Oral dydrogesterone versus vaginal progesterone gel in the luteal phase support: randomized controlled trial

Abstract

Objectives: To compare efficacy, satisfaction and tolerability of oral dydrogesterone and micronized vaginal progesterone gel used for luteal supplementation.

Study design: 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.

Clinical trial registration number: NCT01178931; www.clinicaltrials.gov.

Keywords: Dydrogesterone; IVF/ET; Luteal phase support; Pregnancy rate; Vaginal progesterone.