- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07259967
Laterality Success Determination of Microscopic Testicular Sperm Extraction in Non Obstructive Azoopsermia Patients
November 28, 2025 updated by: mohamed diab mohamed ramadan, Assiut University
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
Study Overview
Status
Not yet recruiting
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mohamed Diab, Master
- Phone Number: 01005886962
- Email: md01147169166@gmail.com
Study Contact Backup
- Name: Mohamed D Mohamed, Master
- Phone Number: 01501501772
- Email: md01501501772@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Male patients diagnosed as non obstructive azoospermia and will do bilateral TESE.
Description
Inclusion Criteria:
• Male patients diagnosed as non obstructive azoospermia.
- Will do bilateral TESE.
Exclusion Criteria:
• Obstructive azoospermia.
- Incomplete medical record .
- Prior testicular Trauma.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
percentage of successful sperm retrieval in single testis in cases who will do bilateral TESE.
Time Frame: 1 day Postoperative
|
1 day Postoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mohamed Diab Mohamed Ramadan, Master, Assiut University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Levin 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.
- Witt 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.
- Ichioka 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
December 1, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
January 1, 2027
Study Registration Dates
First Submitted
November 20, 2025
First Submitted That Met QC Criteria
November 28, 2025
First Posted (Actual)
December 2, 2025
Study Record Updates
Last Update Posted (Actual)
December 2, 2025
Last Update Submitted That Met QC Criteria
November 28, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Laterality of micro TESE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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