Virtual RealityNCT05457764
Erotica by Virtual Reality on Sperm Donors
A study testing Virtual reality headset in people with Virtual Reality, run by Cryos International at 4 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 44 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality
- What is being tested?
- Virtual reality headset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 4 sitesDenmark
- Study dates
- 1 Aug 2021to 25 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 44 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Not an 'accepted' donor at Cryos International
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Cryos International - Aalborg ApS
Aalborg, 9000
Cryos International - Aarhus ApS
Aarhus C, 8000
Cryos International - København ApS
Copenhagen, 1620
Cryos International - Odense ApS
Odense, 5000
About this study
Official title: Does Erotica by Virtual Reality Improve Sperm Quality
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.
Read the detailed description
The study design was within-subjects repeated measures, using balanced, randomized, controlled, cross-over sampling. Data was collected between 1 August and 25 November 2021 in the four largest cities in Denmark (Copenhagen, Aarhus, Odense, and Aalborg) from consenting sperm donors at Cryos International. A total of 63 'accepted' donors (aged 19 - 44 years old and with a BMI between 17 to 35) participated in the study.
The VR setup involved a headset (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.
Sperm samples were donated in private rooms dedicated for the purpose and equipped with a touch screen showing erotic material. The men were asked to donate as usual and self-report the amount of time (in hours) since their last ejaculation (the abstinence period). Every other donation, donors rolled dice to determine whether a VR headset would be used; with the subsequent donation performed with the opposite condition. To maximize privacy and minimize stress on the donors, the amount of time the donors took to produce a sperm sample (donation period) was recorded as the number of seconds from closing the door to the private room to when it was opened again.
Each semen sample was weighed to determine ejaculate volume and allowed to liquify at room temperature for up to 1 hour. After liquefaction, aliquots were loaded in duplicate onto Makler counting chambers (Sefi-Medical, Israel) and observed at 200x magnification using an Olympus CX41 microscope (Olympus, Japan). Measurements of sperm concentration, motility and motile sperm concentration were made using a MICROPTIC, S.L. (Barcelona, Spain) Computer Assisted Sperm Analysis system with at least 500 cells counted per analysis. No analysis of sperm morphology was performed.
The investigators used linear mixed models (LMMs) to assess the relationship between VR-use and ejaculate volume, donation period and total motile sperm count (TMSC) for each ejaculate sample, while controlling for several factors that might also influence ejaculates: (i) abstinence period, (ii) donor age, (iii) donor BMI, (iv) day of the year (season), and (v) location (donation site). In each model, the investigators included anonymized donor identity as a random effect to avoid pseudo-replication as each donor provided multiple samples. The interaction between VR-use and abstinence period was initially included in models as abstinence period is known to increase ejaculate size and quality, though sometimes a decrease has been observed. The investigators considered it to be at least plausible that the influence of VR might diminish as abstinence period increased and both ejaculate size and quality approached their maxima for each donor. The investigators removed those interaction terms from models when p-values for the interactions was >0.20.
- Conditions
- Virtual Reality
- Being tested
- Virtual reality headset
- Keywords
- ejaculate quality, virtual reality, male fertility, sperm donation, erotic stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality headsetDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | Participants use Virtual reality headsets as medium of erotica to produce their sperm sample Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total motile sperm count
The total number of motile sperm cells in the ejaculate. Counted by computer assisted sperm analyzer
Measured: Within 1 hour of ejaculate sample procurement
Secondary outcomes (1)
Donation time
The time of which the sperm donors used in the donation rooms to produce the sperm sample
Measured: Within 120 minutes of commencement of donation of sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start1 Aug 2021
- Primary completion25 Nov 2021
- Study completion25 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Balanced and randomized controlled cross-over within-subjects design
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cryos International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Daniel Rosenkjær, Cryos International
- Investigators
- Daniel Rosenkjær, Principal investigator, Research Scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457764
- Sponsor's protocol ID
- VRStudy
- Status last verified
- Jul 2022
- First submitted
- 27 Jun 2022
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be publicly available on figshare.com, but in anonymized form so that IPD cannot be discerned.
Publications
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.
PubMed 36221120
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Erotica by Virtual Reality Improve Sperm Quality
- ClinicalTrials.gov ID
- NCT05457764
- Acronym / sponsor ID
- VRStudy
- Conditions
- Virtual Reality
- Keywords
- ejaculate quality, virtual reality, male fertility, sperm donation, erotic stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Cryos InternationalIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 25 Nov 2021 (actual)
- Study completion
- 25 Nov 2021 (actual)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study design was within-subjects repeated measures, using balanced, randomized, controlled, cross-over sampling. Data was collected between 1 August and 25 November 2021 in the four largest cities in Denmark (Copenhagen, Aarhus, Odense, and Aalborg) from consenting sperm donors at Cryos International. A total of 63 'accepted' donors (aged 19 - 44 years old and with a BMI between 17 to 35) participated in the study.
The VR setup involved a headset (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.
Sperm samples were donated in private rooms dedicated for the purpose and equipped with a touch screen showing erotic material. The men were asked to donate as usual and self-report the amount of time (in hours) since their last ejaculation (the abstinence period). Every other donation, donors rolled dice to determine whether a VR headset would be used; with the subsequent donation performed with the opposite condition. To maximize privacy and minimize stress on the donors, the amount of time the donors took to produce a sperm sample (donation period) was recorded as the number of seconds from closing the door to the private room to when it was opened again.
Each semen sample was weighed to determine ejaculate volume and allowed to liquify at room temperature for up to 1 hour. After liquefaction, aliquots were loaded in duplicate onto Makler counting chambers (Sefi-Medical, Israel) and observed at 200x magnification using an Olympus CX41 microscope (Olympus, Japan). Measurements of sperm concentration, motility and motile sperm concentration were made using a MICROPTIC, S.L. (Barcelona, Spain) Computer Assisted Sperm Analysis system with at least 500 cells counted per analysis. No analysis of sperm morphology was performed.
The investigators used linear mixed models (LMMs) to assess the relationship between VR-use and ejaculate volume, donation period and total motile sperm count (TMSC) for each ejaculate sample, while controlling for several factors that might also influence ejaculates: (i) abstinence period, (ii) donor age, (iii) donor BMI, (iv) day of the year (season), and (v) location (donation site). In each model, the investigators included anonymized donor identity as a random effect to avoid pseudo-replication as each donor provided multiple samples. The interaction between VR-use and abstinence period was initially included in models as abstinence period is known to increase ejaculate size and quality, though sometimes a decrease has been observed. The investigators considered it to be at least plausible that the influence of VR might diminish as abstinence period increased and both ejaculate size and quality approached their maxima for each donor. The investigators removed those interaction terms from models when p-values for the interactions was >0.20.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Balanced and randomized controlled cross-over within-subjects design
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Device: Virtual reality headsetParticipants use Virtual reality headsets as medium of erotica to produce their sperm sample |
| 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. |
Who may qualify
- Ages
- 19 to 44 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Not an 'accepted' donor at Cryos International
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality headsetThe 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. | Device | Virtual Reality |
Primary outcome
Total motile sperm count
Time frame: Within 1 hour of ejaculate sample procurement
The total number of motile sperm cells in the ejaculate. Counted by computer assisted sperm analyzer
1 secondary outcome
Donation time
Time frame: Within 120 minutes of commencement of donation of sample
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- Derived from this study: PubMed 36221120Rosenkjaer 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.
- Individual participant dataSharing planned: No. The data will be publicly available on figshare.com, but in anonymized form so that IPD cannot be discerned.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Rosenkjær principal investigator
Research Scientist
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality headset in people with Virtual Reality, run by Cryos International at 4 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total motile sperm count (time frame: Within 1 hour of ejaculate sample procurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05457764, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2022.