Condition category
Urological and Genital Diseases
Date applied
03/04/2014
Date assigned
09/05/2014
Last edited
07/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The seminal vesicles are part of the male inner genitals. It is not known if the seminal vesicles have an impact on sexual interest, i.e. if full seminal vesicles increase sexual interest. This would potentially make sense from a biological/behavioural point of view. The aim of this study is to find out if there is any specific brain area that changes its activity in relation to the filling status of the seminal vesicles. The detection of such a specific brain area would suggest that the filling status of the seminal vesicles changes the activity in the brain.

Who can participate?
Heterosexual men between the ages of 20 and 30.

What does the study involve?
On day 1 in the morning, participants will provide a blood sample for analysis of sex hormone levels, a conventional MRI scan of the pelvis to assess the size of the seminal vesicles, and a functional MRI of the brain. After these examinations, they masturbate in order to empty their seminal vesicles. On day 2 in the morning, they undergo the same examinations.

What are the possible benefits and risks of participating?
The detection of specific brain areas would potentially have a clinical impact in men undergoing radical prostatectomy for prostate cancer, which nowadays is usually performed with removal of both seminal vesicles. If a relationship is found between seminal vesicle filling status, specific brain areas and sexual interest and confirmed by further clinical studies, the standard removal of the seminal vesicles during radical prostatectomy could be re-thought in order to potentially help to preserve sexual interest. There are no risks involved in this study.

Where is the study run from?
University Hospital Bern (Switzerland).

When is the study starting and how long is it expected to run for?
The study started in May 2014 and will run until April 2015.

Who is funding the study?
Max and Hedwig Niedermaier Foundation and University Hospital Bern (Switzerland).

Who is the main contact?
Dr Frédéric Birkhäuser
frederic.birkhaeuser@insel.ch

Trial website

Contact information

Type

Scientific

Primary contact

Dr Frédéric Birkhäuser

ORCID ID

Contact details

Freiburgstrasse 4
Bern
3010
Switzerland
frederic.birkhaeuser@insel.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Does the filling state of the seminal vesicles influence sexual desire? A pilot study

Acronym

Study hypothesis

We hypothesize that filling state of seminal vesicles is an independent factor for the intensity of sexual desire, influencing sexual arousal in healthy men.

Ethics approval

Kantonale Ethikkommission Bern (KEK), 05/09/2014, ref: 005/14

Study design

Interventional study

Primary study design

Interventional

Secondary study design

Not specified

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

The physiological role of healthy seminal vesicles on sexual desire

Intervention

The five participants all undergo the same intervention. On day 1 in the morning, they first undergo a blood analysis (5 min), thereafter they undergo a conventional MRI of the pelvis and a functional MRI of the brain (40 min). After these examinations, they masturbate in order to empty their seminal vesicles. On day 2 in the morning, they undergo exactly the same examinations.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The effect of seminal vesicle filling state on cortical activation and sexual arousal investigated by fMRI, which would be reflected by a reduced activation of specific regions in fMRI of the brain on study after ejaculation.

Secondary outcome measures

1. Changes in sexual arousal score with full/empty seminal vesicles
2. Changes of volume in seminal vesicles during first (before ejaculation) and second (after ejaculation) MRI examination

Overall trial start date

01/05/2014

Overall trial end date

30/04/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men between the age of 20 and 30
2. Heterosexuality
3. Written informed consent
4. Ejaculation abstention of 3-5 days before first fMRI examination

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

5

Participant exclusion criteria

1. Erectile dysfunction
2. Claustrophobia
3. Depression
4. Status post brain trauma
5. Severely reduced visibility
6. Medication intake with possible side effects on libido

Recruitment start date

01/05/2014

Recruitment end date

30/04/2015

Locations

Countries of recruitment

Switzerland

Trial participating centre

Freiburgstrasse 4
Bern
3010
Switzerland

Sponsor information

Organisation

University Hospital Bern (Switzerland)

Sponsor details

Freiburgstrasse 4
Bern
3010
Switzerland
urology@insel.ch

Sponsor type

Hospital/treatment centre

Website

http://www.insel.ch/en/

Funders

Funder type

Charity

Funder name

Max and Hedwig Niedermaier Foundation (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University Hospital Bern (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes