Effect of Pentoxifylline and Zinc Co-administration in Patients With Oligoasthenoteratozoospermia (OAT)
Primary Purpose
Idiopathic Infertility
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Placebo
Pentoxifylline
zinc
zinc + pentoxifylline
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Infertility
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
placebo group
pentoxifylline group
Zinc group
pentoxifylline+ zinc group
Arm Description
Control group: oral rehydration salts (ORS, Poursina, Tehran, Iran), two times daily
Intervention group 1: received pentoxifylline (TRENTAL 400 mg modified release tablets, OSPS; 400 mg ,two times daily)
Intervention group 2: received zinc ( Zinc Sulfate 220mg Capsules,One time daily)
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 )
Outcomes
Primary Outcome Measures
count of sperm
count of sperm(In per million - with the help of a neobar slide and microscopic observation
motility of sperm
motility of sperm: Calculate the percentage of motile sperm using microscopic observation
morphology of sperm
Calculate the percentage of sperm with a normal shape with the help of Papanic staining
Malon di aldehyd evaluate
Malondialdehyde (nmol/mL), will be measured using related experimental kits
ROS evaluate
reactive oxygen species (ROS (RLU/s)), will be measured using related experimental kits
TAC (Total Antioxidant Capacity) evaluate
total antioxidant capacity (TAC (/m / l)) will be measured using related experimental kits
FSH hormon
FSH (IU / L) will be measured from the blood serum of volunteers using ELISA kit
LH hormon
LH (IU / L) will be measured from the blood serum of volunteers using ELISA kit
Testosteron hormon
testosterone (nanomolar per liter) will be measured from the blood serum of volunteers using ELISA kit
TNF α( Tissue necrosis Factor)
TNF α( Tissue necrosis Factor) (pg/mL) as an inflammatory factor will be measured using related experimental kit
Interleukin-6 (IL-6)
Interleukin-6 (IL-6)/(pg/mL) as an inflammatory factor will be measured using related experimental kit
Sperm DNA Fragmentation Assay(SDFA)
DNA fragmentation will be assessed using an SDFA kit and microscopic observations (as a percentage of damaged sperm).
Secondary Outcome Measures
Full Information
NCT ID
NCT05156684
First Posted
November 5, 2021
Last Updated
December 13, 2021
Sponsor
Arak University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05156684
Brief Title
Effect of Pentoxifylline and Zinc Co-administration in Patients With Oligoasthenoteratozoospermia
Acronym
OAT
Official Title
Evaluating the Therapeutic Effect of Pentoxifylline and Zinc Co-administration in Patients With Idiopathic Oligoasthenoteratozoospermia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2022 (Anticipated)
Primary Completion Date
January 10, 2022 (Anticipated)
Study Completion Date
May 28, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arak University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
placebo group
Arm Type
Experimental
Arm Description
Control group: oral rehydration salts (ORS, Poursina, Tehran, Iran), two times daily
Arm Title
pentoxifylline group
Arm Type
Experimental
Arm Description
Intervention group 1: received pentoxifylline (TRENTAL 400 mg modified release tablets, OSPS; 400 mg ,two times daily)
Arm Title
Zinc group
Arm Type
Experimental
Arm Description
Intervention group 2: received zinc ( Zinc Sulfate 220mg Capsules,One time daily)
Arm Title
pentoxifylline+ zinc group
Arm Type
Experimental
Arm Description
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 )
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
hydration solution
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Pentoxifylline
Other Intervention Name(s)
Trental
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
zinc
Other Intervention Name(s)
zinc sulfate
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
zinc + pentoxifylline
Other Intervention Name(s)
zinc sulfate+ trental
Intervention Description
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
Primary Outcome Measure Information:
Title
count of sperm
Description
count of sperm(In per million - with the help of a neobar slide and microscopic observation
Time Frame
One week after starting the medication
Title
motility of sperm
Description
motility of sperm: Calculate the percentage of motile sperm using microscopic observation
Time Frame
One week after starting the medication
Title
morphology of sperm
Description
Calculate the percentage of sperm with a normal shape with the help of Papanic staining
Time Frame
One week after starting the medication
Title
Malon di aldehyd evaluate
Description
Malondialdehyde (nmol/mL), will be measured using related experimental kits
Time Frame
One week after starting the medication
Title
ROS evaluate
Description
reactive oxygen species (ROS (RLU/s)), will be measured using related experimental kits
Time Frame
One week after starting the medication
Title
TAC (Total Antioxidant Capacity) evaluate
Description
total antioxidant capacity (TAC (/m / l)) will be measured using related experimental kits
Time Frame
One week after starting the medication
Title
FSH hormon
Description
FSH (IU / L) will be measured from the blood serum of volunteers using ELISA kit
Time Frame
One week after starting the medication
Title
LH hormon
Description
LH (IU / L) will be measured from the blood serum of volunteers using ELISA kit
Time Frame
One week after starting the medication
Title
Testosteron hormon
Description
testosterone (nanomolar per liter) will be measured from the blood serum of volunteers using ELISA kit
Time Frame
One week after starting the medication
Title
TNF α( Tissue necrosis Factor)
Description
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
Title
Interleukin-6 (IL-6)
Description
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
Title
Sperm DNA Fragmentation Assay(SDFA)
Description
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
Other Pre-specified Outcome Measures:
Title
caspase 3 expression
Description
expression of caspase 3 gen (in p.c) using real-time PCR and Western blot
Time Frame
3 months
Title
BAX expression
Description
expression of BAX gen(in p.c) using real-time PCR and Western blot
Time Frame
3 months
Title
BCL 2 expression
Description
expression of BCL 2 gen (in p.c) using real-time PCR and Western blot
Time Frame
3 months
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
men with idiopathic infertility
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35182288
Citation
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.
Results Reference
derived
Learn more about this trial
Effect of Pentoxifylline and Zinc Co-administration in Patients With Oligoasthenoteratozoospermia
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