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滋肾育胎丸对卵巢储备功能减退患者体外受精-胚胎移植结局的影响：一项前瞻性、开放性、随机、对照研究
Effects of Zishen Yutai Pills on
in vitro Fertilization-Embryo Transfer Outcomes in Patients with Diminished Ovarian Reserve: A Prospective, Open-Labeled, Randomized and Controlled Study- 中国结合医学杂志（英文版） 2023年29卷第4期 页码：291-298
- Affiliations：
1.The First Clinical College, Shandong University of Traditional Chinese Medicine, Jinan (250014), China
2.Center for Reproductive Medicine, Shandong University, Jinan (250021), China
3.Medical College of Optometry and Ophthalmology, Shandong University of Traditional Chinese Medicine, Jinan(250014), China
4.Department of Traditional Chinese Medicine, Jinan Golden Time Health Nursing Hospital, Jinan (250000), China
5.Reproductive and Genetic Center of Integrated Traditional and Western Medicine, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan (250011), China
- Author bio：
Prof. LIAN Fang, E-mail: fang_lian123@163.com
- Funds：LUO Yuankai Research Fund for Young Scholars(20190810);the National Natural Science Foundation of China(82174429)
DOI：10.1007/s11655-023-3546-y
中图分类号：纸质出版日期：2023-04，
网络出版日期：2023-02-21，
录用日期：2022-12-06
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滋肾育胎丸对卵巢储备功能减退患者体外受精-胚胎移植结局的影响：一项前瞻性、开放性、随机、对照研究[J]. 中国结合医学杂志（英文版）, 2023,29(4):291-298.
LI Xiu-fang, WANG Zhong-qing, XU Hai-yan, et al. Effects of Zishen Yutai Pills on
in vitro Fertilization-Embryo Transfer Outcomes in Patients with Diminished Ovarian Reserve: A Prospective, Open-Labeled, Randomized and Controlled Study[J]. Chinese Journal of Integrative Medicine, 2023,29(4):291-298.滋肾育胎丸对卵巢储备功能减退患者体外受精-胚胎移植结局的影响：一项前瞻性、开放性、随机、对照研究[J]. 中国结合医学杂志（英文版）, 2023,29(4):291-298. DOI： 10.1007/s11655-023-3546-y.
LI Xiu-fang, WANG Zhong-qing, XU Hai-yan, et al. Effects of Zishen Yutai Pills on
in vitro Fertilization-Embryo Transfer Outcomes in Patients with Diminished Ovarian Reserve: A Prospective, Open-Labeled, Randomized and Controlled Study[J]. Chinese Journal of Integrative Medicine, 2023,29(4):291-298. DOI： 10.1007/s11655-023-3546-y.
摘要
目的:
2
探讨滋肾育胎丸对体外受精-胚胎移植(IVF-ET)周期中卵巢储备功能减退(DOR)患者卵母细胞和胚胎质量及妊娠结局的影响
同时观察滋肾育胎丸对骨形态发生蛋白15(BMP15) 和生长分化因子9(GDF9)表达水平的影响.
方法:
2
将120例DOR患者随机分为治疗组和对照组
以1: 1比例进入其中一组. 两组患者均采用GnRH拮抗剂方案
治疗组(60例)在前一个月经周期黄体中期开始服用滋肾育胎丸
对照组(60例)未服药. 主要观察指标为获卵数和优质胚胎数. 次要观察指标包括其他胚胎指标及妊娠结局指标. 通过异位妊娠、妊娠并发症、流产率及早产评估不良事件发生情况. 采用ELISA法测定卵泡液中BMP15和GDF9表达量.
结果:
2
与对照组比较
治疗组患者获卵数和优质胚胎数明显增加(均
P
<
0.05)
滋肾阴胎丸治疗后可上调血清E2及P水平(
P
值分别为0.014和0.008) . 两组胚胎种植率、生化妊娠率、临床妊娠率、活产率和流产率未见明显差异 (均
P
>
0.05) . 滋肾阴胎丸的使用未增加不良事件的发生率. 治疗组卵泡液中BMP15和GDF9表达水平均明显上调 (均
P
<
0.05) .
结论:
2
在IVF治疗周期中应用滋肾育胎丸可以提高DOR患者获卵数和优质胚胎数
上调卵泡液中BMP15和GDF9表达. 然而
滋肾育胎丸对妊娠结局的影响则需要更大样本量的临床试验中进一步研究. 本试验在中国临床试验注册中心注册 (ChiCTR2100048441).
Abstract
Objective:
2
To explore the effects of Zishen Yutai Pills (ZYPs) on the quality of oocytes and embryos
as well as pregnancy outcomes in patients with diminished ovarian reserve (DOR) receiving
in vitro
fertilization-embryo transfer (IVF-ET). The possible mechanisms
involving the regulation of bone morphogenetic protein 15(BMP15) and growth differentiation factor 9 (GDF9)
were also investigated.
Methods:
2
A total of 120 patients with DOR who underwent their IVF-ET cycle were randomly allocated to 2 groups in a 1: 1 ratio. The patients in the treatment group (60 cases) received ZYPs from the mid-luteal phase of the former menstrual cycle by using gonadotropin-releasing hormone (GnRH) antagonist protocol. The patients in the control group (60 cases) received the same protocol but without ZYPs. The primary outcomes were the number of oocytes retrieved and high-quality embryos. Secondary outcomes included other oocyte or embryo indices as well as pregnancy outcomes. Adverse events were assessed by comparison of the incidence of ectopic pregnancy
pregnancy complications
pregnancy loss
and preterm birth. Contents of BMP15 and GDF9 in the follicle fluids (FF) were also quantified with enzyme-linked immunosorbent assay.
Results:
2
Compared with the control group
the numbers of oocytes retrieved and high-quality embryos were significantly increased in the ZYPs group (both
P
<
0.05). After treatment with ZYPs
a significant regulation of serum sex hormones was observed
including progesterone and estradiol. Both hormones were up-regulated compared with the control group (
P
=0.014 and 0.008)
respectively. No significant differences were observed with regard to pregnancy outcomes including implantation rates
biochemical pregnancy rates
clinical pregnancy rates
live birth rates
and pregnancy loss rates (all
P
>
0.05). The administration of ZYPs did not increase the incidence of adverse events. The expressions of BMP15 and GDF9 in the ZYPs group were significantly up-regulated compared with the control group (both
P
<
0.05).
Conclusions:
2
ZYPs exhibited beneficial effects in DOR patients undergoing IVF-ET
resulting in increments of oocytes and embryos
and up-regulation of BMP15 and GDF9 expressions in the FF. However
the effects of ZYPs on pregnancy outcomes should be assessed in clinical trials with larger sample sizes (Trial reqistration No. ChiCTR2100048441).
关键词
Keywords
Zishen Yutai Pillsdiminished ovarian reservein vitro fertilization-embryo transferoocytesembryos
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