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

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

Study Overview

• Status: Withdrawn
• Conditions: Idiopathic Infertility
• Intervention / Treatment: Drug: Coenzyme Q10

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3 ml of blood will be withdrawn from the patient for the serum hormones analysis and total amount of semen will required for analysis of semen parameters.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

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Karachi, Pakistan
    • HillPark Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: coenzyme Q10; 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 Names: NeoQ10

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure the change in semen parameters after 26 Weeks of coenzyme q10.	To measure the change in semen parameters after 26 Weeks of coenzyme q10. Designated as safety issue: No	26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event	Proportion of participants experiencing an adverse event (AE) leading to permanent discontinuation of study medication [Designated as safety issue: Yes]	26 weeks

Collaborators and Investigators

• Sponsor: PharmEvo Pvt Ltd
• Investigators: Study Chair: Masood Jawaid, MRCS,FCPS, PharmEvo Pvt Ltd

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): March 30, 2018
• Study Completion (Anticipated): May 30, 2018

Study Registration Dates

• First Submitted: March 28, 2017
• First Submitted That Met QC Criteria: April 3, 2017
• First Posted (Actual): April 7, 2017

Study Record Updates

• Last Update Posted (Actual): September 17, 2018
• Last Update Submitted That Met QC Criteria: September 13, 2018
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Infertility; Pakistan; Idiopathic; coenzyme q10
• Additional Relevant MeSH Terms: Infertility; Physiological Effects of Drugs; Micronutrients; Vitamins; Coenzyme Q10; Ubiquinone
• Other Study ID Numbers: PE/PK/Neotility/SP/2017-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No