Authors

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

Abstract

Objective:

To compare the efficacy and safety of luteal phase support in IVF with a progesterone (P) vaginal ring or gel (VR or VG).

Design:

Prospective, randomized, single-blind, multicenter, phase III clinical trial (ClinicalTrials.gov identifier: NCT00615251).

Setting:

Nineteen private and 3 academic high-volume US IVF centers.

Patients:

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).

Interventions:

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.

Results:

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.

Conclusion:

The weekly progesterone VR provided similar pregnancy rates to the daily VG, with no major differences in safety.

Read the full text at: http://www.fertstert.org/article/S0015-0282(13)00014-9/fulltext