Oral Dydrogesterone has the potential to become new treatment of choice for an estimated 1.5 million women worldwide who undergo IVF treatment each year. In the Lotus I study, which involved more than 1,000 women across 38 international sites, oral dydrogesterone had similar efficacy and tolerability to micronized vaginal progesterone (MVP), which is the current standard of care globally to prepare the uterus lining for pregnancy3.
IVF is one of several methods of assisted reproduction technology whereby a fertilized embryo is transferred to the woman’s uterus4. Progesterone or a related hormone, such as dydrogesterone, is used in IVF to prepare the lining of the uterus (luteal phase support) to allow a fertilized egg to implant5,6.
MVP is the most commonly used method of administering progesterone in IVF centers globally7, but is associated with side effects, such as irritation and discharge, as well as poor patient acceptance6.
Lotus I, a Phase III randomized controlled clinical study8, evaluated the effects of oral dydrogesterone in luteal support in IVF. The findings of the study provide clinical evidence for an oral treatment option. Besides its ease of administration, the Lotus I study concluded that oral dydrogesterone is similarly well-tolerated and efficacious compared to MVP.
“The findings from this study have the potential to have important implications for women undergoing IVF,” said Herman Tournaye, M.D., Ph.D., Director of the Center for Reproductive Medicine at Universitair Ziekenhuis Brussel, and lead clinical researcher for the Lotus I study. “We found oral dydrogesterone to be effective, well tolerated and easy to administer – all of which point to it becoming the new preferred treatment option.”
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