ANZCTR - Registration

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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]

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

Condition category

Condition code

Other

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]

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]

How many men fail to provide a semen sample in
a) the EM group and
b) the no EM group

Timepoint [1]

Single visit

Secondary outcome [1]

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]

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]

Hospital

Name [1]

Department of Andrology

Address [1]

Concord Hospital
Hospital Rd
Concord
NSW 2139

Country [1]

Australia

Primary sponsor type

Hospital

Name

Sydney Local Health District

Address

Concord Hospital
Hospital Road
Concord
NSW 2139

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney South West Area Helath Service HREC (CRGH Zone) (EC00118)

Ethics committee address [1]

Concord Hospital
Hospital Road
Concord
NSW 2139

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

08/08/2011

Approval date [1]

05/09/2011

Ethics approval number [1]

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

Prof David Handelsman

Address

Dept of Andrology Building 22 CRGH NSW 2139

Country

Australia

Phone

00612 9767 7222

Fax

djh@anzac.edu.au

Contact person for public queries

Name

Amanda Idan

Address

Dept of Andrology
Building 22
CRGH
NSW 2139

Country

Australia

Phone

00 612 9767 5286

Fax

aidan@med.usyd.edu.au

Contact person for scientific queries

Name

Professor David Handelsman

Address

ANZAC Reserach Institute
Hospital Road
Concord
NSW 2139

Country

Australia

Phone

00612 9767 7222

Fax

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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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