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已发表论文
针刺治疗卵巢储备功能减退伴失眠的整合管理：一项前瞻性随机对照试验的研究方案
Authors Lai Y , Chen D, Tian C, Huang Y , Gan D, Liu L, Yang J
Received 13 July 2025
Accepted for publication 3 November 2025
Published 11 November 2025 Volume 2025:17 Pages 4369—4378
DOI https://doi.org/10.2147/IJWH.S553524
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Vinay Kumar
Yuanyuan Lai,1,* Dan Chen,1,* Chunhui Tian,1 Yufei Huang,1 Di Gan,1,2 Liying Liu,1 Jie Yang1,3
1Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu, People’s Republic of China; 2Department of Traditional Chinese Medicine, Sichuan Jinxin Xinnan Women and Children’s Hospital, Chengdu, People’s Republic of China; 3Department of Traditional Chinese Medicine, West China Second University Hospital/West China Women’s and Children’s Hospital, Chengdu, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Jie Yang, Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, No. 37 Shi’er Qiao Road, Chengdu, Sichuan, 610075, People’s Republic of China, Tel +86 13882296714, Email jenny_yang_jie@126.com Liying Liu, Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, No. 37 Shi’er Qiao Road, Chengdu, Sichuan, 610075, People’s Republic of China, Tel +86 18628115041, Email 767000032@qq.com
Background: Insomnia, a prevalent but often overlooked comorbidity in women with diminished ovarian reserve (DOR), remains underaddressed in reproductive care. This study explores the novel integration of acupuncture as a dual-benefit intervention, aiming to simultaneously address insomnia and potentially improve fertility in DOR patients.
Methods: This single-blind randomized controlled trial (RCT) will recruit 128 DOR patients with insomnia. They will be randomly allocated to receive either verum acupuncture or sham acupuncture. The acupuncture course lasts for 12 weeks, with three sessions per week, each lasting 30 minutes, and is carried out continuously during menstruation. The primary outcome is the change in sleep quality, assessed by the Pittsburgh Sleep Quality Index (PSQI) scores. Secondary outcomes include the assessment of sleep dysfunction, anxiety and depression status, and ovarian function in DOR patients. Sleep dysfunction will be profiled using the Insomnia Severity Index (ISI) to quantify insomnia severity, whereas daytime somnolence will be assessed using the Epworth Sleepiness Scale (ESS), and daytime fatigue will be evaluated with Flinders Fatigue Scale (FFS). Circadian rhythm will be characterized using both Morningness-Eveningness Questionnaire (MEQ) and Munich Chronotype Questionnaire (MCTQ). Anxiety fluctuations will be tracked with the State-Trait Anxiety Inventory (STAI), and depressive symptomatology will be indexed using the Beck Depression Inventory (BDI). In parallel, ovarian reserve parameters will also be assessed. Safety outcomes will be systematically recorded and reported following the STRICTA-recommended framework.
Expected Results and Conclusion: This study develops an acupuncture protocol for DOR patients with insomnia, and aims to generate robust clinical evidence to support the integration of acupuncture into reproductive medicine practice.
Trial Registration Number: ITMCTR2025001081.
Keywords: acupuncture, diminished ovarian reserve, insomnia, Pittsburgh Sleep Quality Index
1Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu, People’s Republic of China; 2Department of Traditional Chinese Medicine, Sichuan Jinxin Xinnan Women and Children’s Hospital, Chengdu, People’s Republic of China; 3Department of Traditional Chinese Medicine, West China Second University Hospital/West China Women’s and Children’s Hospital, Chengdu, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Jie Yang, Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, No. 37 Shi’er Qiao Road, Chengdu, Sichuan, 610075, People’s Republic of China, Tel +86 13882296714, Email jenny_yang_jie@126.com Liying Liu, Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, No. 37 Shi’er Qiao Road, Chengdu, Sichuan, 610075, People’s Republic of China, Tel +86 18628115041, Email 767000032@qq.com
Background: Insomnia, a prevalent but often overlooked comorbidity in women with diminished ovarian reserve (DOR), remains underaddressed in reproductive care. This study explores the novel integration of acupuncture as a dual-benefit intervention, aiming to simultaneously address insomnia and potentially improve fertility in DOR patients.
Methods: This single-blind randomized controlled trial (RCT) will recruit 128 DOR patients with insomnia. They will be randomly allocated to receive either verum acupuncture or sham acupuncture. The acupuncture course lasts for 12 weeks, with three sessions per week, each lasting 30 minutes, and is carried out continuously during menstruation. The primary outcome is the change in sleep quality, assessed by the Pittsburgh Sleep Quality Index (PSQI) scores. Secondary outcomes include the assessment of sleep dysfunction, anxiety and depression status, and ovarian function in DOR patients. Sleep dysfunction will be profiled using the Insomnia Severity Index (ISI) to quantify insomnia severity, whereas daytime somnolence will be assessed using the Epworth Sleepiness Scale (ESS), and daytime fatigue will be evaluated with Flinders Fatigue Scale (FFS). Circadian rhythm will be characterized using both Morningness-Eveningness Questionnaire (MEQ) and Munich Chronotype Questionnaire (MCTQ). Anxiety fluctuations will be tracked with the State-Trait Anxiety Inventory (STAI), and depressive symptomatology will be indexed using the Beck Depression Inventory (BDI). In parallel, ovarian reserve parameters will also be assessed. Safety outcomes will be systematically recorded and reported following the STRICTA-recommended framework.
Expected Results and Conclusion: This study develops an acupuncture protocol for DOR patients with insomnia, and aims to generate robust clinical evidence to support the integration of acupuncture into reproductive medicine practice.
Trial Registration Number: ITMCTR2025001081.
Keywords: acupuncture, diminished ovarian reserve, insomnia, Pittsburgh Sleep Quality Index