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.
Tianyu Bai, E Zhou, Kai Wang, Weizheng Li, Jieyu Bi, Jiacheng Ju
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引用次数: 0
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.
背景：静息态功能磁共振成像（rs-fMRI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大脑生理活动的无创方法。卵巢储备功能减退（DOR）表明卵巢衰老。在 40 岁之前，患者可能会出现月经异常、生殖能力差、辅助生殖效果不佳等症状。如果不进行治疗，可能会导致卵巢早衰。研究表明，针灸可以改善 DOR 患者的性激素和前卵泡数（AFC）：尽管对其机制的研究有限，但针灸已被证明可治疗 DOR。针灸治疗DOR的脑功能磁共振和脑功能连接方面的研究尚属空白。我们设计了这项临床试验，利用rs-fMRI初步阐明控制DOR患者脑功能网络和针灸影响的神经影像学方法：本研究将涉及 30 名 DOR 患者和 30 名健康人。DOR患者将在针灸前后3个月经周期进行rs-fMRI扫描，而健康人则需要进行一次rs-fMRI扫描。主要终点指标为卵泡刺激素（FSH）和AFC。而次要结果则是黄体生成素（LH）、雌二醇（E2）、抗穆勒氏管激素（AMH）、改良库珀曼量表、焦虑自评量表（SAS）、抑郁自评量表（SDS）和 rs-fMRI 改变：本研究利用 rs-fMRI 技术确定针灸治疗前后 DOR 患者与健康人之间存在差异的脑区。本研究将连接大脑区域，考察针灸对月经和妊娠对DOR患者大脑功能网络的影响，并讨论神经影像学方法：结论：针灸可能具有调节月经和增加 DOR 患者促孕机会的潜力。
期刊介绍：
The Journal of Multidisciplinary Healthcare (JMDH) aims to represent and publish research in healthcare areas delivered by practitioners of different disciplines. This includes studies and reviews conducted by multidisciplinary teams as well as research which evaluates or reports the results or conduct of such teams or healthcare processes in general. The journal covers a very wide range of areas and we welcome submissions from practitioners at all levels and from all over the world. Good healthcare is not bounded by person, place or time and the journal aims to reflect this. The JMDH is published as an open-access journal to allow this wide range of practical, patient relevant research to be immediately available to practitioners who can access and use it immediately upon publication.
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