Evaluation of Treatment With Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile Men With Idiopathic Oligoasthenoteratospermia (infertility)

March 29, 2024 updated by: Ain Shams University

Evaluation of Treatment With Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile Men With Idiopathic Oligoasthenoteratospermia a Placebo Controlled Clinical Trial

Evaluation of treatment with Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile men with Idiopathic Oligoasthenoteratospermia

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Evaluation of treatment with Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile men with Idiopathic Oligoasthenoteratospermia a placebo controlled clinical trial

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • of in¬fertility of 1 year or more without the use of contraception

Exclusion Criteria:

  • o Active genital infections.

    • Patients with ejaculatory dysfunction
    • Azoospermia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
will receive a daily dose of 200 mg of CoQ10 for 3 months
Drug: co enzyme Q10 , L- Carnitine
Patient fulfilling inclusion criteria after obtaining consent will be randomized into four equal groups randomization will be computer based
Active Comparator: Group 2
will receive L-carnitine 1 tablet per day orally for 3 months
Drug: co enzyme Q10 , L- Carnitine
Patient fulfilling inclusion criteria after obtaining consent will be randomized into four equal groups randomization will be computer based
Active Comparator: Group 3
will receive combination of a daily dose of 200 mg of CoQ10 and 1 tablet of L-carnitine for 3 months
Drug: co enzyme Q10 , L- Carnitine
Patient fulfilling inclusion criteria after obtaining consent will be randomized into four equal groups randomization will be computer based
Placebo Comparator: Group 4
will receive a placebo for 3 months
Drug: co enzyme Q10 , L- Carnitine
Patient fulfilling inclusion criteria after obtaining consent will be randomized into four equal groups randomization will be computer based

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Semen analysis parameters compared to baseline
Time Frame: 6 months
Changes in Semen analysis parameters compared to baseline
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum hormone levels ([FSH], [LH], testosterone, and prolactin) levels compared to baseline and Cost analysis
Time Frame: 6 moths
Serum hormone levels ([FSH], [LH], testosterone, and prolactin) levels compared to baseline and Cost analysis
6 moths

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

March 8, 2024

First Submitted That Met QC Criteria

March 29, 2024

First Posted (Actual)

April 2, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • idiopathic infertility

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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