A Trial of Personalized Acupuncture, Fixed Acupuncture, Letrozole and Placebo on Live Birth in Women With PCOS

Summary

This study is a randomized assessor-blind controlled trial. A total of 1,103 women with PCOS will be recruited from 20 hospitals and randomly allocated into four groups: personalized acupuncture, fixed acupuncture, letrozole or placebo letrozole. Patients will receive treatment for 16 weeks and the primary outcome is live birth.

Timeline

Start

2018-08-13

Primary completion

2025-01-22

Completion

2025-01-22

Publications

• Background Homburg R. Management of infertility and prevention of ovarian hyperstimulation in women with polycystic ovary syndrome. Best Pract Res Clin Obstet Gynaecol. 2004 Oct;18(5):773-88. doi: 10.1016/j.bpobgyn.2004.05.006.
• Background Thessaloniki ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group. Consensus on infertility treatment related to polycystic ovary syndrome. Hum Reprod. 2008 Mar;23(3):462-77. doi: 10.1093/humrep/dem426.
• Background Legro RS, Barnhart HX, Schlaff WD, Carr BR, Diamond MP, Carson SA, Steinkampf MP, Coutifaris C, McGovern PG, Cataldo NA, Gosman GG, Nestler JE, Giudice LC, Leppert PC, Myers ER; Cooperative Multicenter Reproductive Medicine Network. Clomiphene, metformin, or both for infertility in the polycystic ovary syndrome. N Engl J Med. 2007 Feb 8;356(6):551-66. doi: 10.1056/NEJMoa063971.
• Background Holzer H, Casper R, Tulandi T. A new era in ovulation induction. Fertil Steril. 2006 Feb;85(2):277-84. doi: 10.1016/j.fertnstert.2005.05.078.
• Background Franik S, Kremer JA, Nelen WL, Farquhar C, Marjoribanks J. Aromatase inhibitors for subfertile women with polycystic ovary syndrome: summary of a Cochrane review. Fertil Steril. 2015 Feb;103(2):353-5. doi: 10.1016/j.fertnstert.2014.10.016. Epub 2014 Nov 5.
• Background Balen AH, Morley LC, Misso M, Franks S, Legro RS, Wijeyaratne CN, Stener-Victorin E, Fauser BC, Norman RJ, Teede H. The management of anovulatory infertility in women with polycystic ovary syndrome: an analysis of the evidence to support the development of global WHO guidance. Hum Reprod Update. 2016 Nov;22(6):687-708. doi: 10.1093/humupd/dmw025. Epub 2016 Aug 10.
• Background Jedel E, Labrie F, Oden A, Holm G, Nilsson L, Janson PO, Lind AK, Ohlsson C, Stener-Victorin E. Impact of electro-acupuncture and physical exercise on hyperandrogenism and oligo/amenorrhea in women with polycystic ovary syndrome: a randomized controlled trial. Am J Physiol Endocrinol Metab. 2011 Jan;300(1):E37-45. doi: 10.1152/ajpendo.00495.2010. Epub 2010 Oct 13.
• Background Johansson J, Redman L, Veldhuis PP, Sazonova A, Labrie F, Holm G, Johannsson G, Stener-Victorin E. Acupuncture for ovulation induction in polycystic ovary syndrome: a randomized controlled trial. Am J Physiol Endocrinol Metab. 2013 May 1;304(9):E934-43. doi: 10.1152/ajpendo.00039.2013. Epub 2013 Mar 12.
• Background Benrick A, Kokosar M, Hu M, Larsson M, Maliqueo M, Marcondes RR, Soligo M, Protto V, Jerlhag E, Sazonova A, Behre CJ, Hojlund K, Thoren P, Stener-Victorin E. Autonomic nervous system activation mediates the increase in whole-body glucose uptake in response to electroacupuncture. FASEB J. 2017 Aug;31(8):3288-3297. doi: 10.1096/fj.201601381R. Epub 2017 Apr 12.
• Background Wu XK, Stener-Victorin E, Kuang HY, Ma HL, Gao JS, Xie LZ, Hou LH, Hu ZX, Shao XG, Ge J, Zhang JF, Xue HY, Xu XF, Liang RN, Ma HX, Yang HW, Li WL, Huang DM, Sun Y, Hao CF, Du SM, Yang ZW, Wang X, Yan Y, Chen XH, Fu P, Ding CF, Gao YQ, Zhou ZM, Wang CC, Wu TX, Liu JP, Ng EHY, Legro RS, Zhang H; PCOSAct Study Group. Effect of Acupuncture and Clomiphene in Chinese Women With Polycystic Ovary Syndrome: A Randomized Clinical Trial. JAMA. 2017 Jun 27;317(24):2502-2514. doi: 10.1001/jama.2017.7217.
• Background Napadow V, Kaptchuk TJ. Patient characteristics for outpatient acupuncture in Beijing, China. J Altern Complement Med. 2004 Jun;10(3):565-72. doi: 10.1089/1075553041323849.
• Background Linde K, Streng A, Jurgens S, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S, Pfaffenrath V, Hammes MG, Weidenhammer W, Willich SN, Melchart D. Acupuncture for patients with migraine: a randomized controlled trial. JAMA. 2005 May 4;293(17):2118-25. doi: 10.1001/jama.293.17.2118.
• Background Cherkin DC, Sherman KJ, Avins AL, Erro JH, Ichikawa L, Barlow WE, Delaney K, Hawkes R, Hamilton L, Pressman A, Khalsa PS, Deyo RA. A randomized trial comparing acupuncture, simulated acupuncture, and usual care for chronic low back pain. Arch Intern Med. 2009 May 11;169(9):858-66. doi: 10.1001/archinternmed.2009.65.
• Background Macklin EA, Wayne PM, Kalish LA, Valaskatgis P, Thompson J, Pian-Smith MC, Zhang Q, Stevens S, Goertz C, Prineas RJ, Buczynski B, Zusman RM. Stop Hypertension with the Acupuncture Research Program (SHARP): results of a randomized, controlled clinical trial. Hypertension. 2006 Nov;48(5):838-45. doi: 10.1161/01.HYP.0000241090.28070.4c. Epub 2006 Oct 2.
• Background Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c869. doi: 10.1136/bmj.c869. No abstract available.
• Background MacPherson H, Altman DG, Hammerschlag R, Youping L, Taixiang W, White A, Moher D; STRICTA Revision Group. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): Extending the CONSORT statement. J Evid Based Med. 2010 Aug;3(3):140-55. doi: 10.1111/j.1756-5391.2010.01086.x.
• Background Zhao X, Ni R, Li L, Mo Y, Huang J, Huang M, Azziz R, Yang D. Defining hirsutism in Chinese women: a cross-sectional study. Fertil Steril. 2011 Sep;96(3):792-6. doi: 10.1016/j.fertnstert.2011.06.040. Epub 2011 Jul 18.
• Background Ni RM, Mo Y, Chen X, Zhong J, Liu W, Yang D. Low prevalence of the metabolic syndrome but high occurrence of various metabolic disorders in Chinese women with polycystic ovary syndrome. Eur J Endocrinol. 2009 Sep;161(3):411-8. doi: 10.1530/EJE-09-0298. Epub 2009 Jun 19.
• Background Balen AH, Laven JS, Tan SL, Dewailly D. Ultrasound assessment of the polycystic ovary: international consensus definitions. Hum Reprod Update. 2003 Nov-Dec;9(6):505-14. doi: 10.1093/humupd/dmg044.
• Background Jin C, Pang R, Xu L, Wu Z, Zhao J. [Clinical rules for acupoint selection and prescription composition in treatment of polycystic ovary syndrome with acupuncture]. Zhongguo Zhen Jiu. 2015 Jun;35(6):625-30. Chinese.
• Background Kuang H, Li Y, Wu X, Hou L, Wu T, Liu J, Ng EH, Stener-Victorin E, Legro RS, Zhang H. Acupuncture and clomiphene citrate for live birth in polycystic ovary syndrome: study design of a randomized controlled trial. Evid Based Complement Alternat Med. 2013;2013:527303. doi: 10.1155/2013/527303. Epub 2013 Aug 20.
• Franik S, Le QK, Kremer JA, Kiesel L, Farquhar C. Aromatase inhibitors (letrozole) for ovulation induction in infertile women with polycystic ovary syndrome. Cochrane Database Syst Rev. 2022 Sep 27;9(9):CD010287. doi: 10.1002/14651858.CD010287.pub4.
• Huang S, Hu M, Ng EHY, Stener-Victorin E, Zheng Y, Wen Q, Wang C, Lai M, Li J, Gao X, Wang X, Hu Z, Xia T, Hu R, Liu J, Wen X, Li S, Quan K, Liang X, Shang H, Ma H, Qiao J. A multicenter randomized trial of personalized acupuncture, fixed acupuncture, letrozole, and placebo letrozole on live birth in infertile women with polycystic ovary syndrome. Trials. 2020 Mar 4;21(1):239. doi: 10.1186/s13063-020-4154-1.

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Indications