scholarly journals A multicenter randomized trial of personalized acupuncture, fixed acupuncture, letrozole and placebo on live birth for infertility in women with polycystic ovary syndrome

2019 ◽  
Author(s):  
Shiya Huang ◽  
Min Hu ◽  
Ernest Hung Yu Ng ◽  
Elisabet Stener-Victorin ◽  
Yanhua Zheng ◽  
...  
Keyword(s):  
Polycystic Ovary Syndrome ◽  
Live Birth ◽  
Polycystic Ovary ◽  
Controlled Trial ◽  
P Value ◽  
Miscarriage Rate ◽  
Ovary Syndrome ◽  
Ongoing Pregnancy Rate ◽  
Infertile Women ◽  
Multicenter Randomized Controlled Trial

Abstract BACKGROUND Traditional Chinese Medicine (TCM) usually involves syndrome and disease differentiation, and for acupuncture selection of appropriate points and skillful needling techniques. Many clinical trials on acupuncture used fixed acupuncture protocols without accounting for individual differences. We here design a multicenter randomized controlled trial (RCT) to evaluate whether personalized or fixed acupuncture increases the likelihood of live births for infertility in women with polycystic ovary syndrome (PCOS) compared with placebo letrozole. We hypothesis that letrozole is more effective than personalized acupuncture, and personalized acupuncture is more effective than fixed acupuncture, which is more effective than placebo letrozole. Moreover, personalized acupuncture is more likely to reduce miscarriage rate and the risk of pregnancy complications than letrozole.METHODS / DESIGN The study is a randomized assessor-blind controlled trial. A total of 1,100 infertile women with PCOS will be recruited from 28 hospitals and randomly allocated into four groups: A) letrozole, B) personalized acupuncture, C) fixed acupuncture, or D) placebo letrozole. They will receive treatment for 16 weeks and the primary outcome is live birth. Secondary outcomes include ovulation rate, ongoing pregnancy rate, miscarriage rate, hormonal and metabolic profile, and quality-of-life scores. The side effect profile will be recorded throughout the trial. 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.DISCUSSION This study is the first multicentre RCT to compare personalized or fixed acupuncture, letrozole or placebo letrozole on live birth for infertility in women with PCOS. This findings will inform whether personalized acupuncture therapy could be as an alternative treatment method on live birth for infertile women with PCOS.

scholarly journals A multicenter randomized trial of personalized acupuncture, fixed acupuncture, letrozole and placebo on live birth for infertility in women with polycystic ovary syndrome

2020 ◽  
Author(s):  
Shiya Huang ◽  
Min Hu ◽  
Ernest Hung Yu Ng ◽  
Elisabet Stener-Victorin ◽  
Yanhua Zheng ◽  
...  
Keyword(s):  
Polycystic Ovary Syndrome ◽  
Live Birth ◽  
Polycystic Ovary ◽  
Controlled Trial ◽  
Treatment Method ◽  
P Value ◽  
Miscarriage Rate ◽  
Ovary Syndrome ◽  
Infertile Women ◽  
Multicenter Randomized Controlled Trial

Abstract BACKGROUND traditional Chinese Medicine (TCM) usually involves syndrome and disease differentiation, and for acupuncture selection of appropriate points and skillful needling techniques. Many clinical trials on acupuncture used fixed acupuncture protocols without accounting for individual differences. We here design a multicenter randomized controlled trial (RCT) to evaluate whether personalized or fixed acupuncture increases the likelihood of live births for infertility in women with polycystic ovary syndrome (PCOS) compared with letrozole or placebo letrozole. We hypothesis that letrozole is more effective than personalized acupuncture, and personalized acupuncture is more effective than fixed acupuncture, which is more effective than placebo letrozole. Moreover, personalized acupuncture is more likely to reduce miscarriage rate and the risk of pregnancy complications than letrozole.METHODS / DESIGN The study is a randomized assessor-blind controlled trial. A total of 1,100 infertile women with PCOS will be recruited from 28 hospitals and randomly allocated into four groups: A) personalized acupuncture, B) fixed acupuncture, C) letrozole, or D) 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. The adverse events (AEs) will be recorded throughout the trial. 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.DISCUSSION This study is the first multicentre RCT to compare personalized or fixed acupuncture, letrozole or placebo letrozole on live birth for infertility in women with PCOS. The findings will inform whether personalized acupuncture therapy could be as an alternative treatment method on live birth for infertile women with PCOS.

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

2020 ◽  
Author(s):  
Shiya Huang ◽  
Min Hu ◽  
Ernest Hung Yu Ng ◽  
Elisabet Stener-Victorin ◽  
Yanhua Zheng ◽  
...  
Keyword(s):  
Polycystic Ovary Syndrome ◽  
Live Birth ◽  
Polycystic Ovary ◽  
Controlled Trial ◽  
Syndrome Differentiation ◽  
P Value ◽  
Ovary Syndrome ◽  
Infertile Women ◽  
Multicenter Rct ◽  
Multicenter Randomized Controlled Trial

Abstract BACKGROUND Traditional Chinese medicine (TCM) usually involves syndrome differentiation and treatment. Acupuncture, one form of TCM, requires the selection of appropriate acupoints points and needling techniques, but many clinical trials on acupuncture have used fixed acupuncture protocols without accounting for individual differences among patients. 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 to letrozole. METHODS / DESIGN The study is designed as a randomized assessor-blinded controlled trial. A total of 1,100 infertile women with PCOS will be recruited from 28 hospitals and randomly allocated into four groups: A) personalized acupuncture, B) fixed acupuncture, C) letrozole, or D) 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. The adverse events will be recorded throughout the trial. 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. DISCUSSION This study will be the first multicenter RCT to compare 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.

scholarly journals Acupuncture and Clomiphene Citrate for Live Birth in Polycystic Ovary Syndrome: Study Design of a Randomized Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-11 ◽  
Author(s):  
Hongying Kuang ◽  
Yan Li ◽  
Xiaoke Wu ◽  
Lihui Hou ◽  
Taixiang Wu ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Polycystic Ovary Syndrome ◽  
Live Birth ◽  
Polycystic Ovary ◽  
Controlled Trial ◽  
Clomiphene Citrate ◽  
Fertility Treatment ◽  
Ovary Syndrome ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial

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.

scholarly journals Randomized Controlled Trial of Preconception Interventions in Infertile Women With Polycystic Ovary Syndrome

2015 ◽  
Vol 100 (11) ◽  
pp. 4048-4058 ◽  
Author(s):  
Richard S. Legro ◽  
William C. Dodson ◽  
Penny M. Kris-Etherton ◽  
Allen R. Kunselman ◽  
Christy M. Stetter ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Polycystic Ovary Syndrome ◽  
Polycystic Ovary ◽  
Controlled Trial ◽  
Ovary Syndrome ◽  
Infertile Women ◽  
Randomized Controlled

scholarly journals Ovulation Rate after Metformin and Clomiphene vs Clomiphene Alone in Polycystic Ovary Syndrome (PCOS): A Randomized, Double-Blind, Placebo-Controlled Trial

2020 ◽  
Vol 02 (01) ◽  
pp. 32-36 ◽  
Author(s):  
Georgia Heathcote ◽  
Clare Boothroyd ◽  
Kevin Forbes ◽  
Alan Lee ◽  
Margaret Gregor ◽  
...  
Keyword(s):  
Live Birth ◽  
Birth Rate ◽  
Polycystic Ovary ◽  
Controlled Trial ◽  
Live Birth Rate ◽  
Ovulation Rate ◽  
Miscarriage Rate ◽  
Ovary Syndrome ◽  
Double Blind ◽  
Double Blind Placebo

Background: Polycystic ovary syndrome (PCOS) affects 5%-15% of women of reproductive age and has a negative impact on their fertility. The primary outcome of this study is ovulation rate when standard (immediate release) metformin (MF) is added to clomiphene citrate (CC) in oligoovulatory and anovulatory women with PCOS. Methods: This is a randomized, double-blind, placebo-controlled trial. Twenty-seven women with PCOS (according to the Rotterdam consensus), desiring pregnancy and without another cause of subfertility were recruited from a public hospital outpatient gynecology clinic. Up to six cycles of CC (25-150 mg) plus either MF 500 mg tds (CC+MF) or placebo (CC+Pl) were offered. Student’s t-test, Chi-squared test, and Fisher’s exact test were used for analysis. Results: Thirteen women with up to six cycles each were included in the final analysis. The rate of ovulation and ovulation rate per cycle was similar between women in the CC+MF and CC+Pl groups RR 1.09 (95% CI 0.80-1.49) and RR 0.88 (95% CI 0.63-1.22), respectively as was chemical pregnancy rate RR 1.77 (95% CI 0.58-5.38). The live birth rate was higher in CC+MF RR 6.83 (95% CI 0.83-56.27) and miscarriage rate was lower RR 0.21 (95% CI 0.002-1.07). The number needed to treat for live birth was 10. Conclusion: Use of standard MF, 500 mg tds, when given with CC results in an increase in live birth rate, and a decrease in miscarriage rate.

scholarly journals A randomized sham-controlled trial of manual acupuncture for infertile women with polycystic ovary syndrome

2021 ◽  
pp. 100830
Author(s):  
Wen Pan ◽  
Feng-xing Li ◽  
Qiao Wang ◽  
Zou-qin Huang ◽  
Yu-ming Yan ◽  
...  
Keyword(s):  
Polycystic Ovary Syndrome ◽  
Polycystic Ovary ◽  
Controlled Trial ◽  
Manual Acupuncture ◽  
Ovary Syndrome ◽  
Infertile Women

Randomized controlled trial of different doses of metformin for ovulation induction in infertile women with polycystic ovary syndrome

2011 ◽  
Vol 37 (9) ◽  
pp. 1229-1237 ◽  
Author(s):  
Sawaek Weerakiet ◽  
Areepan Sophonsritsuk ◽  
Srithean Lertvikool ◽  
Chonthicha Satirapot ◽  
Supatra Leelaphiwat ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Polycystic Ovary Syndrome ◽  
Ovulation Induction ◽  
Polycystic Ovary ◽  
Controlled Trial ◽  
Ovary Syndrome ◽  
Infertile Women ◽  
Randomized Controlled ◽  
Different Doses
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