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OAT: Effect of Pentoxifylline and Zinc Co-administration in Patients With Oligoasthenoteratozoospermia

Sponsor
Arak University of Medical Sciences (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05156684
Collaborator
(none)
140
Enrollment
4
Arms
4.8
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The aim of this study is to investigate the impact of co-administration of Pentoxifylline and Zinc sulfate on oxidative stress, apoptosis, and inflammation, sperm capacitation and parameters in infertile men.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

This study will be performed as a double-blind randomized clinical trial on idiopathic infertile men (including oligoasthenosospermia, dyspnea, astheno-teratozoospermia, oligo-astheno-teratozoospermia) referred to Shafa Infertility 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. A food questionnaire is also taken from them to identify patients. Any medication that may affect sperm production should be discontinued within three months of the study.

Sampling and administration of pentoxifylline and zinc:

Preparation and analysis of semen samples are performed according to WHO 2010 recommendations. Semen samples are prepared by masturbating after a 3 to 5 day abstinence period. Two semen samples from these men, one before and the other after the intervention, are evaluated for basic parameters. For liquefaction, semen samples are incubated for 30 to 60 minutes at 37 ° C. Microscopic tests are performed to evaluate indicators such as sperm concentration in semen, motility and sperm morphology. Objectives and study methods are explained to patients who meet the inclusion criteria. Written consent is then obtained from the candidate. Body mass index (BMI) is assessed for patients. Also, at the beginning of the study, 5 cc of blood is taken from patients to measure reproductive hormones.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Evaluating the Therapeutic Effect of Pentoxifylline and Zinc Co-administration in Patients With Idiopathic Oligoasthenoteratozoospermia
Anticipated Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Jan 10, 2022
Anticipated Study Completion Date :
May 28, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: placebo group

Control group: oral rehydration salts (ORS, Poursina, Tehran, Iran), two times daily

Drug: Placebo
Infertile men referred to the infertility treatment center who, have had at least one year of unprotected intercourse, Natural fertility has not happened in their spouse. These men will all be married These men will be between the ages of 20 and 50. According to WHO criteria, Sperm parameters abnormalities should be observed in at least two spermogram within 2 weeks. Candidates receive two placebo tablets daily
Other Names:
  • hydration solution

    		•
    Experimental: pentoxifylline group

    Intervention group 1: received pentoxifylline (TRENTAL 400 mg modified release tablets, OSPS; 400 mg ,two times daily)

    Drug: Pentoxifylline
    Infertile men referred to the infertility treatment center who, have had at least one year of unprotected intercourse, Natural fertility has not happened in their spouse. These men will all be married These men will be between the ages of 20 and 50. According to WHO criteria, Sperm parameters abnormalities should be observed in at least two spermogram within 2 weeks. Candidates receive two trental tablets daily
    Other Names:
  • Trental

    		•
    Experimental: Zinc group

    Intervention group 2: received zinc ( Zinc Sulfate 220mg Capsules,One time daily)

    Drug: zinc
    Infertile men referred to the infertility treatment center who, have had at least one year of unprotected intercourse, Natural fertility has not happened in their spouse. These men will all be married These men will be between the ages of 20 and 50. According to WHO criteria, Sperm parameters abnormalities should be observed in at least two spermogram within 2 weeks. Candidates receive one zinc sulfate tablet daily
    Other Names:
  • zinc sulfate

    		•
    Experimental: pentoxifylline+ zinc group

    Intervention group 3: received pentoxifylline+ zinc (TRENTAL 400 mg modified release tablets, OSPS; 400 mg ,two times daily + Zinc Sulfate 220mg Capsules,One time daily )

    Drug: zinc + pentoxifylline
    Infertile men referred to the infertility treatment center who, have had at least one year of unprotected intercourse, Natural fertility has not happened in their spouse. These men will all be married These men will be between the ages of 20 and 50. According to WHO criteria, Sperm parameters abnormalities should be observed in at least two spermogram within 2 weeks. Candidates receive two pentoxifylline tablets+ one zinc tablet daily
    Other Names:
  • zinc sulfate+ trental

    		•

    Outcome Measures

    Primary Outcome Measures

    1. count of sperm [One week after starting the medication]

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

    2. motility of sperm [One week after starting the medication]

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

    3. morphology of sperm [One week after starting the medication]

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

    4. Malon di aldehyd evaluate [One week after starting the medication]

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

    5. ROS evaluate [One week after starting the medication]

      reactive oxygen species (ROS (RLU/s)), will be measured using related experimental kits

    6. TAC (Total Antioxidant Capacity) evaluate [One week after starting the medication]

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

    7. FSH hormon [One week after starting the medication]

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

    8. LH hormon [One week after starting the medication]

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

    9. Testosteron hormon [One week after starting the medication]

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

    10. TNF α( Tissue necrosis Factor) [One week after starting the medication]

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

    11. Interleukin-6 (IL-6) [One week after starting the medication]

      Interleukin-6 (IL-6)/(pg/mL) as an inflammatory factor will be measured using related experimental kit

    12. Sperm DNA Fragmentation Assay(SDFA) [One week after starting the medication]

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

    Other Outcome Measures

    1. caspase 3 expression [3 months]

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

    2. BAX expression [3 months]

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

    3. BCL 2 expression [3 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 50 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Idiopathic infertile men

    • have had at least one year of unprotected intercourse infertility

    • Sperm parameters abnormality

    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

    • diabetes mellitus

    • consumption of medications affecting carbohydrate metabolism

    • severe hepatic

    • pancreatitis

    • kidney diseases

    • gallbladder diseases

    • Patients with alcohol consumption

    • Patients who use cigarettes and drugs

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Arak University of Medical Sciences

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zeynab, Principal Investigator, Arak University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT05156684
    Other Study ID Numbers:
    • 96/197
    First Posted:
    Dec 14, 2021
    Last Update Posted:
    Jan 3, 2022
    Last Verified:
    Dec 1, 2021
    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
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Infertility
    Oligospermia
    Zinc
    Pentoxifylline
    Zinc Sulfate

    Study Results

    No Results Posted as of Jan 3, 2022