General Information

Gonal-F (follitropin alfa for injection) is a gonadotropin.

Gonal-F is specifically indicated for:

• Induction of ovulation and pregnancy in oligo-anovulatory infertile women for whom the cause of infertility is functional and not due to primary ovarian failure.
• Development of multiple follicles in ovulatory infertile women as part of Assisted Reproductive Technology (ART) cycles.

The recommended dosing is as follows:

Induction of Ovulation

Initial starting dose of the first cycle: 75 International Units of Gonal-F per day for 14 days, administered subcutaneously. Individualize doses after 14 days. Do not administer doses greater than 300 International Units per day

Development of Multiple Follicles in Assisted Reproductive Technology (ART)

Initial starting dose of the first cycle: 150 International Units per day, administered subcutaneously. Dosage adjustments after 3 to 5 days and by 75 to 150 International Units at each adjustment. Do not administer doses greater than 450 International Units per day

Mechanism of Action

Gonal-F (follitropin alfa for injection) is a gonadotropin. Gonal-F stimulates ovarian follicular growth in women who do not have primary ovarian failure. In order to bring about final maturation of the follicle and ovulation in the absence of an endogenous LH surge, human chorionic gonadotropin (hCG) must be given, following the administration of Gonal-F, when monitoring of the patient indicates that sufficient follicular development is achieved.

Side Effects

Adverse effects associated with the use of Gonal-F in ovulation induction may include, but are not limited to, the following:

• headache
• abdominal pain
• ovarian hyperstimulation
• injection site pain
• diarrhea
• flatulence
• nausea
• ovarian cyst
• injection site inflammation.

Adverse effects associated with the use of Gonal-F in development of multiple follicles in AR may include, but are not limited to, the following:

• abdominal pain
• headache
• abdominal enlargement
• injection site bruising
• nausea
• injection site pain
• ovarian hyperstimulation
• injection site inflammation
• injection site reaction
• injection site edema

Clinical Trial Results

​​​Induction of Ovulation was evaluated in a randomized, assessor-blind, multinational, multicenter, active-controlled trial in oligo-anovulatory infertile women. Women were randomized to either Gonal-F (n=83), administered subcutaneously, or a comparator recombinant human FSH product. The use of insulin-sensitizing agents was allowed during the trial. The trial was designed to evaluate and compare mean ovulation rates in the first cycle of treatment.

Development of Multiple Follicles as part of an Assisted Reproductive Technology (ART) Cycle

The efficacy of Gonal-F was evaluated in a randomized, assessor-blind, multinational, multicenter active-controlled trial in ovulatory, infertile women treated for one cycle with controlled ovarian stimulation as part of an ART [in vitro fertilization (IVF), or intracytoplasmic sperm injection (ICSI)] cycle. Women were randomized to either Gonal-F (n=237), administered subcutaneously, or a comparator recombinant human FSH product. Randomization was stratified by insemination technique (IVF versus ICSI). All women received a GnRH agonist for pituitary down-regulation before receiving stimulation with recombinant FSH. The primary endpoint was the mean number of fertilized oocytes the day after insemination. The initial doses of Gonal-F were 150 International Units per day for women less than 35 years of age and 225 International Units per day for women 35 years of age and older. The maximal dose given for both age groups was 450 International Units per day.