Progesterone vaginal ring versus vaginal gel for luteal support with in vitro fertilization A randomized comparative study

Capsule:
Luteal supplementation with a weekly progesterone vaginal ring or daily vaginal gel provided similar high clinical pregnancy rates in in vitro fertilization.

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.

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