Department of Gynecological Endocrinology and Reproductive Medicine, University Hospital of Schleswig-Holstein, Luebeck, Germany.
Center for Reproductive Medicine, Universitair Ziekenhuis Brussel, Brussels, Belgium.
Fertil Steril. 2018 May;109(5):756-762. doi: 10.1016/j.fertnstert.2018.03.034.
Oral dydrogesterone has been used for luteal phase support on an empirical basis since the early days of in vitro fertilization (IVF) treatment. Systematic comparisons of oral dydrogesterone with vaginal progesterone, so far considered to be the standard of care, started to appear in the middle 2000s. Recently, a large, randomized, double-blind, double-dummy phase III trial on the use of daily 30 mg oral dydrogesterone versus daily 600 mg micronized vaginal progesterone for LPS in IVF was published. This company-sponsored trial confirmed the efficacy findings from previous independent researchers and firmly established the noninferiority of daily 30 mg oral dydrogesterone for luteal phase support. Despite oral administration and first pass through the liver, dydrogesterone was as well tolerated as vaginal progesterone in safety analyses. Moreover, no new fetal safety concerns have arisen from that trial. Given the widespread preference of women for an oral compound, dydrogesterone may well become the new standard for luteal phase support in fresh embryo transfer IVF cycles.
自体外受精(IVF)治疗早期以来,口服地屈孕酮一直被用于黄体期支持,这是基于经验。2000 年代中期开始出现将口服地屈孕酮与阴道用黄体酮进行系统比较的研究,后者被认为是标准的治疗方法。最近,一项关于每日 30mg 口服地屈孕酮与每日 600mg 微粒化阴道用黄体酮用于 IVF 中 LPS 的大型、随机、双盲、双模拟 III 期试验发表。这项由公司赞助的试验证实了先前独立研究人员的疗效发现,并确定了每日 30mg 口服地屈孕酮用于黄体期支持的非劣效性。尽管口服并在肝脏中首次通过,但在安全性分析中,地屈孕酮与阴道用黄体酮一样耐受良好。此外,该试验未出现新的胎儿安全性问题。鉴于女性对口服药物的广泛偏好,地屈孕酮很可能成为新鲜胚胎移植 IVF 周期中黄体期支持的新标准。