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

Primary Purpose

Idiopathic Infertility

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Placebo
Pentoxifylline
zinc
zinc + pentoxifylline
Sponsored by
Arak University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Infertility

Eligibility Criteria

20 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    placebo group

    pentoxifylline group

    Zinc group

    pentoxifylline+ zinc group

    Arm Description

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

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

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

    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 )

    Outcomes

    Primary Outcome Measures

    count of sperm
    count of sperm(In per million - with the help of a neobar slide and microscopic observation
    motility of sperm
    motility of sperm: Calculate the percentage of motile sperm using microscopic observation
    morphology of sperm
    Calculate the percentage of sperm with a normal shape with the help of Papanic staining
    Malon di aldehyd evaluate
    Malondialdehyde (nmol/mL), will be measured using related experimental kits
    ROS evaluate
    reactive oxygen species (ROS (RLU/s)), will be measured using related experimental kits
    TAC (Total Antioxidant Capacity) evaluate
    total antioxidant capacity (TAC (/m / l)) will be measured using related experimental kits
    FSH hormon
    FSH (IU / L) will be measured from the blood serum of volunteers using ELISA kit
    LH hormon
    LH (IU / L) will be measured from the blood serum of volunteers using ELISA kit
    Testosteron hormon
    testosterone (nanomolar per liter) will be measured from the blood serum of volunteers using ELISA kit
    TNF α( Tissue necrosis Factor)
    TNF α( Tissue necrosis Factor) (pg/mL) as an inflammatory factor will be measured using related experimental kit
    Interleukin-6 (IL-6)
    Interleukin-6 (IL-6)/(pg/mL) as an inflammatory factor will be measured using related experimental kit
    Sperm DNA Fragmentation Assay(SDFA)
    DNA fragmentation will be assessed using an SDFA kit and microscopic observations (as a percentage of damaged sperm).

    Secondary Outcome Measures

    Full Information

    First Posted
    November 5, 2021
    Last Updated
    December 13, 2021
    Sponsor
    Arak University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05156684
    Brief Title
    Effect of Pentoxifylline and Zinc Co-administration in Patients With Oligoasthenoteratozoospermia
    Acronym
    OAT
    Official Title
    Evaluating the Therapeutic Effect of Pentoxifylline and Zinc Co-administration in Patients With Idiopathic Oligoasthenoteratozoospermia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2022 (Anticipated)
    Primary Completion Date
    January 10, 2022 (Anticipated)
    Study Completion Date
    May 28, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Arak University of Medical Sciences

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Idiopathic Infertility

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    140 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    placebo group
    Arm Type
    Experimental
    Arm Description
    Control group: oral rehydration salts (ORS, Poursina, Tehran, Iran), two times daily
    Arm Title
    pentoxifylline group
    Arm Type
    Experimental
    Arm Description
    Intervention group 1: received pentoxifylline (TRENTAL 400 mg modified release tablets, OSPS; 400 mg ,two times daily)
    Arm Title
    Zinc group
    Arm Type
    Experimental
    Arm Description
    Intervention group 2: received zinc ( Zinc Sulfate 220mg Capsules,One time daily)
    Arm Title
    pentoxifylline+ zinc group
    Arm Type
    Experimental
    Arm Description
    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 )
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    hydration solution
    Intervention Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Pentoxifylline
    Other Intervention Name(s)
    Trental
    Intervention Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    zinc
    Other Intervention Name(s)
    zinc sulfate
    Intervention Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    zinc + pentoxifylline
    Other Intervention Name(s)
    zinc sulfate+ trental
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    count of sperm
    Description
    count of sperm(In per million - with the help of a neobar slide and microscopic observation
    Time Frame
    One week after starting the medication
    Title
    motility of sperm
    Description
    motility of sperm: Calculate the percentage of motile sperm using microscopic observation
    Time Frame
    One week after starting the medication
    Title
    morphology of sperm
    Description
    Calculate the percentage of sperm with a normal shape with the help of Papanic staining
    Time Frame
    One week after starting the medication
    Title
    Malon di aldehyd evaluate
    Description
    Malondialdehyde (nmol/mL), will be measured using related experimental kits
    Time Frame
    One week after starting the medication
    Title
    ROS evaluate
    Description
    reactive oxygen species (ROS (RLU/s)), will be measured using related experimental kits
    Time Frame
    One week after starting the medication
    Title
    TAC (Total Antioxidant Capacity) evaluate
    Description
    total antioxidant capacity (TAC (/m / l)) will be measured using related experimental kits
    Time Frame
    One week after starting the medication
    Title
    FSH hormon
    Description
    FSH (IU / L) will be measured from the blood serum of volunteers using ELISA kit
    Time Frame
    One week after starting the medication
    Title
    LH hormon
    Description
    LH (IU / L) will be measured from the blood serum of volunteers using ELISA kit
    Time Frame
    One week after starting the medication
    Title
    Testosteron hormon
    Description
    testosterone (nanomolar per liter) will be measured from the blood serum of volunteers using ELISA kit
    Time Frame
    One week after starting the medication
    Title
    TNF α( Tissue necrosis Factor)
    Description
    TNF α( Tissue necrosis Factor) (pg/mL) as an inflammatory factor will be measured using related experimental kit
    Time Frame
    One week after starting the medication
    Title
    Interleukin-6 (IL-6)
    Description
    Interleukin-6 (IL-6)/(pg/mL) as an inflammatory factor will be measured using related experimental kit
    Time Frame
    One week after starting the medication
    Title
    Sperm DNA Fragmentation Assay(SDFA)
    Description
    DNA fragmentation will be assessed using an SDFA kit and microscopic observations (as a percentage of damaged sperm).
    Time Frame
    One week after starting the medication
    Other Pre-specified Outcome Measures:
    Title
    caspase 3 expression
    Description
    expression of caspase 3 gen (in p.c) using real-time PCR and Western blot
    Time Frame
    3 months
    Title
    BAX expression
    Description
    expression of BAX gen(in p.c) using real-time PCR and Western blot
    Time Frame
    3 months
    Title
    BCL 2 expression
    Description
    expression of BCL 2 gen (in p.c) using real-time PCR and Western blot
    Time Frame
    3 months

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Gender Eligibility Description
    men with idiopathic infertility
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    35182288
    Citation
    Dadgar Z, Shariatzadeh SMA, Mehranjani MS, Kheirolahi A. The therapeutic effect of co-administration of pentoxifylline and zinc in men with idiopathic infertility. Ir J Med Sci. 2023 Feb;192(1):431-439. doi: 10.1007/s11845-022-02931-0. Epub 2022 Feb 19.
    Results Reference
    derived

    Learn more about this trial

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

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