A Phase III randomized controlled trial of oral dydrogesterone versus intravaginal progesterone gel for luteal phase support in in vitro fertilization (Lotus II): results from the Chinese mainland subpopulation. (1st February 2020)

• Record Type: Journal Article
• Authors: Yang, Dong-Zi; Griesinger, Georg; Wang, Wei; Gong, Fei; Liang, Xiaoyan; Zhang, Hanwang; Sun, Yingpu; Kahler, Elke; Pexman-Fieth, Claire; Olofsson, Jan I.; Tournaye, Herman; Chen, Zi-Jiang
• Is Part Of: Gynecological endocrinology. Volume 36:Number 2(2020)
• Page Start: 175
• Page End: 183
• Publication Date: 2020-02-01
• Subjects: Chinese mainland -- dydrogesterone -- luteal phase support -- micronized vaginal progesterone gel -- IVF -- randomized clinical trial; Endocrine gynecology -- Periodicals; Generative organs, Female -- Diseases -- Periodicals; 618.1
• DOI: 10.1080/09513590.2019.1645110
• Languages: English
• ISSNs: 0951-3590

Abstract

Abstract: Lotus II, a randomized, open-label, multicenter, international study compared the efficacy and safety of oral dydrogesterone versus micronized vaginal progesterone (MVP) gel for luteal support in IVF. A prespecified subgroup analysis was performed on 239 Chinese mainland subjects from the overall study population ( n = 1034), who were randomized to oral dydrogesterone 30 mg or 8% MVP gel 90 mg daily from the day of oocyte retrieval until 12 weeks of gestation. The aim was to demonstrate non-inferiority of oral dydrogesterone to MVP gel, assessed by the presence of a fetal heartbeat at 12 weeks of gestation. In the Chinese mainland subpopulation, there was a numerical difference of 9.4% in favor of oral dydrogesterone, with ongoing pregnancy rates at 12 weeks of gestation of 61.4% and 51.9% in the oral dydrogesterone and MVP gel groups, respectively (adjusted difference, 9.4%; 95% CI: −3.4 to 22.1); in the overall population, these were 38.7% and 35%, respectively (adjusted difference, 3.7%; 95% CI: −2.3 to 9.7). In both the Chinese mainland subpopulation and the overall population, dydrogesterone had similar efficacy and safety to MVP gel. With convenient oral administration, dydrogesterone has potential to transform luteal support treatment.