Is hCG legal?
FDA approved · biologic- FDA status
- hCG is FDA approved for: Prepubertal cryptorchidism; Hypogonadotropic hypogonadism in males; Ovulation induction.
- Compounding
- It remains an FDA-approved prescription medicine (Novarel, Pregnyl), but since March 23, 2020 it has been regulated as a biological product, so it cannot be compounded under section 503A or 503B. Use outside the approved indication is off-label and a clinician’s decision.
- Prescription
- A licensed US clinician can prescribe hCG.
- Sport
- Prohibited in sport under the World Anti-Doping Agency list.
US status checked October 2026 against FDA’s compounding lists. Sources at the foot of the page.
What is hCG?
Human chorionic gonadotropin (hCG) is a hormone made by the placenta in early pregnancy. It is the hormone that home pregnancy tests detect. Strictly speaking it is a glycoprotein, a protein with sugar chains attached, rather than a short peptide. It appears in peptide directories because it is injected and often used alongside peptide drugs.
hCG was identified in the 1920s, and hormone purified from urine has been used in medicine for most of the last century. In the US it is sold as Pregnyl and Novarel, which are purified from urine, and as Ovidrel, a recombinant version made in cell culture. Approved uses include ovulation induction, hypogonadotropic hypogonadism in men and prepubertal cryptorchidism (undescended testes). Its best-known off-label use today is in men on testosterone replacement therapy (TRT), who take it to keep the testes working and to protect fertility.
- Anecdotal only
- In vitro only
- Animal models only
- Preliminary human
- Clinical trials
- Regulator approved
How hCG works
In men, the pituitary gland releases luteinizing hormone (LH), which tells the testes to make testosterone. hCG looks enough like LH to press the same button. When a man takes testosterone from outside, his brain senses plenty of hormone and stops sending LH. The testes go quiet, shrink and make fewer sperm. hCG skips the brain and signals the testes directly, so it keeps them active even when the brain's signal is switched off.
In women, the same LH-like signal triggers the final maturation and release of an egg. That is why hCG is used as the "trigger shot" in fertility treatment.
In more precise terms, LH and hCG share one receptor, the LH/choriogonadotropin receptor (LHCGR), a G protein-coupled receptor found on Leydig cells in the testis and on cells of the ovarian follicle.5 Men born with inactivating mutations in this receptor have Leydig cell hypoplasia and low testosterone, which shows how central the pathway is.5 hCG's beta subunit carries extra sugar chains that slow its clearance, so a single injection acts for a day or more, much longer than natural LH. hCG raises testosterone inside the testis, but it does not supply follicle-stimulating hormone (FSH), the second pituitary signal that full sperm production also needs.
Kisspeptin starts the cascade; gonadorelin is GnRH itself; hCG acts like LH at the testes or ovaries. Continuous GnRH agonists such as triptorelin switch the axis off rather than on.
What the research shows on hCG
hCG's core effects are not in doubt. It has decades of clinical use and several FDA-approved indications. The open questions concern specific off-label uses, above all how well it protects fertility in men on testosterone.
The rationale for that use is solid. Exogenous testosterone suppresses gonadotropins, sharply lowers testosterone inside the testis and impairs sperm production.8 Recovery after stopping TRT is often slow and varies a great deal between men.8 A 2025 review lists hCG and FSH among therapies that may preserve or restore sperm production in selected men on TRT.8 The word "may" matters. Most supporting data come from small observational studies rather than large randomized trials, and protocols differ.
Men coming off anabolic steroids show a similar evidence gap. A 2014 review planned as a meta-analysis found no studies of high enough quality to pool. It fell back on expert opinion, which supports hCG, selective estrogen receptor modulators and careful use of testosterone.3
In adolescents with hypogonadotropic hypogonadism, hCG alone or combined with FSH is used to induce puberty in a way intended to protect future fertility. A recent review notes there is still no clear consensus on the best protocol.4
hCG also has a diagnostic role. Clinicians use hCG stimulation tests to assess testicular function in boys with conditions such as micropenis.1
The weakest claim attached to hCG is weight loss. The "hCG diet" pairs small daily doses with a very low calorie diet. Controlled trials found the weight loss came from the calorie restriction, not the hormone, and FDA-approved labeling states that hCG has not been shown to be effective for obesity.
Studied for: Preservation of fertility and testicular volume on TRT, Hypogonadotropic hypogonadism, Ovulation induction.
hCG reference data
| Molecular weight | 36,700 Da |
|---|---|
| CAS number | 9002-61-3 |
| FDA status | Prepubertal cryptorchidism; Hypogonadotropic hypogonadism in males; Ovulation induction |
| Prohibited in sport | Yes, under the WADA prohibited list |
hCG dosage in published research
2-3x weekly (dosed in international units). A reference pattern, not a prescription.
How hCG is used in practice
In fertility medicine hCG is a standard, well-understood drug. Reproductive endocrinologists use it to trigger ovulation. Urologists and endocrinologists use it, often with FSH or HMG, to restore sperm production in men with hypogonadotropic hypogonadism.
In men's health clinics, including telehealth services, it is usually prescribed off-label alongside testosterone and injected under the skin a few times a week. The dosing table on this page shows the ranges commonly used. Monitoring typically covers testosterone and estradiol, plus semen analysis for men planning a family.
Supply has been a recurring problem. In 2020 the FDA began regulating hCG as a biological product, which largely ended pharmacy compounding of it. Many clinics now use branded products, and some moved patients to gonadorelin or enclomiphene instead.
hCG is also sold on research-chemical and grey-market sites and is common in bodybuilding after steroid cycles. Those vials have no regulated quality control. A large glycoprotein depends on correct manufacture, storage and refrigeration to keep its potency, and buyers have no reliable way to check any of that. hCG is prohibited in male athletes under anti-doping rules.
hCG risks and side effects
Reported side effects include breast tenderness or gynecomastia, water retention, acne, mood changes and injection-site reactions. Many relate to estrogen. Stimulating the testes raises testosterone and also the testes' own estradiol output. Some clinicians add an aromatase inhibitor, but that brings its own risks, since estradiol that is pushed too low can affect bone, mood and libido.
hCG should not be used with hormone-sensitive cancers such as prostate or breast cancer, in precocious puberty or in pregnancy. In women having ovulation induction, the main serious risks are ovarian hyperstimulation syndrome and multiple pregnancy.
hCG also interferes with lab tests. It will produce a positive pregnancy test, and beta-hCG is a standard blood marker for testicular germ cell tumors.2 A man taking hCG will have raised levels for reasons unrelated to cancer, so anyone using it should tell clinicians before blood work.
Long-term outcomes of years of combined hCG and TRT have not been well studied. Grey-market products add the risk of wrong dose, contamination or no active hormone at all.
Reported side effects
Alternatives to hCG
For men who want to protect fertility, the most direct option is to avoid testosterone while trying to conceive. A 2025 review states that exogenous testosterone is contraindicated in men trying to conceive, and notes that newer short-acting oral and nasal formulations may suppress the axis less.8
Clomiphene citrate, used off-label in men, and enclomiphene, which is not FDA approved, raise the body's own LH and FSH. Gonadorelin works one step higher, at the pituitary, but needs a responsive pituitary and has thinner evidence in TRT. When sperm counts stay low on hCG alone, clinicians add recombinant FSH or HMG (menotropins). For weight loss, FDA-approved options such as semaglutide and tirzepatide have strong trial evidence, unlike hCG.
The bottom line on hCG
hCG is a proven, approved hormone with a clear mechanism and a long track record in fertility care. Its use with TRT is reasonable and widely practiced, but it rests on smaller studies than most people assume, and it does not replace FSH. It works best under a prescriber with lab monitoring and a pharmacy-grade product. It has no place in weight loss.
Questions for a clinician
- What evidence applies to my situation, and at what level?
- What established alternatives should I consider first?
- What monitoring would be necessary, and how often?
hCG FAQ
What is hCG?
A placental glycoprotein hormone that mimics LH directly at the testis, the long-standing standard for preserving fertility on TRT. It is classed as reproductive & HPTA.
Is hCG FDA approved?
Yes. hCG is FDA approved for: Prepubertal cryptorchidism; Hypogonadotropic hypogonadism in males; Ovulation induction.
Is hCG legal in the US?
hCG is FDA approved for: Prepubertal cryptorchidism; Hypogonadotropic hypogonadism in males; Ovulation induction. It remains an FDA-approved prescription medicine (Novarel, Pregnyl), but since March 23, 2020 it has been regulated as a biological product, so it cannot be compounded under section 503A or 503B. Use outside the approved indication is off-label and a clinician’s decision.
What dose of hCG is used in research?
Published research and practitioner protocols report 250 mcg - 1.5 mg, 2-3x weekly (dosed in international units). This is a reference range, not a recommendation; dosing should be set by a licensed clinician.
What are the side effects of hCG?
Reported side effects include gynaecomastia, water retention, acne, mood changes, injection-site reactions. Contraindications: hormone-sensitive malignancy, precocious puberty, pregnancy.
What is the half-life of hCG?
The reported half-life of hCG is ~24-36 hours.
Is hCG banned in sport?
Yes. hCG falls under the World Anti-Doping Agency prohibited list.
Which telehealth clinics prescribe hCG?
Clinics in our directory that list hCG include Marek Health, Defy Medical, Hone Health, Fountain TRT, TRT Nation, Craft Medical. Each is scored on our published rubric.
References
Regulatory and primary sources
- FDA: Bulk drug substances that may present significant safety risks (Category 2 and withdrawn nominations) ↗ · content current as of April 22, 2026; checked October 18, 2026
- FDA: Bulk drug substances used in compounding under section 503A ↗ · how the 503A categories work
- PubChem compound record (CID 4369448) ↗ · structure, identifiers, synonyms
- DailyMed: FDA-approved labeling for hCG ↗ · indications, dosing, warnings as approved
- FDA Drugs@FDA database ↗ · approval history
- WADA Prohibited List ↗ · current year
- CAS Registry Number 9002-61-3 ↗ · chemical identity
Published literature
- Micropenis.Indian J Pediatr 2023.PubMed 37079255 · doi:10.1007/s12098-023-04540-w
- Testicular Germ Cell Tumors: A Review.JAMA 2025.PubMed 39899286 · doi:10.1001/jama.2024.27122
- Anabolic steroid-induced hypogonadism: diagnosis and treatment.Fertil Steril 2014.PubMed 24636400 · doi:10.1016/j.fertnstert.2014.02.002
- A Current Perspective on Delayed Puberty and Its Management.J Clin Res Pediatr Endocrinol 2024.PubMed 38683021 · doi:10.4274/jcrpe.galenos.2024.2024-2-7
- Gonadotropin resistance.Endocr Dev 2013.PubMed 23392092 · doi:10.1159/000342496
- The normal menstrual cycle in women.Anim Reprod Sci 2011.PubMed 20869180 · doi:10.1016/j.anireprosci.2010.08.030
- Anti-fertility vaccines.Vaccine 1989.PubMed 2665354 · doi:10.1016/0264-410x(89)90043-1
- Testosterone replacement therapy and spermatogenesis in reproductive age men.Nat Rev Urol 2025.PubMed 40346275 · doi:10.1038/s41585-025-01032-8
Literature retrieved from PubMed on October 16, 2026, favouring human studies and reviews. Numbered markers in the text show which paper supports which statement; uncited entries are background reading.
