title: Oral dydrogesterone versus vaginal progesterone gel in the luteal phase support: randomized controlled trial.
abstract: OBJECTIVE
  To compare efficacy, satisfaction and tolerability of oral dydrogesterone and micronized vaginal progesterone gel used for luteal supplementation.
  
  
  METHODS
  Randomized controlled trial. A total of 853 infertile women undergoing IVF/ICSI treatment in University Hospital Center "Sisters of Mercy", Zagreb, Croatia. Luteal support was provided as Crinone 8%(®) vaginal progesterone gel (90mg) administered daily, or oral dydrogesterone Duphaston(®) (2× 10mg) administered two times daily. Progesterone was administered from the day of oocyte retrieval (day 0) till pregnancy test or in a case of pregnancy, until week 10.
  
  
  RESULTS
  The on-going pregnancy rates were comparable between Crinone 8%(®) vaginal progesterone gel and oral dydrogesterone - Duphaston(®) (28.1% versus 30.3%; OR 1.11 (0.82-1.49 with 95% CI)). Overall satisfaction and tolerability were significantly higher in the dydrogesterone group than in the Crinone group. Vaginal bleeding, interference with coitus and local adverse side effects such as vaginal irritation and discharge occurred significantly more in Crinone group than in dydrogesterone group.
  
  
  CONCLUSIONS
  Oral dydrogesterone is effective drug, well tolerated and accepted among patients and can be considered for routine luteal support.
  
  
  BACKGROUND
  NCT01178931; www.clinicaltrials.gov.
authors.affiliation: Department of Gynecology and Obstetrics, University Clinical Centre "Sisters of Mercy", Zagreb, Croatia; Department of Gynecology and Obstetrics, DZ Zagreb Centar, Zagreb, Croatia. Electronic address: tomic.vlatka@gmail.com.
authors.forename: Vlatka
authors.initials: V
authors.lastname: Tomic
authors.affiliation: Department of Gynecology and Obstetrics, University Clinical Centre "Sisters of Mercy", Zagreb, Croatia.
authors.forename: Jozo
authors.initials: J
authors.lastname: Tomic
authors.affiliation: Department of Gynecology and Obstetrics, DZ Zagreb Centar, Zagreb, Croatia.
authors.forename: Djurdja Zigmundovac
authors.initials: DZ
authors.lastname: Klaic
authors.affiliation: Department of Gynecology and Obstetrics, University Clinical Centre "Zagreb", Zagreb, Croatia.
authors.forename: Miro
authors.initials: M
authors.lastname: Kasum
authors.affiliation: Department of Gynecology and Obstetrics, University Clinical Centre "Sisters of Mercy", Zagreb, Croatia.
authors.forename: Krunoslav
authors.initials: K
authors.lastname: Kuna
mesh_terms: D000282:Administration, Intravaginal; D000284:Administration, Oral; D000328:Adult; D004311:Double-Blind Method; D004394:Dydrogesterone / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D007247:Infertility, Female / Q000628:therapy*; D008183:Luteal Phase / Q000187:drug effects*; D017060:Patient Satisfaction; D011247:Pregnancy; D018873:Pregnancy Rate; D011374:Progesterone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D011372:Progestins / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D020554:Sperm Injections, Intracytoplasmic / Q000379:methods*; D014592:Uterine Hemorrhage / Q000139:chemically induced; D014622:Vaginal Creams, Foams, and Jellies / Q000008:administration & dosage / Q000009:adverse effects; D019522:Vaginal Discharge / Q000139:chemically induced; D055815:Young Adult
chemical_list: C400424:Crinone; D011372:Progestins; D014622:Vaginal Creams, Foams, and Jellies; D011374:Progesterone; D004394:Dydrogesterone
keywords: Dydrogesterone; IVF/ET; Luteal phase support; Pregnancy rate; Vaginal progesterone