Regulatory evidence describes a specific recombinant hCG product in monitored assisted-reproduction and ovulation-induction programs.
Population: Women undergoing assisted reproductive technology or ovulation induction after monitored follicular development
Design: Two assisted-reproduction studies and one ovulation-induction study summarized in the approved label
- The evidence applies to a defined fertility program and a specific prefilled product.
- It does not support unmonitored use, weight loss, or transfer of handling instructions to urinary, compounded, or research products.