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

NCT ID: NCT03104998

Last Updated: 2018-09-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2018-05-30

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3 ml of blood will be withdrawn from the patient for the serum hormones analysis and total amount of semen will required for analysis of semen parameters.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

Conditions

Idiopathic Infertility

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

coenzyme Q10

Dose of 200 mg of CoQ10 taken daily by mouth from day 1 till 26 weeks

Group Type: OTHER

Coenzyme Q10

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

NeoQ10

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

PharmEvo Pvt Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Masood Jawaid, MRCS,FCPS

Role: STUDY_CHAIR

PharmEvo Pvt Ltd

Locations

HillPark Hospital

Karachi, , Pakistan

Countries

Pakistan

References

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.

Reference Type: DERIVED

PMID: 35506389 (View on PubMed)

Other Identifiers

PE/PK/Neotility/SP/2017-01

Identifier Type: -

Identifier Source: org_study_id