Trial Finds Oral Drug Could Become Standard of Care for In Vitro Fertilization

Global healthcare and research company, Abbott, has announced the results of their phase III clinical trial assessing the efficacy of oral dydrogesterone in women undergoing in vitro fertilization (IVF). The Lotus I study involved over 1,000 women across 38 international study sites, and found that the drug had similar efficacy and tolerability compared to the standard of care, micronized vaginal progesterone (MVP).

IVF is just one of the many available methods used to assist women with reproductive issues. Dydrogesterone, a progesterone analogue, is used to prepare the uterine lining for implantation of a fertilized egg.

While MVP remains the most common form of the hormone administered in IVF clinics, it can cause unpleasant side effects, including irritation and discharge. Based on the results of the Lotus I clinical trial, oral dydrogesterone could be a viable treatment alternative to MVP.

“The findings from this study have the potential to have important implications for women undergoing IVF,” said Dr. Herman Tournaye, 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.”

Compared to patients given MVP, those that were randomized to receive oral dydrogesterone showed similar evidence of ongoing pregnancy at 12 weeks gestation. This endpoint was assessed by testing for the presence of a fetal heartbeat.

Pregnancy rates at 12 weeks gestation were 37.6 percent for the oral dydrogesterone treatment group, and 33.1 percent for patients who received MVP. Full findings – including those pertaining to live birth rates – were published in the journal, Human Reproduction.

Currently, oral dydrogesterone manufactured by Abbott is only available in countries outside the US. The drug is currently approved for a number of region-specific indications, including recurrent miscarriage, endometriosis and hormone replacement therapy (HRT).