OPERA project, thanks to the involvement of a total of 18 clinics between Italy and Germany, has led to the creation of one of the most relevant databases related to Assisted Reproductive Technology (ART).
Scientific evidence, technology in research methodology, big data management and privacy regulation are intertwined within the OPERA project. FROM – Fondazione per la Ricerca Ospedale di Bergamo – Ente del Terzo Settore (FROM – E.T.S.), as the Promoter of the study, managed its overall coordination and helped develop a model for the secondary reuse of data that were first collected for clinical purposes. Data that, therefore, will now be made available to the scientific community to generate and verify further research questions, which allows the potential of the information collected from patients (clinical parameters, response to treatment, reaction to drugs…) to be exploited, guaranteeing according to current regulations the protection of people’s Privacy.
What
OPERA is a retrospective, multicenter, observational study aimed at collecting Real World Data (RWD) on assisted reproductive technology (ART) procedures conducted in national and international referral clinics in order to build a large, homogeneous database for specific research questions in the context of real clinical practice. The project, promoted by FROM – Fondazione per la Ricerca Ospedale di Bergamo – Ente del Terzo Settore (FROM – E.T.S.), began in June 2022 and involves clinics with proven experience in ART procedures. OPERA has the peculiarity of collecting a robust number of ART cycles/clinical procedures, anonymously, ensuring a research database fully compliant with current regulations. The principal objective of the project is to make available 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 fertilization procedures and couples’ characteristics, thus improving the evaluation of efficiency and effectiveness of different ART interventions.
OPERA will provide a reliable source of data to:
- Develop RWE studies
- Provide a descriptive analysis of ART procedures and couples’ characteristics
- Evaluate efficiency and effectiveness of different interventions in ART.
Real World Data (RWD), are all those data related to the patient and his or her health status, which are routinely collected in the course of real clinical practice within health care facilities. OPERA will provide a robust source of information to develop Real-World Evidence (RWE) studies to provide a descriptive analysis of both, ART procedures and couples’ characteristics, and evaluate the efficiency and effectiveness of different ART interventions.
RWE provides an alternative and complementary approach to randomized controlled trials (RCTs) to generate scientific evidence to guide clinical treatment for infertile couples.
In order to establish a multicenter international database, OPERA has collected anonymized data from several centers specializing in assisted reproductive technology (ART) located in Germany and Italy.
How
For the Opera project, we collected data from clinics using MedITEX® DB software, which is widely used in countries throughout Europe
As part of OPERA, the first data collection phase has been completed covering the period from 01/01/2016 to 31/12/2020 involving 9 Italian centers and 9 German centers. A total of data was collected on approximately 106 thousand PMA cycles.
- The data were extracted anonymously to respect patients’ privacy and comply with legal requirements
- OPERA also guarantee the privacy of all participating Centres, as it is impossible to identify the sending Centre from extracted data
Goals
The primary objective is to establish a multicenter, multinational data collection on ART procedures to develop a comprehensive database for RWE studies and generate RWDs aimed at describing and improving standard clinical practice in ART. The secondary objectives are to evaluate the efficiency and effectiveness of Level 2 and Level 3 ART, different ovarian stimulation protocols, gonadotropins used, endometrial preparation protocols, and various embryologic parameters on pregnancy outcomes.