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

NCT ID: NCT05178953

Last Updated: 2022-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-01-20

Brief Summary

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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

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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.

Conditions

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Men Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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pentoxifylline group

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

Group Type EXPERIMENTAL

Pentoxifylline

Intervention Type 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

Zinc Sulfate group

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

Group Type EXPERIMENTAL

Zinc Sulfate 220 mg Capsules

Intervention Type 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

pentoxifylline+ zinc group

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

Group Type EXPERIMENTAL

Zinc Sulfate 220 mg Capsules

Intervention Type 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

Pentoxifylline

Intervention Type 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

Interventions

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Zinc Sulfate 220 mg Capsules

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

Pentoxifylline

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

Intervention Type DRUG

Other Intervention Names

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zinc Trental

Eligibility Criteria

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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
Minimum Eligible Age

23 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Arak University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Zeynab

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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zeynab dadgar, dr

Role: PRINCIPAL_INVESTIGATOR

arak university of medical science

Locations

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Infertility Center

Arak, Markazi Province, Iran

Site Status RECRUITING

Arak university of medical science

Arak, Markazi Province, Iran

Site Status COMPLETED

Countries

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Iran

Central Contacts

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zeynab dadgar, dr

Role: CONTACT

09163619937 ext. arak

hamzeh amiri, dr

Role: CONTACT

09163631770 ext. shafa

Facility Contacts

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zeynab dadgar, dr

Role: primary

+989163619937

Other Identifiers

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1898

Identifier Type: -

Identifier Source: org_study_id

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