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针刺和克罗米芬对多囊卵巢综合征妇女 活产率的影响:国际合作随机对照试验
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注册号:

Registration number:

ChiCTR-TRC-12002081 

最近更新日期:

Date of Last Refreshed on:

2015-08-08 

注册时间:

Date of Registration:

2012-03-20 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

针刺和克罗米芬对多囊卵巢综合征妇女 活产率的影响:国际合作随机对照试验 

Public title:

Effect of Acupuncture and Clomiphene Citrate on Live Birth in Infertile Women with Polycystic Ovary Syndrome: A Randomized Controlled Trial 

注册题目简写:

 

English Acronym:

PCOSAct 

研究课题的正式科学名称:

针刺和克罗米芬对多囊卵巢综合征妇女 活产率的影响:国际合作随机对照试验 

Scientific title:

Effect of Acupuncture and Clomiphene Citrate on Live Birth in Infertile Women with Polycystic Ovary Syndrome: A Randomized Controlled Trial 

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:

马红丽 

研究负责人:

吴效科 

Applicant:

Hongli Ma 

Study leader:

XIAOKE WU 

申请注册联系人电话:

Applicant telephone:

+86 13796036734 

研究负责人电话:

Study leader's telephone:

+86 13796025599 

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:

mahongli1983@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

xiaokewu2002@vip.sina.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:

黑龙江省哈尔滨市香坊区和平路26号 

研究负责人通讯地址:

黑龙江省哈尔滨市香坊区和平路26号 

Applicant address:

26 Heping Road, Xiangfang District, Harbin, Heilongjiang, China 

Study leader's address:

26 Heping Road, Xiangfang District, Harbin, Heilongjiang, China 

申请注册联系人邮政编码:

Applicant postcode:

1500040 

研究负责人邮政编码:

Study leader's postcode:

150040 

申请人所在单位:

黑龙江中医药大学附属第一医院 

Applicant's institution:

First Affiliated Hospital Heilongjiang University of Chinese Medicine 

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:

2010HZYLL-010 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

黑龙江中医药大学附属第一医院伦理委员会 

Name of the ethic committee:

Ethic Committee of First Affiliated Hospital, Heilongjiang University of Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2011-12-15 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

黑龙江中医药大学 

Primary sponsor:

Heilongjiang University of Chinese Medicine 

研究实施负责(组长)单位地址:

黑龙江省哈尔滨市香坊区和平路26号 

Primary sponsor's address:

26 Heping Road, Xiangfang District, Harbin, Heilongjiang 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

黑龙江省

市(区县):

Country:

China

Province:

Heilongjiang Province

City:

单位(医院):

黑龙江中医药大学附属第一医院

具体地址:

黑龙江省哈尔滨市香坊区和平路26号

Institution
hospital:

First Affiliated Hospital of Heilongjiang University of Chinese Medicine

Address:

26 Heping Road, Xiangfang District, Harbin, Heilongjiang

经费或物资来源:

国家中医药管理局 

Source(s) of funding:

State Administration of Traditional Chinese Medicine of China 

研究疾病:

多囊卵巢综合征 

Target disease:

Polycystic ovarian 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:

其它 

Study phase:

N/A 

研究目的:

本试验的目的是对无排卵的多囊卵巢综合征(PCOS)妇女验证以下三种假设: 1)针刺方案1加克罗米芬(CC)与针刺方案2加CC相比,更有效的能促排卵和提高活产率。 2)针刺方案2加CC比针刺方案1加安慰剂CC更有效或等效。 3)针刺方案1加安慰剂CC比针刺方案2加安慰剂CC能促排卵和提高活产率。 

Objectives of Study:

The objectives of the present trial are to test the following three hypotheses in anovulatory women with Polycystic ovary syndrome (PCOS): 1) Acupuncture treatment 1 plus Clomiphene citrate (CC) (Arm A) is more likely to induce ovulation and results in live birth than acupuncture treatment 2 plus CC (Arm B), 2) Acupuncture treatment 2 plus CC (Arm B) is more or equally effective than real acupuncture treatment 1 plus placebo CC (Arm C), 3)Acupuncture treatment 1 plus placebo CC (Arm C) is more likely to induce ovulation and live birth than Acupuncture treatment 2 and placebo CC (Arm D). 

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. 年龄介于20岁至40岁之间的妇女。 2. 根据 Rotterdam标准确诊的PCOS患者并且所有受试者必须有不排卵和多囊样卵巢或者高雄激素血症。 3. 输卵管通液测试包括子宫输卵管造影和诊断性腹腔镜,它们显示至少有一侧输卵管通畅。 4. 根据世界卫生组织标准(2010)丈夫的精液分析正常,精子浓度必需是至少每毫升1千5百万,精子活力至少为32%和正常形态至少为4%。 

Inclusion criteria

1. Age between 20 and 40 years. 2. Confirmed diagnosis of PCOS according to the modified Rotterdam criteria and all subjects must have anovulation plus either polycystic ovaries and/or hyperandrogenism. 3. One tube patent and a normal uterine cavity by hysterosalpingogram, HyCosi or diagnostic laparoscopy. 4. Normal semen analysis of the husband according to the criteria of World Health Organization (2010) i.e. sperm concentration of at least 15 million per milliliter, forward motility of at least 32% and normal morphology of at least 4%. 

排除标准:

1排除其他内分泌障碍 ①高泌乳素血症患者(定义为两个催乳素水平至少一个星期相距20纳克/毫升或由地方标准值确定)。排除高泌乳素血症患者的目的是降低PCOS人口的不均一性。这些患者可能是使用替代疗法促排卵的候选人(多巴胺受体激动剂)。在过去一年内或在治疗时水平正常适合入选 ②21-羟化酶缺乏或其他酶缺乏导致表型先天性肾上腺增生的患者。 ③绝经期FSH水平 (> 15 mIU/mL)。在过去一年,水平正常可适当入选。 ④未矫正的甲状腺疾病的患者 (定义为TSH < 0.2 mIU/mL or >5.5 mIU/mL)。在过去一年,水平正常可以入选 ⑤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胰岛素,噻唑降糖药物,阿卡波糖,或磺脲类药物可能混淆研究药物的效果;为了诊断是I或II型糖尿病或PCOS的患者正在接受二甲双胍XR治疗也同样明确地排除。 ⑥疑似库欣综合征患者。 2 至少在过去3个月使用激素或其他药物,包括中药方剂,这可能会影响结果。 3 6周内有怀孕史。 4 6周内有流产或生产史。 5 近6个月有哺乳史。 6 近6个月接受过针刺治疗。 7 不同意签署本研究的知情同意书。 8 特殊排除标准 (1)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,特别是埋植剂仍埋植的地方,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。 (2) 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。 (3)显著性贫血患者 (血红蛋白 < 10 g/dL)。 (4)有深静脉血栓形成,肺栓塞,或脑血管意外病史的患者 (5)怀孕后可加重的患有心脏病患者。 (6)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进行子宫颈涂片检查 (7)目前有酗酒史的患者。酗酒的定义是> 14 杯/周或暴饮。 (8)同时参加其他调查研究的需要药物治疗、禁止本研究药物治疗、限制性交,或其他妨碍遵从本方案的患者。 (9)预期在方案研究期间,需中断治疗1个月以上的患者不应该被纳入。 (10)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 (11)怀疑肾上腺或卵巢肿瘤分泌雄激素的患者。 (12)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。同时做过绝育松解术及PCOS的患者很少见,不会影响招募。 (13)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。 (14)未经治疗血压控制不佳的高血压患者,定义为至少60分钟分别两次测量,收缩压160 mm Hg或舒张压100 mm Hg。 

Exclusion criteria:

1.Exclusion of other endocrine disorders (1) Patients with hyperprolactinemia (defined as two prolactin levels at least one week apart 25 ng/mL or greater or as determined by local normative values). The goal of eliminating patients with documented hyperprolactinemia is to decrease the heterogeneity of the PCOS population. These patients may be candidates for ovulation induction with alternate regimens (dopamine agonists). A normal level within the last year or on treatment is adequate for entry; (2) Patients with known 21-hydroxylase deficiency or other enzyme deficiency leading to the phenotype of congenital adrenal hyperplasia; (3) Patients with FSH levels > 15 mIU/mL. A normal level within the last year is adequate for entry; (4) 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; (5) Patients diagnosed with Type I or Type II diabetes who are poorly controlled (defined as a glycohemoglobin level > 7.0%), or patients receiving antidiabetic medications such as insulin, thiazolidinediones, acarbose, or sulfonylureas likely to confound the effects of study medication; patients currently receiving metformin XR for a diagnosis of Type I or Type II diabetes or for PCOS are also specifically excluded; (6) Patients with suspected Cushing's syndrome. 2. Use of hormonal or other medication including Chinese Herbal prescriptions which may affect the outcome at least in the past 3 months; 3. Pregnancy within the past 6 weeks; 4. Within 6 weeks post-abortion or postpartum; 5. Breastfeeding within the last 6 months; 6. Acupuncture within the last 6 months; 7. Not willing to give written consent to the study; 8. Specific Exclusion Criteria; (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 significant anemia (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 simultaneously into other investigative studies that require medications, proscribe 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, anti-obesity drugs, Chinese herbal formula, anti-diabeteic drugs such as metformin and thiazolidinediones, somatostatin, diazoxide, 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 mm Hg or a diastolic 100 mm Hg obtained on two measures obtained at least 60 minutes apart. 

研究实施时间:

Study execute time:

From2012-04-01To 2015-12-31 

干预措施:

Interventions:

组别:

A

样本量:

250

Group:

A

Sample size:

干预措施:

针刺方案1加CC

干预措施代码:

Intervention:

Acupuncture treatment 1 plus CC

Intervention code:

组别:

B

样本量:

250

Group:

B

Sample size:

干预措施:

针刺方案2加CC

干预措施代码:

Intervention:

Acupuncture treatment 2 plus CC

Intervention code:

组别:

C

样本量:

250

Group:

C

Sample size:

干预措施:

针刺方案1加CC安慰剂

干预措施代码:

Intervention:

Acupuncture treatment 1 plus CC placebo

Intervention code:

组别:

D

样本量:

250

Group:

D

Sample size:

干预措施:

针刺方案2加CC安慰剂

干预措施代码:

Intervention:

Acupuncture treatment 2 plus CC placebo

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

哈尔滨 

Country:

China 

Province:

Heilongjiang 

City:

Harbin 

单位(医院):

黑龙江中医药大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

First Affiliated Hospital,Heilongjiang University of Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

哈尔滨 

Country:

China 

Province:

Heilongjiang 

City:

Harbin 

单位(医院):

黑龙江中医药大学附属第二医院 

单位级别:

三级甲等 

Institution
hospital:

Second Affiliated Hospital,Heilongjiang University of Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

哈尔滨 

Country:

China 

Province:

Heilongjiang 

City:

Harbin 

单位(医院):

哈尔滨医科大学附属第四医院 

单位级别:

三级甲等 

Institution
hospital:

Forth Affiliated Hospital of Harbin Medical University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

大庆 

Country:

China 

Province:

Heilongjiang 

City:

Daqing 

单位(医院):

大庆油田总医院 

单位级别:

三级甲等 

Institution
hospital:

The Daqing Oilfield General Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

大庆 

Country:

China 

Province:

Heilongjiang 

City:

Daqing 

单位(医院):

大庆龙南医院 

单位级别:

三级甲等 

Institution
hospital:

Daqing Longna Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

沈阳 

Country:

China 

Province:

Liaoning 

City:

Shenyang 

单位(医院):

辽宁中医药大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

Liaoning University of Chinese Medicine Affiliated Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

天津 

Country:

China 

Province:

Tianjin 

City:

Tianjin 

单位(医院):

天津中医药大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

Second Affiliated Hospital,Changchun University of Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

天津 

Country:

China 

Province:

Tianjin 

City:

Tianjin 

单位(医院):

天津中医药大学附属第二医院 

单位级别:

三级甲等 

Institution
hospital:

Second Affiliated Hospital,Changchun University of Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

天津 

Country:

China 

Province:

Tianjin 

City:

Tianjin 

单位(医院):

天津市塘沽区妇幼保健院 

单位级别:

三级甲等 

Institution
hospital:

Tianjin Tanggu Maternity and Child Care Center  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

温州 

Country:

China 

Province:

Zhejiang 

City:

Wenzhou 

单位(医院):

浙江温州中山医院 

单位级别:

三级甲等 

Institution
hospital:

Wenzhou Zhongshan Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

温州 

Country:

China 

Province:

Zhejiang 

City:

Wenzhou 

单位(医院):

温州市中医院 

单位级别:

三级甲等 

Institution
hospital:

Wenzhou Chinese Medicine Hospital  

Level of the institution:

Tertiary A Hospital 

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):

浙江省中西医结合医院 

单位级别:

三级甲等 

Institution
hospital:

Integrated Chinese and Western Medicine Hospital of Zhejiang Province  

Level of the institution:

Tertiary A Hospital 

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):

杭州市中医院 

单位级别:

三级甲等 

Institution
hospital:

Hangzhou Chinese Medicine Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

山西 

市(区县):

太原 

Country:

China 

Province:

Shanxi 

City:

Taiyuan 

单位(医院):

山西省中医院 

单位级别:

三级甲等 

Institution
hospital:

Shanxi Chinese Medicine Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

河南 

市(区县):

郑州 

Country:

China 

Province:

Henan 

City:

Zhengzhou 

单位(医院):

河南省中医院 

单位级别:

三级甲等 

Institution
hospital:

Henan Chinese Medicine 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):

江苏徐州妇幼保健院 

单位级别:

三级甲等 

Institution
hospital:

Maternal and Child Health Hospital of Xuzhou  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

江苏 

市(区县):

淮安 

Country:

China 

Province:

Jiangsu 

City:

Huaian 

单位(医院):

江苏淮安妇幼保健院 

单位级别:

三级甲等 

Institution
hospital:

Maternal and Child Health Hospital of Huaian  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

安徽 

市(区县):

合肥 

Country:

China 

Province:

Anhui 

City:

Hefei 

单位(医院):

安徽中医学院第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

First Affiliated Hospital,Anhui University of Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

苏州 

Country:

China 

Province:

Zhejiang 

City:

Suzhou 

单位(医院):

苏州市中医院 

单位级别:

三级甲等 

Institution
hospital:

Suzhou Chinese Medicine Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

华中科技大学武汉同济医院 

单位级别:

三级甲等 

Institution
hospital:

Huazhong university of science and technology, Wuhan Tongji Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

湖北省中医院 

单位级别:

三级甲等 

Institution
hospital:

Hubei Chinese Medicine Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

江西 

市(区县):

南昌 

Country:

China 

Province:

Jiangxi 

City:

Nanchang 

单位(医院):

江西中医学院附属医院 

单位级别:

三级甲等 

Institution
hospital:

Jiangxi University of Chinese Medicine Affiliated Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖南 

市(区县):

长沙 

Country:

China 

Province:

Hunan 

City:

Changsha 

单位(医院):

湖南中医药大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

First Affiliated Hospital,Hunan University of Chinese Medicine  

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):

广州医学院附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

First Affiliated Hospital,Guangzhou University of Chinese Medicine  

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):

广东省中医院 

单位级别:

三级甲等 

Institution
hospital:

Guangdong Chinese 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:

Guangzhou 

单位(医院):

广州市荔湾区中医医院 

单位级别:

三级甲等 

Institution
hospital:

Guangzhou Liwan Chinese Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

大连 

Country:

China 

Province:

Liaoning 

City:

Dalian 

单位(医院):

大连市妇产医院 

单位级别:

三级甲等 

Institution
hospital:

Dalian maternity hospital  

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:促卵泡生成素、促黄体生成素、总睾酮、性激素结合球蛋白、及脱氢表雄酮

指标类型:

次要指标 

Outcome:

Hormonal profile: Testosterone(T), Sex hormone-binding globulin (SHBG), Follicle stimulating hormone

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:包括血糖、胰岛素浓度、胆固醇、甘油三酯、高密度脂蛋白、低密度脂蛋白

指标类型:

次要指标 

Outcome:

Metabolic profile includes: Serum glucose concentration, Insulin concentration, cholesterol

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。克罗米芬的不良反应包括潮热、情绪改变、肿胀、卵巢囊肿形成、疼痛极少数发生垂体卒中和深静脉血栓形成。针刺的不良反应主要为局部皮肤刺激、不适、及迷走神经反射

指标类型:

次要指标 

Outcome:

Side effects of CC include hot flashes, mood changes, bloating, formation of ovarian cysts, and pain

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):

中央随机

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

Central randomization

盲法:

单盲

Blinding:

The results assessor will be blinded.

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:

即时公开/Real time access

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):

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

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:

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

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2012-03-20
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