Men InfertilityEarly Phase 1PTX-ZnNCT05178953
The Therapeutic Effect of Co-administration of Pentoxifylline and Zinc in Men With Idiopathic Asthenozoospermia
A Early Phase 1 study testing Zinc Sulfate 220 mg Capsules and Pentoxifylline in people with Men Infertility, run by Arak University of Medical Sciences at 2 sites in Iran.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 23 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Men Infertility
- What is being tested?
- Zinc Sulfate 220 mg Capsules and Pentoxifylline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesIran
- Study dates
- 1 Aug 2021to 20 Jan 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- infertile men
- have had at least one year of unprotected intercourse infertility
- asthenozoospermia
Who cannot join
- Men with varicocele
- Hypersensitivity to pentoxifylline \& zinc,
- pelvic organic pathologies
- congenital adrenal hyperplasia
- thyroid dysfunction
- Cushing's syndrome
Show all 14Show fewer
- hyper prolactinemia
- androgen secreting neoplasia
- severe hepatic
- pancreatitis
- kidney diseases
- gallbladder diseases
- Patients with alcohol consumption
- Patients who use cigarettes and drugs
Trial locations and contacts
2 sites in 1 country.
Iran2 sites, 1 recruiting
- Recruiting
Infertility Center
Arak, Markazi Province, 6853462355
zeynab dadgar, dr, +989163619937, z.dadgar67@gmail.com
- Completed
Arak university of medical science
Arak, Markazi Province, 68985432
About this study
Official title: The Therapeutic Effect of Co-administration of Pentoxifylline and Zinc on Semen Parameters, Reproductive Hormones, DNA Fragmentation, and Some Biochemical, and Inflammatory Parameters in Men With Idiopathic Infertility
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
Read the detailed description
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.
- Conditions
- Men Infertility
- Being tested
- Zinc Sulfate 220 mg Capsules, Pentoxifylline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc Sulfate 220 mg CapsulesDrug
Also called zinc
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
PentoxifyllineDrug
Also called Trental
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
| Study group | Role | What they receive |
|---|---|---|
| pentoxifylline group | Experimental | 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 Receives: Drug: Pentoxifylline |
| Zinc Sulfate group | Experimental | 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 Receives: Drug: Zinc Sulfate 220 mg Capsules |
| pentoxifylline+ zinc group | Experimental | 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 Receives: Drug: Zinc Sulfate 220 mg Capsules; Drug: Pentoxifylline |
What is being measured
The primary outcome is the main question the study is designed to answer.
sperm concentration
count of sperm(In per million - with the help of a neobar slide and microscopic observation
Measured: 1 day
spem motility
motility of sperm: Calculate the percentage of motile sperm using microscopic observation
Measured: 1 day
sperm morphology
Calculate the percentage of sperm with a normal shape with the help of Papanic staining
Measured: 1 day
lipid proxidation
Malondialdehyde (nmol/mL), is measured using related experimental kits
Measured: One week
reactive oxygen species
eactive oxygen species (ROS (RLU/s)), is measured using related experimental kits
Measured: One week
total antioxidant capacity
total antioxidant capacity (TAC (/m / l)) is measured using related experimental kits
Measured: One week
FSH hormon
FSH (IU / L) is measured from the blood serum of volunteers using ELISA kit
Measured: One week
LH hormon
LH (IU / L) is measured from the blood serum of volunteers using ELISA kit
Measured: 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
Measured: One week
(Tissue necrosis Factor)
TNF α( Tissue necrosis Factor) (pg/mL) as an inflammatory factor is measured using related experimental kit
Measured: One week
interleukin-6
interleukin-6 (IL-6)/(pg/mL) as an inflammatory factor is measured using related experimental kit
Measured: One week
Sperm DNA Fragmentation Assay(SDFA)
DNA fragmentation is assessed using an SDFA kit and microscopic observations (as a percentage of damaged sperm).
Measured: One week
Secondary outcomes (3)
BAX expression
BAX expression [ Time Frame: 3 months ]
expression of BAX gen(in p.c) using real-time PCR and Western blot
Measured: 3 month
Bcl2 expression
Bcl-2 gen(in p.c) using real-time PCR and Western blot
Measured: 3 months
caspase 3 expression
expression of caspase 3 gen(in p.c) using real-time PCR and Western blot
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start1 Aug 2021
- Primary completion8 Jan 2022 (estimated)
- Study completion20 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Men InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arak University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynab, Arak University of Medical Sciences
- Investigators
- zeynab dadgar, dr, Principal investigator, arak university of medical science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05178953
- Sponsor's protocol ID
- 1898
- Acronym
- PTX-Zn
- Status last verified
- Jan 2022
- First submitted
- 15 Dec 2021
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Therapeutic Effect of Co-administration of Pentoxifylline and Zinc on Semen Parameters, Reproductive Hormones, DNA Fragmentation, and Some Biochemical, and Inflammatory Parameters in Men With Idiopathic Infertility
- ClinicalTrials.gov ID
- NCT05178953
- Acronym / sponsor ID
- PTX-Zn / 1898
- Conditions
- Men Infertility
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Arak University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 8 Jan 2022 (estimated)
- Study completion
- 20 Jan 2022 (estimated)
- First posted
- 5 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pentoxifylline group | Experimental | Drug: PentoxifyllineGroup 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 |
| Zinc Sulfate group | Experimental | Drug: Zinc Sulfate 220 mg CapsulesInfertile 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 |
| pentoxifylline+ zinc group | Experimental | Drug: Zinc Sulfate 220 mg Capsules, Drug: PentoxifyllineInfertile 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 |
Who may qualify
- Ages
- 23 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- infertile men
- have had at least one year of unprotected intercourse infertility
- asthenozoospermia
Key exclusion criteria (14 listed)
- Men with varicocele
- Hypersensitivity to pentoxifylline \& zinc,
- pelvic organic pathologies
- congenital adrenal hyperplasia
- thyroid dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zinc Sulfate 220 mg CapsulesAlso: zincZinc 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 | Drug | Zinc Sulfate group, pentoxifylline+ zinc group |
| PentoxifyllineAlso: TrentalOral 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 | Drug | pentoxifylline group, pentoxifylline+ zinc group |
Primary outcome
sperm concentration
Time frame: 1 day
count of sperm(In per million - with the help of a neobar slide and microscopic observation
spem motility
Time frame: 1 day
motility of sperm: Calculate the percentage of motile sperm using microscopic observation
sperm morphology
Time frame: 1 day
Calculate the percentage of sperm with a normal shape with the help of Papanic staining
lipid proxidation
Time frame: One week
Malondialdehyde (nmol/mL), is measured using related experimental kits
reactive oxygen species
Time frame: One week
eactive oxygen species (ROS (RLU/s)), is measured using related experimental kits
total antioxidant capacity
Time frame: One week
total antioxidant capacity (TAC (/m / l)) is measured using related experimental kits
FSH hormon
Time frame: One week
FSH (IU / L) is measured from the blood serum of volunteers using ELISA kit
LH hormon
Time frame: One week
LH (IU / L) is measured from the blood serum of volunteers using ELISA kit
testosteron hormon [ Time Frame: One week after starting the medication ] testosterone
Time frame: One week
testosterone (nanomolar per liter) is measured from the blood serum of volunteers using ELISA kit
(Tissue necrosis Factor)
Time frame: One week
TNF α( Tissue necrosis Factor) (pg/mL) as an inflammatory factor is measured using related experimental kit
interleukin-6
Time frame: One week
interleukin-6 (IL-6)/(pg/mL) as an inflammatory factor is measured using related experimental kit
Sperm DNA Fragmentation Assay(SDFA)
Time frame: One week
DNA fragmentation is assessed using an SDFA kit and microscopic observations (as a percentage of damaged sperm).
3 secondary outcomes
BAX expression
Time frame: 3 month
Bcl2 expression
Time frame: 3 months
caspase 3 expression
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
zeynab dadgar, dr principal investigator
arak university of medical science
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Zinc Sulfate 220 mg Capsules and Pentoxifylline in people with Men Infertility, run by Arak University of Medical Sciences at 2 sites in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zeynab dadgar, dr (09163619937 ext. arak, z.dadgar67@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sperm concentration (time frame: 1 day). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2022.