Neotililty Trial: Effect of Coenzyme Q10 on Semen Parameters in Men With Idiopathic Infertility (Neotility)
|Idiopathic Infertility||Drug: Coenzyme Q10 Drug: Placebo Oral Tablet||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Neotililty Trial: Effect of Coenzyme Q10 on Semen Parameters in Men With Idiopathic Infertility|
- Measure the change in semen parameters after 26 Weeks of coenzyme q10. [ Time Frame: 26 weeks ]
To measure the change in semen parameters after 26 Weeks of coenzyme q10.
Designated as safety issue: No
- Adverse Event [ Time Frame: 26 weeks ]Proportion of participants experiencing an adverse event (AE) leading to permanent discontinuation of study medication [Designated as safety issue: Yes]
|Anticipated Study Start Date:||April 10, 2017|
|Estimated Study Completion Date:||May 30, 2018|
|Estimated Primary Completion Date:||March 31, 2018 (Final data collection date for primary outcome measure)|
Active Comparator: Active intervention: Coenzyme q10
Coenzyme Q10 (CoQ10) is an essential component of oxidative phosphorylation at mitochondrial level, and also functions to stabilize cell membranes as well as acting as a potent antioxidant. Coenzyme Q 10 shows a very strong correlation between sperm count, motility in disease associated with oxidative stress.
Drug: Coenzyme Q10
200 mg of CoQ10 or placebo daily by mouth from day 1 till 26 weeks. CoQ10 treatment is safe, even at the highest doses cited in the literature. Most clinical trials have not reported significant adverse effects that necessitated stopping therapy. However, gastrointestinal effects such as abdominal discomfort, nausea, vomiting, diarrhea, and anorexia have occurred. Allergic rash and headache have also been reported
Placebo Comparator: Placebo
Placebo will be identical packaging bottle as active comparator only identified by the patient allocation number
Drug: Placebo Oral Tablet
Placebo will be packaged in identical plastic bottles
Decreased serum CoQ10 concentrations as well as a decrease in the CoQ10H2 to-ubiquinone ratio have been demonstrated in diseases associated with OS. A strong correlation among sperm count, motility and ubiquinol-10 levels in seminal fluid has also been reported.
The aim of the present study is to investigate whether the effects of the exogenous administration of ubiquinol in the improvement of semen parameters in Pakistani men population.
Patients who full filled the inclusion criteria and gave informed written consent will be included in the trial. Patient will start to take coenzyme q10 and will take it for 26 weeks.
All men undergo a thorough physical examination, a detail history, serum biochemical and hematological laboratory tests and measurement of serum sex and thyroid hormone levels. Randomization codes will provided by the first investigator using a computer generated random number table. The randomization codes will centrally assign by the coordination with the eligibility criteria. A questionnaire will be used to collect information on demographic characteristics. Two semen samples 1and 2 month apart will be obtained after 3 to 5 days of sexual abstinence and process within 1 hour of ejaculation. The mean of the two will be used for statistical analysis. Semen analyses will be performed using WHO recommended methods
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