Ma Saihua, Ma Ruihong, Xia Tian, Afnan Masoud, Song Xueru, Xu Fengqin, Hao Guimin, Zhu Fangfang, Han Jingpei, Zhao Zhimei
Reproductive Center, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, No. 88 Chang Ling Street, Xi Qing district, Tianjin, 300112, China.
Center of Reproductive Medicine, Tianjin United Family Hospital and Clinics, No. 22 Tanjiang Street, Hexi district, Tianjin, 300221, China.
Trials. 2018 Feb 20;19(1):124. doi: 10.1186/s13063-018-2511-0.
Women undergoing in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) who have a predicted poor ovarian response (POR) present a challenge for reproductive medicine specialists. Traditional Chinese medicine (TCM) is commonly used in China for such patients, in the belief that it will improve the ovarian response and ultimately increase pregnancy rates. However, there is a lack of high-quality evidence about the effect of TCM on improving ovarian response in such patients. The purpose of this study is to evaluate ongoing viable pregnancy rate at 12 weeks' gestation and related indicators of ovarian response in fertile women who have a predicted poor ovarian response having immediate versus delayed IVF/ICSI after 3 months of Ding-Kun-Dan (DKD) pre-treatment.
METHODS/DESIGN: This study is a multicenter, randomized controlled, parallel-group, phase III, superiority clinical trial. Two hundred and seventy-eight eligible female infertility patients with POR will be included in the study and randomly allocated into an immediate treatment group and a DKD group in a 1:1 ratio. Both groups will receive IVF or ICSI as a standard treatment while in the DKD group, a commercially available Chinese medicine, DKD, will be administrated for 3 months before the IVF/ICSI cycle starts. The primary outcome of the study is the ongoing pregnancy rate at 12 weeks' gestation. The secondary outcomes include total gonadotropin dosage, duration of stimulation, estradiol (E) and progesterone (P) levels on human chorionic gonadotropin (hCG) trigger day, cycle cancellation rate, number of oocytes retrieved, high-quality embryo rate, biochemical pregnancy rate, the change of serum anti-Müllerian hormone (AMH), follicle-stimulating hormone (FSH), and E levels and all side effects, safety outcomes, and any adverse events. The protocol was approved by the Ethics Committee of the First Teaching Hospital of Tianjin university of TCM (approval no. TYLL2017[K] 004).
IVF/ICSI is increasingly used to treat couples desiring a baby. Many of these women will have poor ovarian function. In China, DKD is commonly used for these patients prior to undergoing IVF/ICSI. There is no effective treatment for poor ovarian response in Western medicine currently. It is important, therefore, to undertake this randomized control trial to determine whether DKD is effective or not.
Chinese Clinical Trial Registry, ID: ChiCTR-IOR-17011697 . Registered on 19 June 2017.
接受体外受精（IVF）/卵胞浆内单精子注射（ICSI）且预测卵巢反应不良（POR）的女性给生殖医学专家带来了挑战。在中国，中药常用于此类患者，人们认为它能改善卵巢反应并最终提高妊娠率。然而，关于中药对改善此类患者卵巢反应的效果，缺乏高质量证据。本研究的目的是评估在接受3个月定坤丹（DKD）预处理后立即进行与延迟进行IVF/ICSI的预测卵巢反应不良的育龄妇女在妊娠12周时的持续活产率及卵巢反应的相关指标。
方法/设计：本研究是一项多中心、随机对照、平行组、III期优效性临床试验。278例符合条件的POR女性不育患者将被纳入研究，并按1:1的比例随机分配到立即治疗组和DKD组。两组均接受IVF或ICSI作为标准治疗，而DKD组在IVF/ICSI周期开始前3个月给予市售中药DKD。研究的主要结局是妊娠12周时的持续妊娠率。次要结局包括总促性腺激素剂量、刺激时间、人绒毛膜促性腺激素（hCG）触发日的雌二醇（E）和孕酮（P）水平、周期取消率、取卵数、优质胚胎率、生化妊娠率、血清抗苗勒管激素（AMH）、卵泡刺激素（FSH）和E水平的变化以及所有副作用、安全性结局和任何不良事件。该方案已获得天津中医药大学第一附属医院伦理委员会批准（批准号：TYLL2017[K]004）。
IVF/ICSI越来越多地用于治疗想要孩子的夫妇。这些女性中许多人的卵巢功能较差。在中国，DKD常用于这些患者进行IVF/ICSI之前。目前西医对卵巢反应不良没有有效的治疗方法。因此，进行这项随机对照试验以确定DKD是否有效很重要。
中国临床试验注册中心，注册号：ChiCTR-IOR-17011697。于2017年6月19日注册。
