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

Fertil Steril. 2013 May;99(6):1543-9. doi: 10.1016/j.fertnstert.2012.12.052. Epub 2013 Mar 4.

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 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.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Contraceptive Devices, Female*
  • Female
  • Fertilization in Vitro / methods*
  • Humans
  • Infertility, Female / drug therapy
  • Infertility, Female / epidemiology
  • Live Birth / epidemiology
  • Luteal Cells / drug effects*
  • Luteal Cells / physiology
  • Pregnancy
  • Progesterone / administration & dosage*
  • Prospective Studies
  • Single-Blind Method
  • Vaginal Creams, Foams, and Jellies / administration & dosage*
  • Young Adult

Substances

  • Vaginal Creams, Foams, and Jellies
  • Progesterone

Associated data

  • ClinicalTrials.gov/NCT00615251