Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000957998
Ethics application status
Approved
Date submitted
5/09/2011
Date registered
6/09/2011
Date last updated
20/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of Erotic Material (EM) to Aid Semen Collection
Scientific title
A non interventional, low risk, randomised, controlled, parallel group clinical trial of the supply of erotic material to aid sample collection in adult men referred to the Andrology laboratory for semen analysis
Secondary ID [1] 262985 0
None
Universal Trial Number (UTN)
U1111-1124-2845
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Provision of a semen sample for analysis, with or without the use of erotic material 270708 0
Condition category
Condition code
Other 270886 270886 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All men attending the Dept of Andrology, Concord Hospital, for a semen collection and laboratory analysis who are willing to provide written consent will be randomly assigned to a private collection room that either does or does not contain EM.
Participants will be recriuted over a 12 month period. The erotic material used is in the form of pornographic magazines sold freely in the community to adults.
Intervention code [1] 269328 0
Behaviour
Comparator / control treatment
Participants will be randomly assigned to either have EM available or no EM available when providing a semen sample for analysis.
Control group
Active

Outcomes
Primary outcome [1] 279565 0
How many men fail to provide a semen sample in
a) the EM group and
b) the no EM group
Timepoint [1] 279565 0
Single visit
Secondary outcome [1] 287904 0
How many men refuse to take part in the study, and of those refusing how many request EM and how many do not.
Timepoint [1] 287904 0
The number of refusals per group will be assessed and compared at the end of the study.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Men unable or unwilling to provide written informed consent

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Men referred to the Andrology laboratory for a clinical semen analysis will be asked if they are willing to take part in the study. Those who agree and provide written informed consent will be allocated to a collecting room that either does or does not contain EM.
The person who enrolls the participants will be aware as to whether or not the collection rooms contain EM.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Collecting rooms will contain EM every other week. The alternate weeks the collecting rooms will not contain EM.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
A non interventional low risk randomised controlled parallel group clinical trial of the supply of EM to aid sample collection required for laboratory semen analysis.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/09/2011
Actual
1/10/2011
Date of last participant enrolment
Anticipated
Actual
31/01/2013
Date of last data collection
Anticipated
Actual
31/01/2013
Sample size
Target
800
Accrual to date
Final
1520
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 269794 0
Hospital
Name [1] 269794 0
Department of Andrology
Country [1] 269794 0
Australia
Primary sponsor type
Hospital
Name
Sydney Local Health District
Address
Concord Hospital
Hospital Road
Concord
NSW 2139
Country
Australia
Secondary sponsor category [1] 268837 0
None
Name [1] 268837 0
Address [1] 268837 0
Country [1] 268837 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271763 0
Sydney South West Area Helath Service HREC (CRGH Zone) (EC00118)
Ethics committee address [1] 271763 0
Concord Hospital
Hospital Road
Concord
NSW 2139
Ethics committee country [1] 271763 0
Australia
Date submitted for ethics approval [1] 271763 0
08/08/2011
Approval date [1] 271763 0
05/09/2011
Ethics approval number [1] 271763 0
LNR/11/CRGH/176

Summary
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.
Trial website
N/A
Trial related presentations / publications
https://www.ncbi.nlm.nih.gov/pubmed/24124176
Public notes

Contacts
Principal investigator
Name 33114 0
Prof David Handelsman
Address 33114 0
Dept of Andrology Building 22 CRGH NSW 2139
Country 33114 0
Australia
Phone 33114 0
00612 9767 7222
Fax 33114 0
Email 33114 0
djh@anzac.edu.au
Contact person for public queries
Name 16361 0
Amanda Idan
Address 16361 0
Dept of Andrology
Building 22
CRGH
NSW 2139
Country 16361 0
Australia
Phone 16361 0
00 612 9767 5286
Fax 16361 0
Email 16361 0
aidan@med.usyd.edu.au
Contact person for scientific queries
Name 7289 0
Professor David Handelsman
Address 7289 0
ANZAC Reserach Institute
Hospital Road
Concord
NSW 2139
Country 7289 0
Australia
Phone 7289 0
00612 9767 7222
Fax 7289 0
Email 7289 0
djh@anzac.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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