ADVERSE EFFECTS OF GONADOTROPINS USED IN INFERTILITY TREATMENT

Abstract

Introduction: Infertility represents a problem for more and more couples all over the world, including in Romania. Thus, more and more women need to resort to drugs to treat infertility, treatments which are not without adverse reactions (Boivin et al., 2007). Modern therapy brings significant benefits in the treatment of infertility. Despite all the benefits, the controlled ovarian stimulation treatment does not lack the possibility of adverse reactions to the administered drugs.

Objectives: The aim of this study was to determine the potential adverse reactions experienced by patients during the treatment with gonadotropins followed by assisted conception

Methods: A study was done based on a questionnaire which included the adverse reactions comprised in the SmPCs (Summaries of Product Characteristics) of the original drugs, and also based on the adverse reactions frequently reported in clinical studies. The questionnaire was distributed in the online environment, from May 2018 to July 2018, in Romania, to patients to whom at least one of the analysed gonadotropins (corifollitropin alpha, follitropin alpha, follitropin beta, follitropin alpha/follitropin beta, menotropin, urofollitropin) was administered during the controlled ovarian stimulation treatment, in the routine practice of assisted human reproduction technology.

Results: The results show that a total number of 319 events suspected of being adverse reactions was reported, grouped on the highest MedDRA level, SOC (system – organ- class), with an average of 8.18 adverse reactions (AR)/patient.

Conclusions: The results of the study demonstrate the fact the disorders appeared after drug administration in the controlled ovarian stimulation treatment in the context of the routine practice of assisted human reproduction technology, were considered adverse reactions by the patients.