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

This study is currently recruiting participants.
Verified March 2017 by PharmEvo Pvt Ltd
Sponsor:
ClinicalTrials.gov Identifier:
NCT03104998
First Posted: April 7, 2017
Last Update Posted: November 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
PharmEvo Pvt Ltd
  Purpose
To study the effect of coenzyme Q10 on semen parameters in men with idiopathic infertility

Condition Intervention Phase
Idiopathic Infertility Drug: Coenzyme Q10 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neotililty Trial: Effect of Coenzyme Q10 on Semen Parameters in Men With Idiopathic Infertility

Resource links provided by NLM:


Further study details as provided by PharmEvo Pvt Ltd:

Primary Outcome Measures:
  • 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



Secondary Outcome Measures:
  • 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]


Estimated Enrollment: 200
Actual Study Start Date: August 1, 2017
Estimated Study Completion Date: May 30, 2018
Estimated Primary Completion Date: March 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: NeoQ10

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Anum Siddiqui, PharmD 9221-34315195 anum.siddiqui@pharmevo.biz
Contact: Masood Jawaid, MRCS,FCPS

Locations
Pakistan
HillPark Hospital Recruiting
Karachi, Pakistan
Contact: Sonia Naqvi, MBBS    0300 8248208    Sonia_naqvi@hotmail.com   
Sponsors and Collaborators
PharmEvo Pvt Ltd
Investigators
Study Chair: Masood Jawaid, MRCS,FCPS PharmEvo Pvt Ltd
  More Information

Responsible Party: PharmEvo Pvt Ltd
ClinicalTrials.gov Identifier: NCT03104998     History of Changes
Other Study ID Numbers: PE/PK/Neotility/SP/2017-01
First Submitted: March 28, 2017
First Posted: April 7, 2017
Last Update Posted: November 1, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by PharmEvo Pvt Ltd:
Idiopathic
Infertility
coenzyme q10
Pakistan

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Coenzyme Q10
Ubiquinone
Micronutrients
Growth Substances
Physiological Effects of Drugs
Vitamins