Abstract

To explore the efficacy of vaginal progesterone inserts, Endometrin®, compared to intramuscular injections of progesterone in oil (PIO) for luteal support in PCOS patients who are undergoing IVF cycles. A multicenter, randomized, open-label exploratory study. Standard IVF practice of each center, with randomization prior to stimulation with either Menopur® or rFSH (Follistim®) and luteal support in the form of either Endometrin® or progesterone in oil. Treatment group comparisons for continuous variables were based on one-way analysis of variance (ANOVA) or the Wilcoxon rank sum test (or the Kruskal-Wallis test when number of groups more than two), as appropriate. The continuing pregnancy rate for the Endometrin® group (n = 53) was 47.2% for the PIO group (n = 57) was 49.1%.Tabled 1Endometrin®PIOn = 53n = 57Age30.931.5BMI26.928.9Total dose of gonadotropins (IUs)1863.91993.1No. oocytes retrieved14.814.0No. embryos transferred2.93.1Biochemical PR (%)60.464.9Ongoing PR (%)47.249.1 Open table in a new tab This analysis indicates that in a prospective randomized clinical trial of autologous fresh cycles, vaginal progesterone support in the form of Endometrin was equivalent to PIO for luteal support. With greater patient tolerability Endometrin® provides a more patient friendly form of luteal support without compromising efficacy.

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