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The Development of a New Imaging Modality for Micro-TESE based on the Preliminary First Clinical Trial

The Need to Develop Micro-TESE in Male Infertility in Light of Current Literature: Investigation of the Clinical Effectiveness of a New Imaging Method

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600123728
Enrollment
Unknown
Registered
2026-04-29
Start date
2020-01-08
Completion date
Unknown
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male Infertility

Interventions

Gold Standard:The reference standard used to determine the presence of spermatozoa will be microscopic examination of testicular tissue by experienced embryologists in the IVF laboratory following mic
Index test:Novel telecentric lens–based imaging system

Sponsors

Department of Urology School of Medicine, Marmara University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Participants must meet all of the following criteria: 1. Male patients aged 18–40 years. 2. Diagnosis of non-obstructive azoospermia confirmed by at least two semen analyses. 3. Scheduled to undergo micro-TESE for infertility treatment. 4. Female partner eligible for intracytoplasmic sperm injection (ICSI). 5. Ability to understand the study procedures and willingness to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Obstructive azoospermia. 2. Known chromosomal abnormalities incompatible with sperm retrieval. 3. Prior testicular surgery significantly altering anatomy. 4. Inability or refusal to provide consent.

Design outcomes

Primary

MeasureTime frame
Sperm detection accuracy of telecentric lens imaging system;Sensitivity ;Specificity ;Positive predictive value (PPV) ;Negative predictive value (NPV) ;—

Countries

TURKEY

Contacts

Public ContactKamil CAM

Department of Urology School of Medicine, Marmara University

kamilcam@hotmail.com+90 216 645 25 25

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026