HCG5000 IU/vial

Established / FDA-approved uses

• Female infertility (ovulation induction): HCG is used, as part of an assisted reproduction/ovulation-induction protocol together with menotropins or other gonadotropins (e.g., FSH), to trigger final follicular maturation and ovulation in anovulatory infertile women whose infertility is functional rather than caused by primary ovarian failure.
• Male hypogonadotropic hypogonadism: HCG is indicated in selected males with hypogonadotropic hypogonadism to stimulate testicular Leydig cell testosterone production; it is often combined with menotropins/FSH when stimulation of spermatogenesis is also required.
• Prepubertal cryptorchidism: HCG is indicated to induce testicular descent in prepubertal boys with cryptorchidism that is not due to anatomic obstruction.

Not an approved use

HCG is not approved and not effective for weight loss or obesity treatment. Regulatory authorities have found no substantial evidence supporting its use as a weight-loss aid, and "hCG diet" products are not a recognized medical use of this hormone.

All uses of HCG require initiation and monitoring by a qualified specialist (reproductive endocrinologist, urologist, or pediatric endocrinologist).

Human Chorionic Gonadotrophin is a purified, urinary-derived glycoprotein hormone supplied as a sterile lyophilized (freeze-dried) powder for injection, typically available in strengths such as 5,000 IU and 10,000 IU per vial, packaged with a diluent (e.g., bacteriostatic water for injection) for reconstitution. Formulations and available pack sizes vary by manufacturer and market.

HCG, commonly abbreviated hCG, is a glycoprotein hormone that shares a common alpha subunit with luteinizing hormone (LH), follicle-stimulating hormone (FSH), and thyroid-stimulating hormone, and a hormone-specific beta subunit. It is extracted and purified from the urine of pregnant women and, because its beta subunit closely resembles that of LH, it binds to and activates the same LH/hCG receptor.

Pharmaceutically, HCG is used to mimic the mid-cycle LH surge that triggers ovulation in women undergoing fertility treatment, to stimulate testosterone production by testicular Leydig cells in men with certain forms of hypogonadism, and to promote testicular descent in prepubertal boys with cryptorchidism.

HCG belongs to the gonadotropin hormone class and is classified as an ovulation-inducing agent / LH-like agent used in fertility and endocrine disorders.

Mechanism

Human Chorionic Gonadotrophin exerts its effects by binding to the same receptor as luteinizing hormone (the LH/hCG receptor) on ovarian and testicular tissue. In women undergoing ovulation induction, an appropriately timed dose of Human Chorionic Gonadotrophin substitutes for the natural LH surge, causing final oocyte maturation, follicular rupture (ovulation), and support of the corpus luteum. In men, Human Chorionic Gonadotrophin stimulates testicular Leydig cells to synthesize and secrete testosterone; combined with FSH-containing gonadotropins it can also support spermatogenesis. In prepubertal boys, Human Chorionic Gonadotrophin stimulates testosterone production that promotes testicular descent.

Pharmacokinetics

After intramuscular or subcutaneous injection, Human Chorionic Gonadotrophin is absorbed into the circulation with peak serum levels reached within several hours, has a biological half-life of roughly 24-36 hours (reported as biphasic, with an initial and a longer terminal phase), and is eliminated primarily via the kidneys, with a portion of the intact hormone recoverable in urine.

• HCG powder must be reconstituted with the accompanying diluent immediately before use (see Reconstitution); do not use if the reconstituted solution is cloudy or discolored.
• Administer by intramuscular or subcutaneous injection exactly as directed; subcutaneous administration is common for self-injection in fertility protocols under specialist instruction.
• Use a fresh needle/syringe for each injection and follow aseptic technique; do not reuse needles or syringes.
• Timing of the HCG injection relative to other fertility medications is critical for effectiveness (e.g., the ovulation-trigger dose must be given on the specific day instructed) - follow the prescriber's schedule precisely.

HCG has no well-established, clinically significant pharmacokinetic drug-drug interactions mediated through major metabolic pathways. Clinically relevant considerations are mainly pharmacodynamic and relate to its concomitant use with other fertility medicines:

• Menotropins/FSH-containing gonadotropins: HCG is routinely used together with these agents in ovulation-induction and spermatogenesis protocols; the combination increases the pharmacodynamic risk of ovarian hyperstimulation syndrome and multiple pregnancy, which is why monitoring is required (see Precautions).
• Other fertility/hormonal agents (e.g., clomiphene, GnRH agonists/antagonists): used in combination protocols under specialist direction; no dose adjustment of HCG itself is established beyond following the specific protocol.

Report all other medicines, supplements, and herbal products to the prescriber before starting HCG.

Reported adverse effects of HCG include:

• Common: pain, redness, swelling, or bruising at the injection site; headache; fatigue or irritability; mood changes; fluid retention/mild edema.
• In males: gynecomastia (breast enlargement/tenderness), fluid retention, precocious puberty signs when used in boys (increased virilization).
• In females: pelvic pain or discomfort, abdominal bloating, mild ovarian enlargement; ovarian hyperstimulation syndrome (OHSS) is an important but less common complication - see Precautions and Warnings for details.
• Less common/serious: allergic reactions (rash, itching, swelling, difficulty breathing), arterial thromboembolic events (rare) - see Precautions.

Patients should promptly report severe abdominal pain, rapid weight gain, significant bloating, breathing difficulty, or signs of an allergic reaction while using HCG.

HCG is used specifically to help achieve pregnancy as part of fertility treatment; once pregnancy is confirmed, HCG is typically discontinued and treatment does not continue into pregnancy. There is limited controlled safety data on HCG exposure in early pregnancy beyond its intended trigger use, so it should be used only under specialist supervision and only for its approved fertility indications, with the potential benefit weighed against any theoretical risk; consult the treating physician regarding any concern about exposure during pregnancy.

It is not known whether HCG passes into breast milk. Because HCG is not typically used during lactation, breastfeeding women should use HCG only if clearly needed and under medical supervision, with the physician weighing benefit against any potential risk to the infant.

Ovarian hyperstimulation syndrome (OHSS)

HCG, when used for ovulation induction (especially together with menotropins/FSH), can trigger OHSS, a potentially serious and rarely life-threatening complication marked by rapid ovarian enlargement, fluid shift into the abdomen/chest, abdominal pain, nausea, vomiting, and in severe cases thromboembolism, renal impairment, or respiratory difficulty. Close monitoring with pelvic ultrasound and serum estradiol levels is required before and after HCG administration, and the dose/timing of HCG should be withheld or adjusted if hyperstimulation is impending.

Multiple pregnancy

Use of HCG for ovulation induction, particularly combined with other gonadotropins, increases the likelihood of multiple follicular development and therefore multiple pregnancy (twins or more), which carries greater maternal and perinatal risk; patients should be counseled about this before treatment.

Arterial thromboembolism

Rare cases of arterial thromboembolic events have been reported in patients receiving HCG as part of fertility treatment, sometimes in association with OHSS; patients with risk factors for thrombosis should be evaluated before HCG is used.

Not for weight reduction

HCG must not be used for weight loss or as part of "hCG diet" regimens; there is no substantial evidence of efficacy for this purpose and it is not an approved use.

Precocious puberty (pediatric use)

In prepubertal boys, HCG can cause premature secondary sexual characteristics (precocious puberty); treatment should be supervised by a pediatric specialist with periodic assessment of growth and pubertal signs, and discontinued if androgenic side effects are excessive.

Specialist supervision

HCG should only be prescribed and monitored by physicians experienced in managing infertility or the relevant endocrine disorder, given the risks above.

There is limited specific data on acute overdose with HCG; in the context of ovulation induction, excessive dosing is expected mainly to increase the risk and severity of ovarian hyperstimulation syndrome (see Precautions) rather than cause classic acute toxicity. If an overdose of HCG is suspected, or if severe abdominal pain, marked bloating, breathing difficulty, or other concerning symptoms occur, seek immediate medical attention or contact emergency services/a poison control center; do not attempt to manage a suspected overdose at home.

Store unreconstituted HCG powder for injection at controlled room temperature (below 30°C), protected from light and moisture. After reconstitution with the supplied diluent, refrigerate (2-8°C) and use within the period specified in the product's package insert (typically up to 30-60 days), discarding any unused reconstituted solution after that time or if it appears cloudy or discolored. Do not freeze. Keep HCG out of reach of children.

• Renal impairment: Limited specific data exist; use HCG with caution and appropriate monitoring in patients with significant renal impairment, since the hormone is renally eliminated.
• Hepatic impairment: Limited specific data exist; use HCG with caution in patients with significant hepatic disease.
• Elderly: HCG is not indicated for use in elderly patients outside its labeled fertility/endocrine indications.
• Pediatric patients: HCG is used specifically for prepubertal cryptorchidism under specialist supervision, with monitoring for precocious puberty (see Precautions); safety and efficacy outside this specific pediatric use are not established.

Duration of HCG treatment depends entirely on the indication and protocol: ovulation induction typically involves a single trigger injection of HCG per treatment cycle; male hypogonadotropic hypogonadism regimens commonly run several weeks to months (e.g., an initial 3-week course followed by a maintenance schedule), with continued treatment guided by clinical and hormonal response; prepubertal cryptorchidism courses are typically limited to a few weeks. The treating specialist determines the total duration and whether repeat courses of HCG are appropriate.

HCG is supplied as a lyophilized (freeze-dried) powder that must be reconstituted before injection. Using aseptic technique, inject the accompanying diluent (e.g., bacteriostatic water for injection) into the vial of HCG powder, directing the stream against the glass wall, and gently swirl (do not shake vigorously) until the powder is fully dissolved and the solution is clear and colorless. Inspect visually for particulate matter or discoloration before use; do not use if the reconstituted HCG solution is cloudy, discolored, or contains particles. Use immediately or store as directed (see Storage Conditions), and follow the specific diluent volume and injection instructions provided with the product.

Gonadotropin hormone; ovulation-inducing agent; LH-receptor agonist

Human Chorionic Gonadotrophin acts as an agonist at the luteinizing hormone (LH)/hCG receptor because its beta subunit closely mimics that of endogenous LH. In women, this LH-like action substitutes for the natural mid-cycle LH surge, driving final maturation of the dominant follicle, oocyte release (ovulation), and continued progesterone production by the corpus luteum. In men, Human Chorionic Gonadotrophin binds LH receptors on testicular Leydig cells, stimulating testosterone synthesis; in prepubertal boys, the resulting rise in testosterone promotes testicular descent into the scrotum.

HCG is used in prepubertal boys specifically to treat cryptorchidism that is not due to anatomic obstruction, under the supervision of a pediatric endocrinologist or pediatric urologist, with a defined short course (commonly a few weeks) and dose individualized by age/weight. Treatment requires monitoring for signs of precocious puberty (early development of pubic hair, genital enlargement, or behavioral changes), and HCG should be discontinued if excessive androgenic effects occur. Safety and efficacy of HCG for any other use in children, including weight management, have not been established, and HCG should never be used for pediatric weight loss.