Recombinant follicle-stimulating hormone (FSH)
ATC code: G03GA05 (Follitropin alfa)
Brand names
Gonal-F, Gonal-F RFF Pen, Ovaleap, Bemfola
Follitropin alfa is recombinant human FSH with amino-acid sequence identical to the endogenous hormone. Binds receptors on ovarian granulosa cells in women and Sertoli cells in men. In women stimulates follicular growth and maturation; in men supports spermatogenesis. Subcutaneous T½ 24 h (beta phase); steady state in 3-4 days of injections.
First line
Stimulation of multiple follicular growth for IVF and ICSI in women. Per 2023 and SEGO 2024 – a standard option. Individualized dose: start 150-225 IU/day subcutaneously, adjust by ultrasound monitoring of follicle size and estradiol. Trigger with hCG or GnRH agonist when ≥3 follicles ≥17 mm. In men with hypogonadotropic hypogonadism and impaired spermatogenesis – 150 IU three times weekly combined with hCG for 4-12 months.
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Not used in an already pregnant woman. After conception in IVF, therapy is stopped.
Not indicated during breastfeeding. For repeat IVF programs, restart is possible after weaning.
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
Follitropin alfa is evaluated for the following indications with varying evidence strength: Ovulation induction for assisted reproduction (evidence tier A). See the full indication matrix with dosing and citations above on this page.
Common side effects of Follitropin alfa (≥ 1 in 100): Injection-site pain and bruising, Headache, Abdominal and pelvic pain, Nausea, Breast pain, Estrogenic effects (bloating, mood changes). See the Safety section for uncommon and serious reactions.
FDA category X. Not used in an already pregnant woman. After conception in IVF, therapy is stopped.
Not indicated during breastfeeding. For repeat IVF programs, restart is possible after weaning.
Follitropin alfa is contraindicated in: Hypersensitivity; Hypothalamic or pituitary tumors; Ovarian, uterine, or breast carcinoma; Undiagnosed gynecologic bleeding; Primary ovarian failure (elevated FSH). Full list in the Safety section.