VaricoceleNCT07684963
Effect of Varicocelectomy on Spermatogenic Cell Count and Semen Parameters
A study testing Subinguinal Microsurgical Varicocelectomy in people with Varicocele and Male Infertility, run by Assiut University.
Trial summary
This study aims to evaluate how varicocele surgery (varicocelectomy) affects the number of immature sperm cells (spermatogenic cells) found in the semen of infertile men. Varicocele, an abnormal dilation of veins in the scrotum, is a common cause of male infertility that can negatively impact semen quality and overall… Read more about this study
- Who is it for?
- Ages 20 to 45 years, men only
- Conditions the study is for
- Varicocele, Male Infertility, Infertility
- What is being tested?
- Subinguinal Microsurgical Varicocelectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Sep 2027
- Phase
- Interventional
- 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
Who may be able to join
- Infertile married males diagnosed with clinical varicocele.
- Age between 20-45 years.
- Patients indicated for varicocelectomy according to standard clinical guidelines.
- Abnormal or suboptimal semen parameters on at least two semen analyses.
Who cannot join
- Azoospermic patients (complete absence of sperm in semen).
- History of previous varicocelectomy or scrotal surgery.
- Presence of other known causes of infertility (e.g., genetic abnormalities, obstructive azoospermia).
- Active genital infection or systemic infection affecting semen analysis.
- Use of medications affecting spermatogenesis within the last 3 months (e.g., testosterone, chemotherapy).
- Chronic systemic diseases known to affect fertility (e.g., uncontrolled diabetes, liver failure).
- Severe leukocytospermia as confirmed by peroxidase (Endtz) test exceeding WHO reference limits.
- Pus cell > 1 million/ml by peroxidase.
About this study
Official title: Seminal Spermatogenic Cell Count Pre and Post Varicocelectomy: Relation to Seminal Parameters
This study aims to evaluate how varicocele surgery (varicocelectomy) affects the number of immature sperm cells (spermatogenic cells) found in the semen of infertile men. Varicocele, an abnormal dilation of veins in the scrotum, is a common cause of male infertility that can negatively impact semen quality and overall testicular function. While surgery is widely performed to improve standard semen parameters, this study specifically investigates its impact on the shedding of immature germ cells into the seminal fluid, which can be an indicator of impaired sperm production.
Researchers will enroll 40 infertile married men, aged 20 to 45, who have been diagnosed with a clinical varicocele and exhibit abnormal semen parameters. All participants will undergo a single surgical intervention known as a subinguinal microsurgical varicocelectomy. To measure the effects of the surgery, participants will undergo careful semen analysis before the procedure, and again at 3 and 6 months postoperatively. The primary goal is to track changes in the spermatogenic cell count and abnormal sperm morphology, and to explore how these changes correlate with conventional semen parameters like sperm concentration, motility, and vitality.
Read the detailed description
Male factor infertility contributes as the sole factor in approximately 20-25% of infertile couples. While semen analysis remains the cornerstone for evaluating male infertility , conventional parameters may not fully reflect underlying functional and molecular alterations. Varicocele, characterized by abnormal dilatation and tortuosity of the pampiniform venous plexus, is one of the most common correctable causes of male infertility. The pathological changes associated with varicocele can adversely affect the seminiferous epithelium, leading to defective spermatogenesis and an increased sloughing of immature germ cells (spermatogenic cells) into the seminal fluid. According to World Health Organization (WHO) recommendations, the presence of these spermatogenic cells is clinically relevant as it reflects impaired spermatogenesis and testicular dysfunction.
This prospective interventional study aims to evaluate changes in seminal spermatogenic cell counts and conventional semen parameters following surgical correction. Participants will undergo a subinguinal microsurgical varicocelectomy. During the procedure, the spermatic cord is delivered and examined under 5-10X microscopic magnification. The internal spermatic artery is carefully identified, utilizing an intraoperative USG probe if necessary, and dissected free of surrounding structures. Internal spermatic veins and cremasteric veins are ligated, while testicular arteries, cremasteric arteries, lymphatic vessels, and the vas deferens are preserved.
To assess the surgical outcomes, semen samples will be collected after 3-5 days of sexual abstinence preoperatively (at least a week apart, utilizing the second sample) and postoperatively at 3 and 6 months. The differentiation of seminal round cells into leukocytes and spermatogenic cells will be conducted using combined morphological and enzymatic methods. Semen smears will be stained with Papanicolaou stain and examined under light microscopy to identify spermatogenic cells based on nuclear morphological features. A peroxidase (Endtz) test will concurrently be used to differentiate peroxidase-positive leukocytes from peroxidase-negative spermatogenic cells. The spermatogenic cell concentration will be quantified using a Neubauer hemocytometer according to the WHO 2021 manual equation.
- Conditions
- Varicocele, Male Infertility, Infertility, Varicocelectomy
- Being tested
- Subinguinal Microsurgical Varicocelectomy
- Keywords
- Spermatogenic Cells, Semen Parameters, Immature Germ Cells, Semen Analysis, Sperm Morphology, Round Cells
- Medical subject headings
- Varicocele, Infertility, Male, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subinguinal Microsurgical VaricocelectomyProcedure or surgery
A 3-4 cm subinguinal incision will be made below the external ring. Under 5-10X microscopic magnification, the internal spermatic artery will be identified and preserved. The internal spermatic veins and cremasteric veins, with the exception of vasal veins, will be ligated. The testicular arteries, cremasteric arteries, cremaster muscle fibers, nerves, lymphatic vessels, and vas deferens will be preserved before the spermatic cord is returned and the incision is closed.
| Study group | Role | What they receive |
|---|---|---|
| Microsurgical Varicocelectomy | Experimental | Infertile married males aged 20-45 with clinical varicocele and abnormal semen parameters will form a single study arm. All participants will undergo a subinguinal microsurgical varicocelectomy. The surgical technique involves opening the spermatic fasciae under microscopic magnification (up to 10X), identifying and preserving the internal spermatic artery, and ligating the internal spermatic and cremasteric veins. Semen analysis, including spermatogenic cell quantification using combined morphological and enzymatic methods, will be conducted preoperatively and at 3 and 6 months postoperatively. Receives: Procedure: Subinguinal Microsurgical Varicocelectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Seminal Spermatogenic Cell Count
Spermatogenic cell concentration will be quantified using a Neubauer hemocytometer and expressed as x10⁶ cells/mL.
Measured: Preoperatively, and at 3 and 6 months postoperatively.
Secondary outcomes (1)
Change in Sperm Concentration
The change in sperm concentration will be analyzed and measured in 10⁶/ml according to the World Health Organization (WHO) Laboratory Manual.
Measured: Preoperatively, and at 3 and 6 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaricoceleStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulkarim Mohammed Abdulkarim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684963
- Sponsor's protocol ID
- Varicocelectomy & Semen Cells
- Status last verified
- Jun 2026
- First submitted
- 28 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seminal Spermatogenic Cell Count Pre and Post Varicocelectomy: Relation to Seminal Parameters
- ClinicalTrials.gov ID
- NCT07684963
- Acronym / sponsor ID
- Varicocelectomy & Semen Cells
- Conditions
- Varicocele, Male Infertility, Infertility, Varicocelectomy
- Keywords
- Spermatogenic Cells, Semen Parameters, Immature Germ Cells, Semen Analysis, Sperm Morphology, Round Cells
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 6 Jul 2026 (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.
This study aims to evaluate how varicocele surgery (varicocelectomy) affects the number of immature sperm cells (spermatogenic cells) found in the semen of infertile men. Varicocele, an abnormal dilation of veins in the scrotum, is a common cause of male infertility that can negatively impact semen quality and overall testicular function. While surgery is widely performed to improve standard semen parameters, this study specifically investigates its impact on the shedding of immature germ cells into the seminal fluid, which can be an indicator of impaired sperm production.
Researchers will enroll 40 infertile married men, aged 20 to 45, who have been diagnosed with a clinical varicocele and exhibit abnormal semen parameters. All participants will undergo a single surgical intervention known as a subinguinal microsurgical varicocelectomy. To measure the effects of the surgery, participants will undergo careful semen analysis before the procedure, and again at 3 and 6 months postoperatively. The primary goal is to track changes in the spermatogenic cell count and abnormal sperm morphology, and to explore how these changes correlate with conventional semen parameters like sperm concentration, motility, and vitality.
Detailed description
Male factor infertility contributes as the sole factor in approximately 20-25% of infertile couples. While semen analysis remains the cornerstone for evaluating male infertility , conventional parameters may not fully reflect underlying functional and molecular alterations. Varicocele, characterized by abnormal dilatation and tortuosity of the pampiniform venous plexus, is one of the most common correctable causes of male infertility. The pathological changes associated with varicocele can adversely affect the seminiferous epithelium, leading to defective spermatogenesis and an increased sloughing of immature germ cells (spermatogenic cells) into the seminal fluid. According to World Health Organization (WHO) recommendations, the presence of these spermatogenic cells is clinically relevant as it reflects impaired spermatogenesis and testicular dysfunction.
This prospective interventional study aims to evaluate changes in seminal spermatogenic cell counts and conventional semen parameters following surgical correction. Participants will undergo a subinguinal microsurgical varicocelectomy. During the procedure, the spermatic cord is delivered and examined under 5-10X microscopic magnification. The internal spermatic artery is carefully identified, utilizing an intraoperative USG probe if necessary, and dissected free of surrounding structures. Internal spermatic veins and cremasteric veins are ligated, while testicular arteries, cremasteric arteries, lymphatic vessels, and the vas deferens are preserved.
To assess the surgical outcomes, semen samples will be collected after 3-5 days of sexual abstinence preoperatively (at least a week apart, utilizing the second sample) and postoperatively at 3 and 6 months. The differentiation of seminal round cells into leukocytes and spermatogenic cells will be conducted using combined morphological and enzymatic methods. Semen smears will be stained with Papanicolaou stain and examined under light microscopy to identify spermatogenic cells based on nuclear morphological features. A peroxidase (Endtz) test will concurrently be used to differentiate peroxidase-positive leukocytes from peroxidase-negative spermatogenic cells. The spermatogenic cell concentration will be quantified using a Neubauer hemocytometer according to the WHO 2021 manual equation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microsurgical Varicocelectomy | Experimental | Procedure: Subinguinal Microsurgical VaricocelectomyInfertile married males aged 20-45 with clinical varicocele and abnormal semen parameters will form a single study arm. All participants will undergo a subinguinal microsurgical varicocelectomy. The surgical technique involves opening the spermatic fasciae under microscopic magnification (up to 10X), identifying and preserving the internal spermatic artery, and ligating the internal spermatic and cremasteric veins. Semen analysis, including spermatogenic cell quantification using combined morphological and enzymatic methods, will be conducted preoperatively and at 3 and 6 months postoperatively. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Infertile married males diagnosed with clinical varicocele.
- Age between 20-45 years.
- Patients indicated for varicocelectomy according to standard clinical guidelines.
- Abnormal or suboptimal semen parameters on at least two semen analyses.
Key exclusion criteria (8 listed)
- Azoospermic patients (complete absence of sperm in semen).
- History of previous varicocelectomy or scrotal surgery.
- Presence of other known causes of infertility (e.g., genetic abnormalities, obstructive azoospermia).
- Active genital infection or systemic infection affecting semen analysis.
- Use of medications affecting spermatogenesis within the last 3 months (e.g., testosterone, chemotherapy).
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 |
|---|---|---|
| Subinguinal Microsurgical VaricocelectomyA 3-4 cm subinguinal incision will be made below the external ring. Under 5-10X microscopic magnification, the internal spermatic artery will be identified and preserved. The internal spermatic veins and cremasteric veins, with the exception of vasal veins, will be ligated. The testicular arteries, cremasteric arteries, cremaster muscle fibers, nerves, lymphatic vessels, and vas deferens will be preserved before the spermatic cord is returned and the incision is closed. | Procedure or surgery | Microsurgical Varicocelectomy |
Primary outcome
Change in Seminal Spermatogenic Cell Count
Time frame: Preoperatively, and at 3 and 6 months postoperatively.
Spermatogenic cell concentration will be quantified using a Neubauer hemocytometer and expressed as x10⁶ cells/mL.
1 secondary outcome
Change in Sperm Concentration
Time frame: Preoperatively, and at 3 and 6 months postoperatively.
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 6 Jul 2026.
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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?
A study testing Subinguinal Microsurgical Varicocelectomy in people with Varicocele and Male Infertility, 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 4 inclusion and 8 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 6 Jul 2026. 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?
Change in Seminal Spermatogenic Cell Count (time frame: Preoperatively, and at 3 and 6 months postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2026.