Progesterone vaginal ring versus vaginal gel for luteal support with in vitro fertilization A randomized comparative study
Luteal supplementation with a weekly progesterone vaginal ring or daily vaginal gel provided similar high clinical pregnancy rates in in vitro fertilization.
Laurel Stadtmauer, M.D., Ph.D., Kaylen M. Silverberg, M.D., Elizabeth S. Ginsburg, M.D.
Volume 99, Issue 6, Pages 1543-1549, May 2013
To compare the efficacy and safety of luteal phase support in IVF with a progesterone (P) vaginal ring or gel (VR or VG).
Prospective, randomized, single-blind, multicenter, phase III clinical trial (ClinicalTrials.gov identifier: NCT00615251).
Nineteen private and 3 academic high-volume US IVF centers.
1,297 infertile patients were randomized to a weekly progesterone vaginal ring (VR, n=646) or a daily progesterone 8% vaginal gel (VG, n=651).
IVF was performed per site-specific protocols. The day after egg retrieval (ER), patients were randomized and began VR or VG therapy, which continued for up to 10 weeks’ gestation.
Main Outcome Measures:
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.
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 (AE) profiles were similar between groups.
The weekly progesterone VR provided similar pregnancy rates to the daily VG, with no major differences in safety.