Progesterone 100 mg; vaginal insert.
To support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology treatment program for infertile women.
Progesterone supplementation is used to provide support for the luteal phase, preparing the endometrium for implantation of the embryo and for early pregnancy. Endometrin is a quickly dissolving tablet containing micronized progesterone that is vaginally inserted.
After insertion, the tablet disperses locally, rapidly achieving local levels of progesterone.
An active-controlled study evaluated the efficacy of 10 weeks of treatment with two different dosing regimens of Endometrin (100 mg twice daily and 100 mg three times daily). Efficacy was assessed on the end point of ongoing pregnancies, defined as the presence of at least one fetal heartbeat seen on ultrasound at six weeks post-embryo transfer. The ongoing pregnancy rates for those treated with both regimens were non-inferior to the ongoing pregnancy rate for patients treated with the active comparator.
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