Clinical trial NCT03104998: Neotililty Trial: Effect of Coenzyme Q10 on Semen Parameters in Men With Idiopathic Infertility
Official title: Neotililty Trial: Effect of Coenzyme Q10 on Semen Parameters in Men With Idiopathic Infertility
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Idiopathic Infertility
Keywords: Idiopathic
Infertility
coenzyme q10
Pakistan
Lead sponsor: PharmEvo Pvt Ltd
Sponsor class: INDUSTRY
First posted: 2017-04-07
Enrollment: 0
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To study the effect of coenzyme Q10 on semen parameters in men with idiopathic infertility

Detailed description: 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3 ml of blood will be withdrawn from the patient for the serum hormones analysis and total amount of semen will required for analysis of semen parameters.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.

Eligibility criteria: Inclusion Criteria:

* To sign the Informed Consent form
* Patients will be recruited in the study if they will fulfilled the criteria of history of primary infertility of more than 2 years, abnormal sperm count and motility
* age between 20 and 50 years
* No known medical or surgical condition which can result in infertility

Exclusion Criteria:

* Voluntary withdrawal
* Poor compliance of visit/treatment
* A history of cancer chemotherapy or radiotherapy
* A history of genital disease such as cryptorchidism and varicocele; a history of genital surgery
* Body mass index 30 kg/m or greater; any endocrinopathy
* Ychromosome microdeletions or karyotype abnormalities
* leukocytospermia
* Drug or substance abuse; tobacco use;
* Use of anticonvulsants, androgens or antiandrogens
* Significant liver (serum bilirubin greater than 2.0 mg/dl)
* Renal function (serum creatinine greater than 2.0 mg/dl) impairment
* Patients with severe oligozoospermia (less than 5 X 106/ml), azoospermia and testicular volume less than 12 ml will also excluded from study.

Primary outcomes:
measure: Measure the change in semen parameters after 26 Weeks of coenzyme q10.
timeFrame: 26 weeks
Secondary outcomes:
measure: Adverse Event
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: HillPark Hospital
Study officials:
affiliation: PharmEvo Pvt Ltd
name: Masood Jawaid, MRCS,FCPS
role: STUDY_CHAIR
References:
citation: de Ligny W, Smits RM, Mackenzie-Proctor R, Jordan V, Fleischer K, de Bruin JP, Showell MG. Antioxidants for male subfertility. Cochrane Database Syst Rev. 2022 May 4;5(5):CD007411. doi: 10.1002/14651858.CD007411.pub5.