An interventional study of Placebo and Pentoxifylline in Idiopathic Infertility, sponsored by Arak University of Medical Sciences. Status unknown. Open to male participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-03.
Sponsored by Arak University of Medical Sciences · Not applicable, Interventional, and Treatment
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.
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.
2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.
This study's planned enrollment of 140 is close to the median of 135 across 1,412 interventional studies indexed under Infertility.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Control group: oral rehydration salts (ORS, Poursina, Tehran, Iran), two times daily
Drug: Placebo
Intervention group 1: received pentoxifylline (TRENTAL 400 mg modified release tablets, OSPS; 400 mg ,two times daily)
Drug: Pentoxifylline
Intervention group 2: received zinc ( Zinc Sulfate 220mg Capsules,One time daily)
Drug: zinc
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 )
Drug: zinc + 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 placebo tablets daily
Also known as: hydration solution
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
Also known as: Trental
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
Also known as: zinc sulfate
Drug pages: Zinc · 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
Also known as: zinc sulfate+ trental
count of sperm
count of sperm(In per million - with the help of a neobar slide and microscopic observation
Time frame: One week after starting the medication
motility of sperm
motility of sperm: Calculate the percentage of motile sperm using microscopic observation
Time frame: One week after starting the medication
morphology of sperm
Calculate the percentage of sperm with a normal shape with the help of Papanic staining
Time frame: One week after starting the medication
Malon di aldehyd evaluate
Malondialdehyde (nmol/mL), will be measured using related experimental kits
Time frame: One week after starting the medication
ROS evaluate
reactive oxygen species (ROS (RLU/s)), will be measured using related experimental kits
Time frame: One week after starting the medication
TAC (Total Antioxidant Capacity) evaluate
total antioxidant capacity (TAC (/m / l)) will be measured using related experimental kits
Time frame: One week after starting the medication
FSH hormon
FSH (IU / L) will be measured from the blood serum of volunteers using ELISA kit
Time frame: One week after starting the medication
LH hormon
LH (IU / L) will be measured from the blood serum of volunteers using ELISA kit
Time frame: One week after starting the medication
Testosteron hormon
testosterone (nanomolar per liter) will be measured from the blood serum of volunteers using ELISA kit
Time frame: One week after starting the medication
TNF α( Tissue necrosis Factor)
TNF α( Tissue necrosis Factor) (pg/mL) as an inflammatory factor will be measured using related experimental kit
Time frame: One week after starting the medication
Interleukin-6 (IL-6)
Interleukin-6 (IL-6)/(pg/mL) as an inflammatory factor will be measured using related experimental kit
Time frame: One week after starting the medication
Sperm DNA Fragmentation Assay(SDFA)
DNA fragmentation will be assessed using an SDFA kit and microscopic observations (as a percentage of damaged sperm).
Time frame: One week after starting the medication
caspase 3 expression
expression of caspase 3 gen (in p.c) using real-time PCR and Western blot
Time frame: 3 months
BAX expression
expression of BAX gen(in p.c) using real-time PCR and Western blot
Time frame: 3 months
BCL 2 expression
expression of BCL 2 gen (in p.c) using real-time PCR and Western blot
Time frame: 3 months
No study locations are listed for this record.
Plan to share: No
This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Pentoxifylline · Zinc
Arak University of Medical Sciences