AzTrials
AzTrials

InfertilityPhase 2NCT05616000

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

A Phase 2 study testing Acetyl-l-carnitine, folic acid in people with Infertility, run by Khyber Medical University Peshawar at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Infertility
What is being tested?
Acetyl-l-carnitine, folic acid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
1 sitePakistan
Study dates
6 Aug 2022to 29 Nov 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Mohsin Shah, PhD

    Peshawar, Khyber Pakhtunkha, 25120

Other trials in Pakistan

About this study

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

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.

Read the 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
Being tested
Acetyl-l-carnitine, folic acid
Keywords
Infertility, Acetyl-L-Carnitine, Coenzyme Q10
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acetyl-l-carnitine, folic acidDrug

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

Study groups in NCT05616000
Study groupRoleWhat they receive
Acetyl-L-Carnitine groupExperimentalAcetyl-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).
Receives: Drug: Acetyl-l-carnitine, folic acid
Control groupExperimentalCoenzyme 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).
Receives: Drug: Acetyl-l-carnitine, folic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: it will be done at the start of the trial and then after 3 months

  2. 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.

    Measured: it will be done at the start of the trial and then after 3 months

  3. 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

    Measured: it will be done at the start of the trial and then after 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2022
  2. Study start6 Aug 2022
  3. Primary completion28 Nov 2022
  4. Study completion29 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05616000
Sponsor's protocol ID
KMU/IBMS/2022/59
Status last verified
Nov 2022
First submitted
20 Oct 2022
Last updated
30 Nov 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23876974

  • 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.

    PubMed 19801627

  • 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.

    PubMed 11956464

  • 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.

    PubMed 25928197

  • 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.

    PubMed 12749418

  • 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.

    PubMed 20608353

  • 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.

    PubMed 23822772

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

    PubMed 22355991

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Acetyl-l-carnitine, folic acid in people with Infertility, run by Khyber Medical University Peshawar at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in semen analysis before& after the administration of antioxidants& folic acid. (time frame: it will be done at the start of the trial and then after 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05616000, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.

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