A study of the effects of the FertilMate - a Scrotal COoling Patch on male fertility (SCOP)

ISRCTN	ISRCTN94041896
DOI	https://doi.org/10.1186/ISRCTN94041896
Protocol serial number	EM 11024
Sponsor	University of Nottingham (UK)
Funder	University of Nottingham (UK)

Submission date: 15/07/2011
Registration date: 29/09/2011
Last edited: 22/11/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
The testes are housed in the scrotum because the scrotum is a few degrees cooler than the core body temperature, which forms the best environment for sperm production. This study aims to find out whether exposing the scrotum to lower temperatures using a cooling patch improves the fertility of men who have abnormal sperm counts.

Who can participate?
Any man above the age of 18 who has an abnormal sperm count.

What does the study involve?
Participants are randomly allocated to one of two groups. Men in one group wear the cooling patch for 8 hours per day for a period of 90 consecutive days. Men in the other group do not wear the patch. In order to determine if there is an improvement we test the participants’ sperm count at the start and the end of the study.

What are the possible benefits and risks of participating?
To date we do not know of any risks as the cooling patch has been tested and proven to be safe.

Where is the study run from?
Nottingham University Hospitals (UK).

When is the study starting and how long is it expected to run for?
August 2011 to May 2012.

Who is funding the study?
University of Nottingham (UK).

Who is the main contact?
Mr William Atiomo (william.atiomo@nottingham.ac.uk)
Dr Ilias Nikolopoulos (illias.nikolopolous@nuh.nhs.uk)
Dr Waseem Osman (Mohammed.Osman@nuh.nhs.uk)

Contact information

Mr William Atiomo
Scientific

Nottingham University Hospitals
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised control trial pilot study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A pilot randomised study of the effects of the FertilMate - a scrotal cooling patch on male fertility
Study acronym	SCOP
Study objectives	To determine whether exposing the scrotum to lower temperatures by means of a scrotal cooling patch may improve fertility.
Ethics approval(s)	NRES Committee East Midlands - Nottingham 2, 27/05/2011, ref: 11/EM/0163
Health condition(s) or problem(s) studied	Reproductive medicine
Intervention	1. Scrotal cooling patch worn by the study group 2. Semen analyses on all 40 participants on day 0 and day 90 3. Serum metabolomics tested by means of 1x 20ml blood sample
Intervention type	Other
Primary outcome measure(s)	1. To determine whether exposing the scrotum to lower temperatures by means of a scrotal cooling patch may improve fertility 2. The main parameter will be a change to sperm count, quality and concentration 3. Improvements to sperm motility and morphology
Key secondary outcome measure(s)	Scrotal bloodflow
Completion date	01/05/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Male
Target sample size at registration	40
Key inclusion criteria	1. Males 2. Aged 18 to 45 years of age
Key exclusion criteria	1. Candidates who have undergone a vasectomy 2. Candidates who have an allergy to menthol 3. Males aged below 18 and older than 45 years on age 4. We will not be recruiting individuals that are unable to consent for themselves and nor will we be including participants who are from vulnerable groups
Date of first enrolment	01/08/2011
Date of final enrolment	01/05/2012

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Nottingham University Hospitals

Nottingham
NG7 2UH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	27/04/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

22/11/2018: No publications found, verifying study status with principal investigator.