Abstract

Abstract Study question What is the current state of resolving the issue of surplus embryos in Italy, in the absence of clear legislation? Summary answer This paper proposes organic reform of Italian law and European harmonization for informed and conscious patient decision-making on excess embryos. What is known already According to Italian law, embryos obtained through in-vitro fertilization for assisted reproduction that have not reached the transfer phase (including unsuitable ones) cannot be destroyed, resulting in significant resource allocation for indefinite preservation in biobanks. This stems from the legal and ethical recognition of the human embryo as a subject of rights that in turn prohibits destruction, donation to other couples, or use for scientific research. Study design, size, duration My study compares European legal systems and analyzes the evolution of Italian law on medically assisted fertilization (L. 40/2004) since its implementation, with a focus on legal and ethical issues that have been subject of ongoing debate. It also examines the Italian Ministerial Guidelines, the only text where the legislator has dealt with the issue of surplus embryos. Participants/materials, setting, methods Not applicable. Main results and the role of chance The present study examines the various approaches taken by countries to address the issue of surplus embryos. Regulations in countries such as Spain, France were taken into consideration. The British legal system is also examined for its regulations on the donation of embryos and reproductive cells. The Spanish regulation of embryo-sharing (L. 14/2006) is the most organic approach. It grants three options to couples with respect to their remaining embryos: preservation for personal use, donation to other couples, or donation for research. In the United States, the increase in cryopreserved and abandoned blastocysts has led to the spread of conditional embryo adoption and Snowflakes adoption. The Italian provision, however, fails to adequately balance the constitutionally protected interests of couples' self-determination and scientific research for the protection of individual and collective health. Role of chance not applicable here. Limitations, reasons for caution Not applicable. Wider implications of the findings Italian legislation neglecting to intervene has caused numerous issues, such as increased costs for fertility centers and poor practices. Clinics advertising embryo adoption, despite regulatory uncertainty, have created unfair competition leading to psychological distress for couples with cells in limbo and fears of financial obligations. Trial registration number NOT APPLICABLE

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