Сравнительный анализ эффективности и безопасности гестагенов в поддержке лютеиновой фазы в свежих циклах ЭКО/ИКСИ с переносом одного эмбриона

Abstract

Objective. To study the efficacy and safety of dydrogesterone and micronized vaginal progesterone for luteal phase support in fresh IVF/ICSI cycles with single embryo transfer. Patients and methods. A retrospective comparative analysis including 146 women aged 23 to 44 years who entered an assisted reproductive technology (ART) program in 2020 was performed. Patients were divided into two groups: group 1 (n = 67) received dydrogesterone for luteal phase (LP) support in ART, while group 2 (n = 79) received micronized vaginal progesterone (MVP). All patients underwent a single good-quality embryo transfer in a fresh IVF/ICSI cycle. The rate of clinical pregnancy was considered as the primary endpoint, while the rate of live births and the safety profile of medications for mothers and neonates were considered as secondary endpoints. In addition, the incidence of adverse events with dydrogesterone and MVP was evaluated. Results. Clinical pregnancy and live birth rates with dydrogesterone as LP support in ART programs were 25/67 and 19/67 (37.3% and 28.4%, respectively), with MVP – 27/79 and 19/79 (34.2% and 24.1%, respectively). Thus, there was a tendency to improve the results of ART programs in the dydrogesterone group, but no statistically significant difference in outcomes was found (p > 0.05). In the MVP group, one child was diagnosed with a malformation, syndactyly of the second and third toes. In the dydrogesterone group, one term stillbirth was registered due to chronic fetoplacental insufficiency and intrauterine growth restriction (IUGR). The suspected cause of pathological changes was COVID-19 at 30 weeks’ gestation. Based on the global report, the background risk of congenital malformations due to environmental and genetic factors is 6% of worldwide births. The results obtained did not exceed the population average, indicating a high safety profile of gestagens for a fetus in both groups. The incidence of side effects and adverse reactions was significantly lower in the group of women receiving dydrogesterone compared to MVP (3/67 (4.5%) and 11/79 (13.9%) cases, respectively, p <0.05). Conclusion. LP support with gestagens in fresh IVF/ICSI cycles with single embryo transfer showed comparable efficacy. Oral dydrogesterone therapy tended to increase the rate of clinical pregnancy and live births in IVF/ICSI cycles with single embryo transfer and demonstrated a favorable safety profile. The benefits of dydrogesterone included good tolerability and positive patient satisfaction. The oral route of dydrogesterone administration was reported as the most preferred one among patients and physicians. Key words: ART cycles, single embryo transfer, gestagens, dydrogesterone, micronized progesterone