Home » Trials » Trial #197 » original TRDS
SLCTR Registration Number
SLCTR/2014/004
Date of Registration
The date of last modification
Feb 10, 2014
View original TRDS
Scientific Title of Trial
Effects of Co enzyme Q 10 on sperm quality: a Randomized Controlled Trial
Public Title of Trial
A study on the effects of Co enzyme Q 10 on improving semen quality.
Disease or Health Condition(s) Studied
Male Subfertility
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1149-7793
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
What is the effect of Co enzyme Q 10 compared to a placebo in improving the seminal fluid parameters in sub fertile men?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 4
Intervention(s) planned
⢠The study will be carried out at a tertiary care reproductive health centre (Vindana Reproductive Health centre) ⢠Sixty patients with idiopathic asthenozoospermia with normal sperm concentration will be recruited for the study. ⢠Following random allocation 30 patients will be treated with Co enzyme Q 10 (Ubiquinone) 90 mg/day for 3 months duration. ⢠The control group will also be treated with a placebo (An inert capsule) for same duration.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Change of sperm motility as assessed by seminal fluid analysis (SFA) |
[ Baseline seminal fluid analysis (SFA) at recruitment followed by monthly SFA up to 3 months ] |
Secondary outcome(s)
|
1.
Change of sperm concentration and sperm morphology as assessed by seminal fluid analysis (SFA) |
[ Baseline seminal fluid analysis (SFA) at recruitment followed by monthly SFA up to 3 months ] |
Target number/sample size
60
Countries of recruitment
Sri Lanka
Anticipated start date
2014-02-12
Anticipated end date
2014-09-01
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
1. Improving Relevance and Quality of Undergraduate Education (IRQUE) project funded by World Bank 2. A. Baur and Company Private Limited, Sri Lanka
Regulatory approvals
Status
Date of Approval
Approval number
Details of Ethics Review Committee
| Name: | |
| Institutional Address: | |
| Telephone: | |
| Email: |
Contact person for Scientific Queries/Principal Investigator
Athula Kaluarachchi
Professor in Obstetrics and Gynaecology
Department of Obstetrics and Gynaecology,
Faculty of Medicine,
University of Colombo.
0115849567I
0714765180
athula_kal@yahoo.com
Contact Person for Public Queries
Kalana Amarasekara
Research Assistant
Department of Obstetrics and Gynaecology,
Faculty of Medicine,
University of Colombo.
0115849567I
0716330659
akalanag@gmail.com
Primary study sponsor/organization
Improving Relevance and Quality of Undergraduate Education (IRQUE)
Policy planning and development unit
Ministry of Higher Education
No. 23/135, Diyawanna Udyanaya,
Chandra De Silva Mawatha,
Nugegoda.
0112814279
Secondary study sponsor (If any)
A. Baur and Company Private Limited
A. Baur and Company Private Limited.
No 62, Jethawana Road,
Colombo 14.
0114728711, 0774808450
tharindu@baurs.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
