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r-FSH (Gonal-f)
Recombinant follicle-stimulating hormone (r-FSH) stimulates the growth and maturation of ovarian follicles in women by binding to FSH receptors on granulosa cells.
Recombinant follicle-stimulating hormone (r-FSH) stimulates the growth and maturation of ovarian follicles in women by binding to FSH receptors on granulosa cells. Used for Infertility in women undergoing assisted reproductive technology (ART) / in vitro fertilization (IVF), Anovulation and ovulatory disorders in women.
At a glance
| Generic name | r-FSH (Gonal-f) |
|---|---|
| Also known as | puregon |
| Sponsor | Sisli Hamidiye Etfal Training and Research Hospital |
| Drug class | Gonadotropin |
| Target | FSH receptor (FSHR) |
| Modality | Small molecule |
| Therapeutic area | Reproductive Medicine / Fertility |
| Phase | FDA-approved |
Mechanism of action
r-FSH is a recombinant version of the naturally occurring pituitary hormone that promotes follicular development during the menstrual cycle. By activating FSH receptors on ovarian granulosa cells, it increases estrogen production and facilitates the recruitment and growth of multiple follicles. This is used therapeutically to induce controlled ovarian hyperstimulation for assisted reproductive technologies.
Approved indications
- Infertility in women undergoing assisted reproductive technology (ART) / in vitro fertilization (IVF)
- Anovulation and ovulatory disorders in women
Common side effects
- Ovarian hyperstimulation syndrome (OHSS)
- Headache
- Injection site reactions
- Abdominal pain/bloating
- Nausea
Key clinical trials
- An Ethno-bridging Study of Pergoveris in Healthy Premenopausal Participants of Japanese or Caucasian Origin (PHASE1)
- A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA) (PHASE3)
- Effectiveness of Low Dose Gonadotropin Stimulation Protocol Vs High Dose Gonadotropin Protocol in Poor Responders (EARLY_PHASE1)
- Potential Benefit of r-hLH Addition in Patients Aged 35 to 40 Under Ovarian Stimulation Treatment (PHASE4)
- Effect of GnRH Agonist vs GnRH Antagonist on Oocyte Morphology During IVF/ICSI (PHASE4)
- Effect of GnRH Agonist vs GnRH Antagonist on IVF/ICSI Outcomes. (PHASE4)
- Effect of GnRH Agonist vs GnRH Antagonist on Oocyte Morphology in Polycystic Ovary Syndrome Patients During IVF/ICSI (PHASE4)
- Effect of GnRH Agonist vs GnRH Antagonist on IVF/ICSI Outcomes in Polycystic Ovary Syndrome Patients. (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- r-FSH (Gonal-f) CI brief — competitive landscape report
- r-FSH (Gonal-f) updates RSS · CI watch RSS
- Sisli Hamidiye Etfal Training and Research Hospital portfolio CI