Clinical trial NCT05156684: Effect of Pentoxifylline and Zinc Co-administration in Patients With Oligoasthenoteratozoospermia
Official title: Evaluating the Therapeutic Effect of Pentoxifylline and Zinc Co-administration in Patients With Idiopathic Oligoasthenoteratozoospermia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Idiopathic Infertility
Lead sponsor: Arak University of Medical Sciences
Sponsor class: OTHER
First posted: 2021-12-14
Enrollment: 140
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This study will be performed as a double-blind randomized clinical trial on idiopathic infertile men (including oligoasthenosospermia, dyspnea, astheno-teratozoospermia, oligo-astheno-teratozoospermia) referred to Shafa Infertility 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. A food questionnaire is also taken from them to identify patients. Any medication that may affect sperm production should be discontinued within three months of the study.

Sampling and administration of pentoxifylline and zinc:

Preparation and analysis of semen samples are performed according to WHO 2010 recommendations. Semen samples are prepared by masturbating after a 3 to 5 day abstinence period. Two semen samples from these men, one before and the other after the intervention, are evaluated for basic parameters. For liquefaction, semen samples are incubated for 30 to 60 minutes at 37 ° C. Microscopic tests are performed to evaluate indicators such as sperm concentration in semen, motility and sperm morphology. Objectives and study methods are explained to patients who meet the inclusion criteria. Written consent is then obtained from the candidate. Body mass index (BMI) is assessed for patients. Also, at the beginning of the study, 5 cc of blood is taken from patients to measure reproductive hormones.

Eligibility criteria: Inclusion Criteria:

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

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
* diabetes mellitus
* consumption of medications affecting carbohydrate metabolism
* severe hepatic
* pancreatitis
* kidney diseases
* gallbladder diseases
* Patients with alcohol consumption
* Patients who use cigarettes and drugs

Primary outcomes:
measure: count of sperm
timeFrame: One week after starting the medication
measure: motility of sperm
timeFrame: One week after starting the medication
measure: morphology of sperm
timeFrame: One week after starting the medication
measure: Malon di aldehyd evaluate
timeFrame: One week after starting the medication
measure: ROS evaluate
timeFrame: One week after starting the medication
measure: TAC (Total Antioxidant Capacity) evaluate
timeFrame: One week after starting the medication
measure: FSH hormon
timeFrame: One week after starting the medication
measure: LH hormon
timeFrame: One week after starting the medication
measure: Testosteron hormon
timeFrame: One week after starting the medication
measure: TNF α( Tissue necrosis Factor)
timeFrame: One week after starting the medication
measure: Interleukin-6 (IL-6)
timeFrame: One week after starting the medication
measure: Sperm DNA Fragmentation Assay(SDFA)
timeFrame: One week after starting the medication
Secondary outcomes:
Other outcomes:
measure: caspase 3 expression
timeFrame: 3 months
measure: BAX expression
timeFrame: 3 months
measure: BCL 2 expression
timeFrame: 3 months
Locations:
Study officials:
References:
citation: 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.