Effect of Pentoxifylline and Zinc Co-administration in Patients With Oligoasthenoteratozoospermia
- Conditions
- Idiopathic Infertility
- Interventions
- Registration Number
- NCT05156684
- Lead Sponsor
- Arak University of Medical Sciences
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 140
- Idiopathic infertile men
- have had at least one year of unprotected intercourse infertility
- Sperm parameters abnormality
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description pentoxifylline+ zinc group zinc + pentoxifylline Intervention group 3: received pentoxifylline+ zinc (TRENTAL 400 mg modified release tablets, OSPS; 400 mg ,two times daily + Zinc Sulfate 220mg Capsules,One time daily ) placebo group Placebo Control group: oral rehydration salts (ORS, Poursina, Tehran, Iran), two times daily pentoxifylline group Pentoxifylline Intervention group 1: received pentoxifylline (TRENTAL 400 mg modified release tablets, OSPS; 400 mg ,two times daily) Zinc group zinc Intervention group 2: received zinc ( Zinc Sulfate 220mg Capsules,One time daily)
- Primary Outcome Measures
Name Time Method count of sperm One week after starting the medication count of sperm(In per million - with the help of a neobar slide and microscopic observation
Malon di aldehyd evaluate One week after starting the medication Malondialdehyde (nmol/mL), will be measured using related experimental kits
ROS evaluate One week after starting the medication reactive oxygen species (ROS (RLU/s)), will be measured using related experimental kits
Testosteron hormon One week after starting the medication testosterone (nanomolar per liter) will be measured from the blood serum of volunteers using ELISA kit
FSH hormon One week after starting the medication FSH (IU / L) will be measured from the blood serum of volunteers using ELISA kit
LH hormon One week after starting the medication LH (IU / L) will be measured from the blood serum of volunteers using ELISA kit
Interleukin-6 (IL-6) One week after starting the medication Interleukin-6 (IL-6)/(pg/mL) as an inflammatory factor will be measured using related experimental kit
TNF α( Tissue necrosis Factor) One week after starting the medication TNF α( Tissue necrosis Factor) (pg/mL) as an inflammatory factor will be measured using related experimental kit
motility of sperm One week after starting the medication motility of sperm: Calculate the percentage of motile sperm using microscopic observation
morphology of sperm One week after starting the medication Calculate the percentage of sperm with a normal shape with the help of Papanic staining
TAC (Total Antioxidant Capacity) evaluate One week after starting the medication total antioxidant capacity (TAC (/m / l)) will be measured using related experimental kits
Sperm DNA Fragmentation Assay(SDFA) One week after starting the medication DNA fragmentation will be assessed using an SDFA kit and microscopic observations (as a percentage of damaged sperm).
- Secondary Outcome Measures
Name Time Method