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一项随机对照试验的研究方案:评估针刺对卵巢储备功能下降患者月经调节和提高受孕几率的影响,并使用静息态功能磁共振成像评估脑功能网络

Study Protocol for a Randomized Controlled Trial: Evaluating the Impact of Acupuncture on Menstrual Regulation and Pregnancy Enhancement in Patients with DOR Using Rs-fMRI to Assess Brain Functional Networks.

作者信息

Bai Tianyu, Zhou E, Wang Kai, Li Weizheng, Bi Jieyu, Ju Jiacheng

机构信息

Department of Acupuncture and Moxibustion, Shandong Provincial Third Hospital Shandong University, Jinan, Shandong, 250031, People's Republic of China.

出版信息

J Multidiscip Healthc. 2024 Nov 20;17:5425-5434. doi: 10.2147/JMDH.S490162. eCollection 2024.

Abstract

BACKGROUND

Resting-state functional magnetic resonance imaging (rs-fMRI) is a noninvasive way to evaluate brain physiological activity by detecting blood oxygen level fluctuations. Diminished ovarian reserve (DOR) indicates ovarian aging. Before 40, patients may have menstrual abnormalities, poor reproduction, and poor assisted reproductive results. Without treatment, it can cause early ovarian failure. Studies have shown that acupuncture can ameliorate sex hormones and antral follicle count (AFC) in DOR patients.

OBJECTIVE

Despite limited studies on its mechanism, acupuncture have been shown to treat DOR. There is no relevant research on brain functional magnetic resonance and brain functional connectivity of acupuncture in treating DOR. We design this clinical trial to preliminarily elucidate the neuroimaging method of controlling the brain functional network and acupuncture impact in DOR patients using rs-fMRI.

METHODS

This study will involve 30 DOR patients and 30 healthy individuals. DOR patients will have rs-fMRI before and after 3 menstrual cycles of acupuncture, whereas healthy individuals will need one rs-fMRI scan. The primary end measures will be follicle-stimulating hormone (FSH) and AFC. In contrast, the secondary outcomes will be luteinizing hormone(LH), estradiol (E2), anti-Müllerian hormone (AMH), modified Kupperman scale, self-rating anxiety scale (SAS), self-rating depression scale (SDS), and rs-fMRI alterations.

RESULTS

This study uses rs-fMRI technology to identify the brain regions that differ between DOR patients and healthy people before and after acupuncture treatment. This study will connect brain regions, examine the effects of acupuncture on menstruation and pregnancy on DOR patients' brain function networks, and discuss neuroimaging methods.

CONCLUSION

Acupuncture may have the potential to regulate menstruation and increase the chances of pregnancy promotion in patients with DOR.

摘要

背景

静息态功能磁共振成像(rs-fMRI)是一种通过检测血氧水平波动来评估脑生理活动的非侵入性方法。卵巢储备功能减退(DOR)表明卵巢衰老。40岁之前,患者可能出现月经异常、生殖功能差及辅助生殖效果不佳。未经治疗,可导致早期卵巢功能衰竭。研究表明,针刺可改善DOR患者的性激素水平及窦卵泡计数(AFC)。

目的

尽管针刺治疗DOR的机制研究有限,但已证实针刺可治疗DOR。目前尚无针刺治疗DOR的脑功能磁共振及脑功能连接的相关研究。我们设计本临床试验,以初步阐明利用rs-fMRI控制脑功能网络及针刺对DOR患者影响的神经影像学方法。

方法

本研究将纳入30例DOR患者和30名健康个体。DOR患者在接受3个月经周期针刺治疗前后进行rs-fMRI检查,而健康个体只需进行一次rs-fMRI扫描。主要结局指标为促卵泡生成素(FSH)和AFC。相比之下,次要结局指标将为促黄体生成素(LH)、雌二醇(E2)、抗苗勒管激素(AMH)、改良Kupperman量表、自评焦虑量表(SAS)、自评抑郁量表(SDS)及rs-fMRI改变。

结果

本研究采用rs-fMRI技术识别DOR患者与健康人在针刺治疗前后存在差异的脑区。本研究将连接脑区,研究针刺对月经及妊娠的影响对DOR患者脑功能网络的作用,并探讨神经影像学方法。

结论

针刺可能具有调节月经及增加DOR患者妊娠几率的潜力。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7435/11586002/121c6d28b6c1/JMDH-17-5425-g0001.jpg

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