Real-world evaluation of safety and effectiveness of dydrogesterone 20mg extended release in the management of recurrent early pregnancy loss

• Author Details:   
• Ameya C Purandare
• Rujul Jhaveri
• Vaidehi Marathe
• Ratnadeep Goswami
• Rooplekha Chauhan
• Ashok Jaiswal
• Bhavya Shetty ^*

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Background: Recurrent early pregnancy loss (REPL) is a distressing condition affecting 1% to 5% of couples globally. Progesterone plays a crucial role in maintaining pregnancy, and dydrogesterone, a synthetic progestogen, has emerged as a promising therapeutic option due to its selective action and favorable safety profile. With introduction of extended release (ER) formulations of dydrogesterone 20 mg, real-world data on its effectiveness and safety in REPL is not documented.

Materials and Methods: This was a retrospective, multicentric, observational study conducted from the data obtained of patients with history of REPL treated with dydrogesterone 20 mg ER at the discretion of treating physician. Patient data were collected using standardized Case Report Forms (CRFs), and outcomes included miscarriage incidence, pregnancy continuation, and adverse events. Data were analyzed to evaluate the safety, and effectiveness of dydrogesterone 20 mg ER.

Results: The study included data of 828 patients with history of REPL and treated with dydrogesterone 20 mg ER. The analysis reported an incidence of miscarriage in 64 patients (7.7%), with the majority of patients (92.3%) continuing pregnancy beyond 20 weeks of gestation. Among patients who experienced miscarriage (n=64), the mean gestational age at the time of visit was 6.88 ± 2.12 weeks and at the time of miscarriage was found to be 10.62 ± 3.17 weeks. A total of 77 (9.3%) patients developed adverse events during the treatment period and among them 80% of the adverse events were mild in nature.

Conclusion: Dydrogesterone 20 mg ER is safe and effective in managing REPL, demonstrating a low miscarriage rate and prolonged pregnancy continuation beyond 20 weeks. These findings provide real-world evidence supporting its role as a practical therapeutic option for REPL.