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Comparison of acupuncture pretreatment followed by letrozole versus letrozole alone on live birth in anovulatory infertile women with polycystic ovary syndrome: a study protocol for a randomised controlled trial.
BMJ Open. 2016 10 07; 6(10):e010955.BO

Abstract

INTRODUCTION

The high prevalence of insulin resistance in women with polycystic ovary syndrome (PCOS) is considered to be one of the major pathophysiological changes in PCOS that leads to anovulatory infertility. We hypothesise that electroacupuncture pretreatment improves insulin sensitivity and leads to a higher ovulation rate and greater chances of live birth after the induction of ovulation. The effect of electroacupuncture pretreatment followed by ovulation induction in women with anovulatory PCOS has not been investigated before, and we present here a randomised controlled trial to test this hypothesis by comparing electroacupuncture pretreatment followed by letrozole versus letrozole alone in anovulatory women with PCOS.

METHODS/ANALYSIS

This is a multicentre, randomised,and controlled trial. A total of 384 patients will be enrolled in this study and will be randomly allocated by a central randomisation system to the treatment group or the control group in a 1:1 ratio. The treatment group will undergo 16 weeks of electroacupuncture pretreatment followed by 4 cycles of letrozole, and the control group will only undergo 4 cycles of letrozole. The primary outcome will be the live birth rate. All statistical analyses will be performed using the SPSS program V.21.0 (SPSS, Chicago, Illinois, USA), and a p value <0.05 will be considered statistically significant.

ETHICS/DISSEMINATION

This study has been approved by the ethics committees of each participating centre. Written consent will be obtained from each patient and her husband before any study procedure is performed. Adverse events will be categorised, and the percentage of patients experiencing adverse events or serious adverse events during the treatment period will be documented. The results of this trial will be disseminated in peer-reviewed journals and presented at international meetings.

TRIAL REGISTRATION NUMBER

NCT02491320.

Links

PMC Free PDF

Authors+Show Affiliations

Li J
Department of Traditional Chinese Medicine, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.
Ng EH
Department of Obstetrics and Gynecology, The University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, Hong Kong.
Stener-Victorin E
Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.
Hu Z
Department of Gynecology, Xuzhou Maternity and Child Health Hospital, Xuzhou, Jiangsu, China.
Wu W
Department of Traditional Chinese Medicine, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.
Lai M
Department of Traditional Chinese Medicine, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.
Wu T
Chinese Clinical Trial Registry, Beijing, China.
Ma H
Department of Traditional Chinese Medicine, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.

MeSH

Acupuncture TherapyAdultAromatase InhibitorsBirth RateClinical ProtocolsElectroacupunctureFemaleHumansInfertility, FemaleInsulin ResistanceLetrozoleLive BirthNitrilesOvulationOvulation InductionPolycystic Ovary SyndromeResearch DesignTriazolesYoung Adult

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

27855085

Clinical Trial Links

Clinical trial which this article describes

Citation

Li, Juan, et al. "Comparison of Acupuncture Pretreatment Followed By Letrozole Versus Letrozole Alone On Live Birth in Anovulatory Infertile Women With Polycystic Ovary Syndrome: a Study Protocol for a Randomised Controlled Trial." BMJ Open, vol. 6, no. 10, 2016, pp. e010955.
Li J, Ng EH, Stener-Victorin E, et al. Comparison of acupuncture pretreatment followed by letrozole versus letrozole alone on live birth in anovulatory infertile women with polycystic ovary syndrome: a study protocol for a randomised controlled trial. BMJ Open. 2016;6(10):e010955.
Li, J., Ng, E. H., Stener-Victorin, E., Hu, Z., Wu, W., Lai, M., Wu, T., & Ma, H. (2016). Comparison of acupuncture pretreatment followed by letrozole versus letrozole alone on live birth in anovulatory infertile women with polycystic ovary syndrome: a study protocol for a randomised controlled trial. BMJ Open, 6(10), e010955. https://doi.org/10.1136/bmjopen-2015-010955
Li J, et al. Comparison of Acupuncture Pretreatment Followed By Letrozole Versus Letrozole Alone On Live Birth in Anovulatory Infertile Women With Polycystic Ovary Syndrome: a Study Protocol for a Randomised Controlled Trial. BMJ Open. 2016 10 7;6(10):e010955. PubMed PMID: 27855085.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of acupuncture pretreatment followed by letrozole versus letrozole alone on live birth in anovulatory infertile women with polycystic ovary syndrome: a study protocol for a randomised controlled trial. AU - Li,Juan, AU - Ng,Ernest Hung Yu, AU - Stener-Victorin,Elisabet, AU - Hu,Zhenxing, AU - Wu,Wanting, AU - Lai,Maohua, AU - Wu,Taixiang, AU - Ma,Hongxia, Y1 - 2016/10/07/ PY - 2016/11/18/entrez PY - 2016/11/18/pubmed PY - 2017/11/3/medline KW - acupuncture pretreatment KW - letrozole KW - live birth rate KW - polycystic ovary syndrome SP - e010955 EP - e010955 JF - BMJ open JO - BMJ Open VL - 6 IS - 10 N2 - INTRODUCTION: The high prevalence of insulin resistance in women with polycystic ovary syndrome (PCOS) is considered to be one of the major pathophysiological changes in PCOS that leads to anovulatory infertility. We hypothesise that electroacupuncture pretreatment improves insulin sensitivity and leads to a higher ovulation rate and greater chances of live birth after the induction of ovulation. The effect of electroacupuncture pretreatment followed by ovulation induction in women with anovulatory PCOS has not been investigated before, and we present here a randomised controlled trial to test this hypothesis by comparing electroacupuncture pretreatment followed by letrozole versus letrozole alone in anovulatory women with PCOS. METHODS/ANALYSIS: This is a multicentre, randomised,and controlled trial. A total of 384 patients will be enrolled in this study and will be randomly allocated by a central randomisation system to the treatment group or the control group in a 1:1 ratio. The treatment group will undergo 16 weeks of electroacupuncture pretreatment followed by 4 cycles of letrozole, and the control group will only undergo 4 cycles of letrozole. The primary outcome will be the live birth rate. All statistical analyses will be performed using the SPSS program V.21.0 (SPSS, Chicago, Illinois, USA), and a p value <0.05 will be considered statistically significant. ETHICS/DISSEMINATION: This study has been approved by the ethics committees of each participating centre. Written consent will be obtained from each patient and her husband before any study procedure is performed. Adverse events will be categorised, and the percentage of patients experiencing adverse events or serious adverse events during the treatment period will be documented. The results of this trial will be disseminated in peer-reviewed journals and presented at international meetings. TRIAL REGISTRATION NUMBER: NCT02491320. SN - 2044-6055 UR - https://www.unboundmedicine.com/medline/citation/27855085/Comparison_of_acupuncture_pretreatment_followed_by_letrozole_versus_letrozole_alone_on_live_birth_in_anovulatory_infertile_women_with_polycystic_ovary_syndrome:_a_study_protocol_for_a_randomised_controlled_trial_ DB - PRIME DP - Unbound Medicine ER -