KEY FACT: Opera, resulting from a public-private partnership, it involved 18 clinics in Italy and Germany.
PRESS RELEASE Bergamo, 3 July 2023 – The European project OPERA (Observational retrospective ProjEct for a Research database for ART procedures) was signed by FROM – Fondazione per la Ricerca Ospedale di Bergamo ETS and presented at the 39th annual congress of the European Society of Human Reproduction and Embryology (ESHRE), held from 25th to 28 June in Copenhagen. The OPERA project, thanks to the involvement of a total of 18 clinics in Italy and Germany, has led to the creation of one of the most relevant databases relating to Assisted Reproductive Technologies (ART).
Scientific evidence, technology in research methodology, big data management and privacy regulation are intertwined within the OPERA project. FROM, as promoter of the study, managed its general coordination and contributed to the development of a model for secondary reuse of data initially collected for clinical purposes. Data that will now be made available to the scientific community to generate and verify further research questions, which allows to exploit the potential of the information collected from patients (clinical parameters, response to treatment, reaction to drugs, etc.) ensuring the protection of people’s privacy in accordance with current regulations.
The research was developed by two clinical experts in the field of assisted reproduction technologies Francesco Fusi – Principal investigator and scientific coordinator for the Italian centers, Head of the Gynecology Unit 2 – PMA Center of the ASST Papa Giovanni XXIII of Bergamo – and Georg Griesinger – scientific coordinator for the German centers and Head of the Department of Gynecology, Endocrinology and Reproductive Medicine of the German University Hospital of Schleswig-Holstein, Campus of Lübeck.
The pharmaceutical companies Merck KGaA and IBSA SA guaranteed financial support, providing it in compliance with the methods established by current legislation. The Contract Research Organization (CRO) Advice Pharma Group handled the management of the study.
THE STUDY
The OPERA project, launched in June 2022, involves 18 clinics with proven experience in ART procedures, located in Italy and Germany (9 clinics for each country). For the collection of Real World Data (RWD, i.e. all data relating to the patient and his/her health status, which are routinely collected during clinical practice within healthcare facilities), the involved clinics use the MedITEX® DB software, widely used in countries throughout Europe. The ethics committees and data protection officers responsible for the individual facilities examined the study protocol.
The objective of the OPERA project is to create an international multicenter database dedicated to medically assisted procreation (PMA) procedures, through the collection of anonymized data from electronic medical records (through MedITEX® technology) of several specialized European centers located in Italy and Germany. This will provide a solid source of information not only to develop studies related to the complex management of these data, but also to provide a descriptive analysis of assisted reproduction procedures and couples’ characteristics, thus improving the evaluation of the efficiency and effectiveness of different PMA interventions.
Specialized clinics are collecting data on treatment cycles with assisted reproductive technologies in national registries for several decades, and aggregated national data are further collected at international level. This allows for a global understanding of these issues, and can help answer clinical research questions that are relevant to a large patient population. These studies are therefore useful for describing secular trends in ART use and associated outcomes worldwide. However, registries often cannot provide more detailed information and data analysis that taking into account the specificities of patients. Furthermore, national registries may limit access to raw data for open research, for political, infrastructural or privacy reasons.
In the case of the OPERA study, this additional step was taken to improve data management: the pregnancy rate – i.e. the probability of conception – and birth rate recorded for each embryo transfer performed as part of medically assisted reproduction practices were correlated with the woman’s age and other characteristics, such as smoking habits and body mass index. As part of OPERA, the collection of data from 107,000 cycles of Medically Assisted Procreation treatments was completed, and the results of the data analysis from the 18 centers participating in the study were presented at ESHRE. The data presented relate to the protocols used, the average number of oocytes collected and embryos obtained, and the insemination techniques used. In addition, the initial data on the efficacy and efficiency of the procedures were evaluated, which will be the subject of in-depth subsequent analyses. Further scientific questions will be evaluated by a scientific board and conducted according to the most rigorous methodologies.
THE STATEMENTS
Francesco Fusi Principal investigator and scientific coordinator for the Italian centers, Professor of Reproductive Physiopathology at the University of Milan-Bicocca and Head of the Gynecology Unit 2 – PMA Center of the ASST Papa Giovanni XXIII of Bergamo: «OPERA will provide a solid source of information to develop Real World Evidence (RWE) studies, will provide a descriptive analysis of ART (Assisted Reproductive Technology) procedures and couples’ characteristics, and evaluate the efficiency and effectiveness of different ART interventions. The amount of information that such a large database will provide will be able to answer many of the questions that clinicians ask themselves in their daily work, such as choosing the protocol to follow for a patient with certain physical, behavioral and age characteristics. It will also be possible to obtain information on the real efficiency of the various endometrial preparation protocols in cryopreserved embryo transfers (frozen embryo transfers) depending on the patients, or on the influence of additional treatments. There are numerous feasible investigations, and a special committee will evaluate the scientific research proposals that each group participating in the data collection will want to present».
Georg Griesinger Scientific Coordinator for the German Centers, Professor of Gynecologic Endocrinology and Reproductive Medicine, Head of the Department of Gynecology, Endocrinology and Reproductive Medicine at the German University Hospital Schleswig-Holstein, Lübeck Campus: «RWDs have traditionally been understood as merely descriptive data from routine clinical practice. More recently, we have begun to understand the enormous potential of RWD to explore questions that are extremely difficult to address with conventional clinical trials. OPERA is a first attempt to create a large, real-world data registry for ART and a step towards using these data to improve our understanding of the interaction between patient type and outcome in different treatment scenarios».
Eleonora Sfreddo, Operations Director of FROM – Fondazione per la Ricerca Ospedale di Bergamo ETS: «The OPERA project, in addition to being characterized by a significant scientific value demonstrated by the profiles of the two coordinators of the study, represents for FROM a methodological challenge that allowed us to build (within the scope of the current Privacy legislation) a virtuous model for the secondary reuse of data primarily collected for clinical purposes. Data that, after an adequate anonymization process validated by the relevant Ethics Committees, are thus made available to the scientific community to generate and verify further research questions. The governance model for the management of this anonymized data is based on the presence of a scientific board that preliminarily evaluates the questions posed by the researchers, ensuring the quality of the research to protect patients. FROM hopes that the foreseen model for the OPERA study will be preparatory to future projects, for a prospective collection of this data that makes use of the support of innovative technological devices, always in compliance with current regulations».