Video Telescopic Operating MicroscopeNCT07916285
Video Telescopic Operating Microscope (VITOM) Versus Loupe- Assisted Varicocelectomy
A study testing Video telescopic operating microscope and Loupe with magnification 4x in people with Video Telescopic Operating Microscope and Loupe- Assisted Varicocelectomy, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to compare the efficacy, outcome and surgeon satisfaction in Video Telescopic Operating Microscope (VITOM) microsurgical subinguinal varicocelectomy with Loupe- assisted subinguinal varicocelectomy. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Video Telescopic Operating Microscope, Loupe- Assisted Varicocelectomy
- What is being tested?
- Video telescopic operating microscope and Loupe with magnification 4x
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2025to 30 Nov 2026
- 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 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Age: male patients from 18 - 60 years.
- Males with grade II or III varicocele (unilateral or bilateral).
- Males complaining of scrotal swelling or pain not responding to medical treatment.
- Infertile males with impaired semen parameters.
Who cannot join
- Patients with subclinical varicocele or grade 1 varicocele.
- Acute urogenital infection.
- Patients with hypogonadism (hypogonadotrophic or hypergonadotrophic)
- Patients with hyperprolactenemia.
- Patient with small testicular volume.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 12613
Mohamed A Mahmoud, MSc, 00201559589004, galal241019888@gmail.com
Ahmed M ElFeel, MD
About this study
Official title: Comparative Study Between Video Telescopic Operating Microscope (VITOM) and Loupe- Assisted Varicocelectomy (Randomized Controlled Trial)
This study aims to compare the efficacy, outcome and surgeon satisfaction in Video Telescopic Operating Microscope (VITOM) microsurgical subinguinal varicocelectomy with Loupe- assisted subinguinal varicocelectomy.
Read the detailed description
Varicocele is a common medical condition characterized by abnormal dilation and enlargement of the scrotal venous pampiniform plexus, which drains blood from the testicles resulting in complex network of swollen regurging veins.
There are different approaches in varicocelectomy; open surgical inguinal , subinguinal or intrascrotal ,which can be conventional open surgery or by using surgical microscope or Video Telescopic Operating Microscope (VITOM) or Loupeassisted. Also varicocelectomy can be done by laparoscopic retroperitoneal abdominal ligation of gonadal veins or endovascular approach using antegrade sclerotherapy. Improved semen parameters and fewer complications are noticed, when magnification has been used. Magnification can be done using surgical microscope or VITOM or Loupe-assisted.
- Being tested
- Video telescopic operating microscope, Loupe with magnification 4x
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video telescopic operating microscopeDevice
Patients will be managed using video telescopic operating microscope (VITOM).
Loupe with magnification 4xDevice
Patients will be managed using Loupe with magnification 4x.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients will be managed using video telescopic operating microscope (VITOM). Receives: Device: Video telescopic operating microscope |
| Group B | Experimental | Patients will be managed using Loupe with magnification 4x. Receives: Device: Loupe with magnification 4x |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Motile Sperm Count
Total motile sperm count (TMSC), expressed as millions of motile sperm per ejaculate, will be assessed by semen analysis. TMSC will be calculated by multiplying semen volume (mL) by sperm concentration (million/mL) and the proportion of motile sperm.
Measured: 3 months after surgery
Secondary outcomes (6)
Scrotal Pain Intensity
Scrotal pain will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
Measured: 3 months after surgery
Scrotal Swelling
Number of participants with scrotal swelling will be assessed by clinical examination.
Measured: 3 months after surgery
Surgeon Satisfaction With the Visualization Device
Surgeon-reported assessment using the protocol's 13-item questionnaire covering image quality, equipment handling, ergonomics, and educational usefulness. Each item is rated on a five-point scale.
Measured: Immediately after surgery (with in one hour)
Erectile Function
Erectile function will be assessed using the five-item International Index of Erectile Function (IIEF-5). As presented in the protocol, total scores range from 5 to 25, with higher scores indicating better erectile function.
Measured: 3 months after surgery
Serum Total Testosterone
Serum total testosterone concentration will be measured by laboratory testing and compared between treatment groups.
Measured: 3 months after surgery
Varicocele Recurrence
Number of participants with recurrent varicocele will be assessed clinically at follow-up, with scrotal duplex ultrasonography performed at 3 months.
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Nov 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Video Telescopic Operating MicroscopeStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Galal Mahmoud, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916285
- Sponsor's protocol ID
- MD-372-2025 (11-3-2026)
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Video Telescopic Operating Microscope (VITOM) and Loupe- Assisted Varicocelectomy (Randomized Controlled Trial)
- ClinicalTrials.gov ID
- NCT07916285
- Acronym / sponsor ID
- MD-372-2025 (11-3-2026)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 4 Nov 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 compare the efficacy, outcome and surgeon satisfaction in Video Telescopic Operating Microscope (VITOM) microsurgical subinguinal varicocelectomy with Loupe- assisted subinguinal varicocelectomy.
Detailed description
Varicocele is a common medical condition characterized by abnormal dilation and enlargement of the scrotal venous pampiniform plexus, which drains blood from the testicles resulting in complex network of swollen regurging veins.
There are different approaches in varicocelectomy; open surgical inguinal , subinguinal or intrascrotal ,which can be conventional open surgery or by using surgical microscope or Video Telescopic Operating Microscope (VITOM) or Loupeassisted. Also varicocelectomy can be done by laparoscopic retroperitoneal abdominal ligation of gonadal veins or endovascular approach using antegrade sclerotherapy. Improved semen parameters and fewer complications are noticed, when magnification has been used. Magnification can be done using surgical microscope or VITOM or Loupe-assisted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Video telescopic operating microscopePatients will be managed using video telescopic operating microscope (VITOM). |
| Group B | Experimental | Device: Loupe with magnification 4xPatients will be managed using Loupe with magnification 4x. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: male patients from 18 - 60 years.
- Males with grade II or III varicocele (unilateral or bilateral).
- Males complaining of scrotal swelling or pain not responding to medical treatment.
- Infertile males with impaired semen parameters.
Key exclusion criteria (5 listed)
- Patients with subclinical varicocele or grade 1 varicocele.
- Acute urogenital infection.
- Patients with hypogonadism (hypogonadotrophic or hypergonadotrophic)
- Patients with hyperprolactenemia.
- Patient with small testicular volume.
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 |
|---|---|---|
| Video telescopic operating microscopePatients will be managed using video telescopic operating microscope (VITOM). | Device | Group A |
| Loupe with magnification 4xPatients will be managed using Loupe with magnification 4x. | Device | Group B |
Primary outcome
Total Motile Sperm Count
Time frame: 3 months after surgery
Total motile sperm count (TMSC), expressed as millions of motile sperm per ejaculate, will be assessed by semen analysis. TMSC will be calculated by multiplying semen volume (mL) by sperm concentration (million/mL) and the proportion of motile sperm.
6 secondary outcomes
Scrotal Pain Intensity
Time frame: 3 months after surgery
Scrotal Swelling
Time frame: 3 months after surgery
Surgeon Satisfaction With the Visualization Device
Time frame: Immediately after surgery (with in one hour)
Erectile Function
Time frame: 3 months after surgery
Serum Total Testosterone
Time frame: 3 months after surgery
Varicocele Recurrence
Time frame: 3 months after surgery
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 4 Nov 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video telescopic operating microscope and Loupe with magnification 4x in people with Video Telescopic Operating Microscope and Loupe- Assisted Varicocelectomy, run by Cairo University at 1 site in Egypt.
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 5 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Mohamed A Mahmoud, MSc (00201559589004, galal241019888@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Motile Sperm Count (time frame: 3 months after surgery). 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 4 Nov 2026.