ChiCTR2400090594 版本V1.0 版本创建时间2024/10/09 16:08:42 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：

ChiCTR2400090594 

最近更新日期：

Date of Last Refreshed on：

2024-10-09 16:08:24 

注册时间：

Date of Registration：

2024-10-09 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

金凤丸辅助治疗冻胚移植薄型子宫内膜患者的临床疗效观察

Public title：

Clinical effect of Jinfeng pill in the treatment of patients with thin endometrium after frozen embryo transplantation

注册题目简写：

English Acronym：

研究课题的正式科学名称：

金凤丸辅助治疗冻胚移植薄型子宫内膜患者的临床疗效观察

Scientific title：

Clinical effect of Jinfeng pill in the treatment of patients with thin endometrium after frozen embryo transplantation

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：

文艺 

研究负责人：

王德婧 

Applicant：

Wen Yi 

Study leader：

Wang Dejing 

申请注册联系人电话：

Applicant telephone：

+86 137 6524 3515

研究负责人电话：

Study leader's telephone：

+86 139 8424 2677

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：

2961299245@qq.com

研究负责人电子邮件：

Study leader's E-mail：

2430085462@qq.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：

贵州省遵义市红花岗区北京路街道

研究负责人通讯地址：

贵州省遵义市汇川区大连路街道

Applicant address：

Beijing Road, Honghuagang District, Zunyi City, Guizhou Province

Study leader's address：

Dalian Road Street, Huichuan District, Zunyi City, Guizhou province

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：

遵义医科大学附属医院

Applicant's institution：

Affiliated Hospital of Zunyi Medical University

研究负责人所在单位：

遵义医科大学附属医院

Affiliation of the Leader：

Affiliated Hospital of Zunyi Medical UniversityK

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：

KLL-2023-613

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：

遵义医科大学附属医院生物医学伦理委员会

Name of the ethic committee：

Biomedical Ethics Committee, Affiliated Hospital of Zunyi Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2023-12-24 00:00:00

伦理委员会联系人：

李树飞

Contact Name of the ethic committee：

Li Shufei

伦理委员会联系地址：

贵州省遵义市汇川区大连路149号

Contact Address of the ethic committee：

149 Dalian Road, Huichuan District, Zunyi City, Guizhou Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 851 2860 9075

伦理委员会联系人邮箱：

Contact email of the ethic committee：

zyfyll2017@163.com

研究实施负责（组长）单位：

遵义医科大学附属医院

Primary sponsor：

Affiliated Hospital of Zunyi Medical University

研究实施负责（组长）单位地址：

贵州省遵义市汇川区大连路149号

Primary sponsor's address：

149 Dalian Road, Huichuan District, Zunyi City, Guizhou Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

贵州省

市(区县)：

遵义市

Country：

China

Province：

Guizhou Province

City：

Zunyi City

单位(医院)：

遵义医科大学附属医院

具体地址：

贵州省遵义市汇川区大连路149号

Institution
hospital：

Affiliated Hospital of Zunyi Medical University

Address：

149 Dalian Road, Huichuan District, Zunyi City, Guizhou Province

经费或物资来源：

暂无

Source(s) of funding：

None

Target disease：

Thin endometrium

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：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

观察金凤丸改善薄型子宫内膜患者子宫内膜容受性的疗效，为治疗方案的选择提供参考。  

Objectives of Study：

To observe the curative effect of Jinfeng pill on endometrium tolerance in patients with thin endometrium, and to provide reference for the choice of treatment.

药物成份或治疗方案详述：

收集142例2023年07月至2024年12月遵义医科大学附属医院拟行冻胚移植的薄型子宫内膜患者，根据纳入及排除标准，获得患者或（及）家属知情同意后按照就诊顺序将患者分为观察组和对照组。内膜准备方案：对照组通过自然周期方案或激素替代周期方案进行内膜准备，自然周期方案通过超声监测排卵情况和子宫内膜厚度决定胚胎移植时间。激素替代周期方案自月经来潮第2天起口服雌激素（芬吗通或补佳乐）2片/次，2次/天，根据内膜厚度调整药物剂量，通过超声监测排卵和血雌、孕激素水平决定内膜转化时间，内膜转化日肌注黄体酮注射液进行内膜转化。内膜转化后第3天或第5天行冻融胚胎解冻移植术。移植前一日行子宫内膜容受性超声检查。胚胎移植方案：患者取截石位，对阴道及宫颈进行清洗后，将吸有胚胎的移植管置入宫颈内口，在移植内管顶端距离宫底约2-3mm处缓慢注入胚胎，静置片刻后缓慢抽出移植管，确认胚胎移入宫腔后，使用2ml注射器抽取外管中的宫腔液，保存于-80°冰箱中，检测移植管中宫腔液TNF-α、VEGF 水平。观察组在对照组的基础上口服金凤丸，从月经来潮第2天起开始口服金凤丸10粒，2次/天，共12天。在移植后2周查血HCG，移植后4周行阴道超声检查，随访至移植后12周观察终止。 

Description for medicine or protocol of treatment in detail：

A total of 142 patients with thin endometrium who planned to undergo frozen embryo transplantation in the Affiliated Hospital of Zunyi Medical University from July 2023 to December 2024 were collected. According to the inclusion and exclusion criteria, the patients were divided into observation group and control group according to the order of treatment after obtaining the informed consent of the patients or (and) their families. Endometrial preparation regimen: The control group underwent endometrial preparation through natural cycle regimen or hormone replacement cycle regimen, and the natural cycle regimen determined the embryo transfer time through ultrasound monitoring of ovulation and endometrial thickness. The hormone replacement cycle plan began on the second day of menstruation with oral estrogen (fimolone or Bugalol) 2 tablets/time, twice/day, and the drug dose was adjusted according to the endometrial thickness. Ovulation and blood estrogen and progesterone levels were monitored by ultrasound to determine the time of endometrial transformation. On the day of endometrial transformation, progesterone injection was injected intramural for endometrial transformation. Cryo-thawing embryo transplantation was performed on day 3 or 5 after endometrial transformation. Endometrial receptivity ultrasound was performed one day before transplantation. Embryo transfer protocol: The patient was taken to the lithotomy position, and after cleaning the vagina and cervix, the transplant tube containing the embryo was placed into the inner opening of the cervix, and the embryo was slowly injected at the top of the transplant tube about 2-3mm from the uterine floor, and the transplant tube was slowly extracted after standing for a while. After confirming that the embryo was transferred into the uterine cavity, the uterine fluid in the outer tube was extracted with a 2ml syringe and stored in the refrigerator at -80°. The levels of TNF-α and VEGF in uterine fluid were detected. Observation group was given Jinfeng pills orally on the basis of control group. 10 Jinfeng pills were taken orally from the second day of menstruation, twice a day, for 12 days in total. Blood HCG was examined 2 weeks after transplantation, vaginal ultrasound was performed 4 weeks after transplantation, and follow-up was terminated at 12 weeks after transplantation. 

纳入标准：

①经阴道超声检查，在卵泡发育成熟时(直径≥18 mm)或HCG注射日，子宫内膜厚度＜7mm；②符合中医学中薄型子宫内膜的诊断标准；③移植年龄：20-40岁且取卵时年龄＜35岁；④至少冻存1枚优质胚胎；⑤患者及家属签署知情同意书。

Inclusion criteria

1. Transvaginal ultrasonography showed that the endometrial thickness was < 7mm when the follicle was mature (diameter ≥18 mm) or on the day of HCG injection; 2. It meets the diagnostic criteria of thin endometrium in traditional Chinese medicine; 3. Transplantation age: 20-40 years old and < 35 years old at egg retrieval; 4. at least one high-quality embryo should be frozen; 5. Patients and their families sign informed consent forms.

排除标准：

①合并子宫畸形、子宫腺肌症、子宫内膜异位症、严重的子宫肌瘤、输卵管积水、中重度宫腔粘连者、子宫内膜结核、宫腔形态异常者；②生殖道急、慢性炎症；③丈夫精液异常；④有使用激素类药物禁忌症者。

Exclusion criteria：

1. Patients with uterine malformations, adenomyosis, endometriosis, severe uterine fibroids, hydrosalpinx, moderate to severe uterine adhesives, endometrial tuberculosis, and abnormal uterine morphology; 2. Acute and chronic inflammation of reproductive tract; 3. Abnormal semen of husband; 4. There are contraindications to the use of hormone drugs.

研究实施时间：

Study execute time：

从 From 2023-07-01 00:00:00至 To 2024-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2023-07-10 00:00:00 至 To 2024-12-31 00:00:00  

干预措施：

Interventions：

组别：

观察组

样本量：

71

Group：

Observation group

Sample size：

干预措施：

金凤丸+自然/激素替代周期方案

干预措施代码：

Intervention：

Jinfeng Pills + natural/hormone replacement cycle regimen

Intervention code：

组别：

对照组

样本量：

71

Group：

Control group

Sample size：

干预措施：

自然/激素替代周期方案

干预措施代码：

Intervention：

Natural/hormone replacement cycle program

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 贵州省 

市(区县)：

 遵义市 

Country：

China 

Province：

Guizhou Province 

City：

Zunyi City 

单位(医院)：

遵义医科大学附属医院 

单位级别：

三甲 

Institution
hospital：

Affiliated Hospital of Zunyi Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

子宫内膜容受性超声指标

指标类型：

主要指标

Outcome：

Endometrial receptivity related indicators

Type：

Primary indicator

测量时间点：

胚胎移植前一日

测量方法：

移植前一日进行子宫内膜容受性超声检查

Measure time point of outcome：

The day before the embryo transfer

Measure method：

Endometrial receptive ultrasound

指标中文名：

宫腔液中VEGF及TNF-α水平

指标类型：

次要指标

Outcome：

VEGF and TNF-α levels in uterine fluid

Type：

Secondary indicator

测量时间点：

胚胎移植当日

测量方法：

酶联免疫吸附试验

Measure time point of outcome：

Embryo transfer date

Measure method：

Enzyme-linked immunosorbent assay

指标中文名：

血HCG阳性率

指标类型：

次要指标

Outcome：

Blood HCG positive rate

Type：

Secondary indicator

测量时间点：

移植后2周

测量方法：

测血中人绒毛膜促性腺激素值

Measure time point of outcome：

two weeks after transplant

Measure method：

Human chorionic gonadotropin was measured in blood

指标中文名：

临床妊娠率

指标类型：

主要指标

Outcome：

Clinical pregnancy rate

Type：

Primary indicator

测量时间点：

移植后4周

测量方法：

阴道超声检查

Measure time point of outcome：

Four weeks after transplant

Measure method：

Transvaginal ultrasonography

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

宫腔液

组织：

子宫内膜分泌液

Sample Name：

Uterine fluid

Tissue：

Endometrial secretions

人体标本去向

 使用后销毁  

说明

保存于-80°冰箱中，1个月内检测相应指标

Fate of sample：

Destruction after use  

Note：

Store in the -80° refrigerator and test the corresponding index within 1 month

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 20 岁 years
最大 Max age 40 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）：

无

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

NA

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：

无

Blinding：

None

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）：

试验结束后6个月内导出数据上传到 ResMan

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

The exported data were uploaded to ResMan within 6 months after the end of the trial

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：

研究者必须保证完整和准确地填写病例数据收集表。每份病例数据收集表中只记录一个临床研究受试者的数据资料。所有填写错误的数据或文字不可以涂改。病例数据收集表原件保存在研究者，电子数据录入根据病例数据收集表的原始数据进行录入。

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

The investigator must ensure that the case data collection form is completed completely and accurately. Only one clinical study subject was recorded in each case data collection form. All incorrect data or text cannot be corrected. The original case data collection form is kept in the researcher, and electronic data entry is made according to the original data of the case data collection form.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2024-10-09 16:08:24