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

scholarly journals A Randomized Sham-controlled Trial of Manual Acupuncture for Infertile Women with Polycystic Ovary Syndrome

2021 ◽  
Author(s):  
Wen Pan ◽  
Feng-xing Li ◽  
Qiao Wang ◽  
Xiu-qi Yin ◽  
Zou-qin Huang ◽  
...  
Keyword(s):  
Herbal Medicine ◽  
Polycystic Ovary Syndrome ◽  
Pregnancy Rate ◽  
Polycystic Ovary ◽  
Controlled Trial ◽  
Ovulation Rate ◽  
Manual Acupuncture ◽  
Ovary Syndrome ◽  
Menstrual Cycles ◽  
Infertile Women

Abstract Background: To evaluate the effectiveness of acupuncture combined with herbal medicine among the infertile female with polycystic ovary syndrome (PCOS). Method: A randomized, sham-controlled trial was conducted. A total of 86 women who were diagnosed as PCOS infertility for more than 1 year were randomly assigned to receive manual acupuncture (MA) or sham acupuncture (SA) twice per week for three menstrual cycles. Both groups received herbal medicine treatment. The evaluations were conducted at baseline, each menstruation, after three menstrual cycles and 24 weeks follow-up, including pregnancy rate, ovulation rate, sex hormones level, PCOS symptoms and Traditional Chinese Medicine (TCM) syndrome scores. Results: Among 86 randomized patients, 79 (91.86%) completed the trial. The pregnancy rate in the MA group was significantly higher than the SA group (46.34% vs 18.42%; P =0.008). The ovulation rate of the MA group was higher than the SA group (58.14% vs 45.74%; P =0.046). The improvement rate of PCOS score and testosterone level showed a statistical difference between the two groups( P <0.05), others were no significant difference between the two groups. PCOS score and TCM symptom score of the two groups were both decreased after treatment ( P <0.001). Sex hormones level including E2, T, P, LH and LH/FSH were significantly lower after intervention in the MA group ( P values were <0.05) compared with baseline, while only the progesterone level was reduced in the SA group ( P =0.008). Conclusion: Manual acupuncture combined with herbal medicine may be clinically useful for infertile women with PCOS in improving pregnancy and ovulation rate.

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 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 Manual acupuncture for the infertile female with polycystic ovary syndrome (PCOS): study protocol for a randomized sham-controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Qiao Wang ◽  
Haiping Deng ◽  
Ke Cheng ◽  
Zouqin Huang ◽  
Xiuqi Yin ◽  
...  
Keyword(s):  
Polycystic Ovary Syndrome ◽  
Acupuncture Treatment ◽  
Polycystic Ovary ◽  
Controlled Trial ◽  
Resistance Index ◽  
Sham Acupuncture ◽  
Manual Acupuncture ◽  
Clinical Trial Registry ◽  
Ovary Syndrome ◽  
Menstrual Cycles

Abstract Background Polycystic ovary syndrome (PCOS) is one of the most common endocrine diseases for women. Acupuncture is widely used for the infertile female because of it is non-invasive and has fewer side effects, but the powerful evidence for the clinic is still insufficient. Our study intends to explore the effect of manual acupuncture (MA) in the infertile female with PCOS. Methods This study is a randomized, sham-controlled, patient-and assessor-blinded trial and aims to evaluate the effect of MA in women with PCOS and infertility. We will recruit 86 women aged 20–40 years with a diagnosis of infertility with PCOS. Participants will be randomly allocated in a 1:1 ratio to the MA group and the sham acupuncture (SA) group. Both groups will receive real herbal medicine treatment as a basic treatment twice a day for three menstrual cycles, the MA group receive real acupuncture treatment and the SA group received placebo acupuncture treatment (non-penetrating). All patients will receive acupuncture treatment twice per week for three menstrual cycles. The primary outcome is pregnancy rate and secondary outcomes include ovulation rate, sex hormones, insulin resistance index (IRI), PCOS symptoms, and Traditional Chinese Medicine (TCM) syndrome scores. Outcome measures will be collected at baseline, each menstrual cycle, the end of treatments, and six months after the last acupuncture treatment. The present protocol followed the SPIRIT guidelines and fulfilled the SPIRIT checklist. Discussion This study will be conducted to compare the efficacy of MA versus SA. This trial will help to evaluate whether MA is effective in increasing pregnancy and ovulation rates of the infertile female with polycystic ovary syndrome. Trial registration Chinese Clinical Trial Registry, ChiCTR1800014997. Registered on 27 February 2018.

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.

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