Male InfertilityazoospermiaNCT06983626
Management of Non Obstructive Azoospermia in Men
A study testing micro-dissection testicular sperm extraction in people with Male Infertility and Azoospermia, Nonobstructive, run by South Valley University at 1 site in Egypt.
Trial summary
this study predicts the factors of successful micro testicular sperm extraction in azoospermia patients in male infertility Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Infertility, Azoospermia, Nonobstructive
- What is being tested?
- micro-dissection testicular sperm extraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 1 Apr 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- obstructive Azoospermia and bilateral congenital absent of vas
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine, South Valley University
Luxor, Qena Governorate, 83511
About this study
Official title: Predictive Factors of Successful Micro-dissection Testicular Sperm Extraction For Patients With Non Obstructive Azoospermia
this study predicts the factors of successful micro testicular sperm extraction in azoospermia patients in male infertility
Read the detailed description
primary outcomes: these factors were the age, testicular size, hormonal, evidence of varicocles and the out come of Micro_TESE secondary outcomes: make good decision for Micro-TESE with low economic laboratory and radiology requirement As every failed microTESE-ICSI procedure exposes the couple to an emotional, financial burden and increase the incidence of complication such as bleeding, hematoma and testicular atrophy
- Conditions
- Male Infertility, Azoospermia, Nonobstructive
- Being tested
- micro-dissection testicular sperm extraction
- Medical subject headings
- Infertility, Male, Azoospermia, Nonobstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micro-dissection testicular sperm extractionProcedure or surgery
Also called TESE, TESA, PESA
dissection of the seminefrous tubules under microscope to extract sperms
| Study group | Role | What they receive |
|---|---|---|
| male infertility | Active comparator | azoospermia non obstructive type Receives: Procedure: micro-dissection testicular sperm extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sperm Retrieval Success Rate and identification of Predictive Factors
Determine which preoperative factors are significantly associated with successful sperm retrieval. These may include:
Serum Follicle-Stimulating Hormone (FSH) Levels: Elevated FSH levels have been linked to reduced sperm retrieval success.
And patient Age and testicular size to reach the best one to predict the success rate
Measured: 1st 1 year
Secondary outcomes (1)
Assess the success rates of ART procedures following sperm retrieval and complications
Assisted Reproductive Technology (ART) Outcomes
Fertilization Rates: The percentage of oocytes successfully fertilized.
Embryo Development: Quality and progression of embryos to the blastocyst stage.
Clinical Pregnancy Rates: Confirmed pregnancies via ultrasound.
Live Birth Rates: The ultimate success metric of ART procedures
Complication Rates
Monitor and document any complications arising from the sperm retrieval procedure, such as:
Testicular Hematoma
Infection
Testicular Atrophy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start1 Jun 2022
- Primary completion1 Apr 2024
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male InfertilityStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hafez Badawy Hafez, South Valley University
- Investigators
- Gamal abdelhammid alsagheer, professour of urology, professour, Study director, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983626
- Sponsor's protocol ID
- SVU MED URO016 2 22 5 401
- Acronym
- azoospermia
- Status last verified
- Apr 2025
- First submitted
- 28 Apr 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: according to the results
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors of Successful Micro-dissection Testicular Sperm Extraction For Patients With Non Obstructive Azoospermia
- ClinicalTrials.gov ID
- NCT06983626
- Acronym / sponsor ID
- azoospermia / SVU MED URO016 2 22 5 401
- Conditions
- Male Infertility, Azoospermia, Nonobstructive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 21 May 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.
this study predicts the factors of successful micro testicular sperm extraction in azoospermia patients in male infertility
Detailed description
primary outcomes: these factors were the age, testicular size, hormonal, evidence of varicocles and the out come of Micro_TESE secondary outcomes: make good decision for Micro-TESE with low economic laboratory and radiology requirement As every failed microTESE-ICSI procedure exposes the couple to an emotional, financial burden and increase the incidence of complication such as bleeding, hematoma and testicular atrophy
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| male infertility | Active comparator | Procedure: micro-dissection testicular sperm extractionazoospermia non obstructive type |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- obstructive Azoospermia and bilateral congenital absent of vas
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 |
|---|---|---|
| micro-dissection testicular sperm extractionAlso: TESE, TESA, PESAdissection of the seminefrous tubules under microscope to extract sperms | Procedure or surgery | male infertility |
Primary outcome
Sperm Retrieval Success Rate and identification of Predictive Factors
Time frame: 1st 1 year
Determine which preoperative factors are significantly associated with successful sperm retrieval. These may include: Serum Follicle-Stimulating Hormone (FSH) Levels: Elevated FSH levels have been linked to reduced sperm retrieval success. And patient Age and testicular size to reach the best one to predict the success rate
1 secondary outcome
Assess the success rates of ART procedures following sperm retrieval and complications
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- AzoospermiaLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. according to the results
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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 abdelhammid alsagheer, professour of urology, professour study director
South Valley University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing micro-dissection testicular sperm extraction in people with Male Infertility and Azoospermia, Nonobstructive, 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 0 inclusion and 1 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: finished, as of the sponsor's last update on 25 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sperm Retrieval Success Rate and identification of Predictive Factors (time frame: 1st 1 year). 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 25 May 2025.