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Recombinant Follicle Stimulating Hormone
Recombinant FSH binds to follicle-stimulating hormone receptors on granulosa cells to stimulate follicular growth and estrogen production in the ovaries.
Recombinant FSH binds to follicle-stimulating hormone receptors on granulosa cells to stimulate follicular growth and estrogen production in the ovaries. Used for Infertility in women undergoing assisted reproductive technology (ART), Anovulation and ovulatory disorders in women.
At a glance
| Generic name | Recombinant Follicle Stimulating Hormone |
|---|---|
| Also known as | Gonal-f |
| Sponsor | Bezmialem Vakif University |
| Drug class | Gonadotropin |
| Target | FSH receptor (FSHR) |
| Modality | Small molecule |
| Therapeutic area | Reproductive Endocrinology / Fertility |
| Phase | FDA-approved |
Mechanism of action
FSH is a gonadotropin that acts on FSH receptors (FSHR) expressed on ovarian granulosa cells, promoting their proliferation and differentiation. This leads to follicular development, increased estrogen secretion, and preparation of oocytes for ovulation. The recombinant form is produced using genetic engineering to provide a consistent, pure source of the hormone for therapeutic use.
Approved indications
- Infertility in women undergoing assisted reproductive technology (ART)
- Anovulation and ovulatory disorders in women
Common side effects
- Ovarian hyperstimulation syndrome (OHSS)
- Headache
- Injection site reactions
- Abdominal pain/bloating
- Nausea
Key clinical trials
- PPOS vs GnRH Antagonist in Ovarian Stimulation (ProGanOS Study) (NA)
- An Ethno-bridging Study of Pergoveris in Healthy Premenopausal Participants of Japanese or Caucasian Origin (PHASE1)
- Risk of Infertility Related to Adjuvant Chemotherapy for Early Breast Cancer: Oocyte/Embryo Cryopreservation (NA)
- 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)
- Exogenous Progesterone as Ovulation Trigger (PHASE4)
- Comparison of Follitropin Delta and Follitropin Alfa in Combination With Menotropin
- Comparison of Sequential CFA vs CFA +rFSH for Elective Fertility Preservation. (PHASE3)
- A Study to Assess the Bioequivalence of Follitropin Alfa Solution in Pen and Follitropin Alfa Powder in Vial in Healthy Downregulated Male Participants (PHASE1)
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 |
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