Optimization of management for pregnancy loss: a progesterone support strategy

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Pregnancy loss remains one of the most important and challenging medical and social issues in obstetrics. This problem is particularly relevant in Ukraine, where physiological risks are further exacerbated by the adverse effects of chronic war-related stress on women’s reproductive health.Progesterone therapy in early pregnancy is a well-established and effective approach for preventing pregnancy loss. Progesterone is essential for implantation and the maintenance of pregnancy and plays a key role in endometrial receptivity, immune modulation, angiogenesis, and uterine quiescence through its tocolytic effects.A review of current international clinical guidelines and evidence from large randomized clinical trials highlights the need for a differentiated approach to progesterone support. The two main agents used for luteal phase support on the Ukrainian pharmaceutical market are progesterone and dydrogesterone. Owing to its unique retro structure, dydrogesterone exhibits high selectivity for progesterone receptors and significantly greater oral bioavailability than progesterone. Over the past decade, generic formulations of dydrogesterone have been developed, expanding the range of available treatment options on the domestic pharmaceutical market. However, extrapolating pharmacokinetic bioequivalence data from generic products to real-world clinical practice has certain limitations.Despite similarities in key pharmacokinetic parameters with the originator product, differences in excipients and in the technologies used for the complex stereoselective synthesis of dydrogesterone may influence therapeutic outcomes in such a vulnerable patient population as pregnant women.A secondary analysis demonstrated that both originator and generic dydrogesterone provide substantial absolute clinical benefit compared with no treatment (NNT (number needed to treat) ≈ 12 and NNT ≈ 14.5, respectively), whereas the additional benefit of the originator product over the generic corresponds to an NNT of ≈ 70.The assessment of drug interchangeability in obstetrics and reproductive medicine should be based not only on pharmacokinetic studies but also on evidence from clinical trials, pregnancy registries, post-marketing surveillance, and systematic reviews. Definitive confirmation of any differences between originator and generic dydrogesterone requires prospective randomized controlled trials.

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