First College of Clinical Medicine, Shandong University of Traditional Chinese Medicine, Jinan, China.
College of Traditional Chinese Medicine, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, Shandong, China.
Trials. 2021 Dec 13;22(1):917. doi: 10.1186/s13063-021-05867-5.
In recent years, the prevalence of infertility has significantly increased and has become a global reproductive health problem. The female ovarian reserves have been shown to decrease progressively with an increase in age. Besides, the rate of embryo implantation and clinical pregnancy also decreases. Traditional Chinese medicine has been widely applied in assisted reproductive technology. It is reported to have a significant influence on improving the quality of oocytes, improving endometrial receptivity, increasing clinical pregnancy rate, reducing pregnancy-related complications, etc. Therefore, this study will investigate the effect of Guilu Xian, a traditional Chinese medicine formula on IVF-ET outcome in older women with low prognosis.
This trial is a prospective, multicenter, randomized double-blind clinical trial. A total of 120 infertile patients with low prognosis and receiving IVF or ICSI in 3 public hospitals in China will be randomly divided into two parallel groups: Guilu Xian group (n = 60) and placebo group (n = 60). Patients in both groups will be treated with antagonist regimens to promote ovulation, and all the patients will be required to take the medication from the 2nd to 4th day of the menstrual cycle to the day of egg retrieval. A comparison of the total number of oocytes obtained, the fertilization rate, clinical pregnancy rate, embryo quality, embryo implantation rate, and early spontaneous abortion rate between the experimental group and the placebo group will be performed.
Chinese Clinical Trials Registry ChiCTR1900028255 . Registered on 16 December 2019.
近年来，不孕症的患病率显著增加，已成为全球性的生殖健康问题。女性卵巢储备功能随年龄增长呈渐进性下降，胚胎着床率和临床妊娠率也随之下降。中医药在辅助生殖技术中得到了广泛应用，据报道，它对改善卵母细胞质量、提高子宫内膜容受性、增加临床妊娠率、降低妊娠相关并发症等方面有显著影响。因此，本研究将探讨龟鹿仙方对低预后高龄女性接受体外受精-胚胎移植（IVF-ET）结局的影响。
这是一项前瞻性、多中心、随机、双盲的临床试验。共纳入中国 3 家公立医院 120 例低预后接受 IVF 或 ICSI 的不孕患者，将其随机分为龟鹿仙方组（n = 60）和安慰剂组（n = 60）。两组患者均采用拮抗剂方案促排卵，所有患者均于月经周期第 2-4 天开始服药至取卵日。比较两组患者获得的总卵数、受精率、临床妊娠率、胚胎质量、胚胎着床率和早期自然流产率。
中国临床试验注册中心，ChiCTR1900028255，于 2019 年 12 月 16 日注册。
