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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05616000
• Other study ID #: KMU/IBMS/2022/59
• Status: Completed
• Phase: Phase 2
• Start date: August 6, 2022
• Est. completion date: November 29, 2022

Study information

• Verified date: November 2022
• Source: Khyber Medical University Peshawar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: November 29, 2022
• Est. primary completion date: November 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Acetyl-l-carnitine, folic acid
Acetyl-l-carnitine 2gm once a day& folic acid will be given to 43 primary infertile men

Locations

Country	Name	City	State
Pakistan	Mohsin Shah, PhD	Peshawar	Khyber Pakhtunkha

Sponsors (1)

Lead Sponsor	Collaborator
Khyber Medical University Peshawar

Country where clinical trial is conducted

Pakistan, 

References & Publications (8)

Agarwal A, Mulgund A, Hamada A, Chyatte MR. A unique view on male infertility around the globe. Reprod Biol Endocrinol. 2015 Apr 26;13:37. doi: 10.1186/s12958-015-0032-1. — View Citation

Agarwal A, Saleh RA, Bedaiwy MA. Role of reactive oxygen species in the pathophysiology of human reproduction. Fertil Steril. 2003 Apr;79(4):829-43. doi: 10.1016/s0015-0282(02)04948-8. — View Citation

Ahmed SD, Karira KA, Jagdesh, Ahsan S. Role of L-carnitine in male infertility. J Pak Med Assoc. 2011 Aug;61(8):732-6. — View Citation

Banihani S, Agarwal A, Sharma R, Bayachou M. Cryoprotective effect of L-carnitine on motility, vitality and DNA oxidation of human spermatozoa. Andrologia. 2014 Aug;46(6):637-41. doi: 10.1111/and.12130. Epub 2013 Jul 3. — View Citation

Jarow JP, Sharlip ID, Belker AM, Lipshultz LI, Sigman M, Thomas AJ, Schlegel PN, Howards SS, Nehra A, Damewood MD, Overstreet JW, Sadovsky R; Male Infertility Best Practice Policy Committee of the American Urological Association Inc. Best practice policies for male infertility. J Urol. 2002 May;167(5):2138-44. — View Citation

Shi JZ, Zhang SS, Zhang Z, Liang Q, Shi Y, Hua JL, Sun T. [Expressions of sperm-specific genes in carnitine-cultured testis sperm of obstructive azoospermia patients]. Zhonghua Nan Ke Xue. 2010 Jun;16(6):504-9. Chinese. — View Citation

Wischmann T, Thorn P. (Male) infertility: what does it mean to men? New evidence from quantitative and qualitative studies. Reprod Biomed Online. 2013 Sep;27(3):236-43. doi: 10.1016/j.rbmo.2013.06.002. Epub 2013 Jun 19. — View Citation

Zegers-Hochschild F, Adamson GD, de Mouzon J, Ishihara O, Mansour R, Nygren K, Sullivan E, van der Poel S; International Committee for Monitoring Assisted Reproductive Technology; World Health Organization. The International Committee for Monitoring Assisted Reproductive Technology (ICMART) and the World Health Organization (WHO) Revised Glossary on ART Terminology, 2009. Hum Reprod. 2009 Nov;24(11):2683-7. doi: 10.1093/humrep/dep343. Epub 2009 Oct 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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