DNA DamageNCT07144891
sperDNA Fragmentation a a Predictor for Outcome After Varicocelectomy,m
An observational study of DNA Damage, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men only
- Conditions the study is for
- DNA Damage
- What is being tested?
- Sperm DNA fragmentation
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 years
- Men only
- No healthy volunteers
- Adult
Study population: infertile male from 20 years old to 45 years old
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Sperm DNA Fragmentation Among Other Variableas a Predictor for Outcome After Varicocelectomy,
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.
Read the detailed description
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 prevalence of clinically relevant varicocele ranges from 5 to 20%. It has affected 19-41% of men with primary infertility and 45-81% of men with secondary 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.
Current guidelines recommend that varicoceles be treated in cases of documented infertility, palpable varicocele, normal or potentially corrected female fertility, and at least one abnormal sperm parameter with no clear statement about abnormal sperm DNA or function Furthermore, Zavattaro et al. reported that around 15% of varicocele patients with normal semen analysis are diagnosed as infertile .
Due to conflicting studies and a lack of high-quality evidence, it is unclear how SDF testing should best be applied in the evaluation and treatment of infertile men, making SDF an active area of research [. Although most men with abnormal semen parameters will have an improvement in semen parameters after varicocelectomy, until recently we had no way to accurately predict which men would respond positively to VC repair .
While preoperative total motile sperm count (TMSC) coupled with sperm concentration can be a significant predictor of semen improvement and pregnancy after varicocelectomy , Despite the presence of numerous studies about the prognostic variables with VC repair, little well designed studies were published about the role of more objective factors as sperm DNA damage and oxidative stress as a prognostic factors with VC repair in infertile men. These variables were found to be more objective predictors for normal and assisted conception even more than conventional semen parameters.
- Conditions
- DNA Damage
- Being tested
- Sperm DNA fragmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sperm DNA fragmentationGenetic
Estimation of sperm DFI level with sperm chromatin dispersion
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Genetic: Sperm DNA fragmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DNA DamageStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Deif Abdelghani Ghidan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144891
- Sponsor's protocol ID
- SDV
- Status last verified
- Aug 2025
- First submitted
- 5 May 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32944248Wang 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.
PubMed 39376021
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sperm DNA Fragmentation Among Other Variableas a Predictor for Outcome After Varicocelectomy,
- ClinicalTrials.gov ID
- NCT07144891
- Acronym / sponsor ID
- SDV
- Conditions
- DNA Damage
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 28 Aug 2025 (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.
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.
Detailed description
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 prevalence of clinically relevant varicocele ranges from 5 to 20%. It has affected 19-41% of men with primary infertility and 45-81% of men with secondary 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.
Current guidelines recommend that varicoceles be treated in cases of documented infertility, palpable varicocele, normal or potentially corrected female fertility, and at least one abnormal sperm parameter with no clear statement about abnormal sperm DNA or function Furthermore, Zavattaro et al. reported that around 15% of varicocele patients with normal semen analysis are diagnosed as infertile .
Due to conflicting studies and a lack of high-quality evidence, it is unclear how SDF testing should best be applied in the evaluation and treatment of infertile men, making SDF an active area of research [. Although most men with abnormal semen parameters will have an improvement in semen parameters after varicocelectomy, until recently we had no way to accurately predict which men would respond positively to VC repair .
While preoperative total motile sperm count (TMSC) coupled with sperm concentration can be a significant predictor of semen improvement and pregnancy after varicocelectomy , Despite the presence of numerous studies about the prognostic variables with VC repair, little well designed studies were published about the role of more objective factors as sperm DNA damage and oxidative stress as a prognostic factors with VC repair in infertile men. These variables were found to be more objective predictors for normal and assisted conception even more than conventional semen parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Genetic: Sperm DNA fragmentation |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- infertile male from 20 years old to 45 years old
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Sperm DNA fragmentationEstimation of sperm DFI level with sperm chromatin dispersion | Genetic | 1 |
Primary outcome
we will assess sperm DNA fragmentation as a pridector for outcome of varicoelectomy in a group of infertile males with palpable varicocele.
Time frame: 1 year
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Background: PubMed 32944248Birowo 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.
- Background: PubMed 39376021Wang 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.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of DNA Damage, run by Assiut University.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 28 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
we will assess sperm DNA fragmentation as a pridector for outcome of varicoelectomy in a group of infertile males with palpable varicocele. (time frame: 1 year). 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 NCT07144891, which also lists 2 linked publications.
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 28 Aug 2025.