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

NCT ID: NCT05616000

Last Updated: 2022-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-06
• Study Completion Date: 2022-11-29

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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).

Group Type: EXPERIMENTAL

Acetyl-l-carnitine, folic acid

Intervention Type: DRUG

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

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).

Group Type: EXPERIMENTAL

Acetyl-l-carnitine, folic acid

Intervention Type: DRUG

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

Interventions

Acetyl-l-carnitine, folic acid

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Khyber Medical University Peshawar

OTHER

Sponsor Role: lead

Responsible Party

Mohsin Shah

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mohsin Shah, PhD

Peshawar, Khyber Pakhtunkha, Pakistan

Countries

Pakistan

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 11956464 (View on PubMed)

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

PMID: 20608353 (View on PubMed)

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.

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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Other Identifiers

KMU/IBMS/2022/59

Identifier Type: -

Identifier Source: org_study_id