Abstract: P-652

Comparison of Crinone® versus Intramuscular Progesterone for Luteal Support on the Ongoing Pregnancy Rate of Fresh Embryo Transfer Cycles in Chinese Population: a Prospective, Randomized, Multi-center Study

Presenter: Chi Hongbin


Abstract


OBJECTIVE: To compare the ongoing pregnancy rate in patients receiving IVF/ICSI-ET treatment with Crinone® vaginal gel or intramuscular progesterone (IMP) for luteal phase support.
DESIGN: Prospective, randomized, open-label, multi-center study. view more

OBJECTIVE: To compare the ongoing pregnancy rate in patients receiving IVF/ICSI-ET treatment with Crinone® vaginal gel or intramuscular progesterone (IMP) for luteal phase support.
DESIGN: Prospective, randomized, open-label, multi-center study.
MATERIALS AND METHODS: 1313 patients were enrolled this study and 1248 participants were randomized to progesterone vaginal gel or IMP group from December 2014 to March 2016. Finally 1058 participants were analyzed. Progesterone vaginal gel (90mg) or progesterone oil (60mg) were given once daily to all patients who had received IVF/ICSI-ET treatment from the day of oocytes retrieval, and were continued for at least 6 weeks after the embryo transfer if the pregnancy test was positive. Primary endpoint was ongoing pregnancy rate. The statistical analyses were basing on the two side 95% CI differences of ongoing pregnancy rate and non-inferiority delta margin (clinically significant differences) was set as 10% between the two groups. Percentages and corresponding CIs were reported for secondary outcomes (see Table).
RESULTS: The ongoing pregnancy rate was 48.39% [95%CI: 44.04-52.75] in progesterone vaginal gel group and 46.33% [95% CI: 42.02-50.67] in IMP group. The lower limit of 95%CI (progesterone vaginal gel- IMP group) was -3.96% (>-10%) which showed non-inferiority to the IMP. Results of secondary endpoints are shown in Table. Results of secondary endpoints are shown in Table. Luteal phase bleeding was observed in both groups but mainly occurred in subjects who were not pregnant (>70%). Biochemical pregnancy rates were similar in two groups (57.50% vs 56.50%) despite of slightly higher luteal phase bleeding in progesterone vaginal gel group than the IMP group.
Table Results of secondary endpoints


Crinone® IMP
implantation rate 37.32% 34.83%
biochemical pregnancy rate 57.50% 95%CI:53.15~61.76 56.50% 95%CI: 52.16~60.76
clinical pregnancy rate 52.18% 95% CI:47.82~56.52 50.66% 95% CI:46.32~54.99
multiple pregnancy rate 38.55% 95% CI:33.14~45.04 33.96% 95% CI:28.53~40.25
early abortion rate 8.00% 95%CI:5.08~11.869 8.92% 95%CI:5.80~12.98

CONCLUSIONS: Efficacy of progesterone vaginal gel was non-inferior to the IMP for luteal phase support in IVF/ICSI-ET. Difference of luteal phase bleeding did not affect biochemical pregnancy outcome. Progesterone vaginal gel can be an option other than intramuscular progesterone for luteal support in ART.

1. Efficacy of progesterone vaginal gel was non-inferior to the IMP for luteal phase support in IVF/ICSI-ET.

2. Difference of luteal phase bleeding did not affect pregnancy outcome.

3. Progesterone vaginal gel can be an option other than intramuscular progesterone for luteal support in ART.

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