Neotililty Trial: Effect of Coenzyme Q10 on Semen Parameters in Men With Idiopathic Infertility (Neotility)
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|ClinicalTrials.gov Identifier: NCT03104998|
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : November 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Infertility||Drug: Coenzyme Q10||Phase 4|
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 medication 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. A questionnaire will be used to collect information on demographic characteristics. Two semen samples 1 and 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.
3 ml of blood will be withdrawn from the patient for the serum hormones analysis and total amount of semen will required for analysis of semen parameters.
Sponsor will bear the test cost of patient during the study treatment period.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neotililty Trial: Effect of Coenzyme Q10 on Semen Parameters in Men With Idiopathic Infertility|
|Actual Study Start Date :||August 1, 2017|
|Estimated Primary Completion Date :||March 31, 2018|
|Estimated Study Completion Date :||May 30, 2018|
Dose of 200 mg of CoQ10 taken daily by mouth from day 1 till 26 weeks
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
Other Name: NeoQ10
- 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]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03104998
|Contact: Anum Siddiqui, PharmDfirstname.lastname@example.org|
|Contact: Masood Jawaid, MRCS,FCPS|
|Contact: Sonia Naqvi, MBBS 0300 8248208 Sonia_naqvi@hotmail.com|
|Study Chair:||Masood Jawaid, MRCS,FCPS||PharmEvo Pvt Ltd|