Male Infertility Due to AzoospermiaNCT06307639
Seminal Levels of PGK2 and ACRV1 as Predictors of Micro-TESE Results in NOA
An observational study of Male Infertility Due to Azoospermia, run by Assiut University.
Trial summary
Measurement of PGK2 and ACRV1 levels in the semen of infertile males undergoing testicular sperm extraction (TESE). Correlate seminal levels of PGK2 and ACRV1 with sperm retrieval results and histopathology analysis of testicular biopsy samples. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Infertility Due to Azoospermia
- What is being tested?
- Measurement of PGK2 and ACRV1 levels in the semen of infertile males undergoing testicular sperm extraction (TESE).
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 Apr 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Infertile males with normal volume, functional (non-obstructive) azoospermia.
Who may be able to join
- Infertile males with normal volume, functional (non-obstructive) azoospermia.
- Age: 18-45 years
Who cannot join
- Patients with proven obstructive azoospermia.
- Cryptorchidism.
- Testicular Agenesis and testicular atrophy.
- Patient with exposure to gonadal toxins like chemotherapy, radiotherapy, and alkylating agents.
About this study
- Measurement of PGK2 and ACRV1 levels in the semen of infertile males undergoing testicular sperm extraction (TESE).
- Correlate seminal levels of PGK2 and ACRV1 with sperm retrieval results and histopathology analysis of testicular biopsy samples.
- Conditions
- Male Infertility Due to Azoospermia
- Being tested
- Measurement of PGK2 and ACRV1 levels in the semen of infertile males undergoing testicular sperm extraction (TESE).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of PGK2 and ACRV1 levels in the semen of infertile males undergoing testicular sperm extraction (TESE).Diagnostic test
Measurement of PGK2 and ACRV1 levels in the semen of infertile males undergoing testicular sperm extraction (TESE).
What is being measured
The primary outcome is the main question the study is designed to answer.
Know more about the functional role of PGK2 and ACRV1 in the process of spermatogenesis.
Measured: 2 years
Detect if PGK2 and/or AVRV1 level can used as predictor for spermatogenesis in infertile men with non-obstructive azoospermia undergoing Testicular Sperm Extraction.
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 posted13 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male Infertility Due to AzoospermiaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 64 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Yousef Muhammad Swifee, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307639
- Sponsor's protocol ID
- MYMSwifee
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seminal Levels of PGK2 and ACRV1 as Predictors of Micro-TESE Results in NOA
- ClinicalTrials.gov ID
- NCT06307639
- Acronym / sponsor ID
- MYMSwifee
- Conditions
- Male Infertility Due to Azoospermia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 13 Mar 2024 (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.
- Measurement of PGK2 and ACRV1 levels in the semen of infertile males undergoing testicular sperm extraction (TESE).
- Correlate seminal levels of PGK2 and ACRV1 with sperm retrieval results and histopathology analysis of testicular biopsy samples.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Infertile males with normal volume, functional (non-obstructive) azoospermia.
Key inclusion criteria (2 listed)
- Infertile males with normal volume, functional (non-obstructive) azoospermia.
- Age: 18-45 years
Key exclusion criteria (4 listed)
- Patients with proven obstructive azoospermia.
- Cryptorchidism.
- Testicular Agenesis and testicular atrophy.
- Patient with exposure to gonadal toxins like chemotherapy, radiotherapy, and alkylating agents.
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 |
|---|---|---|
| Measurement of PGK2 and ACRV1 levels in the semen of infertile males undergoing testicular sperm extraction (TESE).Measurement of PGK2 and ACRV1 levels in the semen of infertile males undergoing testicular sperm extraction (TESE). | Diagnostic test | – |
Primary outcome
Know more about the functional role of PGK2 and ACRV1 in the process of spermatogenesis.
Time frame: 2 years
Detect if PGK2 and/or AVRV1 level can used as predictor for spermatogenesis in infertile men with non-obstructive azoospermia undergoing Testicular Sperm Extraction.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No
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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.
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 Male Infertility Due to Azoospermia, 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 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 Mar 2024. 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?
Results are not available in the source record.
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?
Know more about the functional role of PGK2 and ACRV1 in the process of spermatogenesis. (time frame: 2 years). The study lists 2 primary outcomes in all. 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 Mar 2024.