scholarly journals Accuracy and efficacy of diagnosis using clinical characteristics integrated with metabolomics in patients with polycystic ovary syndrome: study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
Cheng-Ming Ni ◽  
Wen-Long Huang ◽  
Yan-min Jiang ◽  
Juan Xu ◽  
Ru Duan ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Polycystic Ovary Syndrome ◽  
Clinical Characteristics ◽  
Polycystic Ovary ◽  
Controlled Trial ◽  
Control Group ◽  
Ovary Syndrome ◽  
Randomized Controlled ◽  
Group 2 ◽  
Group 1

Abstract Background Polycystic ovary syndrome (PCOS) is defined as a complex endocrine syndrome, and the mechanisms underlying its various clinical signs and symptoms are still poorly understood. It is critical to precisely diagnose the phenotypes of PCOS in order to provide patients with individualized therapy[1, 2] . However, the criteria by which to diagnose different phenotypes, which are mostly based on symptoms, physical examination, and laboratory evaluation, remain unclear. The aim of this study is to compare the accuracy and precision of metabolomic markers with common clinical characteristics to determine a more effective way to diagnose and treat two subgroups, one based on clinical indexes and another based on metabolomic indexes[3], of PCOS patients. The effects of different the interventions based on the two subgroups will also be observed. Methods This is a prospective, multicenter, analyst-blinded, randomized controlled trial. There will be one healthy control group and two parallel experimental arms in this study: (1) people without PCOS (health control group); (2) PCOS patients diagnosed based on clinical indexes (group 1); (3) PCOS patients diagnosed based on metabolomic indexes (group 2). A total of 276 eligible people will be recruited, including 60 healthy people and 216 PCOS patients, who will be randomly assigned to different diagnosis groups in a 1:1 ratio. Patients in the two different diagnosis groups will be divided into two different subgroups based on their clinical characteristics (group 1 based on clinical indexes, group 2 based on metabolomic indexes); thereafter, they will receive a 6-month different treatment. The primary outcome for experimental groups will be the treatment effect of PCOS. Discussion The purpose of this trial is to determine whether integrated metabolomic indexes are more accurate and effective than clinical characteristics in the diagnosis of the phenotypes of reproductive females with PCOS. This trial will therefore contribute to the provision of a solid foundation for the precise clinical diagnosis of two PCOS subgroups, as well as for future research on individualized PCOS therapy.

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 Efficacy of Bushen Huatan Decoction combined with Baduanjin in the treatment of polycystic ovary syndrome with insulin resistance (IR-PCOS), kidney deficiency and phlegm dampness: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Haiqing Qian ◽  
Wenting Xu ◽  
Lijuan Cui ◽  
Rong Wang ◽  
Jiahui Wang ◽  
...  
Keyword(s):  
Insulin Resistance ◽  
Randomized Controlled Trial ◽  
Menstrual Cycle ◽  
Polycystic Ovary Syndrome ◽  
Polycystic Ovary ◽  
Controlled Trial ◽  
Close Monitoring ◽  
Ovary Syndrome ◽  
Kidney Deficiency ◽  
Randomized Controlled

Abstract Background Polycystic ovary syndrome (PCOS) is a common reproductive endocrine disease in women. Insulin resistance (IR) has emerged as a central contributor to the pathogenesis of this disease. According to traditional Chinese medicine (TCM), kidney deficiency is the main syndrome of PCOS. The deficiency of the kidney cannot vaporize water-dampness, and the retention of water-dampness accumulates into phlegm dampness stagnation, resulting in visceral dysfunction and metabolic disorder. TCM involving syndrome differentiation and treatment is widely used to adjust women’s menstrual cycles. Our patented formula Bushen Huatan Decoction (BSHTD) has been proven to be effective in the clinical treatment of IR-PCOS. Baduanjin also plays an important role in improving metabolic syndrome through lifestyle intervention. This study investigates the clinical efficacy of Bushen Huatan Decoction combined with Baduanjin in IR-PCOS, to form a specific TCM-behaviour intervention plan in the treatment of IR-PCOS. Methods/design This is a randomized controlled trial involving 190 participants diagnosed with IR-PCOS. All participants will be randomly allocated into 5 groups: group A will receive metformin; group B, BSHTD; group C, Baduanjin; group D, BSHTD combined with metformin; and group E, BSHTD combined with Baduanjin. One course of treatment lasts 3 months, a total of two courses. The primary outcomes are changes in the homeostatic model assessment of insulin resistance (HOMA-IR) and improvements in the oral glucose tolerance test (OGTT) and insulin-releasing test (INS). The secondary outcomes are improvements in the menstrual cycle, ovulation rate, clinical pregnancy rate, basic serum sex hormone levels, free androgen index (FAI), Ferriman-Gallwey scores, body mass index (BMI) and TCM syndrome scores. The related observation indexes will be collected at baseline, during the process of treatment and at the 6-month follow-up. Simultaneously, close monitoring of possible adverse events will be performed throughout the trial process. Discussion This trial will investigate the efficacy of the comprehensive intervention program of Bushen Huatan Decoction combined with Baduanjin on the adjustment of the menstrual cycle, improvement of insulin resistance and correction of glucose metabolism disorder in IR-PCOS patients. It is expected to form an alternative treatment of TCM-behaviour intervention therapy for IR-PCOS and promote the Chinese fitness Qigong Baduanjin in the application of lifestyle diseases. Trial registration Chinese Clinical Trial Registry ChiCTR2100043415. Registered on 15 February 2021.

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
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