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

NCT05616000 | Completed Phase 2 DMC

• 1 other identifier: KMU/IBMS/2022/59
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

Infertility, Acetyl-L-Carnitine, Coenzyme Q10

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Acetyl-L-Carnitine group

EXPERIMENTAL

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

Control group

EXPERIMENTAL

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

Interventions

Acetyl-l-carnitine, folic acid DRUG

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

Acetyl-L-Carnitine group; Control group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Azoospermic patients
• Patients with varicocoele
• Erectile dysfunction
• Secondary infertility
• Patients already taking treatment for primary infertility

Sponsors & Collaborators

• Khyber Medical University Peshawar: lead

Study Sites (1)

Mohsin Shah, PhD

Peshawar, Khyber Pakhtunkha, 25120, Pakistan

Location

Related Publications (8)

• 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.

  PMID: 23876974 BACKGROUND

• 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.

  PMID: 19801627 BACKGROUND

• 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. No abstract available.

  PMID: 11956464 BACKGROUND

• 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.

  PMID: 25928197 BACKGROUND

• 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.

  PMID: 12749418 BACKGROUND

• 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.

  PMID: 20608353 BACKGROUND

• 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.

  PMID: 23822772 BACKGROUND

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

  PMID: 22355991 BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Acetylcarnitine; Folic Acid

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Carnitine; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: November 14, 2022
• Study Start: August 6, 2022
• Primary Completion: November 28, 2022
• Study Completion: November 29, 2022
• Last Updated: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)