An Early Phase 1 interventional study of Zinc Sulfate 220 mg Capsules and Pentoxifylline in Men Infertility, sponsored by Arak University of Medical Sciences. Status unknown at 2 sites in Iran, Islamic Republic of. Open to male participants aged 23 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-05.
Sponsored by Arak University of Medical Sciences · Early Phase 1, Interventional, and Treatment
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
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.
2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.
This study's planned enrollment of 160 is above the median of 135 across 1,412 interventional studies indexed under Infertility.
Browse Infertility studies →Arak University of Medical Sciences is the lead sponsor of 5 studies on the registry; none are open to participants now.
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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.
Group 1: Patients receiving pentoxifylline (TRENTAL 400 mg tablets, OSPS; 400 mg, twice daily) Infertile men referred to an infertility treatment center who have had unprotected sex for at least one year have not had normal fertility in their partner. These men are all married. According to WHO criteria, sperm motility abnormalities are observed in these patients. These volunteers receive two pentoxifylline tablets(400 mg) daily for 3 month, (TRENTAL 400 mg modified release tablets, OSPS; 400 mg ,two times daily) Other names: Trental
Drug: Pentoxifylline
Infertile men referred to an infertility treatment center who have had unprotected sex for at least one year have not had normal fertility in their partner. These men are all married. According to WHO criteria, sperm motility abnormalities are observed in these patients. Candidates receive one zinc sulfate tablet(229 mg) daily for 3 month,(Zinc Sulfate 220mg Capsules) Other Names: zinc sulfate
Drug: Zinc Sulfate 220 mg Capsules
Infertile men referred to an infertility treatment center who have had unprotected sex for at least one year have not had normal fertility in their partner. These men are all married. According to WHO criteria, sperm motility abnormalities are observed in these patients. Candidates receive one zinc sulfate(220mg) tablet+ two pentoxifylline tablets(400 mg) daily for 3 month (TRENTAL 400 mg modified release tablets, OSPS; 400 mg +Zinc Sulfate 220mg Capsules) Other Names: zinc sulfate
Drug: Zinc Sulfate 220 mg Capsules · Drug: Pentoxifylline
Zinc is an element that is involved in the activity of antioxidant enzymes. For example, the superoxide dismutase needs copper and zinc to function properly. Infertile men with asthenospermia receive 220 mg zinc sulfate tablets for 3 months
Also known as: zinc
Oral use of pentoxifylline is effective in treating cardiovascular disease, cerebrovascular disease, and other conditions associated with local circulatory disorders. Pentoxifylline affects blood viscosity. Infertile men with asthenospermia receive 400 mg pentoxifylline tablets for 3 months
Also known as: Trental
sperm concentration
count of sperm(In per million - with the help of a neobar slide and microscopic observation
Time frame: 1 day
spem motility
motility of sperm: Calculate the percentage of motile sperm using microscopic observation
Time frame: 1 day
sperm morphology
Calculate the percentage of sperm with a normal shape with the help of Papanic staining
Time frame: 1 day
lipid proxidation
Malondialdehyde (nmol/mL), is measured using related experimental kits
Time frame: One week
reactive oxygen species
eactive oxygen species (ROS (RLU/s)), is measured using related experimental kits
Time frame: One week
total antioxidant capacity
total antioxidant capacity (TAC (/m / l)) is measured using related experimental kits
Time frame: One week
FSH hormon
FSH (IU / L) is measured from the blood serum of volunteers using ELISA kit
Time frame: One week
LH hormon
LH (IU / L) is measured from the blood serum of volunteers using ELISA kit
Time frame: One week
testosteron hormon [ Time Frame: One week after starting the medication ] testosterone
testosterone (nanomolar per liter) is measured from the blood serum of volunteers using ELISA kit
Time frame: One week
(Tissue necrosis Factor)
TNF α( Tissue necrosis Factor) (pg/mL) as an inflammatory factor is measured using related experimental kit
Time frame: One week
interleukin-6
interleukin-6 (IL-6)/(pg/mL) as an inflammatory factor is measured using related experimental kit
Time frame: One week
Sperm DNA Fragmentation Assay(SDFA)
DNA fragmentation is assessed using an SDFA kit and microscopic observations (as a percentage of damaged sperm).
Time frame: One week
BAX expression
BAX expression \[ Time Frame: 3 months \] expression of BAX gen(in p.c) using real-time PCR and Western blot
Time frame: 3 month
Bcl2 expression
Bcl-2 gen(in p.c) using real-time PCR and Western blot
Time frame: 3 months
caspase 3 expression
expression of caspase 3 gen(in p.c) using real-time PCR and Western blot
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2021 (actual). Primary completion is estimated for Jan 2022, 5 months after the start.
Of 27 phase 1 interventional studies under Infertility, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 38. This study's planned 5 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Zinc Sulfate · Pentoxifylline
Arak University of Medical Sciences