18 June 2013
USA: Progesterone vaginal ring versus vaginal gel for luteal support with IVF
The study set out to compare the efficacy and safety of luteal phase support in IVF with a progesterone (P) vaginal ring or gel (VR or VG). From Fertility and Sterility.
This was a prospective, randomized, single-blind, multicenter, phase III clinical trial (ClinicalTrials.gov identifier: NCT00615251). The setting was 19 private and three academic high-volume U.S. IVF centers.
One thousand two hundred ninety-seven infertile patients were randomized to a weekly P VR (n = 646) or a daily P 8% VG (n = 651).
IVF was performed per site-specific protocols. The day after egg retrieval, patients were randomized and began VR or VG therapy, which continued for up to 10 weeks’ gestation.
The main outcome measures were clinical pregnancy rates at 8 and 12 weeks of pregnancy; rates of biochemical pregnancy, live birth, spontaneous abortion, ectopic pregnancy, and cycle cancellation; and safety and tolerability were secondary measures.
The results found that clinical pregnancy rates at 8 and 12 weeks were high and comparable between groups: 48.0% for VR and 47.2% for VG at week 8 and 46.4% (VR) and 45.2% (VG) at week 12. Live-birth rates were 45% (VR) and 43% (VG). Adverse event profiles were similar between groups.
The authors concluded that the weekly P VR provided similar pregnancy rates to the daily VG, with no major differences in safety.
Progesterone vaginal ring versus vaginal gel for luteal support with in vitro fertilization: a randomized comparative study. Stadtmauer L, Silverberg KM, Ginsburg ES, Weiss H, Howard B. Fertility and Sterility. 2013 May;99(6):1543-9. doi: 10.1016/j.fertnstert.2012.12.052. Epub 2013 Mar 4.