Randomized controlled trials confirm dydrogesterone's effectiveness in reducing miscarriage risk during in vitro fertilization, demonstrating its role in luteal phase support.
Progesterone is a key hormone essential for maintaining pregnancy. Its deficiency can lead to the risk of miscarriage, recurrent pregnancy loss, and unsuccessful attempts at in vitro fertilization. In clinical practice, progestogens are used for luteal phase support, particularly in women with corpus luteum insufficiency or in assisted reproductive technologies cycles.After the synthetic progestogen 17-hydroxyprogesterone caproate was withdrawn from the pharmaceutical market due to low efficacy and multiple side effects, only two effective agents remain in obstetrics and reproductive medicine – progesterone and dydrogesterone.Dydrogesterone is a synthetic analog of natural progesterone with high oral bioavailability, making it a convenient alternative to other forms of progestogens. It selectively binds to progesterone receptors, ensuring stable endometrial support and promoting early pregnancy maintenance. Unlike some other progestogens, dydrogesterone has no androgenic, estrogenic, or glucocorticoid effects, which contributes to its better tolerability.The evidence base supporting dydrogesterone’s efficacy includes numerous randomized controlled trials, particularly LOTUS I and LOTUS II, which demonstrated that oral dydrogesterone is as effective as vaginal progesterone for luteal phase support at in vitro fertilization cycles. Additionally, multiple meta-analyses confirm that dydrogesterone use in the first trimester significantly reduces the risk of miscarriage, and over 70 studies have confirmed the high efficacy and safety of its molecule for both women and fetuses.The safety of dydrogesterone is particularly important. The international expert group on the safety of progestogens in early pregnancy REASSURE concluded that there is currently no basis for making statements about a causal relationship between the use of dydrogesterone in the first trimester and the risk of congenital malformations.Thus, due to its proven efficacy and excellent safety profile, supported by over 60 years of clinical use, dydrogesterone is the optimal choice for luteal phase support in both natural cycles and assisted reproductive technologies.
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Татарчук et al. (2025) studied this question.
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