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

Idiopathic Infertility Clinical Trial

— OAT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05156684
• Other study ID #: 96/197
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: May 28, 2022

Study information

• Verified date: December 2021
• Source: Arak University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: May 28, 2022
• Est. primary completion date: January 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Idiopathic Infertility
• Infertility
• Oligospermia

Intervention

Drug:
• Placebo
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
• 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 trental tablets daily
• zinc
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 + 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Arak University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	caspase 3 expression	expression of caspase 3 gen (in p.c) using real-time PCR and Western blot	3 months
Other	BAX expression	expression of BAX gen(in p.c) using real-time PCR and Western blot	3 months
Other	BCL 2 expression	expression of BCL 2 gen (in p.c) using real-time PCR and Western blot	3 months
Primary	count of sperm	count of sperm(In per million - with the help of a neobar slide and microscopic observation	One week after starting the medication
Primary	motility of sperm	motility of sperm: Calculate the percentage of motile sperm using microscopic observation	One week after starting the medication
Primary	morphology of sperm	Calculate the percentage of sperm with a normal shape with the help of Papanic staining	One week after starting the medication
Primary	Malon di aldehyd evaluate	Malondialdehyde (nmol/mL), will be measured using related experimental kits	One week after starting the medication
Primary	ROS evaluate	reactive oxygen species (ROS (RLU/s)), will be measured using related experimental kits	One week after starting the medication
Primary	TAC (Total Antioxidant Capacity) evaluate	total antioxidant capacity (TAC (/m / l)) will be measured using related experimental kits	One week after starting the medication
Primary	FSH hormon	FSH (IU / L) will be measured from the blood serum of volunteers using ELISA kit	One week after starting the medication
Primary	LH hormon	LH (IU / L) will be measured from the blood serum of volunteers using ELISA kit	One week after starting the medication
Primary	Testosteron hormon	testosterone (nanomolar per liter) will be measured from the blood serum of volunteers using ELISA kit	One week after starting the medication
Primary	TNF a( Tissue necrosis Factor)	TNF a( Tissue necrosis Factor) (pg/mL) as an inflammatory factor will be measured using related experimental kit	One week after starting the medication
Primary	Interleukin-6 (IL-6)	Interleukin-6 (IL-6)/(pg/mL) as an inflammatory factor will be measured using related experimental kit	One week after starting the medication
Primary	Sperm DNA Fragmentation Assay(SDFA)	DNA fragmentation will be assessed using an SDFA kit and microscopic observations (as a percentage of damaged sperm).	One week after starting the medication