Urofollitropin

Summary

Urofollitropin (urinary FSH) is a purified human follicle-stimulating hormone used in assisted reproductive technology (ART) to induce ovulation in anovulatory infertile women and for controlled ovarian stimulation. It is also used in males to stimulate spermatogenesis in cases of hypogonadotropic hypogonadism.

Mechanism of Action

Urofollitropin is a purified preparation of follicle-stimulating hormone (FSH) extracted from the urine of postmenopausal women. It binds to FSH receptors on ovarian granulosa cells, stimulating follicular growth and maturation, and on testicular Sertoli cells to support spermatogenesis.

Routes of Administration

Goals & Uses

• Spermatogenesis induction in malesMale InfertilityModerate
• Follicular monitoring and maturationReproductive EndocrinologyHigh
• Ovulation inductionReproductive EndocrinologyHigh
• Controlled ovarian stimulation for ART/IVFReproductive EndocrinologyHigh

Contraindications

• PregnancyPopulationHighPotential fetal risk or insufficient safety data
• Primary ovarian failure / high baseline FSHEndocrineHigh
• Hormone-sensitive tumors (e.g., ovarian, uterine, breast)OncologyHigh
• Ovarian cysts or enlarged ovaries of unknown etiologyGynecologyModerate
• Uncontrolled thyroid or adrenal dysfunctionEndocrinologyHigh
• Hypersensitivity to FSH preparationsAllergy/ImmunologyHigh

Adverse Effects

• Injection site reactionsLocalCommon
• Multiple gestationReproductiveUncommon
• Hypersensitivity/anaphylaxisImmunologicalRare
• HeadacheNeurologicCommonPain in the head or upper neck
• Abdominal bloating and discomfortGastrointestinalCommon
• Ovarian hyperstimulation syndrome (OHSS)ReproductiveUncommon

Drug Interactions

• Human Chorionic Gonadotropin (hCG)Low
• GnRH antagonists (e.g., cetrorelix, ganirelix)Low
• Clomiphene citrateLow
• GnRH agonists (e.g., leuprolide)Low

Population Constraints

• Women with poor ovarian reserveReproductive EndocrinologyRelative
• Women with PCOSReproductive EndocrinologyRelative
• Pediatric patientsAgeAbsolute
• Postmenopausal womenReproductive StatusAbsolute

Regulatory Status

• European UnionApprovedApproved: Anovulation including PCOS unresponsive to clomiphene, Controlled ovarian stimulation for ART, Male hypogonadotropic hypogonadismFostimon (IBSA) remains available in several EU member states.
• United StatesApprovedApproved: Induction of ovulation in oligo-anovulatory infertile women, Controlled ovarian stimulation for ARTBravelle (Ferring) was approved by FDA but was voluntarily discontinued from the US market around 2016. Urinary FSH products are largely replaced by recombinant FSH.
• United KingdomApprovedApproved: Ovulation induction, Controlled ovarian stimulation for ARTAvailable under MHRA authorization; urinary FSH still used in some UK fertility clinics.

Approved by the FDA and EMA for ovulation induction and controlled ovarian stimulation. Available as Bravelle (US, now discontinued) and Fostimon (EU). Largely being supplanted by recombinant FSH preparations.

Evidence & Sources

No sources recorded yet.