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The UK´s anomalous 10-year limit on oocyte storage: time to change the law

      Abstract

      There has been a growing recognition in the UK that the statutory storage limit for frozen eggs, which currently stands at 10 years, requires a review. The UK regulator, the Human Fertilization and Embryology Authority (HFEA), has recognized the problem and the Equality and Human Rights Commission is also sympathetic with the demand to change the current legislation. There is also strong desire on the part of assisted reproductive technology (ART) professionals and patients to change the current guidelines. For many women, the available alternatives of transporting their eggs to an overseas destination or having them fertilized with donor sperm and then stored as embryos is objectionable.

      Keywords

      There has been an active campaign in Britain for the past 2 years to extend the statutory storage time for oocytes beyond 10 years, its current threshold (
      Petitions
      Extend the 10-year storage limit on egg freezing.
      ). The limit was introduced in the UK’s Human Fertilization and Embryology Act of 1990, at a time when slow-freezing methods were not providing comprehensively good survival rates and, it was thought, a 10-year window would be adequate for most women contemplating oocyte cryopreservation ().
      However, a 2008 amendment to the 1990 Act does allow women ‘likely to become prematurely infertile’ (as with the potential destruction of their ovarian function through chemotherapy or radiotherapy) – to extend storage of their eggs for further periods of 10 years and up to 55 years total, subject to the opinion of a registered medical practitioner (

      Human Fertilization and Embryology Authority Regulations (2009): Statutory Storage Period for Embryos and Gametes Regulations 2009)

      ,
      Human Fertilization and Embryology Authority
      Directions given under the HFEA Act 1990 (as amended): Import and Export of gametes and embryos (16 April 2018).
      ). It seems something of a paradox, therefore, that if a young woman wishes to freeze her eggs for social (and not medical) reasons at a time of her maximum fertility she is limited to a 10-year period, and even more paradoxical that today we have a successful freezing technology in vitrification and that social freezing, as an insurance policy against age-related infertility, has become popular. We are rapidly approaching a time when these women, mostly now in their late 30s and early 40s, face the prospect of having their eggs destroyed because of the anachronistic rules imposed by Parliament.
      This anomaly was highlighted in 2016 when it was proposed that the statutory time limits imposed on the storage of gametes in the UK could ‘have unintended and perhaps even perverse consequences for women freezing their eggs as insurance against age-related fertility decline’ (
      • Jackson E.
      ‘Social’ egg freezing and the UK’s statutory storage time limits.
      ). The author of the report, a Professor of Law at the London School of Economics, emphasized that ‘the optimum time to freeze one’s eggs, from a clinical point of view, would be during a woman’s teens or 20s’. Emphasis here was specifically on ‘social’ indications for fertility preservation.
      In late 2017, MP Tonia Antoniazzi made a request to the UK Parliament that legislation be introduced to extend the egg storage limit to 55 years without any medical indication or practitioner opinion. However, the Minister of Health in a written reply said that there were no plans to change the law at present ().
      The thrust of the UK campaign, therefore, is with oocyte storage for social indications and with the argument that 10 years is too short a time for ‘healthy young women wanting to preserve their opportunities to conceive later in life’ (
      • Harper J.
      • Baldwin K.
      • Van de Wiel L.
      • Boivin J.
      Campaign for UK Parliament to extend the 10-year storage limit on egg freezing.
      ). There are two further arguments behind the campaign: first, that there is an inequality of human rights in the provision of statutory male and female gamete storage times; and second, that vitrification as a preservation technology has enhanced cryopreservation such that vitrified oocytes now have the same clinical viability as fresh ones.
      The question of gender discrimination is not so much about the legislation itself as about the impact it has on men and women choosing to store gametes. As with women, men storing sperm are subject to the same 10-year storage limit as women, with similarly allowed 10-year extension periods subject to medical indication and opinion. Thus, a registered medical practitioner must certify that the subject is or is not likely to be prematurely infertile because of a medical intervention. In the case of men, however, almost all reasons for sperm storage are related to the prospect of premature infertility. We initially took up this issue with the Equality and Human Rights Commission, which in February 2018 declined to ‘offer assistance’ in revising the provisions of the UK legislation and extending the 55-year storage limit to women freezing their eggs for social reasons. An appeal from us against this decision was reviewed in May 2018, when the Commission – somewhat illogically – wrote that: ‘legislative change, rather than a legal challenge, would be the most effective way to remedy this unfairness and ensure that regulations in this area fully take account of the evolving landscape’. Legislative change was in fact the basis of what we were looking for in the first complaint. Nevertheless, the Commission did indeed seem to recognize the anomalous nature of the present legislation, accepting, ‘in line with your assertions’, that it does have ‘a discriminatory impact on women who are freezing eggs for social rather than medical reasons’ (

      Bowen-Simpkins, P. Decision review by Clare Collier on behalf of UK Equality and Human Rights Commission letter dated 2 May 2018.

      ).
      Currently, women wishing to store their eggs for non-medical reasons beyond the 10-year limit have no alternative options than to circumnavigate the UK law and freeze their oocytes in overseas jurisdictions. Otherwise, eggs can only be fertilized (in most cases, presumably, with donor sperm) and stored as embryos – where legislation does allow storage up to 55 years. The former option – cross-border oocyte storage – appears to be condoned under the HFEA’s amended directions to the HFEA Act of 1990 (
      Human Fertilization and Embryology Authority
      Directions given under the HFEA Act 1990 (as amended): Import and Export of gametes and embryos (16 April 2018).
      ,
      • Templeton Sarah-Kate
      Women challenge 10-year limit on freezing eggs.
      ). There is also anecdotal evidence that this is an alternative route taken by some UK patients faced with an unacceptable 10-year deadline or prospect of donor sperm for embryo storage.
      Oocyte cryopreservation is just a further example of how vitrification has changed the ‘evolving landscape’ of assisted reproduction, such that egg banking, egg donation, male and female fertility preservation and embryo transfer have all now moved up to a new level of applicability and success. Indeed, despite a lack of strong evidence from clinical trials, a freeze-all embryo transfer strategy has been adopted by many clinics (including our own, where around two-thirds of cycles are freeze-all transfers, with results clearly better than fresh), and studies from Spain, Italy, the USA and China have unequivocally demonstrated that vitrified oocytes have the same potential as fresh oocytes in egg donation programmes (
      • Crawford S.
      • Boulet S.L.
      • Kawwass J.F.
      • Jamieson D.J.
      • Kissin D.M.
      Cryopreserved oocyte verses fresh oocyte assisted reproductive technology cycles, United States, 2013.
      ,
      • Rienzi L.
      • Cobo A.
      • Paffoni A.
      Consistent and predictable delivery rates after oocyte vitrification: an observational longitudinal cohort multicentric study.
      ,
      • Shi Y.
      • Sun Y.
      • Hao C.
      • Zhang H.
      • et al.
      Transfer of fresh versus frozen embryos in ovulatory women.
      ). Thus, we too in our own clinics have seen remarkable growth in egg freezing in the past 2 or 3 years. Most patients are women without a partner hoping to protect their fertility against an age-related decline. Treatments at our centre have increased from just six in 2012 to 186 in 2016, and nearly 300 in 2017 (Wang JJ et al., unpublished observations). Vitrification has thus been ‘disruptive’ in its impact, an irresistible force for change in both behaviour and expectation in ART. So never again should assisted reproduction or its patients have to face embryo selection without cryopreservation of supernumerary embryos, or egg donation without egg banking. Indeed, the very concept of ‘safe’ IVF depends on an efficient cryopreservation programme and single embryo transfer. These are welcome changes, and ones that policy should recognize and adopt, even if challenging. In its latest report on IVF in Europe (with results for 2013), for example, ESHRE observed that ‘the freeze-all policy followed by many clinics and the multiple frozen embryo transfers resulting from the same cycle represent important challenges to registries’ (
      • Calhaz-Jorge C.
      • De Geyter C.
      • Kupka M.S.
      • et al.
      Assisted reproductive technology in Europe, 2013: results generated from European registers by ESHRE.
      ). Cumulative live birth rate, ESHRE suggested, might now be a more realistic reflection of success than live birth per transfer or egg retrieval, such is the impact that cryopreservation now has throughout the practice and evaluation of assisted reproduction.
      The HFEA has an enviable record in public consultation and regulatory introductions to keep pace with technological and sociological developments: research in embryo gene editing (
      • Waldron Paul
      First genome editing of human embryos by UK scientists.
      ); the ‘cautious adoption’ of mitochondrial donation for reducing risk of mitochondrial disease (
      • Alikani M.
      • Fauser B.C.J.
      • Garcia-Velasco J.A.
      • Simpson J.L.
      • Johnson M.H.
      First birth following spindle transfer for mitochondrial replacement therapy: hope and trepidation.
      ) and egg sharing (
      • Ahuja K.K.
      • Simons E.G.
      • Edwards R.G.
      Money, morals and medical risks: conflicting notions underlying the recruitment of egg donors.
      ). We thus believe that here, in supporting an extension to the time limit on non-medically indicated oocyte freezing, the HFEA has a further opportunity to consult and take a similar lead. We are pleased to see that ‘extension of storage’ was a topic for consultation in a forthcoming update of the HFEA’s Code of Practice (
      • Gurtin Z.
      Unscrambling HFEA data on egg freezing: where are the missing eggs?.
      ,
      • Riley L.
      The HFEA code of practice is being updated.
      ).
      Meanwhile, the arguments in favour of extending the time limit remain principally practical and demographic. If, as all evidence would attest, oocytes are better retrieved at an earlier age, there seems no sense in denying their eventual use because of some arbitrary cut-off that has no basis in science or in human rights. The average age in Britain at which a woman has her first baby is now over 30. However, many women wish to delay pregnancy beyond this age because of employment commitments or lack of a partner, and fertility preservation before the age of 30 seems pointless with the present limitations of the law. Our experience shows that currently the majority of women seeking egg freezing are in their mid-30s, and not many are currently aware that their eggs will necessarily be destroyed unless they use them within 10 years. A change in this law is long overdue.

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