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个性化针灸、标准化针灸、来曲唑和安慰剂对多囊卵巢综合症无排卵妇女活产率影响:多中心随机试验
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注册号:

Registration number:

ChiCTR1800017304 

最近更新日期:

Date of Last Refreshed on:

2019-04-13 

注册时间:

Date of Registration:

2018-07-23 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

个性化针灸、标准化针灸、来曲唑和安慰剂对多囊卵巢综合症无排卵妇女活产率影响:多中心随机试验 

Public title:

A multicenter, randomized, controlled trial for comparing personalized acupuncture versus standardized acupuncture, versus letrozole, placebo in the treatment of anovulatory women with polycystic ovary syndrome 

注册题目简写:

PPCOSAct 

English Acronym:

PPCOSAct 

研究课题的正式科学名称:

个性化针灸、标准化针灸、来曲唑和安慰剂对多囊卵巢综合症无排卵妇女活产率影响:多中心随机试验 

Scientific title:

A multicenter, randomized, controlled trial for comparing personalized acupuncture versus standardized acupuncture, versus letrozole, placebo in the treatment of anovulatory women 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:

NCT03625531 

申请注册联系人:

黄诗雅 

研究负责人:

马红霞 

Applicant:

Huang Shiya 

Study leader:

Ma Hongxia 

申请注册联系人电话:

Applicant telephone:

+86 13580594424 

研究负责人电话:

Study leader's telephone:

+86 18928868335 

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:

997952449@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

doctorhongxia@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:

广东省广州市越秀区沿江西路151号 

研究负责人通讯地址:

广东省广州市越秀区沿江西路151号 

Applicant address:

151 Yanjiang Road, Yuexiu District, Guangzhou, China  

Study leader's address:

151 Yanjiang Road, Yuexiu District, Guangzhou, China  

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:

广州医科大学附属第一医院 

Applicant's institution:

the First Affiliated Hospital of Guangzhou Medical 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:

2018-19 

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:

广州医科大学附属第一医院伦理委员会 

Name of the ethic committee:

The ethic committee of the First Affiliated Hospital of Guangzhou Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

广州医科大学附属第一医院伦理委员会 

Contact Name of the ethic committee:

The ethic committee of the First Affiliated Hospital of Guangzhou Medical University  

伦理委员会联系地址:

广东省广州市越秀区沿江西路151号 

Contact Address of the ethic committee:

151 Yanjiang Road, Yuexiu District, Guangzhou, China  

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:

广州医科大学附属第一医院 

Primary sponsor:

the First Affiliated Hospital of Guangzhou Medical University  

研究实施负责(组长)单位地址:

广东省广州市越秀区沿江西路151号 

Primary sponsor's address:

151 Yanjiang Road, Yuexiu District, Guangzhou, China  

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东省

市(区县):

广州市

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广州医科大学附属第一医院

具体地址:

广东省广州市越秀区沿江西路151号

Institution
hospital:

the First Affiliated Hospital of Guangzhou Medical University

Address:

151 Yanjiang Road, Yuexiu District, Guangzhou, China

经费或物资来源:

广州医科大学高水平大学建设创新团队培训基金 

Source(s) of funding:

High-level University Construction Innovation Team Training Foundation in Guangzhou Medical University 

研究疾病:

多囊卵巢综合征 

Target disease:

Polycystic Ovary Syndrome 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

目的是评价个性化或标准化针刺对PCOS活产率的影响,与来曲唑和安慰剂比较,是否增加PCOS患者活产率。我们假设来曲唑比个性化针刺更有效,个性化针刺比标准化针刺更有效,而标准化针刺比安慰剂有效。 

Objectives of Study:

The objective of this multicenter randomized trial is to evaluate whether personalized or standardized acupuncture, increases the likelihood of live births among women with PCOS compared with letrozole or placebo. We hypothesis that letrozole is more effective than personalized acupuncture and personalized acupuncture is more effective than standardized acupuncture, which is more effective than placebo.  

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:

1. 20至40岁的女性; 2.慢性月经稀发或闭经:月经稀发被定义为平均月经周期>35天,或每年少于8个月经周期。闭经定义为月经间隔时间>90天; 3.雄激素过多症(多毛症或高雄激素血症)或多囊卵巢。在筛选检查时,多毛症定义是Ferriman-Gallwey (FG)评分≥5分,生化高雄激素症定义为总睾酮(T)> 2.6 nmol / L和游离睾酮≥6.0 pg / mL。多囊性卵巢,即经阴道超声直径≤9mm的窦卵泡数>12个或卵巢体积>10ml;4.如无盆腔操作史、流产史,输卵管通畅试验结果3年内有效。子宫输卵管造影和诊断性腹腔镜等,显示至少有一侧输卵管通畅。如果患者在过去5年内有妊娠史且无盆腔手术史,则不需要进行输卵管通畅试验检查; 5.丈夫精液分析中,丈夫精液分析满足①或者②。①精子密度≥15×106/ml,并且活动精子(向前和非向前)≥40%(a+b+c ≥40%))。②活动精子总数量≥1千万个。在研究期间,同意定期性交,即每周2-3次。 

Inclusion criteria

1. Women aged between 20 and 40 years; 2. Chronic oligomenorrhea or amenorrhea: oligomenorrhea is defined as an intermenstrual interval > 35 days or < 8 menstrual bleedings in the past year. Amenorrhea is defined as an intermenstrual interval >90 days; 3. Hyperandrogenism (either hirsutism or hyperandrogenemia) or polycystic ovaries on ultrasound. Hirsutism is determined by a modified Ferriman-Gallwey Score ≥ 5 at screening examination, and biochemical hyperandrogenism is defined as total testosterone (T) > 2.6 nmol/L and free testosterone ≥ 6.0 pg/mL. Polycystic ovaries are present when there are ≥ 12 antral follicles (2 – 9mm) or ovarian volume > 10 mL on transvaginal scanning; 4. At least one patent tube shown by hysterosalpingogram or diagnostic laparoscopy within 3 years if thepatient does not have a history of abortion or pelvic operation. If the patient has a history of pregnancy and no history of pelvic operation within the past 5 years, she is not required to undergo a tubal patency test; 5. Sperm concentration >=15*10^6/ml and total motility >=40% or total motile sperm count >=10 million in the semen analysis of the husband. Agree to have regular intercourse i.e. 2-3 times per week during the study period. 

排除标准:

1.排除其他内分泌紊乱:a. 伴有高泌乳素血症的患者(定义为至少相隔一个星期两次催乳素水平≥25 ng / mL); b. FSH水平> 15 mIU / mL,过去一年的水平正常可以入组;c. 未矫正的甲状腺疾病(定义为TSH <0.2 mIU / mL或> 5.5 mIU / mL),在过去一年,水平正常可以入组; d. 控制不佳的I或II型糖尿病患者(定义为糖化血红蛋白水平> 7.0%),或者患者接受抗糖尿病药物如二甲双胍、胰岛素、噻唑降糖药物、阿卡波糖或磺脲类药物; e. 怀疑库欣综合征; 2.在过去3个月内使用激素或其他药物,包括中药方剂和中成药; 3.最近6周内有怀孕史 4.最近6周内有流产或生产史。 5.最近6个月有哺乳史。 6.不同意签署本研究的知情同意书。 7.其他排除标准: a. 口服避孕药、孕酮或激素类埋植剂(包括皮下埋植剂)。在筛选使用了这类药物的病人前,需要2个月的清除期。储存避孕药形式或埋植剂,特别是埋植剂没有取出,可能需要更长清除时间。口服避孕药需要1个月的药物清除时间 b. AST 或ALT > 2 倍正常值或总胆红素>2.5 mg/dL的肝病患者。BUN > 30 mg/dL 或血清肌酐> 1.4 mg/dL的肾病患者 c. 显著贫血患者(血红蛋白< 10 g/dL) d. 有深静脉血栓形成、肺栓塞或脑血管病史的患者 e. 怀孕后可能加重的心脏病患者 f. 疑似子宫颈癌、子宫内膜癌或乳腺癌病史的患者。21岁及以上的妇女要求有子宫颈涂片或TCT检查的正常结果。 g. 目前有酗酒史的患者。酗酒的定义是> 14 次/周或暴饮 h. 患者同时参加其他临床研究。这些研究需要药物治疗、限制同房或其他妨碍遵从本方案的患者。 i. 预期在研究期间,可能中断1个月以上治疗的患者不应该被纳入。 j. 服用了其他已知影响生殖功能或代谢药物的患者。这些药物包括口服避孕药、GnRH 激动剂和拮抗剂、抗雄激素、促性腺激素、抗肥胖药物、抗糖尿病药物如二甲双胍和噻唑烷二酮类、生长激素释放抑制激素、二氮嗪、 ACE抑制剂和钙通道阻滞剂。以上药物清除时间需2个月 k. 怀疑肾上腺或卵巢肿瘤分泌雄激素的患者 l. 夫妻双方既往做过绝育手术(输精管结扎术,输卵管结扎术),现结扎已松解。先前的手术可能影响研究结果。夫妻双方同时做过绝育松解术及PCOS的患者情况很少见,需排除这些病人的纳入,不然会影响本研究的进展。 m. 在近期(<12 月)做过减肥外科手术和处于体重急剧下降时期或进行减肥手术禁止怀孕的患者。 n. 未经治疗血压控制不佳的高血压患者,定义为两次血压测定间隔时间≥60min,收缩压≥160 mm Hg或舒张压≥100 mm Hg o. 已知的先天肾上腺皮质增生症患者  

Exclusion criteria:

1. Exclusion of other endocrine disorders: a. patients with hyperprolactinemia (defined as two prolactin levels at least one week apart ≥ 25 ng/mL); (1) Patients with FSH levels > 15 mIU/mL; (2) normal level within the last year is adequate for entry; (3) Patients with uncorrected thyroid disease (defined as TSH < 0.2 mIU/mL or > 5.5 mIU/mL). A normal level within the last year is adequate for entry; (4) Patients diagnosed with Type I or Type II diabetes who are poorly controlled (defined as HbA1c level > 7.0%), or patients receiving antidiabetic medications such as metformin, insulin, thiazolidinediones, acarbose, or sulfonylureas; (5) Patients with suspected Cushing's syndrome; 2. Use of hormonal or other medication including Chinese herbal prescriptions in the past 3 months; 3. Pregnancy within the past 6 weeks; 4. Within 6 weeks postabortion or postpartum; 5. Breastfeeding within the last 6 months; 6. Not willing to give written consent to the study; 7. Additional exclusion criteria are as follows: (1) Patients on oral contraceptives, depot progestins, or hormonal implants (including Implanon). A two-month washout period will be required prior to screening for patients on these agents. Longer washouts may be necessary for certain depot contraceptive forms or implants, especially where the implants are still in place. A one-month washout will be required for patients on oral cyclic progestins; (2) Patients with liver disease defined as AST or ALT > 2 times normal or total bilirubin > 2.5 mg/dL. Patients with renal disease defined as BUN > 30 mg/dL or serum creatinine > 1.4 mg/dL; (3) Patients with hemoglobin < 10 g/dL; (4) Patients with a history of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident; (5) Patients with known heart disease that is likely to be exacerbated by pregnancy; (6) Patients with a history of, or suspected cervical carcinoma, endometrial carcinoma, or breast carcinoma. A normal Pap smear result will be required for women 21 and over; (7) Patients with a current history of alcohol abuse. Alcohol abuse is defined as >14 drinks/week or binge drinking; (8) Patients enrolled into other investigative studies that require medications, prescribe the study medications, limit intercourse, or otherwise prevent compliance with the protocol; (9) Patients who anticipate taking longer than a one-month break during the protocol should not be enrolled; (10) Patients taking other medications known to affect reproductive function or metabolism. These medications include oral contraceptives, GnRH agonists and antagonists, antiandrogens, gonadotropins, antiobesity drugs, Chinese herbal formula, antidiabeteic drugs such as metformin and thiazolidinediones, somatostatin, diazoxide, angiotensin-converting-enzyme (ACE) inhibitors, and calcium channel blockers. The washout period on all these medications will be two months; (11) Patients with a suspected adrenal or ovarian tumor secreting androgens; (12) Couples with previous sterilization procedures (vasectomy, tubal ligation), which have been reversed. The prior procedure may affect study outcomes, and patients with both a reversed sterilization procedure and PCOS are rare enough that exclusion should not adversely affect recruitment; (13) Subjects who have undergone a bariatric surgery procedure in the recent past (< 12 months) and are in a period of acute weight loss or have been advised against pregnancy by their bariatric surgeon; (14) Patients with untreated poorly controlled hypertension defined as a systolic blood pressure 160 mmHg or a diastolic 100 mm Hg obtained on two measures obtained at least 60 minutes apart; (15) Patients with known congenital adrenal hyperplasia. 

研究实施时间:

Study execute time:

From2018-08-01To 2021-10-31 

征募观察对象时间:

Recruiting time:

From2018-08-01To 2020-12-31 

干预措施:

Interventions:

组别:

1

样本量:

275

Group:

1

Sample size:

干预措施:

个性化针灸

干预措施代码:

Intervention:

personalized acupuncture

Intervention code:

组别:

2

样本量:

275

Group:

2

Sample size:

干预措施:

标准化针灸

干预措施代码:

Intervention:

standardized acupuncture

Intervention code:

组别:

3

样本量:

275

Group:

3

Sample size:

干预措施:

来曲唑

干预措施代码:

Intervention:

letrozole

Intervention code:

组别:

4

样本量:

275

Group:

4

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):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

广州医科大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

the First Affiliated Hospital of Guangzhou Medical University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

广东省妇幼保健院 

单位级别:

三级甲等 

Institution
hospital:

Guangdong Maternity and Child Health Care Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

广州医科大学附属第五医院 

单位级别:

三级甲等 

Institution
hospital:

The fifth affiliated hospital of Guangzhou medical university  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

何贤纪念医院 

单位级别:

二甲医院 

Institution
hospital:

Hexian Memorial affiliated hospital of Southern Meidical University  

Level of the institution:

Secondary Hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

荔湾区中医院 

单位级别:

二甲医院 

Institution
hospital:

Guangzhou Liwan District Hospital of Chinese Medicine  

Level of the institution:

Secondary Hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

佛山 

Country:

China 

Province:

Guangdong 

City:

Foshan 

单位(医院):

广东省中西医结合医院 

单位级别:

三级甲等 

Institution
hospital:

Chinese and Western Medicine Hospital of Guangdong Province  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

深圳 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

深圳市宝安区中医院 

单位级别:

三级甲等 

Institution
hospital:

Shenzhen Baoan Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

深圳 

Country:

China 

Province:

Guangdong 

City:

Shenzhen 

单位(医院):

深圳北大医院 

单位级别:

三级甲等 

Institution
hospital:

Peking University Shenzhen Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

江苏 

市(区县):

徐州 

Country:

China 

Province:

Jiangsu 

City:

Xuzhou 

单位(医院):

徐州市妇幼保健院 

单位级别:

三级甲等 

Institution
hospital:

Xuzhou Maternity and Child Health Care Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广西 

市(区县):

南宁 

Country:

China 

Province:

Guangxi 

City:

Nanning 

单位(医院):

广西中医药大学附属瑞康医院 

单位级别:

三级甲等 

Institution
hospital:

Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

活产率

指标类型:

主要指标 

Outcome:

Live birth rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

排卵率

指标类型:

次要指标 

Outcome:

Ovulation 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:

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:

多胎妊娠率

指标类型:

次要指标 

Outcome:

Multiple 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:

流产率

指标类型:

次要指标 

Outcome:

Miscarriage 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:

激素指标

指标类型:

次要指标 

Outcome:

Hormonal profile

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

代谢指标

指标类型:

次要指标 

Outcome:

Metabolic profile

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良反应情况

指标类型:

次要指标 

Outcome:

Side effect profile

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 20 years
最大 Max age 40 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):

采用基于网络的临床试验公共管理平台ResMan实施中央随机化

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

A central randomization will be performed by the public trial management system ResMan

盲法:

模拟剂

Blinding:

Placebo control

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

否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):

可通过ResMan查询共享

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

IPD will be public accessable via ResMan

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:

ResMan

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

ResMan

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:

 2018-07-23
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