NCT05616000

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Khyber Medical University Peshawar · Academic / Other
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Infertility

Interventions

Type	Name	Description
DRUG	Acetyl-l-carnitine, folic acid	Acetyl-l-carnitine 2gm once a day\& folic acid will be given to 43 primary infertile men

Timeline

• Start date: 2022-08-06
• Primary completion: 2022-11-28
• Completion: 2022-11-29
• First posted: 2022-11-14
• Last updated: 2022-11-30

Locations

1 site across 1 country: Pakistan