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Published on: April 7, 2023
Progesterone vaginal ring versus vaginal gel for luteal support with in vitro fertilization: a randomized comparative
Laurel Stadtmauer1, Kaylen M Silverberg, Elizabeth S Ginsburg
1Jones Institute for Reproductive Medicine, Norfolk, Virginia 23507, USA. stadtmla@evms.edu
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 three academic high-volume U.S. IVF centers.
Patient(S):
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).
Intervention(S):
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.
Main Outcome Measure(S):
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.
Result(S):
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.
Conclusion(S):
The weekly P VR provided similar pregnancy rates to the daily VG, with no major differences in safety.
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