Hormone medicines

Follitropin alfa

Recombinant FSH used to support reproductive function in selected infertility diagnoses; an ovulation outcome is not a live-birth outcome.

Randomized ovulation-induction evidence plus diagnosis-specific labeling; checked 2026-10-01

Also known as: Gonal-f · Recombinant FSH

Practical use

Clinical purpose, evidence and review questions

Ask which diagnosis is being treated: Keep pituitary or hypothalamic signaling deficiency separate from primary gonadal failure.
Choose the meaningful endpoint: Ask whether the reported result concerns follicles, ovulation, semen parameters, pregnancy or live birth.
Keep monitoring records together: Bring earlier response, relevant hormone results and the treating team’s ultrasound or semen reports.

Japanese phase III ovulation-induction trial

US prescribing information; checked October 1, 2026

Overview

Follitropin alfa is recombinant follicle-stimulating hormone. US Gonal-f labeling includes ovulation induction and assisted-reproduction follicle development, and sperm-production induction in specified male hypogonadotropic hypogonadism. Primary ovarian or testicular failure is a different problem from inadequate hormonal stimulation.

Risks and limitations

Ovarian hyperstimulation, torsion, multiple pregnancy and pulmonary or vascular complications require careful monitoring in ovarian treatment. Severe pelvic pain, rapid swelling, reduced urination or breathlessness need urgent clinical assessment. Allergy and specified tumors or uncontrolled endocrine disorders also matter.

How to read this

In female care, follicle development, ovulation, pregnancy and live birth are successive outcomes. In male care, a hormone result is not interchangeable with a semen result. Match the evidence to the actual goal.

Research explained

Japanese phase III ovulation-induction trial

Who was studied

265 women aged 20–39 with absent or infrequent ovulation after unsuccessful anti-estrogen therapy entered a single-blind randomized comparison of follitropin alfa with urinary FSH; 261 were in the full analysis.

What was found

Ovulation occurred in 79.1% versus 82.6%. The prespecified noninferiority criterion was met. Treatment-emergent adverse events were reported in 53.5% versus 50.0%.

What it cannot establish

The primary outcome was ovulation, not a demonstrated live-birth advantage. The selected population and study-specific treatment approach limit comparisons with other infertility pathways.

Read the original study

Replace the missing signal only when that is the problem

The labeled male indication concerns deficient gonadotropin signaling, not primary testicular failure. These diagnoses cannot be merged because both can involve infertility.

Supporting source