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highly purified urinary FSH
Highly purified urinary FSH (follicle-stimulating hormone) stimulates follicular development and estrogen production in women, and spermatogenesis in men.
Highly purified urinary FSH (follicle-stimulating hormone) stimulates follicular development and estrogen production in women, and spermatogenesis in men. Used for Female infertility due to anovulation or low ovarian reserve, Male infertility due to hypogonadotropic hypogonadism or low sperm production, Assisted reproductive technology (ART) / in vitro fertilization (IVF).
At a glance
| Generic name | highly purified urinary FSH |
|---|---|
| Sponsor | University Magna Graecia |
| 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 binds to FSH receptors on granulosa cells in ovarian follicles (in women) and Sertoli cells in seminiferous tubules (in men). In women, it promotes follicular growth and maturation, leading to increased estrogen production and ovulation. In men, it stimulates spermatogenesis and testicular function. This urinary-derived formulation is a naturally sourced alternative to recombinant FSH.
Approved indications
- Female infertility due to anovulation or low ovarian reserve
- Male infertility due to hypogonadotropic hypogonadism or low sperm production
- Assisted reproductive technology (ART) / in vitro fertilization (IVF)
Common side effects
- Ovarian hyperstimulation syndrome (OHSS)
- Headache
- Injection site reactions
- Abdominal pain or bloating
- Nausea
Key clinical trials
- Growth Hormone Co-treatment Within a GnRH Antagonist Protocol in Patients With Poor Ovarian Response (PHASE2)
- Extended Letrozole Regimen Co-treatment With Gonadotropin Releasing Hormone Antagonist Protocol Versus Gonadotropin Releasing Hormone Antagonist Protocol in Poor Responders Undergoing IVF-ET (PHASE2)
- Efficacy of Urinary Vs Recombinant FSH in Oocyte Donors Based on Receptor N680S FSH Gene Polymorphism (Genodon Trial) (PHASE4)
- Efficacy and Tolerability of Human FSH Versus Recombinant FSH (Follitropin Alpha) in ICSI. (PHASE3)
- Clomiphene Citrate in Combination With Gonadotropins for Ovarian Stimulation in Women With Poor Ovarian Response. (PHASE2, PHASE3)
- Levels of Anti-Mullerian Hormone (AMH) During Ovarian Stimulation With Gonadotropins (PHASE2, PHASE3)
- Administration of DHEA in Patients With Poor Response to Ovarian Stimulation for IVF (PHASE2, PHASE3)
- Controlled Ovarian Stimulation Followed by Timed Intercourse or Intrauterine Insemination in Infertile PCOS 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
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