Dydrogesterone use in early pregnancy
Keywords:assisted reproductive technology, dydrogesterone, luteal phase support, pregnancy, progestogen, threatened miscarriage, recurrent miscarriage
Successful oocyte implantation and a favorable pregnancy outcome rely on optimal progesterone levels. Therefore, progesterone deficiencies associated with infertility and miscarriage have commonly been treated with progestogens that mimic the activity of progesterone. Among those is dydrogesterone, an oral retrosteroid with a structure closely related to that of progesterone yet with a greater bioavailability and higher selectivity for the progesterone receptor.
Dydrogesterone has been marketed since the 1960s and has been extensively used worldwide for the treatment of threatened miscarriage and recurrent miscarriage, as well as for luteal phase support in the setting of infertility. Additionally, dydrogesterone is approved for hormone replacement therapy, as well as pregnancy and non-pregnancy-related conditions where there is a progesterone deficiency.
This review describes the efficacy of dydrogesterone for the treatment of threatened and recurrent miscarriage, and infertility due to luteal phase insufficiency. Data from clinical trials evaluating dydrogesterone in assisted reproductive technology are also discussed.
Prospective clinical trials, systematic reviews and meta-analyses have demonstrated that dydrogesterone significantly improves pregnancy outcomes in women with threatened miscarriage or with a history of miscarriage. Although this is not yet a registered indication, dydrogesterone was as effective as vaginal micronized progesterone for luteal phase support in the setting of assisted reproductive technology. The safety and tolerability of dydrogesterone treatment in pregnant women are also briefly addressed and the data support a wellestablished and favorable risk-benefit profile.
According to recent systematic reviews and meta-analyses, dydrogesterone appears to be superior to vaginal micronized progesterone for the treatment of threatened miscarriage and with a history of miscarriage. Given its effectiveness as well as its well-established and favorable risk-benefit profile, wider potential benefits of dydrogesterone therapy (currently being investigated in phase III studies for insufficiency of the luteal phase in assisted reproductive technology) are highly anticipated.
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