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PTX-Zn: The Therapeutic Effect of Co-administration of Pentoxifylline and Zinc in Men With Idiopathic Asthenozoospermia

Sponsor
Arak University of Medical Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT05178953
Collaborator
(none)
160
Enrollment
2
Locations
3
Arms
5.7
Anticipated Duration (Months)
80
Patients Per Site
14.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study was to investigate the therapeutic effect of co-administration of pentoxifylline and zinc on sperm apoptosis in men with idiopathic infertility

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Detailed Description

This study is being performed as a double-blind randomized clinical trial on idiopathic infertile men referred to the infertility clinic of Shafa Clinic. Patient satisfaction, non-use of contraceptives, men aged 25 to 43 years, and idiopathic infertility according to WHO criteria (World Health, 2010) are our study criteria. Any medication that may affect the course of spermatogenesis should be discontinued during the study. Semen samples are taken from patients (before and after interventions) and apoptosis tests are performed on semen samples.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
The Therapeutic Effect of Co-administration of Pentoxifylline and Zinc on Semen Parameters, Reproductive Hormones, DNA Fragmentation, and Some Biochemical, and Inflammatory Parameters in Men With Idiopathic Infertility
Actual Study Start Date :
Aug 1, 2021
Anticipated Primary Completion Date :
Jan 8, 2022
Anticipated Study Completion Date :
Jan 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: pentoxifylline group

Group 1: Patients receiving pentoxifylline (TRENTAL 400 mg tablets, OSPS; 400 mg, twice daily) Infertile men referred to an infertility treatment center who have had unprotected sex for at least one year have not had normal fertility in their partner. These men are all married. According to WHO criteria, sperm motility abnormalities are observed in these patients. These volunteers receive two pentoxifylline tablets(400 mg) daily for 3 month, (TRENTAL 400 mg modified release tablets, OSPS; 400 mg ,two times daily) Other names: Trental

Drug: Pentoxifylline
Oral use of pentoxifylline is effective in treating cardiovascular disease, cerebrovascular disease, and other conditions associated with local circulatory disorders. Pentoxifylline affects blood viscosity. Infertile men with asthenospermia receive 400 mg pentoxifylline tablets for 3 months
Other Names:
  • Trental

    		•
    Experimental: Zinc Sulfate group

    Infertile men referred to an infertility treatment center who have had unprotected sex for at least one year have not had normal fertility in their partner. These men are all married. According to WHO criteria, sperm motility abnormalities are observed in these patients. Candidates receive one zinc sulfate tablet(229 mg) daily for 3 month,(Zinc Sulfate 220mg Capsules) Other Names: zinc sulfate

    Drug: Zinc Sulfate 220 mg Capsules
    Zinc is an element that is involved in the activity of antioxidant enzymes. For example, the superoxide dismutase needs copper and zinc to function properly. Infertile men with asthenospermia receive 220 mg zinc sulfate tablets for 3 months
    Other Names:
  • zinc

    		•
    Experimental: pentoxifylline+ zinc group

    Infertile men referred to an infertility treatment center who have had unprotected sex for at least one year have not had normal fertility in their partner. These men are all married. According to WHO criteria, sperm motility abnormalities are observed in these patients. Candidates receive one zinc sulfate(220mg) tablet+ two pentoxifylline tablets(400 mg) daily for 3 month (TRENTAL 400 mg modified release tablets, OSPS; 400 mg +Zinc Sulfate 220mg Capsules) Other Names: zinc sulfate

    Drug: Zinc Sulfate 220 mg Capsules
    Zinc is an element that is involved in the activity of antioxidant enzymes. For example, the superoxide dismutase needs copper and zinc to function properly. Infertile men with asthenospermia receive 220 mg zinc sulfate tablets for 3 months
    Other Names:
  • zinc

    • Drug: Pentoxifylline
    Oral use of pentoxifylline is effective in treating cardiovascular disease, cerebrovascular disease, and other conditions associated with local circulatory disorders. Pentoxifylline affects blood viscosity. Infertile men with asthenospermia receive 400 mg pentoxifylline tablets for 3 months
    Other Names:
  • Trental

    		•

    Outcome Measures

    Primary Outcome Measures

    1. sperm concentration [1 day]

      count of sperm(In per million - with the help of a neobar slide and microscopic observation

    2. spem motility [1 day]

      motility of sperm: Calculate the percentage of motile sperm using microscopic observation

    3. sperm morphology [1 day]

      Calculate the percentage of sperm with a normal shape with the help of Papanic staining

    4. lipid proxidation [One week]

      Malondialdehyde (nmol/mL), is measured using related experimental kits

    5. reactive oxygen species [One week]

      eactive oxygen species (ROS (RLU/s)), is measured using related experimental kits

    6. total antioxidant capacity [One week]

      total antioxidant capacity (TAC (/m / l)) is measured using related experimental kits

    7. FSH hormon [One week]

      FSH (IU / L) is measured from the blood serum of volunteers using ELISA kit

    8. LH hormon [One week]

      LH (IU / L) is measured from the blood serum of volunteers using ELISA kit

    9. testosteron hormon [ Time Frame: One week after starting the medication ] testosterone [One week]

      testosterone (nanomolar per liter) is measured from the blood serum of volunteers using ELISA kit

    10. (Tissue necrosis Factor) [One week]

      TNF α( Tissue necrosis Factor) (pg/mL) as an inflammatory factor is measured using related experimental kit

    11. interleukin-6 [One week]

      interleukin-6 (IL-6)/(pg/mL) as an inflammatory factor is measured using related experimental kit

    12. Sperm DNA Fragmentation Assay(SDFA) [One week]

      DNA fragmentation is assessed using an SDFA kit and microscopic observations (as a percentage of damaged sperm).

    Secondary Outcome Measures

    1. BAX expression [3 month]

      BAX expression [ Time Frame: 3 months ] expression of BAX gen(in p.c) using real-time PCR and Western blot

    2. Bcl2 expression [3 months]

      Bcl-2 gen(in p.c) using real-time PCR and Western blot

    3. caspase 3 expression [3 months]

      expression of caspase 3 gen(in p.c) using real-time PCR and Western blot

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    23 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • infertile men

    • have had at least one year of unprotected intercourse infertility

    • asthenozoospermia

    Exclusion Criteria:

    • Men with varicocele

    • Hypersensitivity to pentoxifylline & zinc,

    • pelvic organic pathologies

    • congenital adrenal hyperplasia

    • thyroid dysfunction

    • Cushing's syndrome

    • hyper prolactinemia

    • androgen secreting neoplasia

    • severe hepatic

    • pancreatitis

    • kidney diseases

    • gallbladder diseases

    • Patients with alcohol consumption

    • Patients who use cigarettes and drugs

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Infertility Center Arak Markazi Iran, Islamic Republic of 6853462355
    2 Arak university of medical science Arak Markazi Iran, Islamic Republic of 68985432

    Sponsors and Collaborators

    • Arak University of Medical Sciences

    Investigators

    • Principal Investigator: zeynab dadgar, dr, arak university of medical science

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zeynab, Principal Investigator, Arak University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT05178953
    Other Study ID Numbers:
    • 1898
    First Posted:
    Jan 5, 2022
    Last Update Posted:
    Jan 5, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infertility
    Zinc
    Pentoxifylline
    Zinc Sulfate

    Study Results

    No Results Posted as of Jan 5, 2022