A randomized controlled trial to compare the efficacy and safety of corifollitropin alfa followed by menotropin versus follitropin β for poor ovarian responders

Abstract

Objective: To compare the efficacy of corifollitropin α followed by menotropin and recombinant FSH (Follitropin β) only protocols for controlled ovarian stimulation in women < 40 years of age diagnosed as poor responders using Bologna criteria.

Materials and methods: This was a randomized controlled trial conducted on 64 women < 40 years old, had at least 1 IVF cycle with ≤ 3 oocytes retrieved and AMH < 1.1 ng/ml or AFC < 7 follicles. Patients randomly received corifollitropin α + hp-hMG (group A) or follitropin β (group B) for ovarian stimulation. Primary endpoint was ongoing pregnancy rate. Secondary endpoints were number of oocytes retrieved, number of canceled cycles due to extremely poor response, number of cycles with embryos transfer, number of cycles with embryo freezing, number and quality of embryos, biochemical pregnancy rate, clinical pregnancy rate and percentage of cycles canceled due to serious adverse events.

Results: Corifollitropin α + hp-hMG group had significantly lower ovarian reserve than Follitropin β group (with day 2-FSH of 11.3 ± 6.3 vs 8.4 ± 4.0, p = 0.03, respectively). There was no significant difference between Corifollitropin α + hp-hMG and Follitropin β groups with regards to ongoing pregnancy rate (15.4% versus 26.7%, p > 0.05) and other secondary putcomes.

Conclusions: Corifollitropin α followed by menotropin protocol is not more effective than Follitropin β protocol for ovarian stimulation in young, Bologna criteria poor ovarian responders. Further research with larger sample size is awaited to confirm this finding.