Non-obstructive AzoospermiaNCT07008495
Testicular Sperm Retrieval Rate After Varicocele Ligation in Men With Non Obstructive Azoospermia
A study testing varicocelectomy in people with Non-obstructive Azoospermia, run by South Valley University at 1 site in Egypt.
Trial summary
A varicocele is an abnormal dilatation and tortuosity of the veins of the spermatic cord. Although varicoceles are common in the general population and are frequently found on routine physical examinations, they represent the most common correctable cause of male factor infertility. Read more about this study
- Who is it for?
- Ages 20 to 60 years, men only
- Conditions the study is for
- Non-obstructive Azoospermia
- What is being tested?
- varicocelectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Men with non obstructive azoospermia.
- Clinically palpable varicocele ( unilateral or bilateral ).
Who cannot join
- Known cases of obstructive azoospermia.
- Non palpable varicocele.
- Uncorrectable female causes of infertility.
- genetic abnormalities like klinefelter syndrome.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
South Valley University Hospital
Qina, South Valley
Mostafa AbdelRazek Ahmed, Assist.Prof, +201004116386, mostafa_uro@med.svu.edu.eg
Omar Mohamed El-Saghier, Assist.Prof, +201095421734, omarelsoqier1983@yahoo.com
About this study
Official title: Testicular Sperm Retrieval Rate After Varicocele Ligation in Men With Non Obstructive Azoospermia.
A varicocele is an abnormal dilatation and tortuosity of the veins of the spermatic cord. Although varicoceles are common in the general population and are frequently found on routine physical examinations, they represent the most common correctable cause of male factor infertility.
Male factor infertility affects up to half of all couples struggling to conceive, and 10-20% of men evaluated for infertility are found to be azoospermic.
Read the detailed description
Generally, azoospermia is classified as obstructive azoospermia (OA) or non-obstructive azoospermia (NOA). While OA is obviously caused by obstruction, NOA has many possible causes and is more difficult to manage.
Non-obstructive azoospermia (NOA) is most often a result of primary testicular dysfunction, Varicoceles are found in 20% of the general male population, in up to 40% of men with infertility, and specifically 4.3-13.3% of men with NOA.
The role of varicoceles in NOA has not been fully elucidated. The current best practice statement on the evaluation of azoospermic males from the AUA acknowledges that impaired spermatogenesis associated with varicoceles may be reversible but does not give a clear recommendation for management.
The primary advantage of varicocelectomy in cases of NOA is the possibility of getting motile sperms in the ejaculate. Other benefit of varicocele repairs in azoospermic men is that there are increased success rates of assisted reproductive techniques (ART) such as intracytoplasmic sperm injection (ICSI) or testicular sperm extraction (TESE).
- Conditions
- Non-obstructive Azoospermia
- Being tested
- varicocelectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
varicocelectomyProcedure or surgery
Also called TESE
to detect testicular sperm retrieval rate after varicocelectomy in men with non obstructive azoospermia.
| Study group | Role | What they receive |
|---|---|---|
| Group of varicocele ligation | Active comparator | About 25 male patients will undergo varicocele ligation then microTESE. Receives: Procedure: varicocelectomy |
| Group of TESE | Active comparator | About 25 male patients will undergo microTESE without varicocele ligation. Receives: Procedure: varicocelectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sperm retrieval rate
Evaluation of Sperm retrieval rate after varicocelectomy in men with non obstructive azoospermia
Measured: Two Weeks
Secondary outcomes (1)
fertility rate
Evaluation of fertility rate after varicocelectomy in men with non obstructive azoospermia
Measured: 3 months from the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start1 Sep 2024
- Primary completion20 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-obstructive AzoospermiaStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yacoub Nagah Abdelwahab, South Valley University
- Investigators
- Gamal A. Alsagheer, Professor, Study chair, Urology Department, Faculty of Medicine, South Valley University, Qena, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008495
- Sponsor's protocol ID
- Non-Obstructive Azoospermia
- Status last verified
- Sep 2024
- First submitted
- 28 May 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testicular Sperm Retrieval Rate After Varicocele Ligation in Men With Non Obstructive Azoospermia.
- ClinicalTrials.gov ID
- NCT07008495
- Acronym / sponsor ID
- Non-Obstructive Azoospermia
- Conditions
- Non-obstructive Azoospermia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 20 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 6 Jun 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.
A varicocele is an abnormal dilatation and tortuosity of the veins of the spermatic cord. Although varicoceles are common in the general population and are frequently found on routine physical examinations, they represent the most common correctable cause of male factor infertility.
Male factor infertility affects up to half of all couples struggling to conceive, and 10-20% of men evaluated for infertility are found to be azoospermic.
Detailed description
Generally, azoospermia is classified as obstructive azoospermia (OA) or non-obstructive azoospermia (NOA). While OA is obviously caused by obstruction, NOA has many possible causes and is more difficult to manage.
Non-obstructive azoospermia (NOA) is most often a result of primary testicular dysfunction, Varicoceles are found in 20% of the general male population, in up to 40% of men with infertility, and specifically 4.3-13.3% of men with NOA.
The role of varicoceles in NOA has not been fully elucidated. The current best practice statement on the evaluation of azoospermic males from the AUA acknowledges that impaired spermatogenesis associated with varicoceles may be reversible but does not give a clear recommendation for management.
The primary advantage of varicocelectomy in cases of NOA is the possibility of getting motile sperms in the ejaculate. Other benefit of varicocele repairs in azoospermic men is that there are increased success rates of assisted reproductive techniques (ART) such as intracytoplasmic sperm injection (ICSI) or testicular sperm extraction (TESE).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group of varicocele ligation | Active comparator | Procedure: varicocelectomyAbout 25 male patients will undergo varicocele ligation then microTESE. |
| Group of TESE | Active comparator | Procedure: varicocelectomyAbout 25 male patients will undergo microTESE without varicocele ligation. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Men with non obstructive azoospermia.
- Clinically palpable varicocele ( unilateral or bilateral ).
Key exclusion criteria (4 listed)
- Known cases of obstructive azoospermia.
- Non palpable varicocele.
- Uncorrectable female causes of infertility.
- genetic abnormalities like klinefelter syndrome.
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 |
|---|---|---|
| varicocelectomyAlso: TESEto detect testicular sperm retrieval rate after varicocelectomy in men with non obstructive azoospermia. | Procedure or surgery | Group of TESE, Group of varicocele ligation |
Primary outcome
Sperm retrieval rate
Time frame: Two Weeks
Evaluation of Sperm retrieval rate after varicocelectomy in men with non obstructive azoospermia
1 secondary outcome
fertility rate
Time frame: 3 months from the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: Yes
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Preimplantation Genetic Testing for Aneuploidy (PGT-A) in Couples With Non-obstructive Azoospermia (NOA)
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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. This study is not recruiting at the moment.
Gamal A. Alsagheer, Professor study chair
Urology Department, Faculty of Medicine, South Valley University, Qena, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing varicocelectomy in people with Non-obstructive Azoospermia, run by South Valley 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 13 Jun 2025. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yacoub Nagah Abdelwahab, Resident (+201092142396, dryacoubn99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sperm retrieval rate (time frame: Two Weeks). 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 13 Jun 2025.