Urofollitropin
Also known as: Bravelle, Fertinex, Fostimon, Metrodin, uFSH, Urinary FSH, Urofollitropin
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Summary
Urofollitropin is a urinary‑derived follicle‑stimulating hormone (FSH) preparation approved for prescription use. It is employed to induce ovulation in women with anovulatory infertility, to stimulate ovarian follicles during assisted reproductive technologies, and, in some regions, to treat male infertility such as idiopathic oligoasthenozoospermia when combined with other agents.
Mechanism of Action
Urofollitropin contains FSH, a pituitary‑derived glycoprotein that binds the FSH receptor on ovarian granulosa cells, promoting follicular growth, estrogen synthesis, and oocyte maturation. In men, FSH acts on Sertoli cells to support spermatogenesis. The urinary source provides a mixture of FSH isoforms that retain biological activity comparable to recombinant forms.
What the Research Shows
Clinical reports indicate that urofollitropin and recombinant FSH achieve similar ovulation rates and pregnancy outcomes in women with WHO type II anovulation, though the risk of ovarian hyperstimulation syndrome (OHSS) remains a concern. A 2025 systematic review found that, when total doses were matched, urofollitropin retrieved a comparable number of oocytes to recombinant preparations, with live‑birth, pregnancy, and miscarriage rates similar across agents. In male patients, a 2023 Chinese trial showed that urofollitropin combined with a herbal capsule improved sperm concentration, motility, and serum testosterone compared with urofollitropin alone. A Cochrane review of PCOS patients reported low‑certainty evidence of little or no difference between urinary‑derived and recombinant FSH for live‑birth, clinical pregnancy, or multiple pregnancy, and uncertain effects on OHSS.
Reported Benefits
Evidence suggests urofollitropin effectively induces ovulation in women who have not responded to clomiphene, supporting follicle development and resulting in pregnancy rates comparable to recombinant FSH. In ART cycles, it yields similar numbers of retrieved oocytes when dosing is equivalent. The male‑infertility study reported improvements in semen quality and hormonal profiles when urofollitropin was combined with adjunct therapy. Its urinary origin may offer a cost advantage where pricing is a concern.
Limitations of the Evidence
Comparative data are limited by low‑certainty evidence and heterogeneity among studies. Meta‑analyses show variable oocyte yields and higher total doses required for urofollitropin, and the risk of OHSS remains incompletely defined. The male‑infertility trial was small, single‑center, and combined urofollitropin with a herbal product, making it difficult to isolate the hormone's effect. Long‑term safety and outcomes beyond live birth have not been robustly studied.
Safety Considerations
Urofollitropin is generally well tolerated, but ovarian hyperstimulation syndrome (OHSS) is a recognized risk, particularly with aggressive dosing protocols in women with polycystic ovary syndrome. Multiple pregnancy rates appear similar to recombinant preparations, but careful monitoring of follicular response is advised. In men, no specific adverse events were reported in the cited trial, though hormonal modulation may affect liver function tests; the study found no significant liver changes. Standard precautions for injectable gonadotropins apply.
How It Is Administered
Urofollitropin is supplied for injection and may be administered either intramuscularly or subcutaneously. Dosing regimens typically follow a low‑dose, step‑up protocol with small incremental increases to minimize overstimulation, especially in women with PCOS. Formulations are derived from purified urinary FSH and are available in standard vial presentations.
Routes of Administration
Goals & Uses
- Spermatogenesis induction in malesMale InfertilityModerate
- Follicular monitoring and maturationReproductive EndocrinologyHigh
- Controlled ovarian stimulationReproductiveHigh
- Ovulation inductionReproductive EndocrinologyHigh
- Controlled ovarian stimulation for ART/IVFReproductive EndocrinologyHigh
Contraindications
- Untreated ovarian cysts or severe PCOSGynecologicModerate
- 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
- Estrogen‑dependent neoplasmsOncologyHigh
- 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
- Multiple pregnancyReproductiveRare
- Injection site reactionLocalCommonRedness, swelling, itching, bruising, or pain at the injection site
- Ovarian hyperstimulation syndrome (OHSS)ReproductiveCommon
Drug Interactions
- Oral contraceptivesModerateDelayed gastric emptying may affect absorption timing
- Human Chorionic Gonadotropin (hCG)Low
- GnRH antagonists (e.g., cetrorelix, ganirelix)Low
- GnRH agonists/antagonistsModerate
- Clomiphene citrateLow
- GnRH agonists (e.g., leuprolide)Low
Population Constraints
- Women with poor ovarian reserveReproductive EndocrinologyRelative
- Women with PCOSReproductive EndocrinologyRelative
- Pediatric patientsAgeAbsolute
- Women with uncontrolled thyroid diseaseEndocrineRelative
- MenSexAbsolute
- Postmenopausal womenReproductive StatusAbsolute
Regulatory Status
- European UnionApprovedApproved: infertility – assisted reproduction
- United StatesApprovedApproved: infertility – controlled ovarian stimulationMarketed as Bravelle, Fertinex.
- United KingdomApprovedApproved: infertility – ovarian stimulation
Extracted from pooled post‑menopausal human urine; approved in multiple jurisdictions for infertility treatment; administered by injection.
Evidence & Sources
- Journal ArticleModeratevan Wely M, et al.2005-01-01T00:00:00.000000Z
- Journal ArticleModerateDaya S2004-01-01T00:00:00.000000Z
- Journal ArticleHighMichael TJF, et al.2025-01-01T00:00:00.000000Z
- Journal ArticleModerateZhao YY, et al.2023-01-01T00:00:00.000000Z
- Journal ArticleHighWeiss NS, et al.2025-01-01T00:00:00.000000Z
Frequently Asked Questions
What conditions is urofollitropin used to treat?
It is prescribed to induce ovulation in women with anovulatory infertility, to stimulate follicular development during assisted reproductive techniques, and, in some settings, as part of therapy for male infertility such as idiopathic oligoasthenozoospermia.
How does urofollitropin differ from recombinant FSH?
Both provide biologically active FSH, but urofollitropin is derived from human urine and contains a mixture of isoforms, whereas recombinant FSH is produced by cell culture with high purity and consistent activity. Clinical data show similar pregnancy outcomes, though recombinant products may require lower total doses.
Is there a risk of ovarian hyperstimulation syndrome with urofollitropin?
Yes. OHSS is a known complication of any FSH therapy, particularly in women with polycystic ovary syndrome. Careful low‑dose, step‑up protocols and monitoring are recommended to mitigate this risk.
Can urofollitropin improve male fertility?
A small Chinese study reported that urofollitropin combined with a herbal capsule increased sperm concentration, motility, and serum testosterone compared with urofollitropin alone, suggesting potential benefit, though the evidence is limited and not isolated to the hormone alone.
What routes of administration are available for urofollitropin?
The medication can be injected intramuscularly or subcutaneously, allowing flexibility in clinical practice. Dosing is individualized and often follows a gradual increase to achieve the desired ovarian response.
What is Urofollitropin?
Urofollitropin is a urinary‑derived follicle‑stimulating hormone (FSH) preparation approved for prescription use. It is employed to induce ovulation in women with anovulatory infertility, to stimulate ovarian follicles during assisted reproductive technologies, and, in some regions, to treat male infertility such as idiopathic oligoasthenozoospermia when combined with other agents.
What is Urofollitropin used for?
Urofollitropin is educationally associated with: Spermatogenesis induction in males, Follicular monitoring and maturation, Controlled ovarian stimulation, Ovulation induction, Controlled ovarian stimulation for ART/IVF. Educational only — not medical advice.
How is Urofollitropin administered?
Recorded routes of administration: Intramuscular, Subcutaneous.
What are the potential side effects of Urofollitropin?
Reported adverse effects include: Injection site reactions, Multiple gestation, Hypersensitivity/anaphylaxis, Headache, Abdominal bloating and discomfort, Multiple pregnancy, Injection site reaction, Ovarian hyperstimulation syndrome (OHSS). This list is not exhaustive — consult a qualified clinician.
Who should avoid Urofollitropin?
Recorded contraindications: Untreated ovarian cysts or severe PCOS, Pregnancy, Primary ovarian failure / high baseline FSH, Hormone-sensitive tumors (e.g., ovarian, uterine, breast), Ovarian cysts or enlarged ovaries of unknown etiology, Uncontrolled thyroid or adrenal dysfunction, Estrogen‑dependent neoplasms, Hypersensitivity to FSH preparations. Consult a qualified clinician before use.