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

Primary Purpose

Men Infertility

Status
Recruiting
Phase
Early Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Zinc Sulfate 220 mg Capsules
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 Men Infertility

Eligibility Criteria

23 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Infertility CenterRecruiting
  • Arak university of medical science

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

pentoxifylline group

Zinc Sulfate group

pentoxifylline+ zinc group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

sperm concentration
count of sperm(In per million - with the help of a neobar slide and microscopic observation
spem motility
motility of sperm: Calculate the percentage of motile sperm using microscopic observation
sperm morphology
Calculate the percentage of sperm with a normal shape with the help of Papanic staining
lipid proxidation
Malondialdehyde (nmol/mL), is measured using related experimental kits
reactive oxygen species
eactive oxygen species (ROS (RLU/s)), is measured using related experimental kits
total antioxidant capacity
total antioxidant capacity (TAC (/m / l)) is measured using related experimental kits
FSH hormon
FSH (IU / L) is measured from the blood serum of volunteers using ELISA kit
LH hormon
LH (IU / L) is measured from the blood serum of volunteers using ELISA kit
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
(Tissue necrosis Factor)
TNF α( Tissue necrosis Factor) (pg/mL) as an inflammatory factor is measured using related experimental kit
interleukin-6
interleukin-6 (IL-6)/(pg/mL) as an inflammatory factor is measured using related experimental kit
Sperm DNA Fragmentation Assay(SDFA)
DNA fragmentation is assessed using an SDFA kit and microscopic observations (as a percentage of damaged sperm).

Secondary Outcome Measures

BAX expression
BAX expression [ Time Frame: 3 months ] expression of BAX gen(in p.c) using real-time PCR and Western blot
Bcl2 expression
Bcl-2 gen(in p.c) using real-time PCR and Western blot
caspase 3 expression
expression of caspase 3 gen(in p.c) using real-time PCR and Western blot

Full Information

First Posted
December 15, 2021
Last Updated
January 4, 2022
Sponsor
Arak University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05178953
Brief Title
The Therapeutic Effect of Co-administration of Pentoxifylline and Zinc in Men With Idiopathic Asthenozoospermia
Acronym
PTX-Zn
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
January 8, 2022 (Anticipated)
Study Completion Date
January 20, 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
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pentoxifylline group
Arm Type
Experimental
Arm Description
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
Arm Title
Zinc Sulfate group
Arm Type
Experimental
Arm Description
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
Arm Title
pentoxifylline+ zinc group
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Zinc Sulfate 220 mg Capsules
Other Intervention Name(s)
zinc
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Pentoxifylline
Other Intervention Name(s)
Trental
Intervention Description
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
Primary Outcome Measure Information:
Title
sperm concentration
Description
count of sperm(In per million - with the help of a neobar slide and microscopic observation
Time Frame
1 day
Title
spem motility
Description
motility of sperm: Calculate the percentage of motile sperm using microscopic observation
Time Frame
1 day
Title
sperm morphology
Description
Calculate the percentage of sperm with a normal shape with the help of Papanic staining
Time Frame
1 day
Title
lipid proxidation
Description
Malondialdehyde (nmol/mL), is measured using related experimental kits
Time Frame
One week
Title
reactive oxygen species
Description
eactive oxygen species (ROS (RLU/s)), is measured using related experimental kits
Time Frame
One week
Title
total antioxidant capacity
Description
total antioxidant capacity (TAC (/m / l)) is measured using related experimental kits
Time Frame
One week
Title
FSH hormon
Description
FSH (IU / L) is measured from the blood serum of volunteers using ELISA kit
Time Frame
One week
Title
LH hormon
Description
LH (IU / L) is measured from the blood serum of volunteers using ELISA kit
Time Frame
One week
Title
testosteron hormon [ Time Frame: One week after starting the medication ] testosterone
Description
testosterone (nanomolar per liter) is measured from the blood serum of volunteers using ELISA kit
Time Frame
One week
Title
(Tissue necrosis Factor)
Description
TNF α( Tissue necrosis Factor) (pg/mL) as an inflammatory factor is measured using related experimental kit
Time Frame
One week
Title
interleukin-6
Description
interleukin-6 (IL-6)/(pg/mL) as an inflammatory factor is measured using related experimental kit
Time Frame
One week
Title
Sperm DNA Fragmentation Assay(SDFA)
Description
DNA fragmentation is assessed using an SDFA kit and microscopic observations (as a percentage of damaged sperm).
Time Frame
One week
Secondary Outcome Measure Information:
Title
BAX expression
Description
BAX expression [ Time Frame: 3 months ] expression of BAX gen(in p.c) using real-time PCR and Western blot
Time Frame
3 month
Title
Bcl2 expression
Description
Bcl-2 gen(in p.c) using real-time PCR and Western blot
Time Frame
3 months
Title
caspase 3 expression
Description
expression of caspase 3 gen(in p.c) using real-time PCR and Western blot
Time Frame
3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
zeynab dadgar, dr
Phone
09163619937
Ext
arak
Email
z.dadgar67@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
hamzeh amiri, dr
Phone
09163631770
Ext
shafa
Email
h.amiri65@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zeynab dadgar, dr
Organizational Affiliation
arak university of medical science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Infertility Center
City
Arak
State/Province
Markazi
ZIP/Postal Code
6853462355
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zeynab dadgar, dr
Phone
+989163619937
Email
z.dadgar67@gmail.com
Facility Name
Arak university of medical science
City
Arak
State/Province
Markazi
ZIP/Postal Code
68985432
Country
Iran, Islamic Republic of
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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