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RCT of Oral Dydrogesterone Versus Intravaginal Progesterone Gel in IVF

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

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Pages 175-183 | Received 12 Jun 2019, Accepted 02 Jul 2019, Published online: 09 Aug 2019

References

  • Zhou Z, Zheng D, Wu H, et al. Epidemiology of infertility in China: a population-based study. BJOG: Int J Obstet Gy. 2018;125:432–441.
  • Qiao J, Feng HL. Assisted reproductive technology in China: compliance and non-compliance. Transl Pediatr. 2014;3:91–97.
  • Wei D, Wang J, Qin Y, et al. Development of in-vitro fertilization in China. In: Kovacs G, Brinsden P, DeCherney A, editors. In-vitro fertilization: The pioneers' history. Cambridge: Cambridge University Press; 2018. p. 152–157.
  • Zhou Z, Chen L, Wu H, et al. Assisted reproductive technology in Beijing, 2013–2015. Reprod Biomed Online. 2018;37:521–532.
  • Farquhar C, Marjoribanks J, Brown J, et al. Management of ovarian stimulation for IVF: narrative review of evidence provided for World Health Organization guidance. Reprod Biomed Online. 2017;35:3–16.
  • Macklon NS, Fauser BC. Impact of ovarian hyperstimulation on the luteal phase. J Reprod Fertil Suppl. 2000;55:101–108.
  • Practice Committee of the American Society for Reproductive Medicine. Progesterone supplementation during the luteal phase and in early pregnancy in the treatment of infertility: an educational bulletin. Fertil Steril. 2008;89:789–792.
  • van der Linden M, Buckingham K, Farquhar C, et al. Luteal phase support for assisted reproduction cycles. Cochrane Database Syst Rev. 2015;7:CD009154.
  • Jasem Y, Khan M, Taha A, et al. Preparation of steroidal hormones with an emphasis on transformations of phytosterols and cholesterol – a review. Mediterr J Chem. 2014;3:796–830.
  • Tavaniotou A, Smitz J, Bourgain C, et al. Comparison between different routes of progesterone administration as luteal phase support in infertility treatments. Hum Reprod Update. 2000;6:139–148.
  • Vaisbuch E, Leong M, Shoham Z. Progesterone support in IVF: is evidence-based medicine translated to clinical practice? A worldwide web-based survey. Reprod Biomed Online. 2012;25:139–145.
  • Sator M, Radicioni M, Cometti B, et al. Pharmacokinetics and safety profile of a novel progesterone aqueous formulation administered by the s.c. route. Gynecol Endocrinol. 2013;29:205–208.
  • Doblinger J, Cometti B, Trevisan S, et al. Subcutaneous progesterone is effective and safe for luteal phase support in IVF: an individual patient data meta-analysis of the Phase III trials. PLoS One. 2016;11:e0151388.
  • Child T, Leonard SA, Evans JS, et al. Systematic review of the clinical efficacy of vaginal progesterone for luteal phase support in assisted reproductive technology cycles. Reprod Biomed Online. 2018;36:630–645.
  • Griesinger G, Tournaye H, Macklon N, et al. Dydrogesterone: pharmacological profile and mechanism of action as luteal phase support in assisted reproduction. Reprod Biomed Online. 2019;38:249–259.
  • Beltsos AN, Sanchez MD, Doody KJ, et al. Patients' administration preferences: progesterone vaginal insert (Endometrin®) compared to intramuscular progesterone for luteal phase support. Reprod Health. 2014;11:78.
  • Griesinger G, Blockeel C, Tournaye H. Oral dydrogesterone for luteal phase support in fresh in vitro fertilization cycles: a new standard? Fertil Steril. 2018;109:756–762.
  • Rižner TL, Brožič P, Doucette C, et al. Selectivity and potency of the retroprogesterone dydrogesterone in vitro. Steroids. 2011;76:607–615.
  • Chakravarty BN, Shirazee HH, Dam P, et al. Oral dydrogesterone versus intravaginal micronised progesterone as luteal phase support in assisted reproductive technology (ART) cycles: results of a randomised study. J Steroid Biochem Mol Biol. 2005;97:416–420.
  • Patki A, Pawar VC. Modulating fertility outcome in assisted reproductive technologies by the use of dydrogesterone. Gynecol Endocrinol. 2007;23:68–72.
  • Ganesh A, Chakravorty N, Mukherjee R, et al. Comparison of oral dydrogesterone with progesterone gel and micronized progesterone for luteal support in 1,373 women undergoing in vitro fertilization: a randomized clinical study. Fertil Steril. 2011;95:1961–1965.
  • Saharkhiz N, Zamaniyan M, Salehpour S, et al. A comparative study of dydrogesterone and micronized progesterone for luteal phase support during in vitro fertilization (IVF) cycles. Gynecol Endocrinol. 2016;32:213–217.
  • Zargar M, Saadati N, Ejtahed MS. Comparison the effectiveness of oral dydrogesterone, vaginal progesterone suppository and progesterone ampule for luteal phase support on pregnancy rate during ART cycles. Int J Pharm Res Allied Sci. 2016;5:229–236.
  • van der Linden M, Buckingham K, Farquhar C, et al. Luteal phase support for assisted reproduction cycles. Cochrane Database Syst Rev. 2011;10:CD009154.
  • Tournaye H, Sukhikh GT, Kahler E, et al. A phase III randomized controlled trial comparing the efficacy, safety and tolerability of oral dydrogesterone versus micronized vaginal progesterone for luteal support in in vitro fertilization. Hum Reprod. 2017;32:1019–1027.
  • Griesinger G, Blockeel C, Sukhikh GT, et al. Oral dydrogesterone versus intravaginal micronized progesterone gel for luteal phase support in in vitro fertilization: a randomized clinical trial. Hum Reprod. 2018;33:2212–2221.
  • Sukhikh GT, Baranov II, Melnichenko GA, et al. Lotus I: a Phase III randomized controlled trial of oral dydrogesterone versus micronized vaginal progesterone for luteal support in in vitro fertilization, with focus on the Russian subpopulation. Akush Ginekol. 2017;7:75–95. Russian.
  • De Geyter C, Calhaz-Jorge C, Kupka MS, et al. ART in Europe, 2014: results generated from European registries by ESHRE: the European IVF-monitoring Consortium (EIM) for the European Society of Human Reproduction and Embryology (ESHRE). Hum Reprod. 2018;33:1586–1601.
  • Toner JP, Coddington CC, Doody K, et al. Society for assisted reproductive technology and assisted reproductive technology in the United States: a 2016 update. Fertil Steril. 2016;106:541–546.
  • McLernon DJ, Harrild K, Bergh C, et al. Clinical effectiveness of elective single versus double embryo transfer: meta-analysis of individual patient data from randomised trials. BMJ. 2010;341:c6945.
  • Pandian Z, Marjoribanks J, Ozturk O, et al. Number of embryos for transfer following in vitro fertilisation or intra-cytoplasmic sperm injection. Cochrane Database Syst Rev. 2013;7:CD003416.
  • Ministry of Health of the People's Republic of China. Reproductive Centre Statistics. National Data Annual Report 2015.
  • Ministry of Health of the People's Republic of China. Reproductive Centre Statistics. National Data Annual Report 2016.
  • Kushnir VA, Barad DH, Albertini DF, et al. Systematic review of worldwide trends in assisted reproductive technology 2004–2013. Reprod Biol Endocrinol. 2017;15:6.
  • Ministry of Health of the People's Republic of China. Specifications for Human Assisted Reproductive Technology. Chn J Reprod Health. 2004;15:4–8.
  • Li Z, Wang AY, Bowman M, et al. ICSI does not increase the cumulative live birth rate in non-male factor infertility. Hum Reprod. 2018;33:1322–1330.
  • Xu X, Zuo H, Shi Z, et al. Determinants of second pregnancy among pregnant women: a hospital-based cross-sectional survey in China. BMJ Open. 2017;7:e014544.
  • Griesinger G, Tournaye H, Connolly MP, et al. A comparison of live birth rates and cost-effectiveness analysis in luteal support based on a multicenter, double-blind RCT of oral dydrogesterone vs. micronized vaginal progesterone. Abstract 2017. 7th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2017); 30 Mar–2 Apr 2017; Kuala Lumpur, Malaysia; 2017.