None listed
Conditions
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.
Interventions
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
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 4 hours per day but have the option of wear longer. Men are given a diary to use for which they can record the 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 by 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.
Sponsors
The University of Newcastle
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to 60 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed