Idiopathic Infertility
Conditions
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.
Interventions
DRUGPlacebo
Infertile men referred to the infertility treatment center who, have had at least one year of unprotected intercourse, Natural fertility has not happened in their spouse. These men will all be married These men will be between the ages of 20 and 50. According to WHO criteria, Sperm parameters abnormalities should be observed in at least two spermogram within 2 weeks. Candidates receive two placebo tablets daily
DRUGPentoxifylline
Infertile men referred to the infertility treatment center who, have had at least one year of unprotected intercourse, Natural fertility has not happened in their spouse. These men will all be married These men will be between the ages of 20 and 50. According to WHO criteria, Sperm parameters abnormalities should be observed in at least two spermogram within 2 weeks. Candidates receive two trental tablets daily
DRUGzinc
Infertile men referred to the infertility treatment center who, have had at least one year of unprotected intercourse, Natural fertility has not happened in their spouse. These men will all be married These men will be between the ages of 20 and 50. According to WHO criteria, Sperm parameters abnormalities should be observed in at least two spermogram within 2 weeks. Candidates receive one zinc sulfate tablet daily
DRUGzinc + pentoxifylline
Infertile men referred to the infertility treatment center who, have had at least one year of unprotected intercourse, Natural fertility has not happened in their spouse. These men will all be married These men will be between the ages of 20 and 50. According to WHO criteria, Sperm parameters abnormalities should be observed in at least two spermogram within 2 weeks. Candidates receive two pentoxifylline tablets+ one zinc tablet daily
Sponsors
Arak University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Testosteron hormon | One week after starting the medication | testosterone (nanomolar per liter) will be measured from the blood serum of volunteers using ELISA 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| TAC (Total Antioxidant Capacity) evaluate | One week after starting the medication | total antioxidant capacity (TAC (/m / l)) will be measured using related experimental kits |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| BAX expression | 3 months | expression of BAX gen(in p.c) using real-time PCR and Western blot |
| BCL 2 expression | 3 months | expression of BCL 2 gen (in p.c) using real-time PCR and Western blot |
| caspase 3 expression | 3 months | expression of caspase 3 gen (in p.c) using real-time PCR and Western blot |
Outcome results
None listed