FDA-Approved Medication Authoritative Evidence Reference Approved clinical use

Human Chorionic Gonadotropin (hCG)

Placental glycoprotein hormone with LH-like activity; urinary chorionic gonadotropin (Novarel, Pregnyl) FDA-approved for prepubertal cryptorchidism, hypogonadotropic hypogonadism in males and ovulation induction.

Language: English العربية (Arabic) →
Drug Class Gonadotropin; luteinising hormone (LH) receptor agonist.
FDA Regulatory Status FDA-Approved Medication
Clinical Stage Approved clinical use
Evidence Verification Active Reference Standards
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60-Second Scientific Briefing

Human chorionic gonadotropin (hCG) is a glycoprotein hormone made by the placenta whose action is almost identical to luteinising hormone (LH): it stimulates testosterone production by the testes and supports the corpus luteum in the ovary. Urinary hCG (Novarel, Pregnyl) is FDA-approved for prepubertal cryptorchidism, selected cases of hypogonadotropic hypogonadism in men, and ovulation induction after menotropins. The US label states in capital letters that hCG has not been shown to help weight loss. It is prohibited for male athletes by WADA.

What is Human Chorionic Gonadotropin (hCG)?

Pharmacological Classification & Molecular Identity

Human chorionic gonadotropin is a placental glycoprotein hormone with an alpha subunit shared with LH, FSH and TSH and a hormone-specific beta subunit. The medicines Novarel and Pregnyl are purified from human pregnancy urine. [1] U.S. National Library of Medicine (DailyMed), 2025 ↗

Verified Chemical & Regulatory Registry Identifiers

Documented Aliases & Research Codes:
hCG HCG chorionic gonadotropin Novarel Pregnyl

Mechanism of Action & Receptor Targets

Biological Pathway and Target Binding

Receptor Selectivity: Its action is virtually identical to pituitary LH, with a small degree of FSH activity: it stimulates the Leydig cells of the testis to produce androgens and the corpus luteum of the ovary to produce progesterone, and can replace the mid-cycle LH surge that triggers ovulation. The label states it has no known effect on fat mobilisation, appetite or body fat distribution. [1] U.S. National Library of Medicine (DailyMed), 2025 ↗

Regulatory & FDA Approval Status

Legal and Regulatory Classifications
⚠️ FDA APPROVED MEDICATION STATUS

Urinary chorionic gonadotropin (Novarel, Pregnyl; initial US approval 1974 for Novarel) is FDA-approved for prepubertal cryptorchidism not due to anatomical obstruction, selected cases of hypogonadotropic hypogonadism in males, and induction of ovulation and pregnancy in anovulatory infertile women pretreated with menotropins. The label states that hCG has not been demonstrated to be effective adjunctive therapy in the treatment of obesity. [1] U.S. National Library of Medicine (DailyMed), 2025 ↗

Human Chorionic Gonadotropin (hCG) has received regulatory approval for specific medical indications. Commercial distribution and medical usage require appropriate prescription and adherence to approved labeling.

Human Evidence & Clinical Trials

Clinical Study Readouts and Evidence Syntheses

Men with hypogonadotropic hypogonadism (Andrology 2026, 50 studies, 1,583 men with azoospermia): gonadotropin therapy induced spermatogenesis in a pooled 74% after a mean 11.8 months, and 52% of couples wanting a child achieved pregnancy; combined gonadotropin therapy (hCG plus FSH) worked better than hCG alone; most studies were of poor methodological quality. Pubertal induction in males (Eur J Endocrinol 2024, 103 studies, 5,328 patients): spermatogenesis 86% with hCG plus FSH vs 40% with hCG alone. [1] Andrology, 2026 ↗ [2] U.S. National Library of Medicine (DailyMed), 2025 ↗ [3] Eur J Endocrinol, 2024 ↗

Clinical Evidence

Men with hypogonadotropic hypogonadism (Andrology 2026, 50 studies, 1,583 men with azoospermia): gonadotropin therapy induced spermatogenesis in a pooled 74% after a mean 11.8 months, and 52% of couples wanting a child achieved pregnancy; combined gonadotropin therapy (hCG plus FSH) worked better than hCG alone; most studies were of poor methodological quality. Pubertal induction in males (Eur J Endocrinol 2024, 103 studies, 5,328 patients): spermatogenesis 86% with hCG plus FSH vs 40% with hCG alone.

Safety Profile & Clinical Limitations

Documented Adverse Events and Known Uncertainties

The label lists headache, irritability, restlessness, depression, fatigue, oedema, precocious puberty, gynaecomastia, injection-site pain and hypersensitivity reactions. When used with menotropins in women, the serious risks are ovarian hyperstimulation syndrome, ovarian cyst enlargement or rupture, multiple births and arterial thromboembolism. Contraindications include precocious puberty, prostate cancer or other androgen-dependent tumours, and pregnancy. [1] U.S. National Library of Medicine (DailyMed), 2025 ↗

ℹ️ Active Research Safety Surveillance

Most fertility studies in men are observational and of low quality, and sperm quality often remains below normal. The label notes sporadic reports of testicular tumours in young men treated for infertility, without an established causal link. [1] Andrology, 2026 ↗

Dose Approval Status

Commercial Dosing Status and Policy Directives
🛑 PRESCRIPTION DOSING INFORMATION

Approved US labelling (intramuscular): regimens depend on the indication, age and weight. For selected hypogonadotropic hypogonadism in males the label lists 500 to 1,000 USP units three times a week for three weeks then twice a week for three weeks, or 4,000 USP units three times weekly for six to nine months followed by 2,000 USP units three times weekly for three more months; for ovulation induction, 5,000 to 10,000 USP units one day after the last dose of menotropins. Dosing is set by the prescriber. [1] U.S. National Library of Medicine (DailyMed), 2025 ↗

Under Egypt Peptides medical governance policies, no personal dosages, titration intervals, cycles, stacking recommendations, or self-injection instructions may be provided for unapproved investigational compounds. Clinical study protocols represent controlled experimental research parameters exclusively.

Storage & Handling Status: Per the Novarel prescribing information: store the powder at 20–25 °C; after reconstitution, refrigerate at 2–8 °C and use within 30 days. [1] U.S. National Library of Medicine (DailyMed), 2025 ↗

What is Known vs. What is Unknown

Evidence Comparison and Clinical Evidence Boundaries

✓ Confirmed Scientific Evidence

  • Human chorionic gonadotropin is a placental glycoprotein hormone with an alpha subunit shared with LH, FSH and TSH and a hormone-specific beta subunit. The medicines Novarel and Pregnyl are purified from human pregnancy urine.
  • Targets & Selectivity: Its action is virtually identical to pituitary LH, with a small degree of FSH activity: it stimulates the Leydig cells of the testis to produce androgens and the corpus luteum of the ovary to produce progesterone, and can replace the mid-cycle LH surge that triggers ovulation. The label states it has no known effect on fat mobilisation, appetite or body fat distribution.
  • Men with hypogonadotropic hypogonadism (Andrology 2026, 50 studies, 1,583 men with azoospermia): gonadotropin therapy induced spermatogenesis in a pooled 74% after a mean 11.8 months, and 52% of couples wanting a child achieved pregnancy; combined gonadotropin therapy (hCG plus FSH) worked better than hCG alone; most studies were of poor methodological quality. Pubertal induction in males (Eur J Endocrinol 2024, 103 studies, 5,328 patients): spermatogenesis 86% with hCG plus FSH vs 40% with hCG alone.
  • Safety considerations: The label lists headache, irritability, restlessness, depression, fatigue, oedema, precocious puberty, gynaecomastia, injection-site pain and hypersensitivity reactions. When used with menotropins in women, the serious risks are ovarian hyperstimulation syndrome, ovarian cyst enlargement or rupture, multiple births and arterial thromboembolism. Contraindications include precocious puberty, prostate cancer or other androgen-dependent tumours, and pregnancy.

? Unknown / Under Ongoing Investigation

  • Most fertility studies in men are observational and of low quality, and sperm quality often remains below normal. The label notes sporadic reports of testicular tumours in young men treated for infertility, without an established causal link.

Verified Questions & Answers

10 Verified scientific answers with permanent anchor keys
#1

What is Human Chorionic Gonadotropin (hCG) and how is it classified?

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Direct Answer

hCG is a placental hormone that acts almost exactly like LH. Urinary hCG (Novarel, Pregnyl) is an FDA-approved medicine for undescended testes in boys, low testosterone due to pituitary deficiency in men, and ovulation induction.

Authoritative Citations:
#2

What is the mechanism of action and receptor profile of Human Chorionic Gonadotropin (hCG)?

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Direct Answer

It activates the LH receptor: in men it stimulates the Leydig cells to make testosterone, and in women it supports the corpus luteum and can trigger ovulation. The label states it has no effect on fat mobilisation or appetite.

Authoritative Citations:
#3

Is Human Chorionic Gonadotropin (hCG) approved by the US FDA or health authorities?

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Direct Answer

Yes. Novarel and Pregnyl are FDA-approved for prepubertal cryptorchidism, selected hypogonadotropic hypogonadism in males, and ovulation induction after menotropins. The label states hCG is not effective for weight loss.

Authoritative Citations:
#4

What human clinical evidence and trials exist for Human Chorionic Gonadotropin (hCG)?

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Direct Answer

In men with hypogonadotropic hypogonadism, a 2026 meta-analysis (50 studies, 1,583 men) found sperm production restored in 74% and pregnancy in 52% of couples; hCG plus FSH worked better than hCG alone.

Andrology 2026 (systematic review and meta-analysis): 50 studies of 1,583 men with hypogonadotropic hypogonadism and azoospermia; pooled spermatogenesis induction 74% (95% CI 66–82%) after a mean 11.8 months, pregnancy in 52% (42–62%) of couples wanting a child after a mean 19 months, mean sperm concentration 9.8 million/mL; dual gonadotropin therapy outperformed hCG monotherapy; most studies were of poor methodological quality. Eur J Endocrinol 2024: 103 studies, 5,328 males treated for pubertal induction; gonadotropins increased testicular volume, penile size and testosterone in over 98% of analyses; spermatogenesis 86% with hCG plus FSH vs 40% with hCG alone; heterogeneity was high.

#5

What adverse effects and safety risks are documented for Human Chorionic Gonadotropin (hCG)?

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Direct Answer

The label lists headache, irritability, depression, fatigue, oedema, gynaecomastia, early puberty in boys, injection-site pain and allergic reactions. With menotropins in women: ovarian hyperstimulation, multiple births and blood clots. It must not be used with prostate cancer or other androgen-dependent tumours.

Authoritative Citations:
#6

What are the critical unknown safety aspects and clinical limitations of Human Chorionic Gonadotropin (hCG)?

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Direct Answer

Most fertility studies in men are observational and low quality, and sperm counts often stay below normal. The label notes sporadic reports of testicular tumours in treated young men, without an established causal link.

#7

What is the approved dosing status for Human Chorionic Gonadotropin (hCG)?

§
Direct Answer

Approved US labelling (intramuscular): regimens depend on the indication. For selected hypogonadotropic hypogonadism in men the label lists, for example, 500–1,000 USP units three times a week for three weeks then twice a week for three weeks; for ovulation induction, 5,000–10,000 USP units one day after the last menotropins dose. Dosing is set by the prescriber.

Authoritative Citations:
#8

What are the storage and handling requirements for Human Chorionic Gonadotropin (hCG)?

§
Direct Answer

Per the Novarel prescribing information: powder at 20–25 °C; after mixing, refrigerate at 2–8 °C and use within 30 days.

Authoritative Citations:
#9

Is Human Chorionic Gonadotropin (hCG) prohibited in competitive sports by WADA?

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Direct Answer

Yes, for male athletes. Chorionic gonadotropin (CG) is prohibited at all times for males under section S2.2.1 of the 2026 WADA Prohibited List.

Authoritative Citations:
#10

What is Egypt Peptides' official medical policy regarding Human Chorionic Gonadotropin (hCG)?

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Direct Answer

Egypt Peptides publishes reviewed scientific reference monographs for documentation and research. The site does not give individual medical advice, preparation or injection instructions, combination protocols or off-label use instructions. Decisions about any medicine belong to the treating physician.

Authoritative Citations:

Authoritative Sources & Literature Registry

Regulatory dossiers, clinical trial registries, and published studies
Source [1] Tier 1 Regulatory / Academic

Boosting Male Fertility: The Impact of Gonadotropin Therapy on Hypogonadotropic Hypogonadism - A Systematic Review and Meta-Analysis ↗

Publisher / Registry: Andrology Publication Date: 2026-04-16 PubMed PMID: 41987691
Verified Locator: https://pubmed.ncbi.nlm.nih.gov/41987691/
Source [2] Tier 1 Regulatory / Academic

NOVAREL (chorionic gonadotropin) for injection: prescribing information ↗

Publisher / Registry: U.S. National Library of Medicine (DailyMed) Publication Date: 2025-09-25
Verified Locator: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac6918ff-9dc3-40d9-8619-54b26e4bdfc8
Source [3] Tier 1 Regulatory / Academic

Gonadotropins for pubertal induction in males with hypogonadotropic hypogonadism: systematic review and meta-analysis ↗

Publisher / Registry: Eur J Endocrinol Publication Date: 2024-01-03 PubMed PMID: 38128110
Verified Locator: https://pubmed.ncbi.nlm.nih.gov/38128110/

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