sperDNA Fragmentation a a Predictor for Outcome After Varicocelectomy,m

NCT07144891 | Not Yet Recruiting

• 1 other identifier: SDV
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

Brief Summary

Varicocele is often associated with infertility and reduction in sperm quality, and it is one of the most common causes of reversible male infertility. The exact mechanism of infertility caused due to varicocele formation remains unclear. One of the suggested theories is related to increased oxidative stress that causes sperm DNA damage, including DNA fragmentation, and is correlated with the decreased capacity of spermatozoa to fertilize oocytes during normal fertilization and assisted reproduction techniques. This is supported by the evidence that there is a higher prevalence of DNA fragmentation in varicocele patients and a correlation between the presence of varicocele and impaired sperm DNA integrity. Several tests have been developed to better assess the fertility potential of sperm, including those designed to measure sperm deoxyribonucleic acid (DNA) fragmentation (SDF). The sperm DNA fragmentation index (DFI) is a potential parameter for fertility investigation, reflecting sperm DNA integrity and damage.

Conditions

DNA Damage

Outcome Measures

Primary Outcomes (1)

• we will assess sperm DNA fragmentation as a pridector for outcome of varicoelectomy in a group of infertile males with palpable varicocele.

  In this study, we will assess sperm DNA fragmentation index as a pridector for outcome of varicoelectomy in a group of infertile males with palpable varicocele.

  1 year

Study Arms (1)

1

Genetic: Sperm DNA fragmentation

Interventions

Sperm DNA fragmentation GENETIC

Estimation of sperm DFI level with sperm chromatin dispersion

1

Eligibility Criteria

• Age: 20 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

infertile male from 20 years old to 45 years old

You may qualify if:

• Patients have been diagnosed with VC (GII and GIII) by physical examination and scrotal color Doppler ultrasonography.
• Patients with stable relationships.
• In the control group, those with high SDF.
• Patients with documented infertility.
• Normal female partners or having correctable cause of infertility.
• Patients age from 20 to 45 years old.

You may not qualify if:

• Patients with a history of scrotal and spermatic cord injuries and congenital genitourinary abnormalities.
• Patients with systemic or endocrine disease, cryptorchidism, hypogonadism, genital infection, hormonal treatment and azoospermic patients.
• Recurrent varicocele.
• Patients with any other disease that may cause VC (such as external kidney tumor, hydronephrosis, etc.)
• Smoker patients and others risk factors (x ray, nuclear) workers
• Abnormal or uncorrectable female factor. 7- Single patient.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• Birowo P, Rahendra Wijaya J, Atmoko W, Rasyid N. The effects of varicocelectomy on the DNA fragmentation index and other sperm parameters: a meta-analysis. Basic Clin Androl. 2020 Sep 10;30:15. doi: 10.1186/s12610-020-00112-6. eCollection 2020.

  PMID: 32944248 BACKGROUND

• Wang L, Zheng L, Jiang H, Jiang T. Does Sperm DNA Fragmentation Index Continuously Decrease Over Time After Varicocelectomy in Varicocele-Induced Infertility? A Systematic Review and Meta-Analysis. Am J Mens Health. 2024 Sep-Oct;18(5):15579883241285670. doi: 10.1177/15579883241285670.

  PMID: 39376021 BACKGROUND

Related Links

• Related Info

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: August 28, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08