hCG (human chorionic gonadotropin)

Research overview

Key studies

1. Lijesen et al., Br J Clin Pharmacol (1995)

   Criteria-based meta-analysis of 8 controlled and 16 uncontrolled trials
   Model: Humans (adults with obesity on Simeons-type regimens)

   Most studies were of poor quality; the authors found no scientific evidence that hCG produces body-weight change, fat redistribution, reduced hunger or well-being ^5.

2. Meta-analysis, Clin Endocrinol (Oxf) (2024)

   Systematic review and meta-analysis of 41 studies
   Model: Humans (1673 men with pathologic gonadotropin deficiency)

   After a median 18 months, 78% achieved any sperm in the ejaculate and 15% exceeded 20 M/mL; combined hCG/FSH produced higher sperm output than hCG alone ^6.

3. Ovidrel prescribing information, clinical pharmacology (2023)

   Pharmacokinetic studies
   Model: Humans (healthy down-regulated women and IVF patients)

   Terminal half-life about 29 hours after subcutaneous dosing; population analysis in IVF patients gave a median elimination half-life of 29.2 hours ^3.

Dosing as stated on the FDA label

Quoted from the prescribing information for reference. Prescribing decisions belong to a licensed clinician; this is not a recommendation or instruction for use.

• The labels state that the regimen depends on indication, age, weight and physician preference, and list regimens 'advocated by various authorities' for intramuscular use only ^1,2.
• Prepubertal cryptorchidism (label regimens): 4,000 USP units three times weekly for three weeks; 5,000 USP units every second day for four injections; 15 injections of 500 to 1,000 USP units over six weeks; or 500 USP units three times weekly for four to six weeks, with a second course at 1,000 USP units one month later if unsuccessful ^1,2.
• Selected male hypogonadotropic hypogonadism (label regimens): 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, then 2,000 USP units three times weekly for three more months ^1,2.
• Ovulation induction in appropriately pretreated anovulatory women: 5,000 to 10,000 USP units one day after the last dose of menotropins/gonadotropins; 10,000 USP units is recommended in the menotropins labeling ^1,2.
• Ovidrel (recombinant): 250 µg one day after the last dose of the follicle-stimulating agent, as part of an ART program ^3.

Published adverse-event data

Reported in the cited trials or product labels. Frequencies apply to the stated population and do not transfer to other settings.

• Ovarian hyperstimulation syndrome
  Not quantified in the urinary hCG labels
  Women receiving hCG after gonadotropins for ovulation induction ² · Can progress rapidly and become serious; ascites, pleural effusion
• Multiple births and rupture of ovarian cysts
  Not quantified
  Same ¹ · Listed among principal serious adverse reactions
• Arterial thromboembolism
  Not quantified
  Same ¹ · Serious
• Headache, irritability, restlessness, depression, fatigue, edema
  Not quantified
  Label adverse reactions (all uses) ¹ · Not graded
• Precocious puberty and gynecomastia
  Not quantified
  Males, including boys treated for cryptorchidism ¹ · Label advises stopping if signs of precocious puberty occur
• Hypersensitivity, including anaphylaxis
  Not quantified
  Urinary-derived hCG products ¹ · Localized and systemic reactions reported

What is not known: Safety and effectiveness in children below age 4 have not been established, and excretion in human milk is unknown ^1. The urinary hCG labels reviewed do not give pharmacokinetic parameters ^1,2.

Regulatory status

Status

FDA-approved prescription products include Novarel (initial U.S. approval 1974; label Rev. 05/2023, U.S. License No. 2112) and Pregnyl (label revised 03/2025) for prepubertal cryptorchidism, selected male hypogonadotropic hypogonadism and ovulation induction; Ovidrel (recombinant) is labeled for final follicular maturation in ART. hCG is not approved for body-weight reduction or for use without a prescription ^1,2,3,4.

United States (FDA)

FDA-approved as Novarel (initial U.S. approval 1974) and Pregnyl, both urinary-derived, and Ovidrel (recombinant) ^1,2,3. FDA states hCG is not approved for body-weight reduction and is not approved for use without a prescription for any purpose ^4.

Sport (WADA)

The 2026 Prohibited List names chorionic gonadotrophin (CG) under S2.2.1, testosterone-stimulating peptides in males; S2 substances are prohibited at all times and are non-Specified Substances ^7.

Status varies by country and changes over time. How we describe regulatory status.

References

1. NOVAREL (chorionic gonadotropin) for injection, for intramuscular use, prescribing information (Rev. 05/2023; DailyMed version Sep 25, 2025) FDA label (DailyMed). 2025
2. PREGNYL (chorionic gonadotropin) for injection, prescribing information (Revised 03/2025; DailyMed version Dec 04, 2025) FDA label (DailyMed). 2025
3. OVIDREL PreFilled Syringe (choriogonadotropin alfa injection), prescribing information (DailyMed version Dec 28, 2023) FDA label (DailyMed). 2023
4. HCG Diet Products Are Illegal (consumer update; content current as of 07/13/2020) FDA. 2020
5. The effect of human chorionic gonadotropin (HCG) in the treatment of obesity by means of the Simeons therapy: a criteria-based meta-analysis Br J Clin Pharmacol. 1995
6. Efficacy of Gonadotropin Treatment for Induction of Spermatogenesis in Men With Pathologic Gonadotropin Deficiency: A Meta-Analysis Clin Endocrinol (Oxf). 2024
7. Tractatenblad 2026 Nr. 25: Anti-doping convention (ETS No. 135), amendment to the appendix - The 2026 Prohibited List, World Anti-Doping Code (English text; entry into force 1 January 2026) Tractatenblad van het Koninkrijk der Nederlanden (official government publication). 2026