Comparison of Acetyl- L- Carnitine& Folic Acid Versus Coenzyme Q10& Folic Acid on Semen& Hormonal Parameters& Semen Oxidative Status in Patients of Primary Infertility. A Double Blind Randomized Clinical Trial

November 29, 2022 updated by: Mohsin Shah, Khyber Medical University Peshawar

Comparison of Acetyl- L- Carnitine and Folic Acid Versus Coenzyme Q10 and Folic Acid on Semen and Hormonal Parameters and Semen Oxidative Status in Patients of Primary Infertility. A Double Blind Randomized Clinical Trial

The investigators aim is to conduct a double blind randomized clinical trial, to study the effects of Acetyl-L-Carnitine and folic acid versus Coenzyme Q10 and folic acid on Semen and hormonal parameters and semen oxidative stress in patients of Primary infertility. Males diagnosed with Primary Infertility are recruited in the study after fulfilling the inclusion nd exclusion criteria. The investigators propose that Primary infertile men may have altered seminal oxidative status & the combinational therapy may achieve favorable seminal , hormonal& antioxidant levels in men having Primary infertility.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Historically, male infertility was considered a taboo subject and its role was deliberately kept in dark until recently when with advances in medical science, the issue was highlighted and its role came into limelight in couple's infertility. Male infertility is mainly caused by oxidative stress. O2- (superoxide anion), OH- (hydroxyl ions), H2O2 (hydrogen peroxide), nitric oxide & ROO- (peroxyl) radicals are all oxygen derived highly reactive oxygen species with a free unpaired electron in their outer orbit making them short lived, highly reactive & unstable. They are produced by the sperms & their normal level help in the sperm maturation, motility, capacitation & facilitation of fertilization. Sperms are at risk of the damage caused by overproduction of these ions. Several factors have been implicated in the overproduction of these reactive oxygen species which include men with testicular hyperthermia (varicocoele, cooks, and drivers) & overproduction by immature sperms & leucocytes. Their overproduction cause damage to the DNA and peroxidation of the lipid membrane leading to detrimental effects on sperms causing infertility There has been no consensus on treatment of male infertility in literature. No standardized treatment is suggested and different treatment combinations are currently been used to manage male infertility. The role of CoQ10 & Acetyl- L-Carnitine is explored recently in the different studies with no consensus on their dosage, duration of treatment & their effect on serum testosterone. This study is conducted to find out the role of Acetyl- L-Carnitine and Co enzyme Q 10 in combination with folic acid and their effect on semen parameters, semen oxidative stress & serum testosterone level in treating primary infertile men.

Objective: To find the effects of Acetyl-l-Carnitine and folic acid versus Coenzyme Q10 and folic acid therapy on sperm parameters, seminal oxidative status & serum testosterone level in primary infertility male patients.

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • Pakistan
    • Khyber Pakhtunkha
      • Peshawar, Khyber Pakhtunkha, Pakistan, 25120
        • Mohsin Shah, PhD

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

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Treatment naïve primary male infertile patients with Oligospermia, Asthenozoospermia , Teratozoospermia & Necrozoospermia
  2. Aged between 20 - 45 years
  3. Married for more than a year with regular intercourse minimum 3/week.
  4. Normal female partner with normal menstrual cycle

Exclusion Criteria:

  1. Azoospermic patients
  2. Patients with varicocoele
  3. Erectile dysfunction
  4. Secondary infertility
  5. Patients already taking treatment for primary infertility

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: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acetyl-L-Carnitine group
Acetyl-L-Carnitine (2gm once a day), folic acid 5mg (once a day) 43 Patients with Primary Infertility will receive Acetyl-L-Carnitine (2gm once a day) orally& folic acid 5mg orally was given to all the participants of this group (once a day).
Drug: Acetyl-l-carnitine, folic acid
Acetyl-l-carnitine 2gm once a day& folic acid will be given to 43 primary infertile men
Experimental: Control group
Coenzyme Q10 (400mg once a day) orally was given to all participants& folic acid 5mg (once a day) was also given orally to these participants 43 Patients with Primary Infertility will receive Coenzyme Q10 (400mg once a day), folic acid 5mg (once a day).
Drug: Acetyl-l-carnitine, folic acid
Acetyl-l-carnitine 2gm once a day& folic acid will be given to 43 primary infertile men

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in semen analysis before& after the administration of antioxidants& folic acid.
Time Frame: it will be done at the start of the trial and then after 3 months
semen analysis of the patients will be done and sperm count million/ml, motility, grading of motility(grade from 0 to 4), volumein ml will be analyzed.
it will be done at the start of the trial and then after 3 months
change in seminal oxidative status before& after the administration of antioxidants& folic acid.
Time Frame: it will be done at the start of the trial and then after 3 months
seminal plasma of the primary infertile men will be analyzed for total antioxidant capacity(TAC)& superoxide dismustase levels through commercially available Elisa kits.
it will be done at the start of the trial and then after 3 months
change in serum testosterone in nanograms/dl before& after the administration of antioxidants& folic acid.
Time Frame: it will be done at the start of the trial and then after 3 months
serum testosterone levels of the patients will be analyzed through commercially available Elisa kits
it will be done at the start of the trial and then after 3 months

Collaborators and Investigators

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

Sponsor

Khyber Medical University Peshawar

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)

August 6, 2022

Primary Completion (Actual)

November 28, 2022

Study Completion (Actual)

November 29, 2022

Study Registration Dates

First Submitted

October 20, 2022

First Submitted That Met QC Criteria

November 8, 2022

First Posted (Actual)

November 14, 2022

Study Record Updates

Last Update Posted (Actual)

November 30, 2022

Last Update Submitted That Met QC Criteria

November 29, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMU/IBMS/2022/59

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

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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