Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000550505
Ethics application status
Approved
Date submitted
19/03/2024
Date registered
1/05/2024
Date last updated
1/05/2024
Date data sharing statement initially provided
1/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of scrotal cooling on semen quality for male-factor infertility.
Scientific title
Investigating the effect of a scrotal cooling device on sperm count, morphology and motility in men with male-factor infertility
Secondary ID [1] 311745 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
asthenoteratozoospermia 333227 0
oligozoospermia 333228 0
teratozoospermia 333229 0
asthenozoospermia 333230 0
idiopathic male-infertility 333231 0
Condition category
Condition code
Reproductive Health and Childbirth 329917 329917 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A new scrotal cooling device has been produced which will be tested in men over the course of 8 weeks to look for improvements in semen quality (motility, morphology, sperm count) and compared to 2 baseline samples. The device has temperature sensors that will trigger fans to turn on allowing for cooling if they detect the temperature is too high. Participants are supplied with the device as well as multiple pairs of underwear with an in-built ‘pouch’ in which the device sits in to maintain its position. Men are required to wear the device for a minimum of 8 hours per day but have the option of wear longer. Men are given a diary to use for which they can record their amount of time being worn. In addition, the device is equipped with a SD memory card. Using this card, it can be determined when the device has been used, whether the intervention was carried out correctly and for how long the device was used for. This can be achieved plotting the temperature data that is recorded every 10 seconds and determine if the device is actively cooling the environment. This serves as a safety net to gather data on usage if diary is neglected by participant. Finally, when men are finished using the device, they are offered the device to continue to use if natural pregnancy is wanted. However, in all cases, we are asking men for 2 semen samples 8 weeks post usage to determine if semen quality falls back to the baseline levels.
Intervention code [1] 328202 0
Treatment: Devices
Comparator / control treatment
The baseline control samples (2 semen samples taken a week apart with at least 48hr abstinence prior to collection) will be used as a control for each individual.
Semen samples will be collected at week 4 and week 8 of wearing the device (with at least 48hr abstinence prior to collection) to determine if semen quality improves with device usage.
An additional 2 semen samples will be collected at week 4 and 8 post-usage or week 12 and 16 trial timeline (with at least 48hr abstinence prior to collection) to determine if semen quality returns to baseline parameters.
Control group
Active

Outcomes
Primary outcome [1] 337686 0
Change in the total amount of sperm produced
Timepoint [1] 337686 0
baseline samples, 4-week samples post-baseline, 8-week samples post-baseline, 4-week samples post-completion, 8-week samples post-completion.
Primary outcome [2] 337951 0
Sperm morphology
Timepoint [2] 337951 0
baseline samples, 4-week samples post-baseline, 8-week samples post-baseline, 4-week samples post-completion, 8-week samples post-completion.
Primary outcome [3] 337952 0
sperm motility
Timepoint [3] 337952 0
baseline samples, 4-week samples post-baseline, 8-week samples post-baseline, 4-week samples post-completion, 8-week samples post-completion.
Secondary outcome [1] 432824 0
Sperm DNA damage
Timepoint [1] 432824 0
baseline samples, 4-week samples post-baseline, 8-week samples post-baseline, 4-week samples post-completion, 8-week samples post-completion.
Secondary outcome [2] 432825 0
Pregnancy rates
Timepoint [2] 432825 0
Pregnancy within the year with treatment

Eligibility
Key inclusion criteria
1) Men presenting to the fertility clinic or donors with reduced semen quality based on one or more of the following parameters:
i. Total sperm number per ejaculate of > 1 million but < 39 million.
ii. Progressive motility less than or equal to 31%.
iii. Normal forms <4%.
2) At least 6 months of regular (2 times/week) sexual intercourse without success.
3) A partner aged 35 years or less and with regular menstrual cycles and no known cause of infertility.
4) Men aged between 18 to 60 years old.
5) Men able to give 6 donations over the trial period.
6) Both male and female partner able to provide signed, written informed consent.
7) Both male and female partner prepared to have unprotected, non-contraceptive sexual intercourse every 2-3 days with the intention to initiate a pregnancy for the duration of the trial.
8) A female partner who is willing to consent to or provide the results of a hCG blood test or ultrasound for pregnancy confirmation.
Minimum age
18 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1) Either partner has a known genetic disorder or chromosomal abnormalities.
2) Either partner with a past history of chemotherapy/radiotherapy that could affect fertility, or men with post-pubertal mumps, orchitis or orchidectomy of any cause.
3) Men who have presented or been treated for orchitis, epididymitis or urethritis in the past year.
4) Any form of smoking (tobacco, marijuana etc) within the past year (self report).
5) Either partner with a past or current history of a relevant infectious disease (chlamydia, gonorrhoea, genital herpes, hepatitis B, HIV/AIDS or syphilis).
6) Either partner with a chronic medical condition, including: Cancer, Chronic Obstructive Pulmonary Disease, Crohns disease, cystic fibrosis, diabetes, epilepsy, heart disease, multiple sclerosis, or Parkinson’s disease.
7) Either partner with a serious psychiatric condition including autism, attention deficit-hyperactivity disorder, bipolar disorder, major depressive disorder and schizophrenia that may prevent compliance with the protocol.
8) Couples that intend on using Assisted concpetion in the next 8 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
we will use a linear mixed model to account for the repeated measures, with a random effect for individual, and a fixed effect for group. We will use group, time, and a group x time interaction term in the model

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2024
Actual
Date of last participant enrolment
Anticipated
1/03/2025
Actual
Date of last data collection
Anticipated
1/05/2026
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 26201 0
Mexico
State/province [1] 26201 0
Mazatlan

Funding & Sponsors
Funding source category [1] 316077 0
Government body
Name [1] 316077 0
National Health and Medical Reserach Council
Country [1] 316077 0
Australia
Primary sponsor type
Government body
Name
National Health and Medical Reserach Council
Address
Country
Australia
Secondary sponsor category [1] 318243 0
None
Name [1] 318243 0
Address [1] 318243 0
Country [1] 318243 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314895 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 314895 0
http://www.newcastle.edu.au/research/research-services/human-ethics/
Ethics committee country [1] 314895 0
Australia
Date submitted for ethics approval [1] 314895 0
10/11/2022
Approval date [1] 314895 0
03/08/2023
Ethics approval number [1] 314895 0
H-2022-0369

Summary
Brief summary
The trial is to test a new device and determine if scrotal cooling improves semen quality. We expect to observe an improvement in all measured semen parameters (morphology, motility, concentration, DNA damage) with the use of the scrotal cooling device.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133082 0
Prof Mark Baker
Address 133082 0
The University of Newcastle, University drive, Callaghan, NSW, 2203
Country 133082 0
Australia
Phone 133082 0
+61 2 4921 7880
Fax 133082 0
Email 133082 0
Mark.Baker@newcastle.edu.au
Contact person for public queries
Name 133083 0
Mark Baker
Address 133083 0
The University of Newcastle, University drive, Callaghan, NSW, 2203
Country 133083 0
Australia
Phone 133083 0
+61 2 4921 7880
Fax 133083 0
Email 133083 0
Mark.Baker@newcastle.edu.au
Contact person for scientific queries
Name 133084 0
Mark Baker
Address 133084 0
The University of Newcastle, University drive, Callaghan, NSW, 2203
Country 133084 0
Australia
Phone 133084 0
+61 2 4921 7880
Fax 133084 0
Email 133084 0
Mark.Baker@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data will be made available with the baseline semen analysis and the 8 week post intervention.
When will data be available (start and end dates)?
Beginning 3 months with no end date
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
any purpose
How or where can data be obtained?
Access subject to approvals can be obtained by emailing the principal investigator (Mark.Baker@newcastle.edu.au)


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.