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

NCT05178953 | Unknown Early Phase 1

• 1 other identifier: 1898
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

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

Conditions

Men Infertility

Outcome Measures

Primary Outcomes (12)

• sperm concentration

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

  1 day

• spem motility

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

  1 day

• sperm morphology

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

  1 day

• lipid proxidation

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

  One week

• reactive oxygen species

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

  One week

• total antioxidant capacity

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

  One week

• FSH hormon

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

  One week

• LH hormon

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

  One week

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

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

  One week

• (Tissue necrosis Factor)

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

  One week

• interleukin-6

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

  One week

• Sperm DNA Fragmentation Assay(SDFA)

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

  One week

Secondary Outcomes (3)

• BAX expression

  3 month

• Bcl2 expression

  3 months

• caspase 3 expression

  3 months

Study Arms (3)

pentoxifylline group

EXPERIMENTAL

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

Zinc Sulfate group

EXPERIMENTAL

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

pentoxifylline+ zinc group

EXPERIMENTAL

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; Drug: Pentoxifylline

Interventions

Zinc Sulfate 220 mg Capsules DRUG

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

Also known as: zinc

Zinc Sulfate group; pentoxifylline+ zinc group

Pentoxifylline DRUG

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

Also known as: Trental

pentoxifylline group; pentoxifylline+ zinc group

Eligibility Criteria

• Age: 23 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• infertile men
• have had at least one year of unprotected intercourse infertility
• asthenozoospermia

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
• severe hepatic
• pancreatitis
• kidney diseases
• gallbladder diseases
• Patients with alcohol consumption
• Patients who use cigarettes and drugs

Sponsors & Collaborators

• Arak University of Medical Sciences: lead

Study Sites (2)

Infertility Center

Arak, Markazi Province, 6853462355, Iran

RECRUITING

Arak university of medical science

Arak, Markazi Province, 68985432, Iran

COMPLETED

MeSH Terms

Interventions

Zinc Sulfate; Zinc; Pentoxifylline

Intervention Hierarchy (Ancestors)

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

Study Officials

• zeynab dadgar, dr

  arak university of medical science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

zeynab dadgar, dr

CONTACT

09163619937; z.dadgar67@gmail.com

hamzeh amiri, dr

CONTACT

09163631770; h.amiri65@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• 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: December 15, 2021
• First Posted: January 5, 2022
• Study Start: August 1, 2021
• Primary Completion: January 8, 2022
• Study Completion: January 20, 2022
• Last Updated: January 5, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IR (2)