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羟氯喹预处理对改善多囊卵巢综合征患者妊娠结局的疗效评估
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注册号:

Registration number:

ChiCTR1900026938 

最近更新日期:

Date of Last Refreshed on:

2019-10-26 

注册时间:

Date of Registration:

2019-10-26 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

羟氯喹预处理对改善多囊卵巢综合征患者妊娠结局的疗效评估 

Public title:

Efficacy of hydroxychloroquine pretreatment on improving pregnancy outcome in patients with polycystic ovary syndrome 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

羟氯喹预处理对改善多囊卵巢综合征患者妊娠结局的疗效评估 

Scientific title:

Efficacy of hydroxychloroquine pretreatment on improving pregnancy outcome in patients with polycystic ovary syndrome 

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:

林仙华 

研究负责人:

林仙华 

Applicant:

Lin Xianhua 

Study leader:

Lin Xianhua 

申请注册联系人电话:

Applicant telephone:

+86 18017310228 

研究负责人电话:

Study leader's telephone:

+86 18017310228 

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:

xl_1290@126.com 

研究负责人电子邮件:

Study leader's E-mail:

xl_1290@126.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:

上海市徐汇区衡山910 号 

研究负责人通讯地址:

上海市徐汇区衡山910 号 

Applicant address:

910 Hengshan, Xuhui District, Shanghai 

Study leader's address:

910 Hengshan, Xuhui District, Shanghai 

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:

国际和平妇幼保健院 

Applicant's institution:

International Peace Maternal and Child Health Hospital 

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:

GKLW-2018-27 

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:

国际和平妇幼保健院伦理委员会 

Name of the ethic committee:

International Peace Maternal and Child Health Hospital Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-12-29 

伦理委员会联系人:

张勇 

Contact Name of the ethic committee:

Zhang Yong 

伦理委员会联系地址:

上海市徐汇区衡山路910 号 

Contact Address of the ethic committee:

910 Hengshan, Xuhui District, Shanghai 

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:

国际和平妇幼保健院 

Primary sponsor:

International Peace Maternal and Child Health Hospital 

研究实施负责(组长)单位地址:

上海市徐汇区衡山910 号 

Primary sponsor's address:

910 Hengshan, Xuhui District, Shanghai 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海

市(区县):

徐汇区

Country:

China

Province:

Shanghai

City:

Xuhui District

单位(医院):

国际和平妇幼保健院

具体地址:

衡山910 号

Institution
hospital:

International Peace Maternal and Child Health Hospital

Address:

910 Hengshan

经费或物资来源:

上海申康医院发展中心临床科技创新项目 

Source(s) of funding:

Clinical Science and Technology Innovation Project of Shanghai Shenkang Hospital Development Center 

研究疾病:

多囊卵巢综合征 

Target disease:

PCOS 

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:

上市后药物 

Study phase:

研究目的:

1.1 主要研究目的:本研究的主要目的是探究在PCOS助孕前,羟氯喹预治疗3个月是否提高活产率,并为其提供医学证据。 1.2 次要研究目的:本研究的次要目的是通过比较两组受试对象体脂成分,糖脂代谢指标,排卵率,获卵率,受精率,优胚率,胚胎种植率,生化妊娠率,临床妊娠率,宫外孕率,早期流产率,持续妊娠率和早产率来评价羟氯喹预治疗是否有助云改善PCOS患者助孕时的效果及妊娠结局。 

Objectives of Study:

1.1 Main research purposes: The main purpose of this study was to investigate whether hydroxychloroquine pre-treatment for 3 months prior to PCOS help to improve live birth rate and provide medical evidence. 1.2 Secondary study objectives: The secondary purpose of this study was to compare the body fat composition, glucose and lipid metabolism index, ovulation rate, egg yield, fertilization rate, excellent embryo rate, embryo implantation rate, and biochemical pregnancy rate of the two groups of subjects. Clinical pregnancy rate, ectopic pregnancy rate, early abortion rate, continued pregnancy rate and preterm birth rate to evaluate whether hydroxychloroquine pretreatment can help improve the outcome and pregnancy outcome of PCOS patients during pregnancy. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

受试者必须符合下述所有标准方可纳入研究: 1. 年龄在20-38岁的中国女性。 2. 根据鹿特丹PCOS诊断标准入组,为以下3 项中符合其中2项: (1) 稀发排卵或无排卵。 (2) 高雄激素血症或高雄激素的临床表现 (如多毛、痤疮等 )。 (3) 超声检查在月经周期或黄体酮撤退后出血的 3~5d进行 ,显示双侧卵巢均有≥12个且直径 2~9mm的小卵泡 ,即卵巢多囊样改变 ,和 (或 )卵巢体积增大 (每侧>10mL,卵巢体积 = 0.15 ×长 cm ×宽 cm ×厚 cm)。 3. 未避孕未孕1年以上;既往未行助孕治疗。 4. 在执行任何研究方案规定的程序之前,完全解释本研究的性质并且必须取得受试者的知情同意。如受试者没有能力表达意见,可由受试者的法定代理人签署书面知情同意。  

Inclusion criteria

Subjects must meet all of the following criteria to be included in the study: 1. Chinese women aged 20-38 years. 2. According to the Rotterdam PCOS diagnostic criteria, 2 of the following 3 items are met: (1) rare ovulation or no ovulation. (2) Clinical manifestations of hyperandrogenism or high androgen (such as hairy, hemorrhoids, etc.). (3) Ultrasound examination occurred in the menstrual cycle or after 3 to 5 days of hemorrhage after progesterone withdrawal, showing that both ovaries have >= 12 small follicles with a diameter of 2 to 9 mm, ie ovarian polycystic changes, and/or ovaries The volume is increased (>10 mL per side, ovarian volume = 0.15 x long cm x width cm x thickness cm). 3. No contraception for more than 1 year of pregnancy; no previous treatment for pregnancy. 4. Fully explain the nature of the study and obtain informed consent from the subject before performing any procedures specified in the study protocol. If the subject is incapable of expressing an opinion, written informed consent may be signed by the subject's legal representative. 

排除标准:

符合下述任何一条标准均应从本研究中排除: 1. 自身存在内分泌系统其他疾病:高血压病,代谢综合征等; 2. 做过单侧卵巢切除术; 3. 妻双方存在染色体异常,需行PGT者; 4. 存在高雄激素血症的其它原因,如甲状腺疾病、先天性肾上腺皮质增生、库欣综合征、雄激素分泌性肿瘤、21- 羟化酶缺乏性非典型肾上腺皮质增生、外源性雄激素应用等; 5. 合并免疫因素的不孕; 6. 存在子宫异常如子宫畸形(单角子宫,纵膈子宫,双子宫,双角子宫)子宫肌腺症,粘膜下肌瘤或宫腔粘连; 7. 有复发性流产病史(包括生化妊娠),即为3次或以上流产病史; 8. 助孕治疗或应用羟氯喹的禁忌症:未明确病因的肝脏疾病或肝功能异常(血清肝酶指标异常);肾脏疾病或肾功能异常;严重贫血;深静脉血栓病史,肺栓塞病史,脑血管意外病史;诊断明确的心脏病;宫颈癌,内膜癌或乳腺癌病史;不明原因的阴道出血。 

Exclusion criteria:

Any of the following criteria should be excluded from the study: 1. Other diseases of the endocrine system: hypertension, metabolic syndrome, etc. 2. Have done unilateral oophorectomy; 3. There are chromosomal abnormalities in both sides of the wife, and PGT is required; 4. Other causes of hyperandrogenism, such as thyroid disease, congenital adrenal hyperplasia, Cushing's syndrome, androgen secreting tumor, 21-hydroxylase deficiency atypical adrenal hyperplasia, exogenous androgen Application, etc. 5. Infertility with combined immune factors; 6. Uterine abnormalities such as uterine malformation (single-horned uterus, mediastinal uterus, double uterus, double-horned uterus), uterine adenomyosis, submucosal fibroids or intrauterine adhesions; 7. History of recurrent abortion (including biochemical pregnancy), which is a history of abortion 3 or more; 8. Contraindications for the treatment or application of hydroxychloroquine: liver disease or abnormal liver function (unused serum enzyme index); renal disease or renal dysfunction; severe anemia; history of deep vein thrombosis, history of pulmonary embolism, History of cerebrovascular accidents; diagnosis of a clear heart disease; history of cervical cancer, endometrial cancer or breast cancer; vaginal bleeding of unknown origin. 

研究实施时间:

Study execute time:

From2019-11-01To 2023-12-30 

征募观察对象时间:

Recruiting time:

From2019-11-01To 2022-11-30 

干预措施:

Interventions:

组别:

试验组

样本量:

217

Group:

experimental group

Sample size:

干预措施:

羟氯喹

干预措施代码:

Intervention:

Hydroxychloroquine

Intervention code:

组别:

对照

样本量:

217

Group:

control group

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

国际和平妇幼保健院 

单位级别:

三级甲等 

Institution
hospital:

International Peace Maternal and Child Health Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

活产率

指标类型:

主要指标 

Outcome:

Live birth

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

临床妊娠率

指标类型:

次要指标 

Outcome:

Clinical pregnancy outcome

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

自然流产率

指标类型:

次要指标 

Outcome:

Spontaneous abortion rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

持续妊娠率

指标类型:

次要指标 

Outcome:

Ongoing pregnancy rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体重指数

指标类型:

附加指标 

Outcome:

BMI

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体脂成分

指标类型:

附加指标 

Outcome:

Body adipose distribution

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血脂

指标类型:

附加指标 

Outcome:

lipids

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胰岛素释放试验

指标类型:

附加指标 

Outcome:

IGTT

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

葡萄糖耐量试验

指标类型:

附加指标 

Outcome:

OGTT

Type:

Additional 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 years
最大 Max age 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):

采用中央型区组随机软件进行随机。

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

Central randomized block sofware

盲法:

双盲

Blinding:

Double blind.

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

都可 请说明共享原始数据的方式和时间

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

all permitted

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:

所有统计学检验都为双侧检验,其显著性水平为 5%, 即 α=0.05。将计算两组间主要及次要重点指标的差异及其95%的可信区间。用二项式近似正态法计算可信区间,包括连续性校正。不使用推算方法处理缺失的数据。统计采取SAS软件9.3(SAS Institute, Inc, Cary, NC)。

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

All statistical tests were two-sided, with a significance level of 5%, or α = 0.05. Differences between the primary and secondary focus indicators between the two groups and their 95% confidence intervals will be calculated. The confidence interval is calculated using the binomial approximation normal method, including continuity correction. Do not use the inference method to process missing data. Statistics were taken using SAS Software 9.3 (SAS Institute, Inc, Cary, NC).

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-10-26
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