神阙穴（RN8）艾灸对不明原因卵巢低反应患者妊娠结局的疗效和安全性：一项随机对照试验。

Efficacy and safety of Shen Que (RN8) moxibustion on reproductive outcomes in unexpected poor ovarian responders: a randomized controlled trial.

机构信息

The First Clinical College, Shandong University of Traditional Chinese Medicine, Jinan, China.

Reproductive Center of Integrated Medicine, The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, China.

出版信息

J Ovarian Res. 2024 Aug 29;17(1):177. doi: 10.1186/s13048-024-01493-2.

DOI:10.1186/s13048-024-01493-2

PMID:39210342

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11363657/

Abstract

BACKGROUND

Managing infertility patients with poor ovarian response (POR) to ovarian stimulation remains unmet clinically. Besides economic burdens, patients with POR have a poor prognosis during in vitro fertilization and embryo transfer (IVF-ET). In this study, we assessed the efficacy and safety of Shen Que (RN8) moxibustion on reproductive outcomes in POSEIDON patients (Group 2a).

METHODS

Women eligible for IVF were invited to participate in this randomized, open-label, superiority trial at an academic fertility center from January 2022 to December 2023. One hundred patients ≤ 44 years old equally divided between Shen Que moxibustion (SQM) and control groups were randomized. These patients must meet the POSEIDON criteria, Group 2a, which requires antral follicle count (AFC) ≥ 5 or anti-müllerian hormone (AMH) ≥ 1.2ng/ml, and a previous unexpected POR (< 4 oocytes). Twelve moxibustion sessions were conducted in the SQM group prior to oocyte retrieval, while only IVF treatment was performed in the control group. The primary outcome was the number of oocytes retrieved.

RESULTS

As compared with the IVF treatment alone, the SQM + IVF treatment significantly increased the number of retrieved oocytes (4.7 vs. 5.8, p = 0.012), mature oocytes (3.0 vs. 5.0, p = 0.008), and available embryos (2.0 vs. 4.0, p = 0.014) in unexpected poor ovarian responders aged more than 35 years. In the SQM group, the cumulative live birth rate was 27.3% (9/33) in comparison to 13.3% (4/30) in the control group, whereas no statistical significance was detected (p = 0.172). During the study, no significant adverse effects were observed.

CONCLUSIONS

Women with unexpected POR who meet POSEIDON Group 2a can benefit from Shen Que (RN8) moxibustion treatment.

TRIAL REGISTRATION

ClinicalTrials.gov, NCT05653557.

摘要

背景

管理卵巢刺激反应不良（POR）的不孕患者在临床上仍未得到满足。除了经济负担外，POR 患者在体外受精和胚胎移植（IVF-ET）期间预后不良。在这项研究中，我们评估了神阙（RN8）艾灸对 POSEIDON 患者（2a 组）生殖结局的疗效和安全性。

方法

邀请符合 IVF 条件的女性参加 2022 年 1 月至 2023 年 12 月在学术生育中心进行的这项随机、开放标签、优效性试验。将 100 名年龄在 44 岁以下的患者平均分为神阙艾灸（SQM）组和对照组。这些患者必须符合 POSEIDON 标准 2a 组，即要求窦卵泡计数（AFC）≥5 或抗苗勒管激素（AMH）≥1.2ng/ml，且以前发生过意外 POR（<4 个卵母细胞）。在取卵前，SQM 组进行 12 次艾灸，而对照组仅进行 IVF 治疗。主要结局是取回的卵母细胞数量。

结果

与单独 IVF 治疗相比，SQM+IVF 治疗显著增加了年龄大于 35 岁的意外 POR 患者取回的卵母细胞数量（4.7 对 5.8，p=0.012）、成熟卵母细胞数量（3.0 对 5.0，p=0.008）和可用胚胎数量（2.0 对 4.0，p=0.014）。在 SQM 组，累积活产率为 27.3%（9/33），而对照组为 13.3%（4/30），但无统计学意义（p=0.172）。在研究期间，未观察到明显的不良反应。