ChiCTR2100053205 版本V1.6 版本创建时间2022/09/13 03:11:07 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：

ChiCTR2100053205 

最近更新日期：

Date of Last Refreshed on：

2022-09-13 03:10:24 

注册时间：

Date of Registration：

2021-11-14 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

左炔诺孕酮宫内节育系统对减少宫腔镜子宫内膜息肉切除术后复发的作用

Public title：

Effect of levonorgestrel intrauterine system on reducing recurrence after hysteroscopic endometrial polypectomy

注册题目简写：

English Acronym：

研究课题的正式科学名称：

左炔诺孕酮宫内节育系统对减少宫腔镜子宫内膜息肉切除术后复发的作用的干预性研究

Scientific title：

Effect of levonorgestrel intrauterine system on reducing recurrence after hysteroscopic endometrial polypectomy

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：

黄秀峰 

研究负责人：

黄秀峰 

Applicant：

Huang Xiufeng 

Study leader：

Huang Xiufeng 

申请注册联系人电话：

Applicant telephone：

+86 13867477997

研究负责人电话：

Study leader's telephone：

+86 13867477997

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：

huangxiufeng@zju.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

huangxiufeng@zju.edu.cn

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：

浙江省杭州市上城区学士路1号

研究负责人通讯地址：

浙江省杭州市上城区学士路1号

Applicant address：

1 Xueshi Road, Shangcheng District, Hangzhou, Zhejiang

Study leader's address：

1 Xueshi Road, Shangcheng District, Hangzhou, Zhejiang

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

浙江大学医学院附属妇产科医院

Applicant's institution：

Obstetrics and Gynecology Hospital Affiliated to Zhejiang University School of Medicine

研究负责人所在单位：

浙江大学医学院附属妇产科医院

Affiliation of the Leader：

Obstetrics and Gynecology Hospital Affiliated to Zhejiang University School of Medicine

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

IRB-20200166-R

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：

浙江大学医学院附属妇产科医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the Obstetrics and Gynecology Hospital Affiliated to Zhejiang University School of Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2020-06-23 00:00:00

伦理委员会联系人：

张莉

Contact Name of the ethic committee：

Zhang Li

伦理委员会联系地址：

浙江省杭州市上城区学士路1号

Contact Address of the ethic committee：

1 Xueshi Road, Shangcheng District, Hangzhou, Zhejiang

伦理委员会联系人电话：

Contact phone of the ethic committee：

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：

浙江大学医学院附属妇产科医院

Primary sponsor：

Obstetrics and Gynecology Hospital Affiliated to Zhejiang University School of Medicine

研究实施负责（组长）单位地址：

浙江省杭州市上城区学士路1号

Primary sponsor's address：

1 Xueshi Road, Shangcheng District, Hangzhou, Zhejiang

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

浙江

市(区县)：

杭州

Country：

China

Province：

Zhejiang

City：

Hangzhou

单位(医院)：

浙江大学医学院附属妇产科医院

具体地址：

上城区学士路1号

Institution
hospital：

Obstetrics and Gynecology Hospital Affiliated to Zhejiang University School of Medicine

Address：

1 Xueshi Road, Shangcheng District

经费或物资来源：

拜耳医药保健有限公司

Source(s) of funding：

Bayer Healthcare Company Limited

Target disease：

Endometrial polyps

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 IV期临床试验 

Study phase：

4

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

1.主要目的是评估LNG-IUS对减少经宫颈子宫内膜息肉切除术（TCRP）的患者子宫内膜息肉复发的影响。 2.次要目的： （1）评估TCRP手术后出血症状的改善； （2）评估TCRP手术后子宫内膜息肉首次复发的时间； （3）探索患者/息肉特征与复发风险之间的关联。  

Objectives of Study：

1. The primary objective was to evaluate the effect of LNG-IUS on reducing recurrence of endometrial polyps in patients undergoing transcervical endometrial polypectomy (TCRP). 2. Secondary purpose: (1) To evaluate the improvement of bleeding symptoms after TCRP surgery; (2) To evaluate the time of first recurrence of endometrial polyps after TCRP surgery; (3) To explore the association between patient/polyp characteristics and recurrence risk.

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.已在知情同意书上签字并签署日期；
2.女性，在筛选时年满 18 周岁，且不足46周岁，且已经至少生育过一孩；
3.在筛选时两次经阴道三维超声检查确诊为子宫内膜息肉，其影像描述符合“宫腔内偏强回声团块（三径之一≥10mm），且可及血流信号”；双侧子宫内膜厚度（不含息肉测量值）应≤18mm；
4.任一子宫内膜息肉的最大直径＜50mm；
5.接受经宫颈子宫内膜息肉切除手术（TCRP）；
6.根据病史、体格检查和妇科检查以及实验室检测结果证明整体健康状况良好（与子宫内膜息肉有关的状况除外）；
7.宫颈涂片结果正常或无临床意义，不需要进一步随访。如果在既往 6 个月内受试者病历中记录了正常结果，则可免去宫颈涂片检查。对出现意义不明确的非典型鳞状细胞（ASCUS）的受试者，可以将人乳头瘤病毒（HPV）检测作为辅助测试。如果 ASCUS 的受试者中高危 HPV 菌株检测为阴性，则可以入选研究；
8.未怀孕，TCRP手术后两年内没有生育计划。在研究开始时直至研究结束，使用可接受的非激素避孕法（如男性避孕套、宫颈帽、避孕膜或避孕海绵，均与杀精子剂联合使用）。如果通过受试者的双侧输卵管结扎或伴侣的输精管结扎达到永久避孕，则不需要采用屏障避孕法。

Inclusion criteria

1. The informed consent form has been signed and dated;
2. Female, aged at least 18 years at the time of screening, but less than 46 years, and has given birth to at least one child;
3. Endometrial polyps were diagnosed by transvaginal three-dimensional ultrasonography twice at the time of screening, and their image descriptions were consistent with ''highly echogenic mass in the uterine cavity (one of the three diameters >= 10 mm), and blood flow signals were accessible''; Bilateral endometrial thickness (excluding polyp measurements) should be <=18mm;
4. The maximum diameter of any endometrial polyp is less than 50mm;
5. Accept transcervical endometrial polypectomy (TCRP);
6. Good general health (except for conditions related to endometrial polyps) based on medical history, physical and gynecological examinations, and laboratory test results;
7. The results of cervical smear are normal or have no clinical significance, and no further follow-up is required. Pap smears may be waived if normal results are documented in the subject's medical record within the previous 6 months. Human papillomavirus (HPV) testing can be used as an adjunct test in subjects with atypical squamous cells of undetermined significance (ASCUS). Subjects with ASCUS were eligible for study entry if they tested negative for high-risk HPV strains;
8. Not pregnant, no fertility plan within two years after TCRP surgery. Use an acceptable non-hormonal method of contraception (eg, male condom, cervical cap, diaphragm, or sponge, all in combination with spermicide) from the start of the study until the end of the study. Barrier contraception is not required if permanent contraception is achieved by the subject's bilateral tubal ligation or the partner's vasectomy.

排除标准：

1.哺乳期（分娩、流产或哺乳距离开始治疗的时间间隔不到 3 个月）；
2.长期接受所有类别的类固醇激素药治疗；对于手术前三个月经期间接受任何可能有效药物（如雌或孕激素制剂、激素避孕药、释放激素的避孕器械）的女性，不适合入选本研究；
3.目前他莫昔芬的使用者；
4.患有恶性生殖道肿瘤（包括外阴癌、阴道癌、宫颈癌、子宫内膜癌、子宫肉瘤、输卵管癌、卵巢癌和腹膜间皮瘤等）或乳腺癌；
5.具有其他LNG-IUS放置禁忌症：已知或怀疑妊娠；现患盆腔炎或盆腔炎复发；下生殖道感染；产后子宫内膜炎；过去3个月内有感染性流产；宫颈炎；宫颈发育异常；子宫或宫颈恶性病变；孕激素依赖性肿瘤；不明原因的异常子宫出血；先天性或获得性子宫异常，包括使宫腔变形的肌瘤；增加感染易感性的状况；急性肝脏疾病或肝肿瘤；对有效成分或辅料过敏；
6.任何可能损害身体系统功能，导致研究药物吸收改变、过度蓄积、代谢损害或者改变其排泄过程的疾病、状况或药物，包括但不限于：
(1)肾功能损害（实验室检查值超出入选标准范围）；
(2)肝酶升高（存在以下至少一种情况）：
1）谷草转氨酶（GOT）/天门冬氨酸氨基转移酶（AST）水平超出 2 倍正常值上限（ULN）；
2）谷丙转氨酶（GPT）/丙氨酸氨基转移酶（ALT）水平超出 2 倍 ULN；
3）碱性磷酸酶（AP）水平超出 2 倍 ULN；
4）总胆红素 1.5 倍 ULN；
(3)慢性肠道疾病，如克罗恩病及溃疡性结肠炎；
7.可能影响研究实施或者结果解释的任何疾病或者情况，包括：
(1)已知的重度凝血障碍；
(2)已知的AUB以外原因引起的贫血；
(3)已知的血红蛋白病；
(4)筛选入组前超声检查测定显示有一个或多个卵巢囊肿直径>30mm，且同侧卵巢囊性结构存在超过2个月经周期；
(5)不明原因的卵巢肿瘤或盆腔肿块，需要进行进一步诊断；
(6)已知或疑似子宫肌瘤>50 mm；
8.酒精、毒品或者药品（例如，精神类药品）滥用；
9.接受其他可能干扰研究实施或者结果解释的治疗，包括：
(1)促性腺激素释放激素激动剂（GnRHa），如果在入组前的至少60天未停用；
(2)使用治疗月经过多的氨甲环酸、中药或其他针对 AUB的药物，如果在入组时未停用；
(3)使用抗凝血剂，且在入组时未停用；
10.同时参与另一项药物临床研究。研究入选前（访视 1 前）参与了可能对本研究目的产生影响的另一项临床研究；
11.与研究中心（例如，研究中心的雇员或者学生、或申办者的员工）或研究中心人员密切相关的人员（例如，研究者的近亲）；
12.因任何原因不能配合研究程序，例如：语言理解存在障碍、精神疾病、无能力前往研究中心、在线操作依从性差。

Exclusion criteria：

1. Lactation period (delivery, miscarriage or breastfeeding less than 3 months after the start of treatment);
2. Long-term treatment with all types of steroid hormone drugs; women who received any potentially effective drugs (such as estrogen or progestin preparations, hormonal contraceptives, hormone-releasing contraceptive devices) during the first trimester before surgery are not suitable for inclusion in this study ;
3. Current users of tamoxifen;
4. Patients with malignant reproductive tract tumors (including vulvar cancer, vaginal cancer, cervical cancer, endometrial cancer, uterine sarcoma, fallopian tube cancer, ovarian cancer and peritoneal mesothelioma, etc.) or breast cancer;
5. Other contraindications for LNG-IUS placement: known or suspected pregnancy; current pelvic inflammatory disease or recurrence of pelvic inflammatory disease; lower genital tract infection; postpartum endometritis; infectious abortion within the past 3 months; cervicitis; cervical dysplasia; malignant lesions of the uterus or cervix; progesterone-dependent tumors; abnormal uterine bleeding of unknown cause; congenital or acquired uterine abnormalities, including fibroids that deform the uterine cavity; conditions that increase susceptibility to infection; acute liver disease or liver tumor; allergic to active ingredients or excipients;
6. Any disease, condition or drug that may impair the function of the body system, lead to altered absorption, excessive accumulation, metabolic impairment or altered excretion of the study drug, including but not limited to:
(1) Impaired renal function (laboratory test values exceed the range of inclusion criteria);
(2) Elevated liver enzymes (at least one of the following conditions exists):
1) Aspartate aminotransferase (GOT)/aspartate aminotransferase (AST) levels exceeding 2 times the upper limit of normal (ULN);
2) Alanine aminotransferase (GPT)/alanine aminotransferase (ALT) levels exceeding 2 times ULN;
3) Alkaline phosphatase (AP) level exceeds 2 times ULN;
4) Total bilirubin 1.5 times ULN;
(3) Chronic intestinal diseases, such as Crohn's disease and ulcerative colitis;
7. Any disease or condition that may affect the conduct of the study or the interpretation of the results, including:
(1) Known severe coagulation disorder;
(2) Anemia caused by known causes other than AUB;
(3) Known hemoglobinopathies;
(4) Ultrasound examination before screening showed that one or more ovarian cysts were >30mm in diameter, and there were cystic structures in the same side of the ovary for more than 2 menstrual cycles;
(5) Unexplained ovarian tumors or pelvic masses require further diagnosis;
(6) Known or suspected uterine fibroids >50 mm;
8. Abuse of alcohol, drugs or drugs (for example, psychotropic substances);
9. Receive other treatments that may interfere with the conduct of the study or the interpretation of the results, including:
(1) Gonadotropin-releasing hormone agonist (GnRHa), if not discontinued at least 60 days before enrollment;
(2) Use of tranexamic acid, traditional Chinese medicine or other drugs for AUB for the treatment of menorrhagia, if not discontinued at the time of enrollment;
(3) Anticoagulants are used and not stopped at the time of enrollment;
10. Participate in another drug clinical study at the same time. Participation in another clinical study that may have an impact on the purpose of this study prior to study entry (before Visit 1);
11. People closely related to the research center (e.g., employees of the research center or students, or employees of the sponsor) or research center personnel (e.g., close relatives of the researcher);
12. Unable to cooperate with the research procedure for any reason, such as: language comprehension disorder, mental illness, inability to go to the research center, poor compliance with online operations.

研究实施时间：

Study execute time：

从 From 2020-12-01 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2021-11-01 00:00:00 至 To 2023-10-31 00:00:00  

干预措施：

Interventions：

组别：

TCRP+曼月乐组

样本量：

100

Group：

TCRP+LNG-IUS Group

Sample size：

干预措施：

宫腔镜术后放置曼月乐环

干预措施代码：

Intervention：

LNG-IUS placed after hysteroscope

Intervention code：

组别：

TCRP组

样本量：

100

Group：

TCRP Group

Sample size：

干预措施：

宫腔镜手术

干预措施代码：

Intervention：

hysteroscope

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江 

市(区县)：

 杭州 

Country：

China 

Province：

Zhejiang 

City：

Hangzhou 

单位(医院)：

浙江大学医学院附属妇产科医院 

单位级别：

三级甲等 

Institution
hospital：

Obstetrics and Gynecology Hospital Affiliated to Zhejiang University School of Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

子宫内膜息肉首次复发的时间

指标类型：

主要指标

Outcome：

Time to the first recurrence of endometrial polyps

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

病人出血症状的变化

指标类型：

次要指标

Outcome：

Changes in patient bleeding symptoms

Type：

Secondary 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：

血液

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：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 46 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

筛选时一旦受试者在知情同意书上签字，研究中心将分配给每例受试者一个唯一的多位数字SID 号，以明确识别受试者。SID 编号由1-3位数字组成（0-200），一旦分配，整个研究过程中将通过 SID 号识别受试者。每例受试者在随机分组接受治疗时都将得到一个唯一的随机分组号。

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

During screening, if the subjects sign the informed consent form, the research center will assign a unique multi-digit SID number to each subject to clearly identify the subject. The SID number consists of 1-3 digits (0-200).

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：

开放

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

No

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）：

拟于试验完成后6个月内共享数据，将以会议及学术杂志投稿方式公布实验数据及原始数据。

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

The result will be presented at domestic and international conferences and submitted to the peer-reviewed journals within 6 months of trial completion data.

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：

数据采集和管理通过本中心CRF表格采集并保存。

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

Data are collected and saved through the center's standard case report form.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-11-14 22:50:59