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A multicenter, double-blind, randomized, placebo-controlled trial for the effect of traditional Chinese medicine formula Dingkun pill on improving outcomes of IVF-ET in women with low prognosis
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注册号:

Registration number:

ChiCTR1900026614 

最近更新日期:

Date of Last Refreshed on:

2019-10-16 

注册时间:

Date of Registration:

2019-10-16 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

传统中药配方定坤丹对低预后女性体外受精-胚胎移植结局的影响:一项多中心、双盲、随机、安慰剂对照试验 

Public title:

A multicenter, double-blind, randomized, placebo-controlled trial for the effect of traditional Chinese medicine formula Dingkun pill on improving outcomes of IVF-ET in women with low prognosis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

传统中药配方定坤丹对低预后女性体外受精-胚胎移植结局的影响:一项多中心、双盲、随机、安慰剂对照试验 

Scientific title:

A multicenter, double-blind, randomized, placebo-controlled trial for the effect of traditional Chinese medicine formula Dingkun pill on improving outcomes of IVF-ET in women with low prognosis 

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:

宋景艳 

研究负责人:

孙振高 

Applicant:

Jingyan Song 

Study leader:

Zhengao Sun 

申请注册联系人电话:

Applicant telephone:

+86 18765800113 

研究负责人电话:

Study leader's telephone:

+86 13708938621 

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:

hanlingjuzei91@126.com 

研究负责人电子邮件:

Study leader's E-mail:

sunzhengao77@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:

山东省济南市历下区文化西路42号 

研究负责人通讯地址:

山东省济南市历下区文化西路42号 

Applicant address:

42 Wenhua Road West, Lixia District, Ji'nan, Shandong, China 

Study leader's address:

42 Wenhua Road West, Lixia District, Ji'nan, Shandong, China 

申请注册联系人邮政编码:

Applicant postcode:

250014 

研究负责人邮政编码:

Study leader's postcode:

250014 

申请人所在单位:

山东中医药大学 

Applicant's institution:

Shandong University of Traditional 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:

SDTCM20191015011 

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:

山东中医药大学附属医院生殖医学伦理委员会 

Name of the ethic committee:

Reproductive Medicine Ethics Committees of the Affiliated Hospital of Shandong University of TCM 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-10-15 

伦理委员会联系人:

孙金龙 

Contact Name of the ethic committee:

Jinlong Sun 

伦理委员会联系地址:

山东省济南市历下区文化西路42号 

Contact Address of the ethic committee:

42 Wenhua Road West, Lixia District, Jinan, Shandong, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 13256704356 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

sjl911120@163.com 

研究实施负责(组长)单位:

山东中医药大学附属医院 

Primary sponsor:

The Affiliated Hospital of Shandong University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

山东省济南市历下区文化西路42号 

Primary sponsor's address:

42 Wenhua Road West, Lixia District, Ji'nan, Shandong, 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):

山东省

市(区县):

济南市

Country:

China

Province:

Shandong

City:

Ji'nan

单位(医院):

山东中医药大学附属医院

具体地址:

历下区文化西路42号

Institution
hospital:

The Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Address:

42 Wenhua Road West, Lixia District

经费或物资来源:

国家自然科学基金 

Source(s) of funding:

National Natural Science Foundation of China 

研究疾病:

低预后 

Target disease:

Low prognosis 

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:

探索性研究/预试验 

Study phase:

研究目的:

不孕症是一个日益严重的生殖健康问题,据估计约有15%的育龄夫妇受到影响。虽然体外受精和胚胎移植(IVF-ET)作为一种治疗不孕不育夫妇的有效方法正迅速得到越来越多的应用,但卵巢储备减少或对外源性促性腺激素刺激反应较差的女性仍然对生殖专家构成挑战。最近2项临床研究结果表明定坤丹在改善卵巢储备功能低下和卵巢低反应女性临床妊娠率方面具有良好疗效,但两者之间的异质性并不能对该药的治疗效果得出明确的结论。本研究旨在通过精心设计的随机对照试验,探讨中药定坤丹对低预后女性IVF临床结局的改善作用。 

Objectives of Study:

Subfertility is a growing severe reproductive health problem and is estimated to affect approximately 15% of couples of reproductive ages. Although in-vitro fertilization and embryo transfer (IVF-ET) as an effective treatment for infertile couples is rapidly becoming more widely available, women who have diminished ovarian reserves (DOR) or with poor ovarian response (POR) to exogenous gonadotropin stimulation still pose challenges to reproductive experts. The results of two recent clinical studies in China showed that traditional Chinese medicine (TCM) formula Dingkun pill (DKP) showed a curative effect on improving the clinical pregnancy rate of DOR and POR women. However, the heterogeneity of these two studies does not provide definitive conclusions about the therapeutic effects of the formula. The purpose of this study was to investigate the effect of TCM formula DKP on improving the clinical outcome of IVF-ET in women with low prognosis through a carefully designed randomized controlled trial. 

药物成份或治疗方案详述:

定坤丹始于清代乾隆年间(1739年),为“宫帏圣药”,专供内廷使用。定坤丹(Lot No. 140170207, Shanxi Guangyuyuan Medicine Co., Ltd., China)由红参、鹿茸、西红花、鸡血藤膏、白芍、熟地黄、当归、黄芩、香附、茺蔚子、川芎、延胡索等30味名贵中药材组成。其配伍独特,炮制讲究,具有补益肝肾、益气养血、调经舒郁、活血止痛等功效。传统临床上,大多数中草药都是在沸水中熬制数小时。而本方则遵循GMP标准,采用水蜜丸的制作形式,每瓶装入7g。 

Description for medicine or protocol of treatment in detail:

DKP was started in the reign of emperor Qianlong of the Qing dynasty (1739) as a "holy medicine in the emperor's harem", used exclusively by the imperial court. DKP (Lot No. Z20059003, Shanxi Guangyuyuan Medicine Co., Ltd., China) is composed of ginseng, deer antler, safflower, caulis spatholobi, white peony root, radix rehmannia preparata, angelica, scutellaria, rhizoma cyperi, leonurus japonicus houtt, ligustrazine, rhizoma corydalis and other 30 traditional precious Chinese herb. The combination of DKP is unique and exquisite in processing, which has the effects of tonifying liver and kidney, invigorating qi and nourishing blood, regulating menstruation and relaxing depression, promoting blood circulation and relieving pain. Traditionally and clinically most Chinese herbal medicines are prepared by decoction in boiling water for hours. However, this formula adopts the form of water honey pills according to the Good Manufacturing Practices (GMP) standard, each TCM bottle will be filled with 7g DKP. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

本研究将招募年龄35-44岁、卵巢储备参数(AFC<5、AMH<1.2 ng/mL)不足、卵巢反应较差(即标准卵巢刺激后获得的卵母细胞少于4个)的受试者。 

Inclusion criteria

Participants aged 35 to 44 years with poor prestimulation ovarian reserve parameters (AFC<5, AMH<1.2 ng/mL) and with an expected poor ovarian response which means fewer than four oocytes were retrieved after standard ovarian stimulation, will be recruited in this study. 

排除标准:

BMI≥30 Kg/m2、双方染色体核型异常、子宫内膜异位症、输卵管积水、先天性或后天性子宫发育异常以及其他辅助生殖技术禁忌证。 

Exclusion criteria:

BMI >= 30 Kg/m2, karyotyping abnormalities in both partners, endometriosis, hydrosalpinx, congenital or acquired dysplasia of the uterus and other contraindications for assisted reproductive technology. 

研究实施时间:

Study execute time:

From2019-11-05To 2020-10-06 

征募观察对象时间:

Recruiting time:

From2019-11-15To 2020-06-10 

干预措施:

Interventions:

组别:

定坤丹组

样本量:

230

Group:

DKP group

Sample size:

干预措施:

定坤丹(水蜜丸)在控制性卵巢刺激前一月经周期第5天开始口服,每次7g,每日3次,直至患者取卵当日停药,共5周。

干预措施代码:

Intervention:

Dingkun pill should be administered on the 5th day of the menstrual cycle prior to controlled ovarian stimulation (COH), 7g each time, 3 times per day, until the oocyte retrieval day, a total of 5 weeks.

Intervention code:

组别:

安慰剂组

样本量:

230

Group:

Placebo group

Sample size:

干预措施:

安慰剂在控制性卵巢刺激前一月经周期第5天开始口服,每次7g,每日3次,直至患者取卵当日停药,共5周。

干预措施代码:

Intervention:

Placebo should be administered on the 5th day of the menstrual cycle prior to controlled ovarian stimulation (COH), 7g each time, 3 times per day, until the oocyte retrieval day, a total of 5 weeks.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

山东 

市(区县):

济南 

Country:

China 

Province:

Shandong 

City:

Ji'nan 

单位(医院):

山东中医药大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

The Affiliated Hospital of Shandong University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

临床妊娠率

指标类型:

主要指标 

Outcome:

Clinical pregnancy outcome

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胚胎种植率

指标类型:

次要指标 

Outcome:

Implantation 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:

早期流产率

指标类型:

次要指标 

Outcome:

Early miscarriage 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:

卵泡液

组织:

Sample Name:

Follicular fluid

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 35 years
最大 Max age 44 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):

当自愿参与研究的患者加入后,使用综合医务组管理的计算机生成随机数,他们将被随机分为两组(1:1)。

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

When patients who volunteer for the study join, they will be randomly divided into two groups (1:1 ratio) using computer-generated random numbers managed by the Integrative Medicine team.

盲法:

研究药物(中药DKP配方和安慰剂)将作为外观相似的药物制备。安慰剂也会模仿中草药的外观和气味。我们提供治疗的临床医生和患者本身将对患者的治疗分组一无所知。

Blinding:

The study medications (DKP formula and placebo) will be prepared as similar-looking medications. The placebo will also mimic the herb appearance and smell. Our clinicians who are providing therapy and the patients themselves will be blinded to the type of treatments.

试验完成后的统计结果(上传文件):

点击下载

Calculated Results ater
the Study Completed(upload file):

download

原始数据公开时间:

The time of sharing IPD:

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):

2020年12月31日 / https://orcid.org/0000-0002-2700-017X

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

December 31, 2020 / https://orcid.org/0000-0002-2700-017X

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:

所有与参加者有关的资料将会被详细记录在CRF上。所有错误将由相应的调查人员划掉并更正并签署。CRF中的研究数据将通过双输入的方式输入并编码到相应的e-CRF中。

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

All information regarding the participant will be carefully recorded on the CRF. All errors will be crossed out and corrected and signed by the corresponding investigator. The study data in the CRF will be entered and coded to a corresponding e-CRF by the double-entry method.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-10-16
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