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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

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Study Contact

Study Contact

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Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study record dates

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Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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