孕前脱氢表雄酮治疗对卵巢反应不良女性体外受精结局的影响：一项随机对照试验的研究方案
Effect of preconceptional DHEA treatment on in vitro fertilization outcome in poor ovarian respond women: study protocol for a randomized controlled trial.
作者信息
Wang Wei, Liu Hong, Li Jing, Wei Daimin, Zhang Jiangtao, Wang Jianfeng, Ma Jinlong, Shi Yuhua, Chen Zi-Jiang
机构信息
Center for Reproductive Medicine, Key Laboratory of Reproductive Endocrinology, Ministry of Education, and National Research Center for Assisted Reproductive Technology and Reproductive Genetics, Shandong Provincial Clinical medicine Research Center for reproductive health, Shandong Provincial Hospital Affiliated with Shandong University, Shandong University, No. 157 Jing Liu Street, Shizhong district, Jinan, 250012, China.
Center for Reproductive Medicine, The Second Clinical Medical College, Yangtze University, No. 2 People Street, Jingzhou district, Jingzhou, 434020, China.
出版信息
Trials. 2019 Jan 15;20(1):50. doi: 10.1186/s13063-018-3146-x.
BACKGROUND
Women undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) with poor ovarian respond (POR) always have very low clinical pregnancy rates. In previous data, dehydroepiandrosterone (DHEA) was suggested as a promising treatment and maybe has a good pregnancy outcome. But there is no sufficient evidence from randomized clinical trials evaluating the effect of DHEA preconceptional treatment on live birth in POR.
METHODS
This trial is a multicenter active-placebo double-blind clinical trial (1:1 treatment ratio of active versus placebo). The infertile POR patients undergoing IVF or ICSI will be enrolled and randomly assigned to two parallel groups. Participants in these two groups will be given 4-12 weeks' treatment of DHEA or placebo, respectively. The primary outcome is live birth rate.
DISCUSSION
The results of this study will provide evidence for the effect of preconceptional DHEA treatment on IVF outcome in POR.
TRIAL REGISTRATION
Chinese Clinical Trial Registry, ChiCTR-IPR-15006909 . Registered on November 9, 2015.
背景
接受体外受精（IVF）或卵胞浆内单精子注射（ICSI）且卵巢反应不良（POR）的女性临床妊娠率一直很低。既往数据表明，脱氢表雄酮（DHEA）是一种有前景的治疗方法，可能会有良好的妊娠结局。但尚无足够的随机临床试验证据评估DHEA孕前治疗对POR患者活产率的影响。
方法
本试验是一项多中心活性安慰剂双盲临床试验（活性药物与安慰剂的治疗比例为1:1）。将招募接受IVF或ICSI的POR不孕患者，并随机分为两个平行组。这两组参与者将分别接受4 - 12周的DHEA或安慰剂治疗。主要结局是活产率。
讨论
本研究结果将为孕前DHEA治疗对POR患者IVF结局的影响提供证据。
试验注册
中国临床试验注册中心，ChiCTR - IPR - 15006909。于2015年11月9日注册。
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