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Effect of acupuncture plus Governor vessel moxibustion combined with letrozole on live birth in anovulatory infertile women with spleen-kidney Yang deficiency polycystic ovary syndrome: a randomised controlled trial

注册号：

Registration number：

ITMCTR2100004939

最近更新日期：

Date of Last Refreshed on：

2021-06-11

注册时间：

Date of Registration：

2021-06-11

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

针刺加督脉灸联合来曲唑对脾肾阳虚型多囊卵巢综合征不孕妇女活产率的影响：随机对照试验

Public title：

Effect of acupuncture plus Governor vessel moxibustion combined with letrozole on live birth in anovulatory infertile women with spleen-kidney Yang deficiency polycystic ovary syndrome: a randomised controlled trial

注册题目简写：

针刺加督脉灸联合来曲唑治疗PCOS

English Acronym：

Acupuncture plus Governor vessel moxibustion combined with letrozole in the treatment of PCOS

研究课题的正式科学名称：

针刺加督脉灸联合来曲唑对脾肾阳虚型多囊卵巢综合征不孕妇女活产率的影响：随机对照试验

Scientific title：

Effect of acupuncture plus Governor vessel moxibustion combined with letrozole on live birth in anovulatory infertile women with spleen-kidney Yang deficiency polycystic ovary syndrome: a randomised controlled trial

研究课题的正式科学名称简写：

针刺加督脉灸联合来曲唑治疗PCOS

Scientific title acronym：

Acupuncture plus Governor vessel moxibustion combined with letrozole in the treatment of PCOS

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：

ChiCTR2100047212 ; ChiMCTR2100004939

申请注册联系人：

全克违

研究负责人：

王乃平

Applicant：

Quan Kewei

Study leader：

Wang Naiping

申请注册联系人电话：

Applicant telephone：

+86 13416820860

研究负责人电话：

Study leader's telephone：

+86 13719382194

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：

279271961@qq.com

研究负责人电子邮件：

Study leader's E-mail：

279271961@qq.com

申请单位网址(自愿提供)：

Study leader's 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：

东莞市东城区堑头花街十八枫华苑5座6D

研究负责人通讯地址：

东莞市东城区松山湖大道3号

Applicant address：

Room 6D, Block 5, 18 Fenghuayuan, QiantouhuaStreet, Dongcheng District, Dongguan, Guangdong

Study leader's address：

3 Songshan Lake Avenue, Dongcheng District, Dongguan, Guangdong

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：

东莞市中医院

Applicant's institution：

Dongguan Traditional Chinese Medicine Hospital

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

202037

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

东莞市中医院医学伦理委员会

Name of the ethic committee：

Ethics Committee of Dongguan Traditional Chinese Medicine Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2020/4/28 0:00:00

伦理委员会联系人：

房志科

Contact Name of the ethic committee：

Fang Zhike

伦理委员会联系地址：

东莞市东城区松山湖大道3号

Contact Address of the ethic committee：

3 Songshan Lake Avenue, Dongcheng District, Dongguan, Guangdong

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 769 26385763

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：

东莞市中医院

Primary sponsor：

Dongguan Traditional Chinese Medicine Hospital

研究实施负责（组长）单位地址：

东莞市东城区松山湖大道3号

Primary sponsor's address：

3 Songshan Lake Avenue, Dongcheng District, Dongguan, Guangdong

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

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

具体地址：

沿江路151号

Institution
hospital：

The First Affiliated Hospital of Guangzhou Medical University

Address：

151 Yanjiang Road

国家：

中国

省(直辖市)：

广东

市(区县)：

东莞

Country：

China

Province：

Guangdong

City：

Dongguan

单位(医院)：

东莞市中医院

具体地址：

东城区松山湖大道3号

Institution
hospital：

Dongguan Hospital of Traditional Chinese Medicine,

Address：

3 Songshan Lake Avenue, Dongcheng District

经费或物资来源：

广东省中医药管理局

Source(s) of funding：

Guangdong Administration of Traditional Chinese Medicine

研究疾病：

多囊卵巢综合征

研究疾病代码：

Target disease：

PCOS

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段：

Study phase：

探索性研究/预试验

Pilot clinical trial

研究目的：

主要目的：假设针刺加督脉灸能够改善脾肾阳虚型PCOS所致不孕症患者的内环境如胰岛素敏感性、雄激素水平和子宫内膜容受性等，进而提高活产率，并期望能够通过本研究验证这一假说：针刺加督脉灸联合LE诱导排卵治疗中国无排卵PCOS妇女比单独LE诱导排卵治疗具有更高的活产率。

Objectives of Study：

Main purpose: Expected to verify this hypothesis through this study:In addition, acupuncture and moxibustion combined with LE induced ovulation in Chinese anovulatory PCOS women has a higher rate of live birth than LE induced ovulation alone.

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.年龄介于20岁至40岁之间的妇女； 2.符合脾肾阳虚型 PCOS 的诊断标准； 3.根据世界卫生组织标准（2010），丈夫精液分析满足（1）或者（2）： （1）精子密度≥15×10^6/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≥9百万个。即：精液体积×精液密度×活动精子的百分率≥9×10^6。 4.输卵管通畅试验，包括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。（如无盆腔操作史、流产史，通畅试验结果3年内有效；如在5年内有生育史且无盆腔操作，不需要行输卵管通畅试验）； 5.同意在接受本研究方法期间停用其他疗法； 6.自愿加入本试验，并签定知情同意书。

Inclusion criteria

1. Women aged 20 to 40 years; 2. It meets the diagnostic criteria of spleen-kidney Yang deficiency type PCOS; 3. According to World Health Organization standards (2010), the husband's semen analysis meets (1) or (2): (1) Sperm density >= 15x10^6/ml, and motile sperm (forward and non-forward) >=40% (A + B + C >=40%)); (2) Total motile sperm number >= 9 million.That is, the percentage of semen volume x semen density x motility sperm >= 9x10^6; 4. Tubal patency tests, including hysterosalpingography and diagnostic laparoscopy, which show that at least one fallopian tube is open.(If there is no history of pelvic operation or abortion, patency test results are effective within 3 years;If there is a history of fertility within 5 years and there is no pelvic operation, the tubal patency test is not required); 5. Agree to discontinue the use of other therapies during the study; 6. Participate in the study voluntarily and sign the informed consent.

排除标准：

1.排除其他内分泌障碍 (1) 高泌乳素血症患者（定义为至少相距一个星期的两次催乳素水平均大于或等于25ng/ml或由当地标准值确定）。排除高泌乳素血症患者的目的是降低PCOS患者的差异性。这些患者可能适用于其他的方法治疗（如多巴胺受体激动剂）。在过去一年内或正在接受治疗者，化验值正常的可以入组； (2) 绝经期FSH水平（> 15 mIU/mL）。在过去一年，水平正常可入组； (3) 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，水平正常可以入组； (4) 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治疗也同样需要排除； (5) 疑似库欣综合征患者。 2.最近2个月内，使用激素或其他药物，包括中药方剂和中成药，这可能会影响结果； 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.特殊排除标准 (1) 怀疑肾上腺或卵巢肿瘤分泌雄激素的患者； (2) 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； (3) 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； (4) 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； (5) 已知的先天肾上腺皮质增生症患者； (6) 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； (7) 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； (8) 显著贫血患者（血红蛋白< 10 g/dL）； (9) 有深静脉血栓形成、肺栓塞或脑血管病史的患者 ； (10) 怀孕后可能加重的心脏病患者； (11) 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； (12) 目前有酗酒史的患者。酗酒的定义是> 14 次/周或暴饮； (13) 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； (14) 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； (15) 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。

Exclusion criteria：

1. Eliminate other endocrine disorders (1) Patients with hyperprolactinemia (defined as two prolactin levels greater than or equal to 25ng/ml or determined by local standard values at least one week apart).The goal of excluding patients with hyperprolactinemia was to reduce variability among PCOS patients.These patients may be treated with alternative therapies (e.g., dopamine agonists).Those who had received treatment within the past year or were receiving treatment with normal test values could be enrolled; (2) Menopausal FSH level (> 15 mIU/mL).Normal levels in the past year are eligible for inclusion; (3) Patients with uncorrected thyroid disease (defined as TSH < 0.2 mIU/mL or >5.5 mIU/mL).In the past year, normal levels can be included in the group; (4) Patients with poorly controlled type i or ii diabetes (defined as a bb0 7.0% glycosylated hemoglobin level) or patients receiving antidiabetic drugs such as insulin, thiazole-lowering drugs, acarbose, or sulfonylureas may obfuscate the effects of the study drugs;Patients who were being treated with metformin in order to be diagnosed with type i or ii diabetes or PCOS also need to be excluded; (5) Suspected patients with Cushing syndrome; 2. In the last 2 months, use of hormones or other drugs, including TCM prescriptions and Chinese patent medicines, may affect the results; 3. Pregnancy history within the last 6 weeks; 4. A history of miscarriage or birth in the last 6 weeks; 5. A history of breastfeeding in the last 6 months; 6. Special exclusion criteria: (1) Patients with adrenal or ovarian tumors suspected of producing androgens; (2) Both the husband and wife have had sterilization operations (vasectomy, tubal ligation) before, and the ligation has been loosened.Previous surgery may have influenced the results of the study.Patients with both husband and wife having undergone sterilization and PCOS at the same time are rare, and the inclusion of these patients should be excluded, otherwise the progress of this study will be affected; (3) Patients who have had bariatric surgery recently (<12 months) and who are in a period of dramatic weight loss or who have had bariatric surgery to prohibit pregnancy; (4) Untreated hypertensive patients with poor blood pressure control were defined as >=60min between two blood pressure measurements, >=160 mm Hg systolic or >=100 mm Hg diastolic; (5) Patients with known congenital adrenocortical hyperplasia; (6) Oral contraceptives, progesterone or hormone implants (including subcutaneous implants).A 2-month clearance period is required before screening of patients who have received these drugs.Storage of contraceptive forms or implants, especially if the implants have not been removed, may require longer removal time.Oral contraceptives take about a month to clear the drug; (7) Patients with liver disease with AST or ALT >2 times normal value or total bilirubin >2.5 mg/dL.Patients with nephropathy with BUN > 30 mg/dL or serum creatinine > 1.4 mg/dL; (8) Patients with significant anemia (hemoglobin < 10 g/dL); (9) Patients with a history of deep vein thrombosis, pulmonary embolism, or cerebrovascular disease; (10) Patients with heart disease that may worsen after pregnancy; (11) Patients with a suspected history of cervical, endometrial or breast cancer.Women 21 years of age and older should have normal results from a Pap smear or TCT test; (12) Patients with a current history of alcoholism.Binge drinking was defined as > 14 times a week or binge drinking; (13) Patients also participated in other clinical studies.These studies require medication, sex restriction, or other barriers to compliance. (14) Patients who are expected to discontinue treatment for more than 1 month during the study period should not be included; (15) Patients taking other medications known to affect reproductive function or metabolism.These drugs include oral contraceptives, GnRH agonists and antagonists, antiandrogens, gonadotropins, anti-obesity drugs, anti-diabetic drugs such as metformin and thiazolidindiones, growth hormone release inhibiting hormones, diazazines, ACE inhibitors, and calcium channel blockers.The removal time of the above drugs should be 2 months.

研究实施时间：

Study execute time：

从From 2021-06-05

至To      2022-12-31

征募观察对象时间：

Recruiting time：

从From 2021-06-10

至To      2022-07-01

干预措施：

Interventions：

组别：

对照组

样本量：

45

Group：

control group

Sample size：

干预措施：

来曲唑

干预措施代码：

Intervention：

letrozole

Intervention code：

组别：

试验组

样本量：

45

Group：

Experimental group

Sample size：

干预措施：

针刺

干预措施代码：

Intervention：

acupuncture

Intervention code：

样本总量 Total sample size ： 90

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)：

东莞

Country：

China

Province：

Guangdong

City：

Dongguan

单位(医院)：

东莞市中医院

单位级别：

三级甲等

Institution/hospital：

Dongguan Hospital of Traditional Chinese Medicine,

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 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：

临床妊娠率

指标类型：

次要指标

Outcome：

Clinical pregnancy rate

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：

正在进行

Recruiting

年龄范围：

最小 20 岁
Min age years
最大 40 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

女性

Female

随机方法（请说明由何人用什么方法产生随机序列）：

由研究者通过计算机，按1:1的比例生成随机数字表。

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

Randomization is based on computer generated random digits table by the researcher.

盲法：

Not stated

Blinding：

Not stated

是否共享原始数据：

IPD sharing：

是

Yes

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）：

试验完成后6个月内公开，东莞市中医院

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

within six months after the trial complete Dongguan Hospital of Traditional Chinese Medicine,

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：

数据记录采用纸质和电子版病例记录表

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

Data is collected by clinical recording fomula (both paper and electronic version)

数据管理委员会：

Data Managemen Committee：

有

Yes

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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