Testicular Sperm Extraction in Azoospermic PatientsNCT07259967
Laterality Success Determination of Microscopic Testicular Sperm Extraction in Non Obstructive Azoopsermia Patients
An observational study of Testicular Sperm Extraction in Azoospermic Patients, run by Assiut University.
Trial summary
Determination of percentage of successful sperm retrieval in single testis in cases who will do bilateral TESE and identification factors mostly associated with successful sperm retrieval Read more about this study
- Who is it for?
- Ages 20 to 60 years, men only
- Conditions the study is for
- Testicular Sperm Extraction in Azoospermic Patients
- What is being tested?
- Testicular sperm extraction
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Jan 2027
- Phase
- Observational
- 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 60 years
- Men only
- Adult
Study population: Male patients diagnosed as non obstructive azoospermia and will do bilateral TESE.
Who may be able to join
- • Male patients diagnosed as non obstructive azoospermia.
- Will do bilateral TESE.
Who cannot join
- • Obstructive azoospermia.
- Incomplete medical record .
- Prior testicular Trauma.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Determination of percentage of successful sperm retrieval in single testis in cases who will do bilateral TESE and identification factors mostly associated with successful sperm retrieval
Read the detailed description
Male infertility is defined as the failure of pregnancy within 12 months despite the presence of a fertile female partner and coitus via a normal vaginal route without contraception. The microscopic absence of spermatozoa in the ejaculate in at least two semen analysis samples is defined as azoospermia. Azoospermia plays a role in the etiology of male infertility with a rate of 10-15% . Azoospermia is divided into two subgroups: obstructive azoospermia (OA) and non obstructive azoospermia (NOA). NOA is detected in 60% of patients with azoospermia. The etiopathogenesis of NOA includes genetic disorders, Y chromosome microdeletions, testicular torsion, cryptorchidism, toxins, radiation and idiopathic factors. Although many techniques including Percutaneous Sperm Aspiration , Testicular Sperm Aspiration , Conventional Testicular Sperm Extraction , Microdissection Testicular Sperm Extraction (MD-TESE) have been used to detect sperm in patients with NOA, MD-TESE is currently accepted as the method with the highest sperm retrieval rate with the least complications and tissue loss. However, no standard approach is available for searching for appropriate tubules during the MD-TESE procedure . A limited number of studies are available in the literature on whether the testicle should be explored transversely or longitudinally, bilaterally or unilaterally, to increase the sperm detection rate in MD-TESE, and there is still no standard systematic procedure for MD-TESE today to minimize the possibility of missing appropriate tubules and obtaining sperm. Furthermore, despite the presence of studies in the literature indicating that parameters such as hormonal values, testicular volume, genetics, age, environmental factors, varicocele and cryptorchidism predict the possibility of finding sperm before the MD-TESE procedure, none of these parameters have a definite predictive value on sperm finding . The present study aims to evaluate if there is difference in testicular sperm retrieval in patients with non obstructive azoospermia in TESE between right and left testes.
- Being tested
- Testicular sperm extraction
- Keywords
- azoospermia, TESE
- Medical subject headings
- Azoospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testicular sperm extractionProcedure or surgery
Bilateral Testicular sperm extraction done under microscopic guidance for non obstructive azoospermic patients
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of successful sperm retrieval in single testis in cases who will do bilateral TESE.
Measured: 1 day Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Testicular Sperm Extraction in Azoospermic PatientsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed diab mohamed ramadan, Assiut University
- Investigators
- Mohamed Diab Mohamed Ramadan, Master, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259967
- Sponsor's protocol ID
- Laterality of micro TESE
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Raman JD, Schlegel PN. Testicular sperm extraction with intracytoplasmic sperm injection is successful for the treatment of nonobstructive azoospermia associated with cryptorchidism. J Urol. 2003 Oct;170(4 Pt 1):1287-90. doi: 10.1097/01.ju.0000080707.75753.ec.
PubMed 14501743Levin HS. Testicular biopsy in the study of male infertility: its current usefulness, histologic techniques, and prospects for the future. Hum Pathol. 1979 Sep;10(5):569-84. doi: 10.1016/s0046-8177(79)80100-8.
PubMed 43278Witt MA, Elsner C, Kort HI, Massey JB, Mitchell-Leef D, Toledo AA, Tucker MJ. A live birth from intracytoplasmic injection of a spermatozoon retrieved from testicular parenchyma. J Urol. 1995 Sep;154(3):1136-7. No abstract available.
PubMed 7637066Ichioka K, Matsui Y, Terada N, Negoro H, Goto T, Ogawa O. Three-dimensional simulation analysis of microdissection testicular sperm extraction for patients with non-obstructive azoospermia. Andrology. 2020 Sep;8(5):1214-1221. doi: 10.1111/andr.12812. Epub 2020 May 18.
PubMed 32374923
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laterality Success Determination of Microscopic Testicular Sperm Extraction in Non Obstructive Azoopsermia Patients
- ClinicalTrials.gov ID
- NCT07259967
- Acronym / sponsor ID
- Laterality of micro TESE
- Keywords
- azoospermia, TESE
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 2 Dec 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.
Determination of percentage of successful sperm retrieval in single testis in cases who will do bilateral TESE and identification factors mostly associated with successful sperm retrieval
Detailed description
Male infertility is defined as the failure of pregnancy within 12 months despite the presence of a fertile female partner and coitus via a normal vaginal route without contraception. The microscopic absence of spermatozoa in the ejaculate in at least two semen analysis samples is defined as azoospermia. Azoospermia plays a role in the etiology of male infertility with a rate of 10-15% . Azoospermia is divided into two subgroups: obstructive azoospermia (OA) and non obstructive azoospermia (NOA). NOA is detected in 60% of patients with azoospermia. The etiopathogenesis of NOA includes genetic disorders, Y chromosome microdeletions, testicular torsion, cryptorchidism, toxins, radiation and idiopathic factors. Although many techniques including Percutaneous Sperm Aspiration , Testicular Sperm Aspiration , Conventional Testicular Sperm Extraction , Microdissection Testicular Sperm Extraction (MD-TESE) have been used to detect sperm in patients with NOA, MD-TESE is currently accepted as the method with the highest sperm retrieval rate with the least complications and tissue loss. However, no standard approach is available for searching for appropriate tubules during the MD-TESE procedure . A limited number of studies are available in the literature on whether the testicle should be explored transversely or longitudinally, bilaterally or unilaterally, to increase the sperm detection rate in MD-TESE, and there is still no standard systematic procedure for MD-TESE today to minimize the possibility of missing appropriate tubules and obtaining sperm. Furthermore, despite the presence of studies in the literature indicating that parameters such as hormonal values, testicular volume, genetics, age, environmental factors, varicocele and cryptorchidism predict the possibility of finding sperm before the MD-TESE procedure, none of these parameters have a definite predictive value on sperm finding . The present study aims to evaluate if there is difference in testicular sperm retrieval in patients with non obstructive azoospermia in TESE between right and left testes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Age groups
- Adult
- Study population
- Male patients diagnosed as non obstructive azoospermia and will do bilateral TESE.
Key inclusion criteria (2 listed)
- • Male patients diagnosed as non obstructive azoospermia.
Key exclusion criteria (3 listed)
- • Obstructive azoospermia.
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 |
|---|---|---|
| Testicular sperm extractionBilateral Testicular sperm extraction done under microscopic guidance for non obstructive azoospermic patients | Procedure or surgery | – |
Primary outcome
percentage of successful sperm retrieval in single testis in cases who will do bilateral TESE.
Time frame: 1 day Postoperative
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 2 Dec 2025.
- Results publication: PubMed 14501743Raman JD, Schlegel PN. Testicular sperm extraction with intracytoplasmic sperm injection is successful for the treatment of nonobstructive azoospermia associated with cryptorchidism. J Urol. 2003 Oct;170(4 Pt 1):1287-90. doi: 10.1097/01.ju.0000080707.75753.ec.
- Results publication: PubMed 43278Levin HS. Testicular biopsy in the study of male infertility: its current usefulness, histologic techniques, and prospects for the future. Hum Pathol. 1979 Sep;10(5):569-84. doi: 10.1016/s0046-8177(79)80100-8.
- Results publication: PubMed 7637066Witt MA, Elsner C, Kort HI, Massey JB, Mitchell-Leef D, Toledo AA, Tucker MJ. A live birth from intracytoplasmic injection of a spermatozoon retrieved from testicular parenchyma. J Urol. 1995 Sep;154(3):1136-7. No abstract available.
- Results publication: PubMed 32374923Ichioka K, Matsui Y, Terada N, Negoro H, Goto T, Ogawa O. Three-dimensional simulation analysis of microdissection testicular sperm extraction for patients with non-obstructive azoospermia. Andrology. 2020 Sep;8(5):1214-1221. doi: 10.1111/andr.12812. Epub 2020 May 18.
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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.
Mohamed Diab Mohamed Ramadan, Master principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Testicular Sperm Extraction in Azoospermic Patients, 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 3 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 2 Dec 2025. 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?
Contact Mohamed Diab, Master (01005886962, md01147169166@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of successful sperm retrieval in single testis in cases who will do bilateral TESE. (time frame: 1 day Postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07259967, which also lists 4 linked publications.
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 2 Dec 2025.