This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified March 2017 by PharmEvo Pvt Ltd
Sponsor:
Information provided by (Responsible Party):
PharmEvo Pvt Ltd
ClinicalTrials.gov Identifier:
NCT03104998
First received: March 28, 2017
Last updated: April 3, 2017
Last verified: March 2017
  Purpose
To study the effect of coenzyme Q10 on semen parameters in men with idiopathic infertility

Condition Intervention Phase
Idiopathic Infertility Drug: Coenzyme Q10 Drug: Placebo Oral Tablet Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel 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
Anticipated Study Start Date: April 10, 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
Active Comparator: Active intervention: Coenzyme q10
Coenzyme Q10 (CoQ10) is an essential component of oxidative phosphorylation at mitochondrial level, and also functions to stabilize cell membranes as well as acting as a potent antioxidant. Coenzyme Q 10 shows a very strong correlation between sperm count, motility in disease associated with oxidative stress.
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
Placebo Comparator: Placebo
Placebo will be identical packaging bottle as active comparator only identified by the patient allocation number
Drug: Placebo Oral Tablet
Placebo will be packaged in identical plastic bottles

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 coenzyme q10 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. Randomization codes will provided by the first investigator using a computer generated random number table. The randomization codes will centrally assign by the coordination with the eligibility criteria. A questionnaire will be used to collect information on demographic characteristics. Two semen samples 1and 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

  Eligibility

Ages Eligible for Study:   25 Years to 44 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
  • Wife age between 20 and 40 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: PharmEvo Pvt Ltd
ClinicalTrials.gov Identifier: NCT03104998     History of Changes
Other Study ID Numbers: Neotility/PV/001
Study First Received: March 28, 2017
Last Updated: April 3, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
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

ClinicalTrials.gov processed this record on September 19, 2017