ChiCTR2600121913 版本V1.0 版本创建时间2026/04/07 11:16:11 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：

 ChiCTR2600121913 

最近更新日期：

Date of Last Refreshed on：

 2026-04-07 11:15:52 

注册时间：

Date of Registration：

 2026-04-07 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

To evaluate and compare the effectiveness of Coenzyme Q10 versus Vitamin E supplementation on serum testosterone levels, luteinizing hormone levels, and semen parameters in men with idiopathic primary infertility.

Public title：

To evaluate and compare the effectiveness of Coenzyme Q10 versus Vitamin E supplementation on serum testosterone levels, luteinizing hormone levels, and semen parameters in men with idiopathic primary infertility.

注册题目简写：

CoQ10-VitE-IMI Trial

English Acronym：

CoQ10-VitE-IMI Trial

研究课题的正式科学名称：

Effectiveness of Coenzyme Q10 versus Vitamin E in improving serum testosterone, luteinizing hormone levels and semen parameters in men with idiopathic primary infertility: A randomized controlled study

Scientific title：

Effectiveness of Coenzyme Q10 versus Vitamin E in improving serum testosterone, luteinizing hormone levels and semen parameters in men with idiopathic primary infertility: A randomized controlled study

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：

Dr. Qudratullah Wazir 

研究负责人：

Dr. Qudratullah Wazir 

Applicant：

Dr. Qudratullah Wazir 

Study leader：

Dr. Qudratullah Wazir 

申请注册联系人电话：

Applicant telephone：

 +92 333 9290691

研究负责人电话：

Study leader's
telephone：

+92 333 9290691

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：

 dr.qudratikd@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 dr.qudratikd@gmail.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：

Institute of Kidney Diseases, Hayatabad Medical Complex, Phase 4, Peshawar, Khyber Pakhtunkhwa, Pakistan

研究负责人通讯地址：

Institute of Kidney Diseases, Hayatabad Medical Complex, Phase 4, Peshawar, Khyber Pakhtunkhwa, Pakistan

Applicant address：

Institute of Kidney Diseases, Hayatabad Medical Complex, Phase 4, Peshawar, Khyber Pakhtunkhwa, Pakistan

Study leader's address：

Institute of Kidney Diseases, Hayatabad Medical Complex, Phase 4, Peshawar, Khyber Pakhtunkhwa, Pakistan

申请注册联系人邮政编码：

Applicant postcode：

 25000

研究负责人邮政编码：

Study leader's postcode：

 25000

申请人所在单位：

Institute of Kidney Diseases, Hayatabad Medical Complex, Phase 4, Peshawar, Khyber Pakhtunkhwa, Pakistan

Applicant's institution：

Institute of Kidney Diseases, Hayatabad Medical Complex, Phase 4, Peshawar, Khyber Pakhtunkhwa, Pakistan

研究负责人所在单位：

Institute of Kidney Diseases, Hayatabad Medical Complex, Phase 4, Peshawar, Khyber Pakhtunkhwa, Pakistan

Affiliation of the Leader：

Institute of Kidney Diseases, Hayatabad Medical Complex, Phase 4, Peshawar, Khyber Pakhtunkhwa, Pakistan

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：

 331/chairman/R&E/COMMITTEE/IKD

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：

Office of the Chairman Research and Ethical Committee Institute of Kidney Disease Hayatabad Peshawar

Name of the ethic committee：

Office of the Chairman Research and Ethical Committee Institute of Kidney Disease Hayatabad Peshawar

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-11-02 00:00:00

伦理委员会联系人：

Dr. Liaqat Ali

Contact Name of the ethic committee：

Dr. Liaqat Ali

伦理委员会联系地址：

Institute of Kidney Diseases, Hayatabad Medical Complex, Phase 4, Peshawar, Khyber Pakhtunkhwa, Pakistan

Contact Address of the ethic committee：

Institute of Kidney Diseases, Hayatabad Medical Complex, Phase 4, Peshawar, Khyber Pakhtunkhwa, Pakistan

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +92 334 0966665

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 Liaqat_99@yahoo.com

研究实施负责（组长）单位：

Department of Urology, Institute of Kidney Diseases (IKD), Hayatabad Medical Complex

Primary sponsor：

Department of Urology, Institute of Kidney Diseases (IKD), Hayatabad Medical Complex

研究实施负责（组长）单位地址：

Institute of Kidney Diseases (IKD), Hayatabad Medical Complex

Primary sponsor's address：

Institute of Kidney Diseases (IKD), Hayatabad Medical Complex

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

Pakistan

省(直辖市)：

Khyber Pakhtunkhwa

市(区县)：

Peshawar

Country：

Pakistan

Province：

Khyber Pakhtunkhwa

City：

Peshawar

单位(医院)：

Institute of Kidney Diseases (IKD), Hayatabad Medical Complex

具体地址：

Institute of Kidney Diseases (IKD), Hayatabad Medical Complex, Phase IV, Hayatabad, Peshawar, Khyber Pakhtunkhwa, Pakistan

Institution
hospital：

Institute of Kidney Diseases (IKD), Hayatabad Medical Complex

Address：

Institute of Kidney Diseases (IKD), Hayatabad Medical Complex, Phase IV, Hayatabad, Peshawar, Khyber Pakhtunkhwa, Pakistan

经费或物资来源：

Institute of Kidney Diseases (IKD), Hayatabad Medical Complex

Source(s) of funding：

Institute of Kidney Diseases (IKD), Hayatabad Medical Complex

研究疾病：

Male infertility  

Target disease：

Male infertility

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

To compare the effectiveness of Coenzyme Q10 and Vitamin E supplementation in improving serum testosterone, luteinizing hormone levels, and semen parameters in men with idiopathic primary infertility.  

Objectives of Study：

To compare the effectiveness of Coenzyme Q10 and Vitamin E supplementation in improving serum testosterone, luteinizing hormone levels, and semen parameters in men with idiopathic primary infertility.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. Male patients aged 20–40 years; 2. History of primary infertility for more than one year despite regular unprotected intercourse; 3. Diagnosis of idiopathic infertility after clinical evaluation; 4. Normal semen parameters according to WHO manual 6th edition; 5. Willingness to participate and provide written informed consent.

Inclusion criteria

1. Male patients aged 20–40 years; 2. History of primary infertility for more than one year despite regular unprotected intercourse; 3. Diagnosis of idiopathic infertility after clinical evaluation; 4. Normal semen parameters according to WHO manual 6th edition; 5. Willingness to participate and provide written informed consent.

排除标准：

1. Known endocrine or systemic disease; 2. History of cryptorchidism, varicocele, testicular hypotrophy, or genital tract infection; 3. Obstructive azoospermia or presence of antisperm antibodies; 4. Previous use of hormonal therapy or antioxidant supplements; 5. Female factor infertility in the partner.

Exclusion criteria：

1. Known endocrine or systemic disease; 2. History of cryptorchidism, varicocele, testicular hypotrophy, or genital tract infection; 3. Obstructive azoospermia or presence of antisperm antibodies; 4. Previous use of hormonal therapy or antioxidant supplements; 5. Female factor infertility in the partner.

研究实施时间：

Study execute time：

从 From 2023-02-01 00:00:00至 To 2024-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-02-10 00:00:00 至 To 2024-02-06 00:00:00

干预措施：

Interventions：

组别：

Coenzyme Q10 group

样本量：

 50

Group：

Coenzyme Q10 group

Sample size：

干预措施：

Coenzyme Q10 10 mg orally, three times daily for 3 months

干预措施代码：

Intervention：

Coenzyme Q10 10 mg orally, three times daily for 3 months

Intervention code：

组别：

Vitamin E group

样本量：

 50

Group：

Vitamin E group

Sample size：

干预措施：

Vitamin E 100 mg orally three times daily for 3 months

干预措施代码：

Intervention：

Vitamin E 100 mg orally three times daily for 3 months

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 Pakistan

省(直辖市)：

 Khyber Pakhtunkhwa 

市(区县)：

 Peshawar 

Country：

Pakistan

Province：

Khyber Pakhtunkhwa

City：

Peshawar

单位(医院)：

 Institute of Kidney Diseases (IKD), Hayatabad Medical Complex 

单位级别：

 Tertiary 

Institution
hospital：

Institute of Kidney Diseases (IKD), Hayatabad Medical Complex

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

Change in serum testosterone level

指标类型：

主要指标

Outcome：

Change in serum testosterone level

Type：

Primary indicator

测量时间点：

Baseline and at 3 months after intervention

测量方法：

Measure time point of outcome：

Baseline and at 3 months after intervention

Measure method：

指标中文名：

Change in serum luteinizing hormone level

指标类型：

次要指标

Outcome：

Change in serum luteinizing hormone level

Type：

Secondary indicator

测量时间点：

Baseline and after 3 months

测量方法：

ELISA

Measure time point of outcome：

Baseline and after 3 months

Measure method：

ELISA

指标中文名：

Change in sperm concentration

指标类型：

次要指标

Outcome：

Change in sperm concentration

Type：

Secondary indicator

测量时间点：

Baseline and after 3 months

测量方法：

Measure time point of outcome：

Baseline and after 3 months

Measure method：

指标中文名：

Change in sperm motility

指标类型：

次要指标

Outcome：

Change in sperm motility

Type：

Secondary indicator

测量时间点：

Baseline and after 3 months

测量方法：

Measure time point of outcome：

Baseline and after 3 months

Measure method：

指标中文名：

Change in sperm morphology

指标类型：

次要指标

Outcome：

Change in sperm morphology

Type：

Secondary indicator

测量时间点：

Baseline and after 3 months

测量方法：

Measure time point of outcome：

Baseline and after 3 months

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

Blood samples will be collected for measurement of serum testosterone and luteinizing hormone using ELISA and will be destroyed immediately after analysis.

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 20 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）：

Participants were randomized into two groups using a computer-generated randomization sequence prepared by an independent investigator not involved in recruitment or assessment.

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

Participants were randomized into two groups using a computer-generated randomization sequence prepared by an independent investigator not involved in recruitment or assessment.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Open-label

Blinding：

Open-label

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

Individual participant data (IPD), including anonymized raw datasets and study protocol, will be made available within 6 months after publication of the study results. Data will be shared upon reasonable request to the corresponding author via email.

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

Individual participant data (IPD), including anonymized raw datasets and study protocol, will be made available within 6 months after publication of the study results. Data will be shared upon reasonable request to the corresponding author via email.

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：

De-identified participant data and study-related documents will be shared upon reasonable request through direct communication with the corresponding author. Data will be provided in electronic format.

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

De-identified participant data and study-related documents will be shared upon reasonable request through direct communication with the corresponding author. Data will be provided in electronic format.

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：

  2026-04-07 11:15:52