Efficacy of follitropin delta in potential low responders: a pooled analysis of individual patient data from five randomized controlled trials
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Rita Lobo1, Ali Falahati2, Ida E Jepsen1
1Office of Chief Medical Officer, Ferring Pharmaceuticals, Copenhagen, Denmark.
Objectives:
This study evaluated the efficacy of individualized follitropin delta dosing in patients with potential low response, defined by anti-Müllerian hormone (AMH) level <9 pmol/L, undergoing ovarian stimulation for assisted reproductive technology.
Methods:
A pooled analysis including 1844 patients from five randomized controlled trials was undertaken. The trials selected for the analysis used individualized dosing of follitropin delta, based on AMH level and body weight. Patients with potential low response (AMH screening level <9 pmol/L [~1.26 ng/mL]; n=329) were compared to patients with potential normal/high response (AMH level ≥9 pmol/L; n=1515). Patients with AMH <9 pmol/L all received the maximum daily dose of follitropin delta (12 µg).
Results:
The mean age was 34.6 years for patients with AMH <9 pmol/L and 32.2 years for patients with AMH ≥9 pmol/L, and the median AMH was 6 pmol/L and 20 pmol/L, respectively. In patients with AMH <9 pmol/L, the mean number of oocytes retrieved (6.3 oocytes) was significantly lower (p<0.0001) than in patients with AMH ≥9 pmol/L (10.8 oocytes), while no significant differences were observed for ongoing pregnancy rate (29.2% versus 31.8% in patients with AMH <9 pmol/L versus ≥9 pmol/L [p=0.32]) or live birth rate (28.6% versus 31.4% [p=0.32]). Seventeen patients (5.2%) with AMH <9 pmol/L and 33 patients (2.2%) with AMH ≥9 pmol/L had cycle cancellations due to poor response. Ovarian hyperstimulation syndrome (OHSS) occurred in 5 patients (1.5%) with AMH <9 pmol/L and 112 patients (7.4%) with AMH ≥9 pmol/L.
Conclusions:
Follitropin delta dosing in young patients with moderately reduced ovarian reserve, using 12 µg/day for ovarian stimulation, demonstrated clinically relevant fresh-cycle pregnancy outcomes as compared to patients with normal or high ovarian reserve. This pooled analysis adds evidence for the efficacy of follitropin delta across all ovarian reserve subgroups of the infertile population. The study was limited to fresh cycle outcomes; further studies are warranted focusing on cumulative outcomes and older patient populations with low ovarian reserve.
