Human Chorionic Gonadotropin (hCG) dosage in published studies and labels
These are the doses used for Human Chorionic Gonadotropin (hCG) in FDA labelling and published clinical studies, reported as each source states them, one row per regimen. They describe what was studied or approved for a specific population. They are not a recommendation, and none of them is a dose for any individual.
Research and educational reference only. This is not medical advice, and no figure on this page is a dosing recommendation.
Last checked against primary sources:
Studied regimens and sources
Human chorionic gonadotropin (hCG) has FDA-approved human dosing, expressed in USP units and given by intramuscular injection, for three indications: prepubertal cryptorchidism, selected cases of hypogonadotropic hypogonadism in males, and induction of ovulation after gonadotropin pretreatment. The labelled regimens run from 500 USP units three times weekly to a single 5,000–10,000 USP unit injection, depending on the indication. All three current US labels state that hCG has not been demonstrated to be effective adjunctive therapy for obesity. Its common use alongside testosterone therapy is not a labelled indication; the nearest published evidence is a 3-week study in healthy men that used 125–500 IU every other day.
| Human dosing established | Yes |
|---|---|
| Route | Intramuscular (the only route on the US urinary hCG labels) · Subcutaneous (compared with intramuscular in small human studies; not a labelled route for urinary hCG) |
| Frequency | By indication: three times weekly or every second day for cryptorchidism; two or three times weekly for hypogonadotropic hypogonadism; a single injection one day after the last gonadotropin dose for ovulation induction |
| Duration studied | By indication: four injections to six weeks for cryptorchidism; six weeks, or nine to twelve months, for hypogonadotropic hypogonadism; a single injection for ovulation induction |
| Evidence level | FDA Approved |
| Last reviewed | 2026-10-05 |
Research-reported dosing
Doses as studied, one row per regimen. Different trials used different regimens; they are listed separately rather than averaged.
| Study / context | Population | Dose | Route | Frequency | Duration | Outcome studied | Source |
|---|---|---|---|---|---|---|---|
| FDA label — Pregnyl, prepubertal cryptorchidismFDA-approved label · FDA prescribing information | Boys with prepubertal cryptorchidism not due to anatomical obstruction; the label says therapy is generally instituted between the ages of 4 and 9 | One of four listed regimens: 4,000 USP units 3 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 6 weeks; or 500 USP units 3 times weekly for 4 to 6 weeks, with a second course at 1,000 USP units per injection 1 month later if the first is not successful | Intramuscular only | Three times weekly or every second day, by regimen | Four injections to six weeks, by regimen | Testicular descent; the label notes that in most cases the response is temporary | PREGNYL (chorionic gonadotropin) for injection — FDA prescribing information (Organon), DailyMed |
| FDA label — Pregnyl, hypogonadotropic hypogonadism in malesFDA-approved label · FDA prescribing information | Males with selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) | 500 to 1,000 USP units 3 times a week for 3 weeks, then the same dose twice a week for 3 weeks; or 4,000 USP units 3 times weekly for 6 to 9 months, after which the dose may be reduced to 2,000 USP units 3 times weekly for an additional 3 months | Intramuscular only | Two or three times weekly, by regimen and phase | Six weeks, or nine to twelve months, by regimen | Treatment of hypogonadotropic hypogonadism; the label states hCG stimulates the Leydig cells of the testis to produce androgens | PREGNYL (chorionic gonadotropin) for injection — FDA prescribing information (Organon), DailyMed |
| FDA label — Pregnyl, induction of ovulationFDA-approved label · FDA prescribing information | Anovulatory infertile women whose anovulation is secondary and not due to primary ovarian failure, after appropriate pretreatment with gonadotropins (human menotropins in the Novarel and Fresenius Kabi labels) | 5,000 to 10,000 USP units; the label notes that 10,000 USP units is the dose recommended in the gonadotropin labeling | Intramuscular only | Single injection, one day after the last dose of gonadotropins | — | Ovulation and pregnancy | PREGNYL (chorionic gonadotropin) for injection — FDA prescribing information (Organon), DailyMed |
| FDA label — Novarel (Ferring)FDA-approved label · FDA prescribing information, BLA 017016 | The same three indications as the Pregnyl label | The same regimens as the Pregnyl label, for all three indications; supplied as 5,000 and 10,000 USP unit vials | Intramuscular only | — | — | Prepubertal cryptorchidism, hypogonadotropic hypogonadism in males, and ovulation induction | NOVAREL (chorionic gonadotropin) for injection — FDA prescribing information (Ferring Pharmaceuticals), DailyMed |
| FDA label — Chorionic Gonadotropin for injection (Fresenius Kabi)FDA-approved label · FDA prescribing information, BLA 017067 | The same three indications as the Pregnyl label | The same regimens as the Pregnyl label, for all three indications; supplied as a 10,000 USP unit vial | Intramuscular only | — | — | Prepubertal cryptorchidism, hypogonadotropic hypogonadism in males, and ovulation induction | CHORIONIC GONADOTROPIN for injection — FDA prescribing information (Fresenius Kabi USA), DailyMed |
| Low-dose hCG during testosterone-induced gonadotropin suppression (Coviello et al., 2005)Clinical trial · Randomised, placebo-controlled dose-response study | Healthy men with normal reproductive physiology (n=29), all given testosterone enanthate 200 mg weekly | 125, 250 or 500 IU, or saline placebo | Subcutaneous, as stated in the methods of a secondary analysis of the same 29 men (Amory et al., Fertil Steril 2008) | Every other day | 3 weeks | Intratesticular testosterone after treatment: 25% below baseline at 125 IU, 7% below at 250 IU and 26% above at 500 IU, against a 94% fall with testosterone plus placebo | Coviello AD et al. Low-dose human chorionic gonadotropin maintains intratesticular testosterone in normal men with testosterone-induced gonadotropin suppression. J Clin Endocrinol Metab. 2005. |
| Subcutaneous versus intramuscular hCG in hypogonadotrophic hypogonadism (Jones et al., 1994)Clinical trial · Within-patient pharmacokinetic comparison of routes | Men with isolated hypogonadotrophic hypogonadism (Kallmann's syndrome, idiopathic or post-traumatic) | 5,000 units, described as the standard dose | Intramuscular in the first week, self-administered subcutaneous in the second | Twice weekly | 2 weeks | Cumulative serum and salivary testosterone were comparable between the two routes | Jones TH et al. Diurnal rhythm of testosterone induced by human chorionic gonadotrophin (hCG) therapy in isolated hypogonadotrophic hypogonadism: a comparison between subcutaneous and intramuscular hCG administration. Eur J Endocrinol. 1994. |
| Subcutaneous versus intramuscular hCG before IVF oocyte retrieval (Stelling et al., 2003)Clinical trial · Prospective comparative study | Women undergoing oocyte retrieval in a university-affiliated IVF programme (n=40) | 10,000 IU | Subcutaneous or intramuscular | Single injection, 36 hours before oocyte retrieval | — | Serum and follicular fluid hCG at retrieval were significantly higher after subcutaneous than after intramuscular injection | Stelling JR et al. Subcutaneous versus intramuscular administration of human chorionic gonadotropin during an in vitro fertilization cycle. Fertil Steril. 2003. |
Where sources disagree
- hCG has no single dose. The labelled regimens range from 500 USP units three times weekly (cryptorchidism and hypogonadotropic hypogonadism) to a single 5,000–10,000 USP unit injection (ovulation induction). The labels present them as regimens "advocated by various authorities" and leave the choice to the indication, the patient's age and weight, and the physician's preference, so quoting one figure without naming the indication is not meaningful.
- All three current US labels — Pregnyl, Novarel and the Fresenius Kabi product — state in their Indications section that hCG has not been demonstrated to be effective adjunctive therapy in the treatment of obesity, and that there is no substantial evidence it increases weight loss beyond that resulting from caloric restriction. Their Clinical Pharmacology sections add that hCG has no known effect on fat mobilisation, appetite or sense of hunger, or body fat distribution. The FDA consumer update "Avoid Dangerous HCG Diet Products" advises consumers to avoid hCG weight-loss products sold as oral drops, pellets and sprays, and states that hCG is not approved for weight loss or for use without a prescription.
- Several DailyMed listings named for hCG — diet drops, sprays and "fat release" liquids — carry the marketing category "unapproved homeopathic", and P.G. 600 is a veterinary product approved under an animal drug application. None of them is an approved human hCG product, and none contributes dosing here.
- hCG is widely used alongside testosterone therapy to preserve testicular function. That is not a labelled indication. The closest published evidence is Coviello et al. (2005): 29 healthy men on testosterone enanthate 200 mg weekly, in whom 250 IU every other day kept intratesticular testosterone near baseline and 500 IU raised it above baseline. The study lasted 3 weeks and its endpoint was intratesticular testosterone; the authors leave the threshold needed to maintain spermatogenesis to future studies, so it does not establish a long-term regimen or a fertility outcome.
- The US urinary hCG labels specify intramuscular use only. Subcutaneous injection has been compared with intramuscular injection in small studies with mixed results: self-administered subcutaneous hCG produced testosterone levels comparable to intramuscular in men with hypogonadotrophic hypogonadism (Jones et al., 1994); serum and follicular hCG were higher after subcutaneous injection at an IVF trigger (Stelling et al., 2003); but in a crossover study of 24 women, peak concentration and AUC were higher after intramuscular injection, and lower in obese than non-obese women by either route (Chan et al., Hum Reprod 2003). The Ovidrel label also describes a controlled IVF study in which urinary hCG was given subcutaneously as the comparator.
- The US labels dose urinary hCG in USP units, while the research literature uses IU; Novarel's own reconstitution table labels its 10,000 USP unit vial as 10,000 IU. Recombinant hCG (choriogonadotropin alfa, Ovidrel) is a different product dosed by mass: 250 mcg subcutaneously, one day after the last dose of the follicle-stimulating agent, for assisted reproduction and ovulation induction. Its label reports that 250 mcg was clinically and statistically equivalent to urinary hCG in controlled infertility studies, but gives no general conversion between micrograms and units, so the two dose scales are not interchangeable.
- On 23 March 2020 approved hCG applications were deemed biologics licences under the BPCI Act, and the three labels above are now marketed under BLAs. The FDA's notice to compounders states that from that date these transitioning biological products are not eligible for the section 503A and 503B compounding exemptions, and names human chorionic gonadotropin among the affected bulk substances.
- The labels differ on how long a reconstituted vial may be kept: refrigerated and used within 30 days for Novarel, and within 60 days for Pregnyl and the Fresenius Kabi product.