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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Infertility

Intervention / Treatment
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* Drug: Acetyl-l-carnitine, folic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Treatment naïve primary male infertile patients with Oligospermia, Asthenozoospermia , Teratozoospermia & Necrozoospermia Aged between 20 - 45 years Married for more than a year with regular intercourse minimum 3/week. Normal female partner with normal menstrual cycle Exclusion Criteria: Azoospermic patients Patients with varicocoele Erectile dysfunction Secondary infertility Patients already taking treatment for primary infertility

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acetyl-L-Carnitine group<br>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<br>* Acetyl-l-carnitine 2gm once a day& folic acid will be given to 43 primary infertile men<br>|
| Experimental: Control group<br>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<br>* Acetyl-l-carnitine 2gm once a day& folic acid will be given to 43 primary infertile men<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in semen analysis before& after the administration of antioxidants& folic acid. | 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. | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infertility, Acetyl-L-Carnitine, Coenzyme Q10