Neotililty Trial: Effect of Coenzyme Q10 on Semen Parameters in Men With Idiopathic Infertility (Neotility)

PharmEvo

Status and phase

Withdrawn

Phase 4

Conditions

Idiopathic Infertility

Treatments

Drug: Coenzyme Q10

Study type

Interventional

Funder types

Industry

Identifiers

NCT03104998

PE/PK/Neotility/SP/2017-01

Details and patient eligibility

About

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

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3 ml of blood will be withdrawn from the patient for the serum hormones analysis and total amount of semen will required for analysis of semen parameters.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

Sex

Male

Ages

20 to 50 years old

Volunteers

No Healthy Volunteers

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.