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Reproductive & melanocortin

HCG (human chorionic gonadotropin)

Also known as hCG, chorionic gonadotropin, Novarel, Pregnyl, urinary hCG

FDA-approved productFDA approval covers the labeled indications (prepubertal cryptorchidism, selected hypogonadotropic hypogonadism in males, and ovulation induction with menotropins). Use alongside testosterone therapy is off-label and rests on limited human data: one 3-week randomized trial in 29 healthy men with a surrogate endpoint, one retrospective series of 26 men without a comparator, and expert review algorithms.

Gonadotropin; luteinizing hormone (LH) receptor agonist (LH analog)

FDA-approved as Novarel and Pregnyl. Compounded hCG is not FDA-approved. Source, Aug 27, 2025

Identity. Human chorionic gonadotropin is a two-subunit glycoprotein hormone. The FDA-approved products (Chorionic Gonadotropin, Novarel, Pregnyl) are obtained from human pregnancy urine and standardized by bioassay. Recombinant hCG (choriogonadotropin alfa) is a different product, labeled in micrograms, and the IU doses here do not apply to it. Labels dose in 'USP units'. The studies and reviews dose in 'IU'. Units are given as each source states them and are not converted. The Novarel label lists its vials as '5,000 IU Vial' and '10,000 IU Vial' in Table 1, so it treats USP unit and IU as interchangeable for dosing, although no conversion factor is published. The formulary vial (5,000 IU) matches the Novarel 5,000 USP unit presentation. The source and labeling of the formulary product are not established. Regulatory status matters for a 503A formulary (see the regulatory section). Reconstitution text for the 10,000-unit Fresenius Kabi and Pregnyl vials does not apply to the 5,000 IU formulary vial, because the concentration differs 2x at the same diluent volume.

At a glance

These dosages are a helpful guide, not a prescription. Every clinician is expected to do their own due diligence before prescribing.

  1. Start

    500 to 1,000 USP units intramuscular per dose (male HH, label regimen 1)1

    Approved label

  2. Typical

    2,000 USP units intramuscular three times weekly, reduced from 4,000 (regimen 2)1

    Approved label

  3. Ceiling

    4,000 USP units intramuscular three times weekly (top male HH dose, regimen 2)1

    Approved label
Frequency
Three times weekly; regimen 1 drops to twice weekly after three weeks1
Route
Intramuscular use only (label)1
Course
Regimen 1: 3 weeks, then 3 weeks; regimen 2: 6 to 9 months, then 3 months1
Label doses are urinary hCG in USP units; the 5,000 IU vial at 10 mL is 500 IU/mL, not the 1,000 IU/mL of 10,000-unit vials.
Calculate this dose

Dosing detail

Approved label

Approved label

  • Prepubertal cryptorchidism not due to anatomical obstruction; regimen 1 of 4 'advocated by various authorities' (Fresenius Kabi label)

    4,000 USP units1

    Route
    intramuscular (label: 'Intramuscular Use Only')
    Frequency
    three times weekly
    Duration
    three weeks
    n
    not stated
    Design
    FDA label text; regimens described as advocated by various authorities, not as trial results
    Source quote
    Prepubertal Cryptorchidism Not Due To Anatomical Obstruction 1. 4,000 USP units three times weekly for three weeks.

    Finding. Labeled regimen option. The label says the dosage depends on indication, age, weight, and physician preference.

  • Prepubertal cryptorchidism; regimen 2 of 4 (Fresenius Kabi label)

    5,000 USP units1

    Route
    intramuscular
    Frequency
    every second day
    Duration
    four injections
    n
    not stated
    Design
    FDA label text
    Source quote
    2. 5,000 USP units every second day for four injections.

    Finding. Labeled regimen option.

  • Prepubertal cryptorchidism; regimen 3 of 4 (Fresenius Kabi label)

    500 to 1,000 USP units1

    Route
    intramuscular
    Frequency
    15 injections
    Duration
    over a period of six weeks
    n
    not stated
    Design
    FDA label text
    Source quote
    3. 15 injections of 500 to 1,000 USP units over a period of six weeks.

    Finding. Labeled regimen option.

  • Prepubertal cryptorchidism; regimen 4 of 4, with retry (Fresenius Kabi label)

    500 USP units1

    Route
    intramuscular
    Frequency
    three times weekly
    Duration
    four to six weeks
    n
    not stated
    Design
    FDA label text
    Source quote
    4. 500 USP units three times weekly for four to six weeks. If this course of treatment is not successful, another is begun one month later giving 1,000 USP units per injection.

    Finding. Labeled regimen option. If the course is unsuccessful, the label starts another one month later at 1,000 USP units per injection.

  • Selected cases of hypogonadotropic hypogonadism in males; regimen 1 of 2 (Fresenius Kabi label)

    500 to 1,000 USP units1

    Route
    intramuscular
    Frequency
    three times a week for three weeks, followed by the same dose twice a week
    Duration
    three weeks, then three weeks
    n
    not stated
    Design
    FDA label text; regimen advocated by various authorities
    Source quote
    Selected Cases Of Hypogonadotropic Hypogonadism In Males 1. 500 to 1,000 USP units three times a week for three weeks, followed by the same dose twice a week for three weeks.

    Finding. Labeled regimen for the male hypogonadotropic hypogonadism indication.

  • Selected cases of hypogonadotropic hypogonadism in males; regimen 2 of 2 (Fresenius Kabi label)

    4,000, then may be reduced to 2,000 USP units1

    Route
    intramuscular
    Frequency
    three times weekly
    Duration
    six to nine months, then an additional three months at the reduced dose
    n
    not stated
    Design
    FDA label text; regimen advocated by various authorities
    Source quote
    2. 4,000 USP units three times weekly for six to nine months, following which the dosage may be reduced to 2,000 USP units three times weekly for an additional three months.

    Finding. Labeled long-course regimen for male hypogonadotropic hypogonadism. The label says the dosage may be reduced after six to nine months.

  • SPECIALIST-ONLY (requires a menotropins/gonadotropin protocol and ovarian monitoring): Induction of ovulation and pregnancy in the anovulatory, infertile woman pretreated with human menotropins (Fresenius Kabi label)

    5,000 to 10,000 USP units1

    Route
    intramuscular
    Frequency
    single dose one day following the last dose of menotropins
    Duration
    single administration
    n
    not stated
    Design
    FDA label text
    Source quote
    5,000 to 10,000 USP units one day following the last dose of menotropins. (A dosage of 10,000 USP units is recommended in the labeling for menotropins.)

    Finding. Labeled female indication. The menotropins labeling recommends 10,000 USP units. The Pregnyl label limits use with gonadotropins to physicians experienced with infertility and requires ovarian monitoring by serum estradiol and transvaginal ultrasound.

Human studies

Human study

  • Hypogonadal men on testosterone replacement (daily gel or weekly IM injection) plus concomitant low-dose hCG; semen parameters preserved

    500 IU2

    Route
    intramuscular
    Frequency
    every other day
    Duration
    mean followup 6.2 months
    n
    26
    Design
    retrospective chart review, single center
    Source quote
    Testosterone replacement consisted of daily topical gel or weekly intramuscular injection with intramuscular human chorionic gonadotropin (500 IU) every other day.

    Finding. No patient became azoospermic on concomitant TRT and hCG. Semen parameters did not differ. 9 of 26 men contributed to pregnancy with the partner.

  • Healthy men with normal reproductive physiology given testosterone enanthate 200 mg weekly plus hCG or saline placebo; intratesticular testosterone (ITT) measured

    125, 250, or 500 IU3

    Route
    subcutaneous (hCG; testosterone enanthate was the intramuscular component)
    Frequency
    every other day
    Duration
    3 weeks
    n
    29
    Design
    randomized, placebo-controlled dose-response study
    Source quote
    Twenty-nine men with normal reproductive physiology were randomized to receive 200 mg T enanthate weekly in combination with either saline placebo or 125, 250, or 500 IU hCG every other day for 3 wk.

    Finding. Intratesticular testosterone (ITT) fell 94% on placebo. After treatment, ITT was 25% below baseline at 125 IU, 7% below at 250 IU, and 26% above baseline at 500 IU.

  • Healthy men with experimentally induced gonadotropin deficiency (GnRH antagonist acyline) given very low-dose hCG; ITT biomarker study

    0, 15, 60, or 125 IU4

    Route
    subcutaneous
    Frequency
    every other day
    Duration
    10 days
    n
    37
    Design
    prospective randomized controlled trial; comparator arm 7.5 g testosterone gel daily
    Source quote
    All men received the GnRH antagonist acyline, plus very low doses of hCG (0 IU, 15 IU, 60 IU, or 125 IU) SC every other day or 7.5 g T gel daily (75 mg delivered).

    Finding. hCG produced dose-dependent increases in serum INSL3 and ITT during gonadotropin suppression. INSL3 correlated highly with ITT.

Clinical practice

Clinical practice

Practice numbers come from urology and andrology reviews and an expert algorithm (Ramasamy, Lipshultz and colleagues; Lee and Ramasamy), not from a controlled titration trial. Testosterone-adjunct use, subcutaneous administration, and the 1,500 IU weekly regimen are outside the FDA label. The sources address men. The label does not support hCG for weight loss.

Start
Adjunct to testosterone therapy for fertility preservation: 500 IU every other day (about 1,750 IU/week; reviews, citing the Hsieh series). Adjunct for testicular size when fertility is not desired: 1,500 IU weekly (reviews). Male hypogonadotropic hypogonadism: 1,500-2,000 IU 2-3 times weekly (about 3,000-6,000 IU/week; review). Tier: limited human evidence for the first two; the HH regimen overlaps the labeled indication.
Titration
Only the hypogonadotropic hypogonadism pathway has a sourced step: if hCG alone has not induced spermatogenesis within 4-6 months, add FSH 75 IU SC every other day (Lee and Ramasamy review). For men seeking pregnancy, semen analysis every 2 months is suggested. No source provides a stepwise up-titration schedule for hCG as a testosterone-therapy adjunct.
Typical
500 IU every other day (about 1,750 IU/week) while continuing testosterone, for pregnancy planned in 6-12 months; 3,000 IU every other day (about 10,500 IU/week; with or without clomiphene) after stopping testosterone, for pregnancy planned within 6 months (reviews, expert algorithm). 3,000 IU is a per-injection dose, not a weekly dose.
Ceiling
No source states a safety ceiling. The upper reference is the FDA label's highest male regimen: 4,000 USP units three times weekly (12,000 USP units/week) for 6-9 months, reduced to 2,000 USP units three times weekly (6,000/week) afterward. Reviews report hCG-only spermatogenesis induction at 1,500 to 5,000 IU 2-3 times per week for three to six months; the top of that range (5,000 IU three times weekly, 15,000 IU/week) exceeds the label's highest male regimen. Reviews also report 5,000 IU weekly added after clomiphene in non-obstructive azoospermia. The Pregnyl label warns that water and sodium retention is occasionally seen after high dosages in men, attributed to excessive androgen production.
Frequency
Every other day (500 IU and 3,000 IU regimens; about 3.5 injections/week); weekly (1,500 IU testicular-size regimen); 2-3 times weekly (hypogonadotropic hypogonadism). Per-injection dose and approximate weekly total: 500 IU EOD = ~1,750/week; 1,500 IU weekly = 1,500/week; 3,000 IU EOD = ~10,500/week; label HH 4,000 USP units TIW = 12,000/week.
Route
Label: intramuscular use only. Practice reviews describe intramuscular or subcutaneous administration (3,000 IU 'intramuscular, or subcutaneous every other day'); subcutaneous use is outside the labeled route.
Cycle
For pregnancy planned beyond 12 months: cycle off testosterone every 6 months and use a 4-week cycle of 3,000 IU hCG every other day (reviews). Hypogonadotropic hypogonadism: up to 2 years may be needed to reach maximum sperm production.

Sources

  • Clinical practicePeer-reviewed review5
    In men who desire pregnancy within 6–12 months TRT can be continued with co-administration of 500 IU of HCG every other day ± clomiphene citrate can be used.
  • Clinical practicePeer-reviewed review5
    For men who do not desire to preserve fertility testicular size can me maintained while undergoing TRT with 1,500 IU of HCG given weekly.
  • Clinical practicePeer-reviewed review5
    For men who wish to obtain pregnancy within six months it was suggested to discontinue TRT and start 3,000 IU of hCG intramuscular, or subcutaneous every other day.
  • Clinical practicePeer-reviewed review5
    most treatment regimens consist of starting with hCG only doses of 1,500 to 5,000 IU 2–3 times per week for three to six months
  • Clinical practicePeer-reviewed review5
    The regimens used to treat men with HH usually consist of hCG 1,500–2,000 IU 2–3 times weekly to achieve at testosterone level within the normal range. If this alone fails to induce spermatogenesis within 4–6 months FSH 75 IU SC every other day can be added
  • Clinical practicePeer-reviewed review6
    If it is not, the patient may maintain testicular size by adding 1500 IU hCG weekly. If the patient desires to maintain some degree of testicular size, he may cycle off of TST every 6 months, with a 4 week treatment cycle of 3000 IU hCG every other day.
  • Clinical practicePeer-reviewed review6
    Intramuscular human chorionic gonadotropin (hCG) therapy is an option shown to protect against, or at least to diminish, the impact that exogenous testosterone has on intratesticular testosterone levels.
  • Clinical practicePeer-reviewed review7
    Intramuscular injections 2 to 3 times per week at doses of 2,000 to 3,000 units for four months can initiate spermatogenesis for men with hypogonadotropic hypogonadism
  • Clinical practicePeer-reviewed review5
    Treatment should be initiated with hCG 2,000 IU every other day and clomiphene citrate 50 mg PO every other day. After 3 months SA and hormones should be repeated. If estradiol is high, then anastrozole 1 mg PO twice weekly can be added.
  • Clinical practicePeer-reviewed study8
    Current American Urological Association (AUA) guidelines recommend hCG for T-deficient men who wish to preserve their fertility.

Safety

Serious warnings

  • Boxed warning: none appears in the openFDA/DailyMed records for the Fresenius Kabi, Novarel or Pregnyl labels reviewed.1
  • The indications section of the label states: 'HCG HAS NOT BEEN DEMONSTRATED TO BE EFFECTIVE ADJUNCTIVE THERAPY IN THE TREATMENT OF OBESITY. THERE IS NO SUBSTANTIAL EVIDENCE THAT IT INCREASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRICTION'1
  • Label warnings: 'The principal serious adverse reactions are: (1) Ovarian hyperstimulation, a syndrome of sudden ovarian enlargement, ascites with or without pain and/or pleural effusion, (2) Rupture of ovarian cysts with resultant hemoperitoneum, (3) Multiple births and (4) Arterial thromboembolism.' (stated in the context of use with menotropins)1
  • Label warnings: 'Anaphylaxis and other hypersensitivity reactions have been reported with urinary-derived HCG products.'1
  • Novarel label warnings: 'Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants.' (diluent contains 0.9% benzyl alcohol)9
  • Pregnyl warning: 'Use hCG in conjunction with gonadotropin therapy only if the physician is experienced with infertility problems and is familiar with the criteria for patient selection, contraindications, warnings, precautions, and adverse reactions described in the package insert for gonadotropins.' Also: 'Safe and effective induction of ovulation with use of PREGNYL requires monitoring of ovarian response with serum estradiol and transvaginal ultrasound on a regular basis.'10

Contraindications

  • 'Precocious puberty, prostatic carcinoma or other androgen-dependent neoplasm, prior allergic reaction to HCG.'1
  • Novarel label adds: 'HCG may cause fetal harm when administered to a pregnant woman.'9
  • Pregnyl label (effective 2025-12-02), stricter list: 'Prior hypersensitivity reactions to human gonadotropins, including hCG, or any of the excipients ... Presence of uncontrolled non-gonadal endocrinopathies (e.g., thyroid, adrenal, or pituitary disorders). Tumors of the hypothalamus or pituitary gland and ovary, breast, or uterus in females and breast or prostate in males.' The labels differ; screen against the strictest current list.10

Adverse effects

  • Label adverse reactions: 'Headache, irritability, restlessness, depression, fatigue, edema, precocious puberty, gynecomastia and pain at the site of injection.'1
  • Novarel label: 'Hypersensitivity reactions both localized and systemic in nature, including erythema, urticaria, rash, angioedema, dyspnea and shortness of breath, have been reported.'9
  • Novarel label: 'There have been sporadic reports of testicular tumors in otherwise healthy young men receiving HCG for secondary infertility. A causative relationship between HCG and tumor development in these men has not been established.'9
  • Pregnyl label (in the male): 'Water and sodium retention is occasionally seen after administration of high dosages; this is regarded as a result of excessive androgen production.' and 'HCG treatment may sporadically cause gynecomastia.'10

Monitoring

  • Label precautions: 'Induction of androgen secretion by HCG may induce precocious puberty in patients treated for cryptorchidism. Therapy should be discontinued if signs of precocious puberty occur.'1
  • Label precautions: 'Since androgens may cause fluid retention, HCG should be used with caution in patients with cardiac or renal disease, epilepsy, migraine or asthma.' The current Pregnyl label adds hypertension to this list: 'Use hCG with caution in patients with cardiac or renal disease, hypertension, epilepsy, migraine, or asthma.'1
  • Practice review: for men seeking pregnancy, 'SA should then be performed every two months' (semen analysis), with baseline semen analysis and hormones (FSH, LH, T, estradiol) before starting.5
  • No single guideline sets male monitoring. The sources suggest baseline and periodic total testosterone, estradiol, and LH/FSH (Lee 2018 repeats semen analysis and hormones at 3 months and adds anastrozole 1 mg twice weekly if estradiol is high; labels list gynecomastia and fluid retention); blood pressure (Pregnyl hypertension caution); and prostate assessment, because prostate cancer is a contraindication. A University of Miami cohort of men on hCG monotherapy tracked T, LH, FSH, estradiol, hematocrit, HbA1c and PSA (Rainer 2022). LH assays may cross-react with hCG (label interaction).5
  • Rainer 2022: 'We evaluated changes in hormones [T, LH, follicle-stimulating hormone (FSH), and estradiol], hematocrit (HCT), glycated hemoglobin (HbA1c), and prostate-specific antigen (PSA).'8

Interactions

  • Label: 'Chorionic gonadotropin may interfere with radioimmunoassay for gonadotropins, particularly luteinizing hormone.'1

Handling

Reconstitution

FORMULARY VIAL (5,000 IU): a 5,000 IU vial plus 10 mL bacteriostatic water for injection gives 500 IU/mL (multi-dose, refrigerate between doses). Adding 1 mL gives 5,000 IU/mL (administer the entire dose at once). Source: Novarel Table 1, 'Reconstitution volume ... 1 mL: 10,000 IU Vial 10,000 IU/mL, 5,000 IU Vial 5,000 IU/mL, Administer entire dose at once; 10 mL: 1,000 IU/mL, 500 IU/mL, Multiple dose administration, refrigerate between doses'. NOT THE FORMULARY VIAL: the Fresenius Kabi and Pregnyl 10,000 USP unit vials (10 mL gives 1,000 IU/mL). Fresenius Kabi text: 'Withdraw sterile air from lyophilized vial and inject into diluent vial. Remove 10 mL from diluent vial and add to lyophilized vial; agitate gently until solution is complete.' Label diluent is Bacteriostatic Water for Injection with 0.9% benzyl alcohol. Labels cover the manufacturer's kit, not a 503A pharmacy's preparation.

Storage before mixing

Fresenius Kabi label: 'Store at room temperature 20°C to 25°C (68°F to 77°F)'. Novarel label: 'Store at room temperature at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C'.

Storage after mixing

Labels differ. Fresenius Kabi: 'the reconstituted vial may be refrigerated between 2℃ to 8℃ (36℉ to 46℉) and must be discarded after 60 days. Do not freeze and do not shake.' Pregnyl: 'discard after 60 days'. Novarel: 'REFRIGERATE RECONSTITUTED PRODUCT AT 2° to 8°C (36° to 46°F) AND USE WITHIN 30 DAYS.' Use the beyond-use date on the dispensed product rather than a label figure.1910

Evidence

FDA-licensed (BLA) products carry labeled indications for prepubertal cryptorchidism, selected hypogonadotropic hypogonadism in males, and ovulation induction. Use as an adjunct during testosterone therapy is not a labeled use. That use rests on three sources. Coviello 2005 was a 3-week randomized dose-finding trial in 29 healthy men. Its endpoint was intratesticular testosterone measured by testicular aspiration, a surrogate rather than sperm or pregnancy. Hsieh 2012 was a retrospective single-center series of 26 men (mean 6.2 months) with no comparator arm. Expert review algorithms are the third source. Neither study proves that 500 IU every other day preserves fertility. No controlled trial of a start-to-ceiling titration in TRT patients was found. The labels apply to the approved products, not to a compounded or repackaged 5,000 IU vial.

Mechanism

hCG acts as an LH analog. It stimulates Leydig cell testosterone production and, in men, raises intratesticular and serum testosterone. It shares an identical alpha subunit with LH and has a longer half-life (reported 36 hours versus 30 minutes for LH). In men on exogenous testosterone, it substitutes for suppressed LH.57

Availability

Amounts offered

  • 5,000 IU

Custom strengths on request.

References

According to PubMed

  1. 1Chorionic Gonadotropin for injection, 10,000 USP units (Fresenius Kabi USA) - prescribing information, revised February 2025DailyMed / openFDA drug label API (set id f93b2baa-03ac-4650-b35a-20b818d712d6; BLA017067; effective 2025-04-11), 2025
  2. 2Concomitant intramuscular human chorionic gonadotropin preserves spermatogenesis in men undergoing testosterone replacement therapy.J Urol 2013;189(2):647-50 (Hsieh, Pastuszak, Hwang, Lipshultz), 2012
  3. 3Low-dose human chorionic gonadotropin maintains intratesticular testosterone in normal men with testosterone-induced gonadotropin suppression.J Clin Endocrinol Metab 2005;90(5):2595-602 (Coviello et al.), 2005
  4. 4Serum insulin-like factor 3 is highly correlated with intratesticular testosterone in normal men with acute, experimental gonadotropin deficiency stimulated with low-dose human chorionic gonadotropin: a randomized, controlled trial.Fertil Steril 2013;99(1):132-139 (Roth et al.), 2012
  5. 5Indications for the use of human chorionic gonadotropic hormone for the management of infertility in hypogonadal men.Transl Androl Urol 2018;7(Suppl 3):S348-S352 (Lee, Ramasamy); full text PMC6087849, 2018
  6. 6Preserving fertility in the hypogonadal patient: an update.Asian J Androl 2015;17(2):197-200 (Ramasamy, Armstrong, Lipshultz); full text PMC4378070, 2015
  7. 7Exogenous testosterone: a preventable cause of male infertility.Transl Androl Urol 2013;2(2):106-13 (Crosnoe, Grober, Ohl, Kim); full text PMC4708215, 2013
  8. 8The Safety of Human Chorionic Gonadotropin Monotherapy Among Men With Previous Exogenous Testosterone Use.Cureus 2022;14(6), 2022
  9. 9Novarel (chorionic gonadotropin) for injection, 5,000 and 10,000 USP units (Ferring) - prescribing informationDailyMed / openFDA drug label API (set id ac6918ff-9dc3-40d9-8619-54b26e4bdfc8; BLA017016; effective 2025-08-27), 2025
  10. 10Pregnyl (chorionic gonadotropin) for injection (Organon) - prescribing informationDailyMed / openFDA drug label API (set id 1e94155f-19be-4944-b197-be4edbb4faf9; BLA017692; effective 2025-12-02), 2025
  11. 11Notice to compounders: changes that will affect compounding on March 23, 2020U.S. Food and Drug Administration, Human Drug Compounding (content current as of 03/05/2020), 2020
  12. 12Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C ActU.S. Food and Drug Administration, Human Drug Compounding (content current as of 05/14/2026), 2026

Last reviewed 2026-10-14. 28 figures checked against their sources. How this works