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
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2

Summary: 
      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: 
      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.
    

Intervention name(s): Acetyl-l-carnitine, folic acid
Intervention type(s): Drug
Intervention description(s): Acetyl-l-carnitine 2gm once a day& folic acid will be given to 43 primary infertile men
Intervention MeSH terms: Folic Acid; Acetylcarnitine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Infertility, Acetyl-L-Carnitine, Coenzyme Q10