None listed
Conditions
Brief summary
A large part of the clinical responsibilities within the Department of Andrology involves the collection and laboratory analysis of semen samples for a wide range of clinical indications. Men usually attend the department and provide a semen sample through masturbation, which takes place in one of two designated collection rooms. The provision of erotic material (EM) in the form of soft core pornography magazines (sold freely in the community to adults) is routinely provided in each room. The practice of providing EM is universal among semen laboratories on the basis that it presumed to aid semen collection through the provision of imaginative stimulation for masturbation, which has to be performed in an unfamiliar environment unconducive to usual sexual activity. However, there is no established standard for such provision among semen laboratories; the WHO Semen Manual (5th Edition) provides guidelines for semen collection in the clinical setting but remains silent on the supply of EM as an aid to semen collection. Recent departmental discussions questioned the practice of routinely providing EM, both on aesthetic grounds as well as the legal issues of supplying prohibited material to minors attending for semen collection (for elective cryostorage prior to cancer treatment). There is also some cost incurred by the department for the replacement (EM is regularly stolen) and updating of EM. Despite the provision of EM some men remain unable to provide a semen sample for a variety of reasons. We therefore undertook a QI analysis of whether supplying EM was required for semen collection. As supplying EM is neither a proven requirement nor a regulated component of the fitout of a semen collection facility, we designed a QI study that randomised supply of such material according to the week in which men attended the laboratory i.e. collection rooms had EM insitu on alternate weeks only. As a variation of the nonstandardised physical facilities provided in the collection rooms, this did not require the individual consent of the men attending the laboratory. This QI study is well advanced, but not yet completed. We are now proposing to extend that QI analysis into a formal RCT to evaluate the impact of the requirement for written, informed consent on the outcomes of the original study question: does the requirement for fully informed, written consent influence the findings of such a study? This could be through refusing to participate, or to requesting crossover (ie requesting magazines when allocated to “nomagazine”) or more complex reasons. We are therefore now planning an extension to the original QI study but with the added requirement for informed, written consent. This extension study would address the original questions (how frequently do men fail to provide a semen sample with or without magazines available?) in a different framework as well as allowing the rare opportunity to determine whether the requirement for informed consent procedures, in themselves, influence the outcome of a study.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
Men referred to the department of Andrology for semen sample analysis will be asked to take part in the study. Only those willing to provide wrtitten informed consent will be included.
Exclusion criteria
Men unable or unwilling to provide written informed consent