Acupuncture and clomiphene citrate for live birth in polycystic ovary syndrome: study design of a randomized controlled trial.

Acupuncture and clomiphene citrate for live birth in polycystic ovary syndrome: study design of a randomized controlled trial.
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DOI:
10.1155/2013/527303
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发表时间:
2013
期刊:
Evidence-based complementary and alternative medicine : eCAM
影响因子:
--
通讯作者:
Zhang H
Zhang H
中科院分区:
其他
文献类型:
--
作者:
Kuang H;Li Y;Wu X;Hou L;Wu T;Liu J;Ng EH;Stener-Victorin E;Legro RS;Zhang H

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针灸是多囊卵巢综合征(PCOS)妇女诱导排卵的一种替代疗法,但尚未有研究报道针刺诱导排卵后的活产率或其作为克罗米芬(CC)辅助治疗的可能性。我们评估了针刺加或不加CC对大陆1,000名多囊卵巢综合征妇女中国活产的疗效。本文报道了一项正在进行的多中心随机对照试验的方法学。随机化方案通过中央机制进行协调,并按参与站点分层。参与者将被随机分为四个治疗组之一:(A)真针灸和CC,(B)对照针灸和CC,(C)真针灸和安慰剂CC,和(D)对照针灸和安慰剂CC。为了确保试验的质量和完整性,我们建立了一个由调查人员和数据和安全监督委员会组成的独特的多国团队。截至2013年4月底,共招募了326名受试者。总之,这项试验的成功将使我们能够以公正的方式评估针灸治疗多囊卵巢综合征妇女生育的一线药物以外的额外益处。
Acupuncture is an alternative therapy to induce ovulation in women with polycystic ovary syndrome (PCOS), but there is no study reporting the live birth rate following ovulation induction by acupuncture or its potential as an adjuvant treatment to clomiphene citrate (CC). We assess the efficacy of acupuncture with or without CC in achieving live births among 1000 PCOS women in Mainland China. This paper reports the methodology of an ongoing multicenter randomized controlled trial. The randomization scheme is coordinated through the central mechanism and stratified by the participating sites. Participants will be randomized into one of the four treatment arms: (A) true acupuncture and CC, (B) control acupuncture and CC, (C) true acupuncture and placebo CC, and (D) control acupuncture and placebo CC. To ensure the quality and integrity of the trial we have developed a unique multinational team of investigators and Data and Safety Monitoring Board. Up to the end of April 2013, 326 subjects were recruited. In conclusion, the success of this trial will allow us to evaluate the additional benefit of acupuncture beyond the first line medicine for fertility treatment in PCOS women in an unbiased manner.
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