Assessment of the immunogenicity of gonadotrophins during controlled ovarian stimulation

PROBLEM: Gonadotrophin hormones are used for the controlled ovarian stimulation (COS) as part of the in vitro fertilization techniques. Therapeutic proteins have the potential to induce an unwanted immune response. METHOD OF STUDY: The presence of anti‐FSH, anti‐LH and anti‐hCG antibodies were determined in patients from two different clinical trials after the repeated administration of hMG or FSH. RESULTS: In the first study, 27 subjects were screening for the presence of anti‐FSH antibodies. From the 27 patients, only one patient showed the presence of low levels of antibodies. In a second study, 25 patients were screened for the presence of anti‐FSH, anti‐LH and anti‐hCG antibodies. At the end of the study, no patients showed the presence of antibodies. CONCLUSION: The results of this study suggest that repeated treatment cycles with FSH or hMG in patients undergoing COS for in vitro fertilization can be safely and effectively applied without concerns for immunogenicity.