Management of prepubertal cryptorchidism not caused by anatomical obstruction.
Induction of testicular descent usually only temporary; response may be permanent in some patients.
Differential diagnosis (hCG stimulatory test) of cryptorchidism in prepubertal boys to predict whether subsequent orchidopexy will be required. In general, hCG is thought to induce testicular descent in patients in whom descent would have occurred at puberty.
Start corrective therapy for cryptorchidism before pubescence to prevent irreparable testicular damage; opinions differ regarding optimum age for treatment. Manufacturers recommend instituting u-hCG therapy for prepubertal cryptorchidism in boys 4–9 years of age.
Stimulation of spermatogenesis in males with hypogonadotropic hypogonadism secondary to pituitary deficiency†. Full response may require concurrent FSH or menotropins therapy†.
Female Infertility
Used in conjunction with follicle-stimulating agent(s) (e.g., menotropins as fixed-combination preparations or separate components, FSH†) to induce ovulation in anovulatory, infertile women in whom anovulation is secondary (e.g., pituitary insufficiency).
Should not be used in infertile women in whom anovulation is due to primary ovarian failure.
Has been used for the treatment of infertility resulting from deficiency of corpus luteum during luteal phase of menstrual cycle†.
Other Uses
Manufacturer states that u-hCG has not been shown to be effective as adjunctive therapy for the treatment of obesity.
Dosage and Administration
General
Female Infertility
Should be prescribed only by clinicians experienced in infertility treatment and who are familiar with criteria for patient selection and cautions, precautions, and contraindications associated with hCG/follicle-stimulating therapy.
Administer follicle-stimulating agent(s) until sufficient follicular maturation (as determined by serum estradiol concentrations and ovary ultrasound examinations) occurs.
When ultrasound assessment and serum estradiol concentrations show sufficient follicular maturation, discontinue follicle-stimulating therapy and administer hCG to complete final follicular maturation and induce ovulation.
Withhold further follicle-stimulating therapy and delay or withhold hCG if ovaries show an excessive response to treatment with gonadotropins because of increased risk of ovarian hyperstimulation syndrome (OHSS). (See Ovarian Hyperstimulation Syndrome under Cautions.)
Encourage daily sexual intercourse beginning 1 day prior to administration of hCG until ovulation occurs (as determined by rise in basal body temperature, increase in serum progesterone concentrations, and menstruation following shift in basal body temperature). (See Adequate Patient Evaluation and Monitoring under Cautions.)
If stimulation of ovulation is unsuccessful, adjust dosage of follicle-stimulating agent administered in subsequent cycles based on woman’s response in preceding cycle.
Administration
IM Administration
Administer only by IM injection.
Reconstitution
Reconstitute vial containing 10,000 units of chorionic gonadotropin lyophilized powder with 10 mL of bacteriostatic water for injection or water for injection (provided by manufacturer).
Gently agitate until powder is completely dissolved.
Dosage
Dosage is expressed in terms of USP units (units). Each mg of u-hCG is approximately equivalent to ≥1500 USP units. One USP unit is equivalent to 1 WHO international unit.
Dosage regimens vary widely; individualize dosage carefully based on condition being treated, patient age and weight, and clinician’s judgment. Following treatment regimens suggested by various experts:
Pediatric Patients
Prepubertal Cryptorchidism
IM
Boys ≥4 years of age: 4000 units 3 times weekly for 3 weeks or 5000 units every other day for 4 doses or 15 doses of 500–1000 units given over 6 weeks suggested.
Alternatively, 500 units may be given 3 times weekly for 4–6 weeks for boys ≥4 years of age. If this course of therapy is not successful, may administer a subsequent course of therapy 1 month later and increase dosage to 1000 units 3 times weekly for 4–6 weeks.
Hypogonadotropic Hypogonadism in Males
IM
500–1000 units 3 times weekly for 3 weeks suggested, followed by same dosage twice weekly for 3 weeks.
Alternatively, 4000 units 3 times weekly for 6–9 months, followed by 2000 units 3 times weekly for 3 months.
Adults
Hypogonadotropic Hypogonadism in Males
IM
500–1000 units 3 times weekly for 3 weeks suggested, followed by same dosage 2 times weekly for 3 weeks.
Alternatively, 4000 units 3 times weekly for 6–9 months, followed by 2000 units 3 times weekly for 3 months.
Female Infertility
Ovulation Induction
IM
5000–10,000 units given 1 day following last dose of follicle-stimulating therapy suggested.
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