Follitropin (FSH)

Status

FDA-approved. FDA-approved labeling exists for follitropin products for development of multiple follicles in ovulatory patients participating in assisted reproductive technology programmes, for ovulation induction, and for induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism. Labels warn about ovarian hyperstimulation syndrome and multiple births.

What it is

Recombinant FSH used in fertility treatment to support gamete development.

What published research measured

Recombinant or purified follicle stimulating hormone, used in assisted reproduction to drive multi-follicular development in women and, in men with hypogonadotropic hypogonadism, to support spermatogenesis alongside hCG. The randomized evidence base in fertility medicine is large and its use is standard of care in that setting. The defining risk is ovarian hyperstimulation syndrome, which ranges from mild abdominal discomfort to a severe form with third-space fluid shift, haemoconcentration, thromboembolism and organ dysfunction, and which is the reason cycles require ultrasound and hormonal monitoring rather than fixed protocols. Multiple pregnancy risk is increased. In men, response is measured over months rather than weeks because of the length of the spermatogenic cycle.

Source

FDA labeling for follitropin products

Sources

No linked primary source is on file for this entry yet.

Educational use only, never medical advice. No doses.