Crinone vaginal gel is equally effective and better tolerated than intramuscular progesterone for luteal phase support in in vitro fertilization-embryo transfer cycles: a prospective randomized study.

Objective: To compare the efficacy of Crinone vaginal gel and intramuscular progesterone (IMP) for luteal phase support in in vitro fertilization-embryo transfer (IVF-ET) with respect to pregnancy rates and outcomes, and to assess patient satisfaction with both products.

Design: Prospective randomized trial.

Setting: University-affiliated IVF unit.

Patient(s): Women under age 40 years with day-3 follicle-stimulating hormone levels <15 mIU/mL undergoing their first, second, or third IVF cycles on gonadotropin releasing-hormone (GnRH) down-regulation protocols.

Intervention(s): Luteal phase supplementation with either Crinone vaginal gel or IMP; phone survey regarding patient satisfaction with Crinone vaginal gel and IMP.

Main Outcome Measure(s): Pregnancy rates, ongoing/delivered, failed pregnancy rates, and product satisfaction scores for patients supplemented with Crinone vaginal gel and with IMP.

Result(s): Four hundred sixty-eight patients were randomized, and 407 completed the study. The patients were randomized on the day of oocyte retrieval to receive either Crinone vaginal gel or IMP for luteal phase support. Pregnancy, ongoing/delivered, and failed pregnancy rates were similar between the Crinone and IMP treatment arms (OR [95% CI]: 1.2 [0.8, 1.8], 1.1 [0.8, 1.7], 1.0 [0.6, 1.7], respectively). On a scale of 1 to 5, patient satisfaction scores were statistically significantly higher with Crinone vaginal gel than with IMP (4.4 ± 0.9 vs. 2.8 ± 1.2).

Conclusion(s): Crinone vaginal gel and IMP are equally effective for luteal phase support in IVF, but Crinone is better tolerated by patients.