What information do cancer clinical trial protocols include on the reproductive risk of treatment and oncofertility management?'

There are many barriers for oncofertility care which include clinician’s knowledge about the teratogenic and gonadotoxic risk of cancer protocols and the recommendations for oncofertility care. The objective of this study was to describe the level of reproductive information about the gonadotoxic and teratogenic risk of chemotherapy treatment in clinical trial protocols and the recommendations for oncofertility investigation and management.The study team reviewed 84 clinical trials protocols (pediatric, adolescent and young adult and adult) covering tumors found in patients of a reproductive age from 0-45 years of age and reviewed the literature for the 78 individual chemotherapy drugs. The team then reviewed each clinical trial protocol to document the reported information on gonadotoxicity and teratogenic risk, as well as recommendations for oncofertility care.The known information on reproductive risk of chemotherapy was not well-incorporated into the clinical trials protocols and when information was not available for new chemotherapy drugs the lack of animal or human data was also not reported.The reproductive complications of cancer treatment are poorly studied and reported in animal and human studies and the research team found information inconsistent and hard to find in the literature. However, when gonadotoxicity and teratogenic effect of treatment were known they were not consistently included into all protocols and the lack of data for new drugs was not reported. Very few protocols gave recommendations for oncofertility management and follow up and this is an additional barrier for fertility preservation consultation or management. Clear accurate information in clinical trials protocols will help to improve oncofertility care for patients of a reproductive age and will avoid medical legal ramifications.A number of recommendations are required for clinicians and pharmaceutical companies developing new trials, enabling clearer information and reco