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

NCT05156684 | Unknown DMC

• 1 other identifier: 96/197
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Idiopathic Infertility

Outcome Measures

Primary Outcomes (12)

• count of sperm

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

  One week after starting the medication

• motility of sperm

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

  One week after starting the medication

• morphology of sperm

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

  One week after starting the medication

• Malon di aldehyd evaluate

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

  One week after starting the medication

• ROS evaluate

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

  One week after starting the medication

• TAC (Total Antioxidant Capacity) evaluate

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

  One week after starting the medication

• FSH hormon

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

  One week after starting the medication

• LH hormon

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

  One week after starting the medication

• Testosteron hormon

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

  One week after starting the medication

• TNF α( Tissue necrosis Factor)

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

  One week after starting the medication

• Interleukin-6 (IL-6)

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

  One week after starting the medication

• Sperm DNA Fragmentation Assay(SDFA)

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

  One week after starting the medication

Other Outcomes (3)

• caspase 3 expression

  3 months

• BAX expression

  3 months

• BCL 2 expression

  3 months

Study Arms (4)

placebo group

EXPERIMENTAL

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

Drug: Placebo

pentoxifylline group

EXPERIMENTAL

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

Drug: Pentoxifylline

Zinc group

EXPERIMENTAL

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

Drug: zinc

pentoxifylline+ zinc group

EXPERIMENTAL

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

Interventions

Placebo DRUG

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

Also known as: hydration solution

placebo group

Pentoxifylline DRUG

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

Also known as: Trental

pentoxifylline group

zinc DRUG

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

Also known as: zinc sulfate

Zinc group

zinc + pentoxifylline DRUG

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

Also known as: zinc sulfate+ trental

pentoxifylline+ zinc group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Gender Eligibility Details: men with idiopathic infertility
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Idiopathic infertile men
• have had at least one year of unprotected intercourse infertility
• Sperm parameters abnormality

You may not qualify if:

• 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

Sponsors & Collaborators

• Arak University of Medical Sciences: lead

Related Publications (1)

• 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.

  PMID: 35182288 DERIVED

MeSH Terms

Interventions

Pentoxifylline; Zinc; Zinc Sulfate

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Zinc Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: December 14, 2021
• Study Start: January 1, 2022
• Primary Completion: January 10, 2022
• Study Completion: May 28, 2022
• Last Updated: January 3, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share