NCT05457764

Brief Summary

Objective To study whether erotica by virtual reality (VR) during masturbation influences the quality of sperm donor ejaculates. Hypothesis Erotica by virtual reality improves ejaculate quality.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 14, 2022

Completed
Last Updated

July 14, 2022

Status Verified

July 1, 2022

Enrollment Period

4 months

First QC Date

June 27, 2022

Last Update Submit

July 11, 2022

Conditions

Keywords

ejaculate qualityvirtual realitymale fertilitysperm donationerotic stimulation

Outcome Measures

Primary Outcomes (1)

  • Total motile sperm count

    The total number of motile sperm cells in the ejaculate. Counted by computer assisted sperm analyzer

    Within 1 hour of ejaculate sample procurement

Secondary Outcomes (1)

  • Donation time

    Within 120 minutes of commencement of donation of sample

Study Arms (2)

Virtual Reality

EXPERIMENTAL

Participants use Virtual reality headsets as medium of erotica to produce their sperm sample

Device: Virtual reality headset

No Virtual Reality

NO INTERVENTION

Participants did not use Virtual reality headsets as medium of erotica to produce their sperm sample. They used a computer screen to display erotica.

Interventions

The VR headset was a Pico G2, Pico Interactive, San Fransisco, USA, offering a choice from 60 erotic videos each of 10-30 minutes duration. The men were allowed to watch any and as many of these video clips as they wished. The "No VR" arm, donors used the computer monitor available in the donation rooms.

Virtual Reality

Eligibility Criteria

Age19 Years - 44 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Must be able to donate at least 3 samples for each study arm (i.e. minimum 6 samples total).
  • Must be an 'accepted' donor at Cryos International i.e. must have a post thaw sperm concentration of ≥5x106 per ml.

You may not qualify if:

  • Not an 'accepted' donor at Cryos International

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Cryos International - Aalborg ApS

Aalborg, 9000, Denmark

Location

Cryos International - Aarhus ApS

Aarhus C, 8000, Denmark

Location

Cryos International - København ApS

Copenhagen, 1620, Denmark

Location

Cryos International - Odense ApS

Odense, 5000, Denmark

Location

Related Publications (1)

  • Rosenkjaer D, Pacey A, Montgomerie R, Skytte AB. Effects of virtual reality erotica on ejaculate quality of sperm donors: a balanced and randomized controlled cross-over within-subjects trial. Reprod Biol Endocrinol. 2022 Oct 11;20(1):149. doi: 10.1186/s12958-022-01021-1.

Study Officials

  • Daniel Rosenkjær

    Research Scientist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Balanced and randomized controlled cross-over within-subjects design
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

June 27, 2022

First Posted

July 14, 2022

Study Start

August 1, 2021

Primary Completion

November 25, 2021

Study Completion

November 25, 2021

Last Updated

July 14, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

The data will be publicly available on figshare.com, but in anonymized form so that IPD cannot be discerned.

Locations