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EMA-approvedaka Gonal-F, Bemfola

Follitropin alfa — Complete Research Guide (2026)

Last updated 2026-06-30

TL;DR

Follitropin alfa (also known as Gonal-F) is a peptide catalogued under Sexual Health (Recombinant FSH). Neutral reference entry; EU status: EU-approved prescription medicine.

What is Follitropin alfa?

Follitropin alfa is a recombinant human follicle-stimulating hormone (r-FSH), marketed chiefly as Gonal-F. It is a prescription biologic, FDA-approved (1997) and EMA-approved, for controlled ovarian stimulation in ART, for ovulation induction in anovulatory (for example WHO Group II) women, and for stimulating spermatogenesis in men with hypogonadotropic hypogonadism.

Evidence comes from multiple randomized controlled trials and Cochrane systematic reviews of recombinant versus urinary FSH; follitropin alfa is the archetypal recombinant FSH within this class evidence.

How does Follitropin alfa work?

It binds FSH receptors on ovarian granulosa cells (and testicular Sertoli cells) to promote follicular recruitment and growth, estradiol production and, in men, support of spermatogenesis, replacing endogenous FSH activity.

What does the research say about Follitropin alfa?

  • Recombinant FSH is at least as effective as urinary gonadotrophins for ovarian stimulation in ART, with similar live birth and clinical pregnancy rates. [1]
  • Low-dose recombinant FSH step-up protocols achieve monofollicular ovulation induction in anovulatory (WHO Group II) women while limiting overstimulation. [4]
  • Individualized decremental/step-up recombinant FSH dosing supports ovulation while reducing excessive multifollicular development. [5]

Clinical research & studies

The references below are the primary sources cited throughout this guide. Each links directly to PubMed or the regulator. Where evidence is preclinical (animal or in-vitro), that is stated rather than implied.

  • [1] Recombinant versus urinary gonadotrophin for ovarian stimulation in assisted reproductive technology cycles — van Wely M et al., Cochrane Database of Systematic Reviews 2011. (Systematic review / meta-analysis (human RCTs))
  • [2] Recombinant versus urinary follicle stimulating hormone for ovarian stimulation in assisted reproduction cycles — Daya S et al., Cochrane Database of Systematic Reviews 2000. (Systematic review / meta-analysis (human RCTs))
  • [3] Recombinant follicle-stimulating hormone (rFSH) versus other recombinant or urinary gonadotropins for ovarian stimulation in assisted reproductive technology cycles — Berkhout RP et al., Cochrane Database of Systematic Reviews 2026. (Systematic review / meta-analysis (human RCTs))
  • [4] Phase IV, open-label, randomized study of low-dose recombinant human follicle-stimulating hormone protocols for ovulation induction — Serour GI et al., Reproductive Biology and Endocrinology 2014. (Phase IV randomized controlled trial)
  • [5] The use of a decremental dose regimen in patients treated with a chronic low-dose step-up protocol for WHO Group II anovulation: a prospective randomized multicentre study — Hugues JN et al., Human Reproduction 2006. (Randomized controlled trial)
  • [6] Factors related to successful ovulation induction in patients with WHO group II anovulatory infertility — Howles CM et al., Reproductive BioMedicine Online 2010. (Analysis of trial data)

Dosing context

This is not medical advice or a usage recommendation. Dosing figures are reported research context only, cited from the published literature.

In monitored cycles it is given as daily subcutaneous injections during the stimulation phase, with the starting dose based on age, ovarian reserve and prior response, then titrated to follicular growth.

Any figures are context only; actual dosing is individualized by the treating clinician and not a recommendation.

Side effects & safety profile

Ovarian hyperstimulation syndrome (OHSS) is the main serious class risk, and higher follicle recruitment raises the chance of multiple pregnancy; both are managed by individualized dosing and close ultrasound/estradiol monitoring.

Injection-site reactions, headache, abdominal or pelvic pain, and ovarian cyst formation are commonly reported.

Treatment is prescribed and supervised by a fertility specialist.

Stacking & combinations

It is used for FSH-driven ovarian stimulation and then followed by an hCG (or GnRH-agonist) trigger for final oocyte maturation, entirely under specialist supervision.

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Frequently asked questions

It is a recombinant FSH used for ovarian stimulation in IVF/ICSI, for ovulation induction in anovulatory women, and for stimulating sperm production in men with hypogonadotropic hypogonadism, all under medical supervision.

References

  1. [1] Recombinant versus urinary gonadotrophin for ovarian stimulation in assisted reproductive technology cycles — van Wely M et al., Cochrane Database of Systematic Reviews 2011. PMID: 21328276. View sourceStudy: Systematic review / meta-analysis (human RCTs)Recombinant FSH and urinary gonadotrophins gave comparable live birth and OHSS rates in ART cycles.
  2. [2] Recombinant versus urinary follicle stimulating hormone for ovarian stimulation in assisted reproduction cycles — Daya S et al., Cochrane Database of Systematic Reviews 2000. PMID: 11034767. View sourceStudy: Systematic review / meta-analysis (human RCTs)Recombinant FSH was associated with clinical pregnancy rates comparable to (and in some analyses favouring) urinary FSH.
  3. [3] Recombinant follicle-stimulating hormone (rFSH) versus other recombinant or urinary gonadotropins for ovarian stimulation in assisted reproductive technology cycles — Berkhout RP et al., Cochrane Database of Systematic Reviews 2026. PMID: 42445958. View sourceStudy: Systematic review / meta-analysis (human RCTs)Updated review found little or no meaningful difference between recombinant FSH and other gonadotropins for key ART outcomes.
  4. [4] Phase IV, open-label, randomized study of low-dose recombinant human follicle-stimulating hormone protocols for ovulation induction — Serour GI et al., Reproductive Biology and Endocrinology 2014. PMID: 24942155. View sourceStudy: Phase IV randomized controlled trialLow-dose recombinant FSH protocols effectively induced ovulation in anovulatory women with an acceptable safety profile.
  5. [5] The use of a decremental dose regimen in patients treated with a chronic low-dose step-up protocol for WHO Group II anovulation: a prospective randomized multicentre study — Hugues JN et al., Human Reproduction 2006. PMID: 16877376. View sourceStudy: Randomized controlled trialA decremental dose step after the step-up phase reduced excessive follicular growth while maintaining ovulation in WHO Group II anovulation.
  6. [6] Factors related to successful ovulation induction in patients with WHO group II anovulatory infertility — Howles CM et al., Reproductive BioMedicine Online 2010. PMID: 20113956. View sourceStudy: Analysis of trial dataBaseline patient characteristics predicted successful monofollicular ovulation induction with recombinant FSH in WHO Group II women.
This article is for educational and research purposes only. Peptides discussed here are not approved for human consumption by the FDA, EMA, or equivalent regulators outside of specific clinical contexts. Always consult a licensed medical professional before any therapeutic use.