Clinical Evidence

Phase III Clinical Evaluation of Foropin

Efficacy and Safety in Assisted Reproductive Technology

The clinical efficacy and safety of Foropin (follitropin alfa) were evaluated in a multicenter, randomized, double-blind, active-controlled Phase III trial, designed to establish non-inferiority to the reference product, GONAL-f (Merck Serono).

The study enrolled 303 women across six fertility centers, with 289 participants included in the final efficacy analysis.

Key Clinical Findings

The study demonstrated non-inferiority of Foropin to GONAL-f in its primary efficacy endpoint, the number of mature metaphase II (MII) oocytes retrieved.

No statistically significant differences were observed in key secondary efficacy outcomes, including oocyte maturation, fertilization, and embryo quality.

The two treatment groups exhibited comparable safety findings, with no severe ovarian hyperstimulation syndrome (OHSS), serious adverse events, or thromboembolic events reported.

Clinical Conclusion

The findings support Foropin as a clinically evaluated biosimilar follitropin alfa for controlled ovarian stimulation in assisted reproductive technology.

Reference: Humer Novin Daroo. Phase III Clinical Study Report, 2025.