Clinical trial NCT05178953: The Therapeutic Effect of Co-administration of Pentoxifylline and Zinc in Men With Idiopathic Asthenozoospermia
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
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Men Infertility
Lead sponsor: Arak University of Medical Sciences
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 160
Sex: MALE
Minimum age (years): 23
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: sperm concentration
timeFrame: 1 day
measure: spem motility
timeFrame: 1 day
measure: sperm morphology
timeFrame: 1 day
measure: lipid proxidation
timeFrame: One week
measure: reactive oxygen species
timeFrame: One week
measure: total antioxidant capacity
timeFrame: One week
measure: FSH hormon
timeFrame: One week
measure: LH hormon
timeFrame: One week
measure: testosteron hormon [ Time Frame: One week after starting the medication ] testosterone
timeFrame: One week
measure: (Tissue necrosis Factor)
timeFrame: One week
measure: interleukin-6
timeFrame: One week
measure: Sperm DNA Fragmentation Assay(SDFA)
timeFrame: One week
Secondary outcomes:
measure: BAX expression
timeFrame: 3 month
measure: Bcl2 expression
timeFrame: 3 months
measure: caspase 3 expression
timeFrame: 3 months
Other outcomes:
Locations:
city: Arak
country: Iran, Islamic Republic of
facility: Infertility Center
state: Markazi
city: Arak
country: Iran, Islamic Republic of
facility: Arak university of medical science
state: Markazi
Study officials:
affiliation: arak university of medical science
name: zeynab dadgar, dr
role: PRINCIPAL_INVESTIGATOR
References: