Efficacy and tolerability of vaginal progesterone capsules (Utrogest 200) compared with progesterone gel (Crinone 8%) for luteal phase support during assisted reproduction.

OBJECTIVE To demonstrate the comparative efficacy and tolerability of capsules containing 200 mg of P (Utrogest 200) or Crinone 8% gel for luteal phase and early pregnancy support during assisted reproduction techniques (ART). DESIGN Prospective, multicenter, randomized, controlled, open, parallel-group Phase III trial. SETTING Seventeen German IVF centers. PATIENT(S) Four hundred thirty women who underwent their first IVF or intracytoplasmic sperm injection cycle were randomized after successful transfer of two or three embryos from July 1999 through September 2001. INTERVENTION(S) Patients vaginally applied capsules containing 200 mg of P (Utrogest 200) three times per day or containing Crinone 8% gel twice per day. Therapy was started in the evening of the ET day and continued up to 10 weeks in pregnant women. If the pregnancy test proved to be negative, application was stopped. MAIN OUTCOME MEASURE(S) Ongoing pregnancy rate at the end of the study (12th week of gestation). Secondary outcomes were rate of implantation and abortion, number and reasons of withdrawals, as well as adverse events, assessment of tolerability, and acceptance. RESULT(S) There were no relevant differences in demographic and other characteristics between the two groups. Ongoing pregnancy rates were 25.2% in the Utrogest 200 group and 22.2% in the Crinone 8% group when patients were analyzed who normally completed the trial. In the Utrogest 200 vs. the Crinone 8% group, the implantation rate (14.7% vs. 11.9%) and abortion rate (18.2% vs. 19.1%) were not statistically different. The rate of withdrawals at the individual visits also did not differ between treatment groups. Tolerability of both drugs was good, and very few study drug-related adverse events were observed in both groups. CONCLUSION(S) The luteal phase support in ART cycles with Utrogest 200 capsules (three times per day) or Crinone 8% gel (two times per day) by the vaginal route resulted in similar outcomes with respect to implantation, ongoing pregnancy, and abortion rates. The two recommended regimens of P supplementation in ART proved to be equivalent and safe.