ChiCTR2600123728 版本V1.0 版本创建时间2026/04/29 11:04:20 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2600123728 

最近更新日期：

Date of Last Refreshed on：

 2026-04-29 11:04:12 

注册时间：

Date of Registration：

 2026-04-29 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

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

Public title：

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

注册题目简写：

English Acronym：

研究课题的正式科学名称：

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

Scientific title：

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

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

Kamil CAM 

研究负责人：

Kamil CAM 

Applicant：

Kamil CAM 

Study leader：

Kamil CAM 

申请注册联系人电话：

Applicant telephone：

 +90 216 645 25 25

研究负责人电话：

Study leader's
telephone：

+90 216 645 25 25

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 kamilcam@hotmail.com

研究负责人电子邮件：

Study leader's E-mail：

 kamilcam@hotmail.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

研究负责人通讯地址：

Applicant address：

Professor and Chair of Urology Department of Urology School of Medicine, Marmara University Pendik 34899 Istanbul - TURKEY

Study leader's address：

Professor and Chair of Urology Department of Urology School of Medicine, Marmara University Pendik 34899 Istanbul - TURKEY

申请注册联系人邮政编码：

Applicant postcode：

 34899

研究负责人邮政编码：

Study leader's postcode：

 34899

申请人所在单位：

Department of Urology School of Medicine, Marmara University

Applicant's institution：

Department of Urology School of Medicine, Marmara University

研究负责人所在单位：

Department of Urology School of Medicine, Marmara University

Affiliation of the Leader：

Department of Urology School of Medicine, Marmara University

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 09.2019.291.21307

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

Marmara University School of Medicine Ethical Committe for Clinical Trials

Name of the ethic committee：

Marmara University School of Medicine Ethical Committe for Clinical Trials

伦理委员会批准日期：

Date of approved by ethic committee：

 2019-03-01 00:00:00

伦理委员会联系人：

Haner DIRISKENELI

Contact Name of the ethic committee：

Haner DIRISKENELI

伦理委员会联系地址：

The Scientific and Technological Research Council of Türkiye Tunus Caddesi No:80 06680 Kavakl?dere Ankara TURKEY

Contact Address of the ethic committee：

The Scientific and Technological Research Council of Türkiye Tunus Caddesi No:80 06680 Kavakl?dere Ankara TURKEY

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +90 216 645 25 25

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

Department of Urology School of Medicine, Marmara University

Primary sponsor：

Department of Urology School of Medicine, Marmara University

研究实施负责（组长）单位地址：

The Scientific and Technological Research Council of Türkiye Tunus Caddesi No:80 06680 Kavakl?dere Ankara TURKEY

Primary sponsor's address：

The Scientific and Technological Research Council of Türkiye Tunus Caddesi No:80 06680 Kavakl?dere Ankara TURKEY

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

TURKEY

省(直辖市)：

ISTANBUL

市(区县)：

Country：

TURKEY

Province：

ISTANBUL

City：

单位(医院)：

Marmara University

具体地址：

The Scientific and Technological Research Council of Türkiye Tunus Caddesi No:80 06680 Kavakl?dere Ankara TURKEY

Institution
hospital：

Marmara University

Address：

The Scientific and Technological Research Council of Türkiye Tunus Caddesi No:80 06680 Kavakl?dere Ankara TURKEY

经费或物资来源：

This work was funded by a grant from the TUBITAK (The Scientific and Technological Research Council of Turkiye) (Protocol No.121S182). This fund was utilsed yo obtaind instruments (lens, camere etc.).

Source(s) of funding：

This work was funded by a grant from the TUBITAK (The Scientific and Technological Research Council of Turkiye) (Protocol No.121S182). This fund was utilsed yo obtaind instruments (lens, camere etc.).

研究疾病：

Male Infertility  

Target disease：

Male Infertility

研究疾病代码：

Target disease code：

研究类型：

诊断试验

Study type：

Diagnostic test

研究所处阶段：

 诊断试验新技术临床试验 

Study phase：

Diagnostic New Technique Clincal Study

研究设计：

诊断试验诊断准确性 

Study design：

Diagnostic test for accuracy 

研究目的：

The primary objective was to evaluate the diagnostic performance of a novel telecentric lens–based imaging system for identifying seminiferous tubules associated with sperm retrieval during micro-TESE in patients with NOA.  

Objectives of Study：

The primary objective was to evaluate the diagnostic performance of a novel telecentric lens–based imaging system for identifying seminiferous tubules associated with sperm retrieval during micro-TESE in patients with NOA.

药物成份或治疗方案详述：

All participants enrolled in this study will undergo microdissection testicular sperm extraction (micro-TESE) as part of standard clinical management for non-obstructive azoospermia. The procedure will be performed under general anesthesia by an experienced urologist using a standard surgical microscope with approximately 24× magnification. After opening the tunica albuginea, the testicular parenchyma will be carefully examined under microscopic magnification to identify dilated seminiferous tubules that may contain spermatozoa. Targeted micro-biopsies will be taken from these areas using microsurgical instruments and immediately sent to the embryology laboratory for examination. During the surgical procedure, an experimental telecentric lens-based imaging system will be used as an additional visualization tool. The imaging system consists of a telecentric zoom lens, a CCD camera, LED illumination sources emitting light at approximately 560 nm, and polarizing filters designed to reduce specular reflection from the tissue surface. The device is mounted on a movable arm and connected to a computer for real-time image display and recording. When dilated seminiferous tubules are identified using the standard surgical microscope, the same area will be imaged with the telecentric lens system before the biopsy is performed. Images of both dilated and non-dilated seminiferous tubules will be recorded and stored in a digital database for later analysis. All biopsies will be performed using the standard surgical microscope according to current clinical and ethical guidelines. The telecentric imaging system will not replace the standard microscope and will not alter the surgical decision-making process, but will only be used to capture high-resolution images of the surgical field. The obtained tissue samples will be examined by embryologists for the presence of spermatozoa. The results of the embryological analysis will later be compared with the telecentric imaging findings in order to evaluate the diagnostic performance of the imaging system. No additional surgical manipulation beyond the standard micro-TESE procedure will be performed as part of this study. 

Description for medicine or protocol of treatment in detail：

All participants enrolled in this study will undergo microdissection testicular sperm extraction (micro-TESE) as part of standard clinical management for non-obstructive azoospermia. The procedure will be performed under general anesthesia by an experienced urologist using a standard surgical microscope with approximately 24× magnification. After opening the tunica albuginea, the testicular parenchyma will be carefully examined under microscopic magnification to identify dilated seminiferous tubules that may contain spermatozoa. Targeted micro-biopsies will be taken from these areas using microsurgical instruments and immediately sent to the embryology laboratory for examination. During the surgical procedure, an experimental telecentric lens-based imaging system will be used as an additional visualization tool. The imaging system consists of a telecentric zoom lens, a CCD camera, LED illumination sources emitting light at approximately 560 nm, and polarizing filters designed to reduce specular reflection from the tissue surface. The device is mounted on a movable arm and connected to a computer for real-time image display and recording. When dilated seminiferous tubules are identified using the standard surgical microscope, the same area will be imaged with the telecentric lens system before the biopsy is performed. Images of both dilated and non-dilated seminiferous tubules will be recorded and stored in a digital database for later analysis. All biopsies will be performed using the standard surgical microscope according to current clinical and ethical guidelines. The telecentric imaging system will not replace the standard microscope and will not alter the surgical decision-making process, but will only be used to capture high-resolution images of the surgical field. The obtained tissue samples will be examined by embryologists for the presence of spermatozoa. The results of the embryological analysis will later be compared with the telecentric imaging findings in order to evaluate the diagnostic performance of the imaging system. No additional surgical manipulation beyond the standard micro-TESE procedure will be performed as part of this study. 

纳入标准：

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.

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.

排除标准：

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.

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.

研究实施时间：

Study execute time：

从 From 2020-01-05 00:00:00至 To 2023-03-14 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2020-01-08 00:00:00 至 To 2022-11-25 00:00:00

诊断试验：

Diagnostic Tests：

金标准或参考标准（即可准确诊断某疾病的单项方法或多项联合方法，在本研究中用于诊断是否有该病的临床参考标准）：

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 microdissection testicular sperm extraction (micro-TESE). Testicular biopsy samples obtained during surgery will be immediately processed and examined under high-magnification laboratory microscopy to identify the presence or absence of spermatozoa. The embryological evaluation result will be considered the gold standard for confirming sperm-containing seminiferous tubules.

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

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 microdissection testicular sperm extraction (micro-TESE). Testicular biopsy samples obtained during surgery will be immediately processed and examined under high-magnification laboratory microscopy to identify the presence or absence of spermatozoa. The embryological evaluation result will be considered the gold standard for confirming sperm-containing seminiferous tubules.

指标试验（即本研究的待评估诊断试验，无论为方法、生物标志物或设备，均请列出名称）：

Novel telecentric lens–based imaging system

Index test:

Novel telecentric lens–based imaging system

目标人群（可以是某种疾病患者或正常人群，详细描述其疾病特征，注意应纳入符合分布特点的全序列病例，具有良好的代表性）

A total of 40 consecutive male patients aged 18–40 years with a confirmed diagnosis of NOA were prospectively enrolled.

例数:

Sample size:

40

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

A total of 40 consecutive male patients aged 18–40 years with a confirmed diagnosis of NOA were prospectively enrolled.

容易混淆的疾病人群（即与目标疾病不易区分的一种或多种不同疾病，应避免采用正常人群对照的病例-对照设计）：

In patients with non-obstructive azoospermia (NOA), some seminiferous tubules may appear morphologically similar regardless of whether they contain spermatozoa. For example, tubules affected by Sertoli cell-only syndrome, maturation arrest, or hypospermatogenesis can be easily mistaken for tubules that contain sperm during visual inspection. These conditions are clinically relevant because they represent the true challenge for the telecentric lens imaging system in distinguishing sperm-containing tubules.

例数:

Sample size:

0

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

In patients with non-obstructive azoospermia (NOA), some seminiferous tubules may appear morphologically similar regardless of whether they contain spermatozoa. For example, tubules affected by Sertoli cell-only syndrome, maturation arrest, or hypospermatogenesis can be easily mistaken for tubules that contain sperm during visual inspection. These conditions are clinically relevant because they represent the true challenge for the telecentric lens imaging system in distinguishing sperm-containing tubules. Normal healthy testes (from fertile men) should not be used as a control population because their tubules are structurally distinct and do not represent the real diagnostic challenge. Using normal controls would overestimate the diagnostic accuracy and would not reflect the clinical spectrum of patients who actually undergo micro-TESE.

研究实施地点：

Countries of recruitment and research settings：

国家：

 TURKEY

省(直辖市)：

 ISTANBUL 

市(区县)：

  

Country：

TURKEY

Province：

ISTANBUL

City：

单位(医院)：

 Marmara University Hospital 

单位级别：

 Tertiary A 

Institution
hospital：

Marmara University Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

Sperm detection accuracy of telecentric lens imaging system

指标类型：

主要指标

Outcome：

Sperm detection accuracy of telecentric lens imaging system

Type：

Primary indicator

测量时间点：

During micro-TESE surgery / immediately after biopsy

测量方法：

Measure time point of outcome：

During micro-TESE surgery / immediately after biopsy

Measure method：

指标中文名：

Sensitivity

指标类型：

主要指标

Outcome：

Sensitivity

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Specificity

指标类型：

主要指标

Outcome：

Specificity

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Positive predictive value (PPV)

指标类型：

主要指标

Outcome：

Positive predictive value (PPV)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Negative predictive value (NPV)

指标类型：

主要指标

Outcome：

Negative predictive value (NPV)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

Testicular tissue

组织：

Testis

Sample Name：

Testicular tissue

Tissue：

Testis

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 40 岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

None

Randomization Procedure (please state who generates the random number sequence and by what method)：

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

Blinding：

是否共享原始数据：

IPD sharing

是Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

Anonymized individual participant data (IPD) will be shared upon reasonable request after publication.Data will be shared via secure email or institutional cloud storage with access granted to qualified researchers. Metadata, study protocol, and CRF will also be provided. No web-based public database is planned at this time.

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Anonymized individual participant data (IPD) will be shared upon reasonable request after publication.Data will be shared via secure email or institutional cloud storage with access granted to qualified researchers. Metadata, study protocol, and CRF will also be provided. No web-based public database is planned at this time.

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

A standard data collection system will be used, including paper Case Report Forms (CRFs) and an electronic data capture (EDC) system. All data will be anonymized and securely stored according to institutional data protection policies.

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

A standard data collection system will be used, including paper Case Report Forms (CRFs) and an electronic data capture (EDC) system. All data will be anonymized and securely stored according to institutional data protection policies.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2026-04-29 11:04:12