A multicenter randomized trial of personalized acupuncture, fixed acupuncture, letrozole, and placebo letrozole on live birth in infertile women with polycystic ovary syndrome.

Abstract

BACKGROUND:

Traditional Chinese medicine (TCM) usually involves syndrome differentiation and treatment. Acupuncture, one form of TCM, requires the selection of appropriate acupoints and needling techniques, but many clinical trials on acupuncture have used fixed acupuncture protocols without accounting for individual patient differences. We have designed a multicenter randomized controlled trial (RCT) to evaluate whether personalized or fixed acupuncture increases the likelihood of live births in infertile women with polycystic ovary syndrome (PCOS) compared with letrozole or placebo letrozole. We hypothesize that letrozole is more effective than personalized acupuncture, which in turn is more effective than fixed acupuncture, and that placebo letrozole is the least effective intervention. Moreover, we hypothesize that personalized acupuncture is more likely to reduce the miscarriage rate and the risk of pregnancy complications compared with letrozole.

METHODS/DESIGN:

The study is designed as an assessor-blinded RCT. A total of 1100 infertile women with PCOS will be recruited from 28 hospitals and randomly allocated to 4 groups: personalized acupuncture, fixed acupuncture, letrozole, or placebo letrozole. They will receive treatment for 16 weeks, and the primary outcome is live birth. Secondary outcomes include ovulation rate, conception rate, pregnancy rate, pregnancy loss rate, changes in hormonal and metabolic parameters, and changes in quality of life scores. Adverse events will be recorded throughout the trial. All statistical analyses will be performed using IBM SPSS Statistics version 21.0 software (IBM Corp., Armonk, NY, USA), and a P value < 0.05 will be considered statistically significant.

DISCUSSION:

This study will be the first multicenter RCT to compare the effect of personalized or fixed acupuncture with letrozole or placebo letrozole on live birth in infertile women with PCOS. The findings will inform whether personalized acupuncture therapy can be considered an alternative treatment to improve the live birth rate in infertile women with PCOS.

TRIAL REGISTRATION:

ClinicalTrials.gov, NCT03625531. Registered on July 13, 2018. Chinese Clinical Trial Registry, ChiCTR1800017304. Registered on July 23, 2018.

• Authors: Shiya Huang, Min Hu, Ernest Hung Yu Ng, Elisabet Stener-Victorin, Yanhua Zheng, Qidan Wen, Cong Wang, Maohua Lai, Juan Li, Xingcheng Gao, Xinhua Wang, Zhenxing Hu, Tian Xia, Rongkui Hu, Jianping Liu, Xiaohui Wen, Shuna Li, Kewei Quan, Xingyan Liang, Hongcai Shang, Hongxia Ma, Jie Qiao
• Journal: Trials (Trials) Vol. 21 Issue 1 Pg. 239 (Mar 04 2020) ISSN: 1745-6215 [Electronic] England
• PMID: 32131886 (Publication Type: Clinical Trial Protocol, Journal Article)

Chemical References

• Aromatase Inhibitors
• Letrozole

Topics

• Abortion, Spontaneous (prevention & control)
• Acupuncture Therapy (methods)
• Aromatase Inhibitors (therapeutic use)
• Female
• Humans
• Infertility, Female (etiology, therapy)
• Letrozole (therapeutic use)
• Live Birth
• Multicenter Studies as Topic
• Ovulation
• Ovulation Induction
• Polycystic Ovary Syndrome (complications, therapy)
• Pregnancy
• Pregnancy Rate
• Quality of Life
• Randomized Controlled Trials as Topic