P–140 Zygote morphokinetics as a predictor of blastocyst quality

Study question Does the total cytoplasmic volume (TCV) of the zygote and time of pronuclei disappearance (tPNf) affect blastocyst development potential and blastocyst quality? Summary answer The total cytoplasmic volume of zygote and the time of pronuclei disappearance strongly affect blastocyst development as well as blastocyst quality. What is known already Extended embryo culture with blastocyst transfer is considered a useful method for selecting embryos with a high implantation potential. One of the main concerns in the German Embryo Protection Act is that the choice of embryos that have a high potential for successful implantation must be made at the pronucleus stage. The introduction of time-lapse technology enabled comprehensive information regarding the morphology and kinetics of the embryo. Although for the past years, strong correlations between embryo morphokinetics and positive outcomes have been demonstrated, some disagreement concerning the wide application of these parameters into an early-stage embryo selection is still present. Study design, size, duration The injection time of ICSI was designated as “time zero”, and computer software was used to calculate the time frame between the injection and the moment of pronuclei disappearance (tPNf). The total cytoplasmic volume was calculated 16–18 h after injection based on manually drawn diameters of the zygotes, by the computer. Obtained measurements were later associated with the blastocyst formation potential as well as with blastocyst quality. Participants/materials, setting, methods A total of 187 oocytes from 34 patients undergoing the antagonist cycle for ICSI treatment were evaluated. All blastocysts were cultured in Embryoscope™ according to the manufacturer’s specifications (Vitrolife, Sweden). The Gardner and Schoolcraft scoring system was used to describe blastocyst quality. Statistical analyses were performed using IBM SPSS version 24. Data were reported as median and range. Differences between groups were tested using the Mann-Whitney U test. Statistical significance was defined as p < 0.05. Main results and the role of chance Obtained data showed that the total cytoplasmic volume values were significantly higher in zygotes that reached the blastocyst stage compared with those that did not [708376,268µm³ (560564,412µm³ - 838602,605µm³) vs 674349,917 (415749,353- 823640,638) respectively; p < 0.0001]. Furthermore, this parameter as well significantly affect blastocyst quality where zygotes which formed better blastocyst quality had smaller cytoplasmic volume [685568,079 µm³ (560564,412- 790112,397µm³) vs 745514,662 µm³ (616581,339- 838602,605) respectively; p < 0.0001]. Time of pronuclei disappearance (tPNf) was significantly different (p < 0.0001) in successfully formed blastocysts [22.00h (17–29 h)] versus arrested or non-blastulating embryos [23.00h (17–56 h)]. Zygotes who had a shorter time frame between injection and pronuclei disappearance showed better blastocyst quality values compared with those who had longer time frame [21.00h (17–28h) vs 23.00h (18–29h) respectively; p < 0.01]. Limitations, reasons for caution The limitation of the presented study was that due to the double-embryo transfer correlation between morphokinetic parameters and pregnancy rate was not possible to be calculated. Further research should link these morphokinetic parameters with pregnancy rate and live birth rate as well. Wider implications of the findings: The potential of the present findings is considerable, especially for countries with strict Embryo Law Regulation. Obtained results might be highly useful for selecting embryos with high implantation potential. In addition, the present work illustrates the possibility of additional information that can potentially be incorporated into an embryo classification model. Trial registration number Not applicable

O-033 Where ethics hits the patients needs - Case Germany

text The German Embryo Protection Act was passed in 1990 and has never been changed since, other than minor changes in 2011 regarding PGD. Germany is a country with 83 million inhabitants, where more than 6 million people of reproductive age are facing infertility or difficulties conceiving and delivering a healthy child. Germany also has the oldest and arguably most restrictive law regulating reproductive medicine, especially IVF. By passing a law with such an imposing title and starting the act with a list of prohibitions, 31 years ago German legislators made their intentions very clear: to protect the embryo rather than to help infertile people to become parents using assisted reproductive technology. Since reproductive medicine has developed tremendously in the last 30 years and since the number of people in need of medical assistance to have a child is constantly growing,Germany now is not only far behind other European countries with its legislation but also seems to be against its patients and citizens in need of the assistance of modern medicine to have children. How can we change an inappropriate and archaic law? How can we create a modern law which suits patients’ needs without compromising ethics? How can reproductive medicine in Germany come back on track again and serve the people by evidence based medicine in the first place?I

Sachstand zur Manipulierbarkeit des menschlichen Embryos hinsichtlich seiner Spezieszugehörigkeit und Entwicklungsfähigkeit

This report presents the current state of research in the debate on embryo protection. On the basis of scientific findings on species membership and the capacity of human embryos to develop properly, the report examines the extent to which these empirical facts influence the debate on the legal status of the human embryo. At the end of the article, the authors present the options for the further discussion with regard to the German Embryo Protection Act.

Der manipulierbare Embryo: Konsequenzen für das Recht

Innovative techniques of developmental biology facilitate the artificial creation of embryo-like entities. This contribution analyses, first, whether certain artificially created embryo-like entities are ‘embryos’ within the meaning of existing statutory law definitions laid down in the Embryo Protection Act, the Stem Cell Act and the Patent Act. These definitions are non-uniform and their interpretation and application with regard to artificially created embryo-like entities is not always conclusive. Accordingly, the legal definitions of the term ‘embryo’ should be harmonised and, thereby, adapted to the state of developmental biology. Any such legislative efforts need to be in conformity with the constitution, primarily with the guarantee of human dignity (Article 1‍(1) of the Basic Law). However, said provision cannot provide guidance to the legislature because the constitutional status of both embryos and embryo-like entities in vitro is highly disputed. It is held that this irresolvable debate is due to a fundamental lack of a widely shared experience that such entities possess a supreme unique value. This article argues that in such a situation it is, in the first instance, for the legislature (i. e. parliament) to determine the legal status of embryos and embryo-like entities in vitro. This argument is based on a particular doctrinal approach according to which the individual right to respect of one’s human dignity arising from Article 1‍(1) BL depends on recognition of the relevant entity as being a ‘human’ or a member of ‘humankind’ respectively. Such recognition has, hitherto, not been accomplished with a view to embryos and embryo-like entities in vitro. Against this backdrop, for the time being, the legislature may determine the legal status of embryos and embryo-like entities in vitro, lay down rules regarding their creation and particular use, and, especially, define the legal term ‘embryo’, albeit within some outer constitutional limits. The article, finally, analyses several elements of, and submits a proposal for, a new legal definition of the term ‘embryo’.

Der manipulierbare Embryo: Philosophische Grundaspekte einer aktuellen Debatte

This article is dedicated to the question of normative aspects in which the relation between responsibly acting subjects and manipulable embryos has to be established. It advocates the thesis that “reflexive identity” between acting subject and treated embryonal “object” is the pivotal and starting point of the debate: the acting subject acts towards a form of objective human existence, which it has undergone by itself and therefore recognizes not only itself, but also poses the condition of possibility of its own current sovereignty in acts. Against this background the concept of “Personalism”, which is found in the German “ESchG” (Embryo Protection Act) and “StZG” (Stem Cell Act), can be understood. If there are new questions arising from complex, technically mediated manipulations of the embryo today, as its entire synthetic production has become possible, it leads to the question regarding the normative meaning of “Besonderung” (particularity/particularization) and the identification of species as living individuality as such. Consequently, it raises the question of the normative relevance of corporal self-objectivations of individuals, which never passes over to just material circumstances. This also applies when embryos are obtained from iPS cells where the biotic substrate, as well as its “administration” and “utilization”, is not regarded an anonymous, but biotic substrate that is embedded in individual biographies that are undetachable and never completely lost. “Biopolitics” that place human biotic substrate in the disposition of arbitrary interests already has to be rejected in the interest of maintaining a perspective of reflexive identity as well as in the horizon of interpersonality.