPU).
The maximum storage period is 5 years and the patients pay CHF 400.- the third, fourth and fifth years of freezing.
The only accepted reason to keep the zygotes more than 5 years is a lost of fertility by the female patient (cancer, etc.).
The 5 year period is appropriate for most of our patients, but a revision of the swiss law project to double this period.
The 5 year period is often too short for the patients when a first or even a second pregnancy has been obtained with the same OPU.
In conclusion, a period storage of 5 years seems appropriate for most of the patients, but the possibility to increase this period for special needs should remain open.

With my best regards,

Alain Chanson
Dr ès Sciences
Biologiste (ESHRE Senior Clinical Embryologist)
Laboratoire de Biologie de la Reproduction
Centre de Procréation Médicalement Assistée

Answer by Sherman J. Silber

Dear Xue,

we do it differently. we provide storage for as long as the patient wishes. many patients come back 10 or 15 years later to use their frozen embryos, eggs, sperm, or ovarian tissue. it is often that long before people are ready to use their frozen gametes. this does eventually lead to increased storage space, but we find this to be very modest compared to the income we gain from the storage fees, and so we can easily purchase more space. it gives our patients in the u.s. a greater sense of security to know that we will not discard their frozen material.

Sherman J. Silber, M.D.
Infertility Center of St. Louis

Answer by Yoshiharu Morimoto

Yes it is true. But if we set the time limit, we need to inform the limit time if it comes and to find somewhere to go for frozen embryos. It would be a complicated work. Maybe you had better set higher rate for further preservation and encourage patients to put them back.
Best wishes
Yoshiharu Morimoto

Yoshiharu Morimoto, MD,PhD
Professor
CEO & Chairman, IVF JAPAN GROUP
IVF NAMBA CLINIC

Answer by Adam Balen

Thank you for your interesting enquiry. From a biological perspective it appears to be safe and reasonable to continue cryo-storage of embryos and gametes indefinitely - or at least for the reproductive lifespan of your patients. From an ethical perspective it is essential to take appropriate, informed consent so that the patients are aware what you as a clinic are undertaking on their behalf and the proposed duration of storage. In the UK for example we are able to continue storage until the patient's 55th birthday. Some clinics charge an annual fee and will dispose of embryos/gametes if the fee is not paid (after appropriate reminders are sent out). From a practical point of view it can be easier to charge a fee for 3 or 5 years' storage to save on administrative costs. Similarly consent for storage in some cases may be 5 years and then the patients are asked to renew consent every 5 years, again to ensure that they remain in contact with clinic and confirm their wish for storage and possible use in the future.
kind regards

Adam Balen MD, DSc, FRCOG
Professor of Reproductive Medicine and Surgery,
Leeds Teaching Hospitals.
The Leeds Centre for Reproductive Medicine,
Seacroft Hospital,
Leeds LS14 6UH, U.K.

Answer by Peter R Brinsden

Dear Dr Xue,

Thank you for your interesting problem. We have a lot of freezer cannisters at Bourn Hall, but nothing like as many as you have!

In the United Kingdom, where we have a strict Regulatory Body called the Human Fertilisation and Embryology Authority (HFEA), we are allowed to store embryos for up to 10 years, after which there must be special reasons for continued storage on a yearly basis. I have attached the regular consent form created by the HFEA for use in UK clinics for your interest - this includes a section on the freezing and storage of embroys. This may be useful to you. Other consent forms can be seen on their website at www.hfea.gov.uk.

Our private patients pay a yearly sum to keep them in storage - about £150, but National Health Service patients do not pay. Our - and your, I am sure - biggest problem is keeping in touch with all the patients and also getting them to pay!! Our protocols etc. are in the freezing chapter of my Textbook, if it is of interest to you; this is now also printed in Chinese.

I am not sure if this is of any help, but I hope so.

Best wishes,

Peter

Peter R Brinsden MB BS FRCOG
Consultant Gynaecologist
Specialist in Reproductive Medicine
Group Medical Director, Bourn Hall International

Answer by Simon Fishel

We can sympathise with them. We take initial consent for 3 years and take consent and payment accordingly. Then they can extend on an annual basis which ensures that we maintain regular contact with couples and do not store unwanted material for extended periods. Regulation may differ but this is our situation. The consent issue is the driver under the HFEA, so we ensure that consent and billing is synchronous.

Prof. Simon Fishel
Managing Director - Professor of Human Reproduction
CARE Fertility Group

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