AzTrials
AzTrials

Idiopathic InfertilityOATNCT05156684

Effect of Pentoxifylline and Zinc Co-administration in Patients With Oligoasthenoteratozoospermia

A study testing Pentoxifylline, zinc and zinc + pentoxifylline in people with Idiopathic Infertility, run by Arak University of Medical Sciences.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Idiopathic Infertility
What is being tested?
Pentoxifylline, zinc and zinc + pentoxifylline
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
140 participants
Where
No sites listed yet
Study dates
1 Jan 2022to 28 May 2022
Phase
Interventional
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 20 to 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Idiopathic infertile men
  • have had at least one year of unprotected intercourse infertility
  • Sperm parameters abnormality

Who cannot join

  • Men with varicocele
  • Hypersensitivity to pentoxifylline \& zinc,
  • pelvic organic pathologies
  • congenital adrenal hyperplasia
  • thyroid dysfunction
  • Cushing's syndrome
Show all 16Show fewer
  • 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

About this study

Official title: Evaluating the Therapeutic Effect of Pentoxifylline and Zinc Co-administration in Patients With Idiopathic Oligoasthenoteratozoospermia

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.

Read the 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.

Being tested
Placebo, Pentoxifylline, zinc, zinc + pentoxifylline

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Also called 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 placebo tablets daily

  • PentoxifyllineDrug

    Also called 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 two trental tablets daily

  • zincDrug

    Also called zinc sulfate

    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

  • zinc + pentoxifyllineDrug

    Also called zinc sulfate+ 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 two pentoxifylline tablets+ one zinc tablet daily

Study groups in NCT05156684
Study groupRoleWhat they receive
placebo groupExperimentalControl group: oral rehydration salts (ORS, Poursina, Tehran, Iran), two times daily
Receives: Drug: Placebo
pentoxifylline groupExperimentalIntervention group 1: received pentoxifylline (TRENTAL 400 mg modified release tablets, OSPS; 400 mg ,two times daily)
Receives: Drug: Pentoxifylline
Zinc groupExperimentalIntervention group 2: received zinc ( Zinc Sulfate 220mg Capsules,One time daily)
Receives: Drug: zinc
pentoxifylline+ zinc groupExperimentalIntervention group 3: received pentoxifylline+ zinc (TRENTAL 400 mg modified release tablets, OSPS; 400 mg ,two times daily + Zinc Sulfate 220mg Capsules,One time daily )
Receives: Drug: zinc + pentoxifylline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. count of sperm

    count of sperm(In per million - with the help of a neobar slide and microscopic observation

    Measured: One week after starting the medication

  2. motility of sperm

    motility of sperm: Calculate the percentage of motile sperm using microscopic observation

    Measured: One week after starting the medication

  3. morphology of sperm

    Calculate the percentage of sperm with a normal shape with the help of Papanic staining

    Measured: One week after starting the medication

  4. Malon di aldehyd evaluate

    Malondialdehyde (nmol/mL), will be measured using related experimental kits

    Measured: One week after starting the medication

  5. ROS evaluate

    reactive oxygen species (ROS (RLU/s)), will be measured using related experimental kits

    Measured: One week after starting the medication

  6. TAC (Total Antioxidant Capacity) evaluate

    total antioxidant capacity (TAC (/m / l)) will be measured using related experimental kits

    Measured: One week after starting the medication

  7. FSH hormon

    FSH (IU / L) will be measured from the blood serum of volunteers using ELISA kit

    Measured: One week after starting the medication

  8. LH hormon

    LH (IU / L) will be measured from the blood serum of volunteers using ELISA kit

    Measured: One week after starting the medication

  9. Testosteron hormon

    testosterone (nanomolar per liter) will be measured from the blood serum of volunteers using ELISA kit

    Measured: One week after starting the medication

  10. TNF α( Tissue necrosis Factor)

    TNF α( Tissue necrosis Factor) (pg/mL) as an inflammatory factor will be measured using related experimental kit

    Measured: One week after starting the medication

  11. Interleukin-6 (IL-6)

    Interleukin-6 (IL-6)/(pg/mL) as an inflammatory factor will be measured using related experimental kit

    Measured: One week after starting the medication

  12. Sperm DNA Fragmentation Assay(SDFA)

    DNA fragmentation will be assessed using an SDFA kit and microscopic observations (as a percentage of damaged sperm).

    Measured: One week after starting the medication

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2021
  2. Study start1 Jan 2022 (estimated)
  3. Primary completion10 Jan 2022 (estimated)
  4. Study completion28 May 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05156684
Sponsor's protocol ID
96/197
Acronym
OAT
Status last verified
Dec 2021
First submitted
5 Nov 2021
Last updated
3 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dadgar Z, Shariatzadeh SMA, Mehranjani MS, Kheirolahi A. The therapeutic effect of co-administration of pentoxifylline and zinc in men with idiopathic infertility. Ir J Med Sci. 2023 Feb;192(1):431-439. doi: 10.1007/s11845-022-02931-0. Epub 2022 Feb 19.

    PubMed 35182288

Questions about this trial

What is this clinical trial studying?

A study testing Pentoxifylline, zinc and zinc + pentoxifylline in people with Idiopathic Infertility, run by Arak University of Medical Sciences.

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 16 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 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

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.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

count of sperm (time frame: One week after starting the medication). 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?

On the ClinicalTrials.gov record for NCT05156684, which also lists 1 linked publication.

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 3 Jan 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in