Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Indian Women

FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their anti-Müllerian hormone (AMH) level at screening and their body weight at randomization. For participants with low AMH (\<15 pmol/L) the daily FE 999049 dose was 12 μg, irrespective of body weight. For participants with high AMH (≥15 pmol/L) the daily FE 999049 dose was on a continuous scale ranging from 0.19 to 0.10 μg/kg, i.e. dependent on actual AMH and body weight. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 12 μg. Participants could be treated for a maximum of 20 days.

GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Participants could be treated for a maximum of 20 days.