What hCG is, and the three things it is actually labelled for
Chorionic gonadotropin is a polypeptide hormone produced by the human placenta and obtained from the urine of pregnant persons (Pregnyl label, Description). It is a purified preparation of an alpha and a beta subunit; the alpha subunit is essentially identical to those of LH, FSH and TSH, while the beta subunits differ. The medicinal products, such as Pregnyl (Organon) and Novarel (Ferring), are sterile dried powders for intramuscular injection after reconstitution. The two current FDA labels print the same three indications and, word for word in substance, the same regimens for each, prefaced by the same instruction: the dosage regimen employed in any particular case depends on the indication for use, the age and weight of the patient, and the physician's preference. The three labelled indications are induction of ovulation and pregnancy in appropriately pretreated anovulatory women, selected cases of hypogonadotropic hypogonadism in males, and prepubertal cryptorchidism not due to anatomical obstruction. Anything outside those three is not a labelled use, and one popular outside use deserves its own section.
Regimen 1: induction of ovulation and pregnancy
For the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure, and who has been appropriately pretreated with human gonadotropins (menotropins), the labelled dose is a single intramuscular injection of 5,000 to 10,000 USP units, given 1 day following the last dose of gonadotropins. The labels add that a dosage of 10,000 USP units is recommended in the labeling for the gonadotropins themselves. This is the largest hCG dose in either label, and it is a one-off dose, not a course: the repeated-injection schedules used in consumer fertility forums at low doses are not this regimen.
Regimen 2: selected cases of hypogonadotropic hypogonadism in males
For hypogonadism secondary to a pituitary deficiency, the labels print two alternative courses. The first is 500 to 1,000 USP units three times a week for 3 weeks, followed by the same dose twice a week for 3 weeks: fifteen injections in total. The second is a long course: 4,000 USP units three times weekly for 6 to 9 months, following which the dosage may be reduced to 2,000 USP units three times weekly for an additional 3 months. Note the spread between the two: a prescriber choosing between 500 unit and 4,000 unit injections is making a clinical judgement the labels explicitly leave to the physician, which is why this page shows both rather than averaging them.
Regimen 3: prepubertal cryptorchidism
For cryptorchidism not due to anatomical obstruction, where therapy is usually instituted in children between the ages of 4 and 9, both labels print four advocated regimens: 4,000 USP units three times weekly for 3 weeks; 5,000 USP units every second day for 4 injections; 15 injections of 500 to 1,000 USP units over a period of 6 weeks; or 500 USP units three times weekly for 4 to 6 weeks, with a second series begun 1 month later at 1,000 USP units per injection if the first course is not successful. The labels explain the rationale: hCG is thought to induce testicular descent in situations where descent would have occurred at puberty, so treatment may help predict whether orchiopexy will be needed; in most cases the response is temporary, though in some it is permanent.
Reconstitution: turning units into a volume to draw
The only arithmetic hCG requires is at the syringe. The Novarel label's Table 1 gives the concentration for each combination of vial size and reconstitution volume:
| Reconstitution volume | 10,000 unit vial | 5,000 unit vial | Label instruction |
|---|---|---|---|
| 1 mL | 10,000 units/mL | 5,000 units/mL | Administer the entire dose at once |
| 10 mL | 1,000 units/mL | 500 units/mL | Multiple dose administration; refrigerate between doses |
Volume to draw is dose divided by concentration. Worked examples: an ovulation dose of 5,000 units from a 10,000 unit vial made up with 10 mL (1,000 units/mL) is 5 mL; the same dose from a vial made up with 1 mL is the entire 1 mL contents only if the full 10,000 units are given, so a 5,000 unit dose at 10,000 units/mL is 0.5 mL, drawn as part of a whole-vial administration per the label instruction. A 500 unit cryptorchidism dose from a 5,000 unit vial made up with 10 mL (500 units/mL) is exactly 1 mL, and that vial holds ten such doses arithmetically. A 1,000 unit hypogonadism dose at 1,000 units/mL is 1 mL. Pregnyl's presentation differs slightly from Novarel's: it is supplied as a single 10,000 USP unit multiple-dose vial with its own 10 mL solvent vial, and its label states that each multiple-dose vial is to be used for one patient only. Both products are for intramuscular use only.
Who must not receive hCG
The Pregnyl label's contraindications are worth reading before any regimen on this page is contemplated: prior hypersensitivity reactions to human gonadotropins, including hCG, or any of the excipients; high serum FSH indicating primary gonadal failure in women (which is also why the ovulation indication excludes primary ovarian failure); uncontrolled non-gonadal endocrinopathies such as thyroid, adrenal or pituitary disorders; tumors of the hypothalamus or pituitary gland, and of the ovary, breast or uterus in females and breast or prostate in males; malformations of the reproductive organs incompatible with pregnancy; fibroid tumors of the uterus incompatible with pregnancy; and abnormal vaginal bleeding of undetermined origin. The solvent supplied with Pregnyl contains benzyl alcohol, which its label flags as not for use in newborns.
Sources
PREGNYL (chorionic gonadotropin) for injection, USP. FDA-approved prescribing information, Organon (DailyMed setid 1e94155f-19be-4944-b197-be4edbb4faf9, SPL version 11): Description (polypeptide hormone produced by the human placenta, obtained from the urine of pregnant persons; 10,000 USP units per multiple-dose vial, one patient per vial; solvent contains benzyl alcohol, not for use in newborns); Indications and Usage (the obesity statement quoted on this page; the three labelled indications); Dosage and Administration (the ovulation induction dose of 5,000 to 10,000 USP units 1 day following the last dose of gonadotropins; both hypogonadotropic hypogonadism regimens; all four cryptorchidism regimens); Contraindications (reproduced in the section above); How Supplied (10,000 USP unit vial with 10 mL solvent). NOVAREL (chorionic gonadotropin) for injection, USP. FDA-approved prescribing information, Ferring Pharmaceuticals (DailyMed setid ac6918ff-9dc3-40d9-8619-54b26e4bdfc8, SPL version 41): Indications and Usage and Dosage and Administration (the same three indications and the same regimens, cross-checked against Pregnyl for this page); Table 1 in the Dosage and Administration section (reconstitution concentrations and administration instructions, reproduced above); How Supplied (5,000 and 10,000 USP unit vials, each with 10 mL of bacteriostatic water for injection containing 0.9% benzyl alcohol).