title: Acupuncture and clomiphene citrate for live birth in polycystic ovary syndrome: study design of a randomized controlled trial.
abstract: 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.
authors.affiliation: Department of Obstetrics and Gynecology, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin 150040, China.
authors.forename: Hongying
authors.initials: H
authors.lastname: Kuang
authors.forename: Yan
authors.initials: Y
authors.lastname: Li
authors.forename: Xiaoke
authors.initials: X
authors.lastname: Wu
authors.forename: Lihui
authors.initials: L
authors.lastname: Hou
authors.forename: Taixiang
authors.initials: T
authors.lastname: Wu
authors.forename: Jianping
authors.initials: J
authors.lastname: Liu
authors.forename: Ernest Hung Yu
authors.initials: EH
authors.lastname: Ng
authors.forename: Elisabet
authors.initials: E
authors.lastname: Stener-Victorin
authors.forename: Richard S
authors.initials: RS
authors.lastname: Legro
authors.forename: Heping
authors.initials: H
authors.lastname: Zhang
references.citation: J Tradit Chin Med. 1993 Jun;13(2):115-9
references.pmid: 8412285
references.citation: Acta Obstet Gynecol Scand. 2000 Mar;79(3):180-8
references.pmid: 10716298
references.citation: J Steroid Biochem Mol Biol. 2005 Dec;97(5):421-5
references.pmid: 16293412
references.citation: Acupunct Med. 2008 Jun;26(2):111-20
references.pmid: 18591910
references.citation: BMJ. 2006 Jun 24;332(7556):1485
references.pmid: 16769748
references.citation: Psychosomatics. 1971 Nov-Dec;12(6):371-9
references.pmid: 5172928
references.citation: Fertil Steril. 2012 Aug;98(2):302-7
references.pmid: 22698637
references.citation: Fertil Steril. 2011 Sep;96(3):792-6
references.pmid: 21762890
references.citation: Fertil Steril. 2010 May 1;93(7):2169-74
references.pmid: 20338559
references.citation: Complement Ther Med. 2003 Dec;11(4):235-42
references.pmid: 15022656
references.citation: J Ethnopharmacol. 2012 Apr 10;140(3):634-42
references.pmid: 22322251
references.citation: Am J Physiol Endocrinol Metab. 2011 Jan;300(1):E37-45
references.pmid: 20943753
references.citation: Contemp Clin Trials. 2012 May;33(3):470-81
references.pmid: 22265923
references.citation: Fertil Steril. 1989 Oct;52(4):564-8
references.pmid: 2806595
references.citation: Lancet. 2007 Aug 25;370(9588):685-97
references.pmid: 17720020
references.citation: Am J Physiol Endocrinol Metab. 2008 Mar;294(3):E576-81
references.pmid: 18198350
references.citation: J Clin Endocrinol Metab. 2011 Oct;96(10):3143-50
references.pmid: 21816787
references.citation: JAMA. 1998 Nov 4;280(17):1518-24
references.pmid: 9809733
references.citation: Zhen Ci Yan Jiu. 2010 Aug;35(4):298-302
references.pmid: 21090334
references.citation: J Clin Endocrinol Metab. 1998 Jul;83(7):2361-5
references.pmid: 9661609
references.citation: Arch Gen Psychiatry. 1965 Jan;12:63-70
references.pmid: 14221692
references.citation: Clin Obstet Gynecol. 2000 Dec;43(4):902-15
references.pmid: 11100305
references.citation: Pain. 2007 Apr;128(3):264-271
references.pmid: 17257756
references.citation: Maturitas. 2009 Dec;65 Suppl 1:S43-6
references.pmid: 20007011
references.citation: Hum Reprod Update. 2010 May-Jun;16(3):231-45
references.pmid: 19934213
references.citation: Aust N Z J Obstet Gynaecol. 2007 Apr;47(2):145-9
references.pmid: 17355306
references.citation: Am J Physiol Regul Integr Comp Physiol. 2009 Aug;297(2):R387-95
references.pmid: 19494176
references.citation: J Appl Physiol (1985). 2006 Jul;101(1):84-91
references.pmid: 16514000
references.citation: Acupunct Med. 2009 Mar;27(1):26-30
references.pmid: 19369191
references.citation: Hum Reprod Update. 2003 Nov-Dec;9(6):505-14
references.pmid: 14714587
references.citation: Acupunct Electrother Res. 1991;16(1-2):1-5
references.pmid: 1674830
references.citation: Health Qual Life Outcomes. 2005 Apr 16;3:26
references.pmid: 15833138
references.citation: PLoS Med. 2010 Jun 08;7(6):e1000261
references.pmid: 20543992
references.citation: Med Care. 1993 Mar;31(3):247-63
references.pmid: 8450681
references.citation: Clin J Pain. 2008 Mar-Apr;24(3):211-8
references.pmid: 18287826
references.citation: Auton Neurosci. 2003 Oct 31;108(1-2):50-6
references.pmid: 14614964
references.citation: J Clin Endocrinol Metab. 1998 Jun;83(6):1976-87
references.pmid: 9626128
references.citation: Neuroimage. 2005 May 1;25(4):1161-7
references.pmid: 15850733
references.citation: J Exp Clin Assist Reprod. 2005 Apr 4;2(1):5
references.pmid: 15807886
references.citation: Cochrane Database Syst Rev. 2007 Jul 18;(3):CD001122
references.pmid: 17636653
references.citation: Hum Reprod. 2005 Aug;20(8):2043-51
references.pmid: 15878925
references.citation: Endocrine. 2006 Aug;30(1):45-53
references.pmid: 17185791
references.citation: N Engl J Med. 2007 Feb 8;356(6):551-66
references.pmid: 17287476
references.citation: Reprod Biol Endocrinol. 2005 Jun 07;3:21
references.pmid: 15941472
references.citation: J R Soc Med. 1995 Apr;88(4):199-202
references.pmid: 7745565
references.citation: Maturitas. 2009 Dec;65 Suppl 1:S47-50
references.pmid: 20005647
references.citation: Cochrane Database Syst Rev. 2010 Jan 20;(1):CD003053
references.pmid: 20091537