Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05457764 |
| Other study ID # |
VRStudy |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2021 |
| Est. completion date |
November 25, 2021 |
Study information
| Verified date |
July 2022 |
| Source |
Cryos International |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
