Home » Trials » SLCTR/2014/004


Effects of Co enzyme Q 10 on sperm quality: a Randomized Controlled Trial

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SLCTR Registration Number

SLCTR/2014/004


Date of Registration

11 Feb 2014

The date of last modification

Apr 30, 2019


View original TRDS


Trial Status



Application Summary


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

EC-09-041 (Ethics Review Committee Faculty of Medicine, University of Colombo)


Trial Details


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

  1. Male partners who are diagnosed to have male factor sub fertility seeking treatment at a tertiary care treatment centre 3.Age 20-45 years
  2. Base line seminal fluid parameters with sperm total motility <40%, sperm concentration >15*10^6 /ml, normal morphology >4%

Exclusion criteria

  1. Any congenital or acquired anatomical defect in the genital tract.(eg. cryptorchidism, varicocele)
  2. Systemic illness that is known to affect seminal fluid parameters
  3. Prescription of any medication that is known affect seminal fluid parameters
  4. History of chemotherapy or radiotherapy
  5. Currently on any other treatment for male sub fertility
  6. Known hypersensitivity for ubiquinone


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



State of Ethics Review Approval


Status

Approved


Date of Approval

2009-05-21


Approval number

EC-09-041


Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Colombo
Institutional Address:No. 25, Kynsey Road, Colombo 00800 Sri Lanka
Telephone:+94-11-2695300 (Extension: 240)
Email: ethicscommitteemfc@gmail.com

Contact & Sponsor Information


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

Trial Completion details


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

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results