hcg
updated
What is hcg?
hCG binds the LH/hCG receptor. In the ovary, LH-like signaling supports final follicular maturation, ovulation, and corpus-luteum steroid production. In the testis, it stimulates Leydig-cell androgen production. The same receptor action produces different clinical outcomes because the organ, baseline diagnosis, companion gonadotropins, and treatment stage differ.
Human chorionic gonadotropin has established roles in female fertility treatment and selected male endocrine conditions. Pregnyl and Novarel are intramuscular urinary products; Ovidrel is a subcutaneous recombinant product. Evidence alongside testosterone comes from small off-label studies, and controlled studies found no weight-loss benefit.
LH receptor agonist gonadotropin
- Placental glycoprotein hormone
- Urinary-derived and recombinant products differ
- Acts at the LH/hCG receptor
Is the question about an ovulation trigger, a male endocrine condition, testosterone use, or weight loss?
Those are four different evidence records. Female fertility and selected male hypogonadotropic hypogonadism are established label contexts. Use alongside testosterone is off-label and supported by small studies with surrogate or semen endpoints. Weight-loss claims are contradicted by controlled evidence and FDA labeling.
| Question | Clinical status | Decisive endpoint |
|---|---|---|
| Female fertility | Labeled, product specific | Follicular maturation, ovulation, pregnancy, or live birth |
| Male pituitary deficiency | Labeled for urinary hCG products | Androgen response, testicular development, or spermatogenesis plan |
| Alongside testosterone | Off-label research | Intratesticular testosterone, semen measures, pregnancy |
| Weight loss | Contradicted | No benefit beyond diet |
Pregnyl label · urinary hCG
FDA prescribing information
Organon. Pregnyl prescribing information, revised 2025.
Defines urinary-derived chorionic gonadotropin, intramuscular product handling, selected female and male indications, LH-like biology, the absence of a weight-loss effect, monitoring, and serious fertility-treatment risks.
- Participants / model
- Selected female-infertility and male endocrine populations covered by the label
- Treatment
- Pregnyl chorionic gonadotropin for injection
- Study design
- Regulatory prescribing information
This product label does not make community subcutaneous use a labeled Pregnyl route.
Read the original sourceNovarel label · urinary hCG
FDA prescribing information
Ferring Pharmaceuticals. Novarel prescribing information.
Defines Novarel's intramuscular route, selected female and male indications, obesity non-efficacy statement, androgen-related reactions, hypersensitivity, and fertility-treatment risks.
- Participants / model
- Selected female-infertility and male endocrine populations covered by the label
- Treatment
- Novarel urinary chorionic gonadotropin powder after reconstitution
- Record date
- Published September 25, 2025
- Study design
- Regulatory prescribing information
Its labeled route is intramuscular; formulation and storage instructions differ from Pregnyl and Ovidrel.
Read the original sourceOvidrel label · recombinant trigger
FDA prescribing information
EMD Serono. Ovidrel prefilled syringe prescribing information.
Defines recombinant choriogonadotropin alfa as a subcutaneous female-fertility product and reports the 99-person ovulation-induction study: 91.9% ovulation, 22% clinical pregnancy, and 15 live births.
- Participants / model
- Selected infertile women undergoing ovulation induction or assisted reproduction
- Treatment
- Ovidrel prefilled subcutaneous syringe
- Study design
- Regulatory prescribing information with product clinical-study tables
- Funding
- Product development program
The label separates follicular maturation, ovulation, clinical pregnancy, and live-birth outcomes and requires monitored fertility care.
Read the original sourceObesity review · no hCG benefit
Criteria-based meta-analysis
Lijesen GK et al. British Journal of Clinical Pharmacology, 1995.
The review traced eight controlled and 16 uncontrolled studies and found no evidence that hCG improved weight loss, fat redistribution, hunger, or well-being.
- Participants / model
- Published obesity-treatment studies
- Treatment
- hCG as an adjunct to calorie restriction
- Follow-up
- Varied across studies
- Study design
- Criteria-based review of controlled and uncontrolled studies
Most included studies were methodologically poor; the better controlled subset did not support the marketed claims.
Read the original sourceFDA · no approved weight-loss hCG
FDA safety and regulatory communication
US Food and Drug Administration. Questions and Answers on HCG Products for Weight Loss.
FDA states that no hCG product is approved for weight loss, evidence does not support obesity efficacy, and very-low-calorie diets marketed with hCG can cause serious complications.
- Participants / model
- Consumers considering prescription or unapproved hCG weight-loss products
- Treatment
- hCG products marketed for weight loss
- Study design
- Regulatory safety communication
FDA distinguishes approved injectable reproductive uses from illegal or unapproved weight-loss products.
Read the original sourceAre Pregnyl, Novarel, and Ovidrel the same product with the same route?
No. Pregnyl and Novarel are urinary-derived chorionic gonadotropin powders whose current US labels specify intramuscular use. Ovidrel is recombinant choriogonadotropin alfa supplied as a prefilled syringe for subcutaneous use and has female-fertility indications.
| Product | Source | Labeled route | Labeled clinical use |
|---|---|---|---|
| Pregnyl | Urine-derived | Intramuscular | Selected female and male reproductive uses |
| Novarel | Urine-derived | Intramuscular | Selected female and male reproductive uses |
| Ovidrel | Recombinant | Subcutaneous | Ovulation induction and assisted reproduction |
An older 18-person crossover found similar total exposure after matched high-dose intramuscular and subcutaneous Pregnyl administrations, but variability prevented proof of peak-concentration and time-to-peak bioequivalence. That pharmacokinetic experiment does not rewrite current product labels or make routes interchangeable.
Pregnyl label · urinary hCG
FDA prescribing information
Organon. Pregnyl prescribing information, revised 2025.
Defines urinary-derived chorionic gonadotropin, intramuscular product handling, selected female and male indications, LH-like biology, the absence of a weight-loss effect, monitoring, and serious fertility-treatment risks.
- Participants / model
- Selected female-infertility and male endocrine populations covered by the label
- Treatment
- Pregnyl chorionic gonadotropin for injection
- Study design
- Regulatory prescribing information
This product label does not make community subcutaneous use a labeled Pregnyl route.
Read the original sourceNovarel label · urinary hCG
FDA prescribing information
Ferring Pharmaceuticals. Novarel prescribing information.
Defines Novarel's intramuscular route, selected female and male indications, obesity non-efficacy statement, androgen-related reactions, hypersensitivity, and fertility-treatment risks.
- Participants / model
- Selected female-infertility and male endocrine populations covered by the label
- Treatment
- Novarel urinary chorionic gonadotropin powder after reconstitution
- Record date
- Published September 25, 2025
- Study design
- Regulatory prescribing information
Its labeled route is intramuscular; formulation and storage instructions differ from Pregnyl and Ovidrel.
Read the original sourceOvidrel label · recombinant trigger
FDA prescribing information
EMD Serono. Ovidrel prefilled syringe prescribing information.
Defines recombinant choriogonadotropin alfa as a subcutaneous female-fertility product and reports the 99-person ovulation-induction study: 91.9% ovulation, 22% clinical pregnancy, and 15 live births.
- Participants / model
- Selected infertile women undergoing ovulation induction or assisted reproduction
- Treatment
- Ovidrel prefilled subcutaneous syringe
- Study design
- Regulatory prescribing information with product clinical-study tables
- Funding
- Product development program
The label separates follicular maturation, ovulation, clinical pregnancy, and live-birth outcomes and requires monitored fertility care.
Read the original sourceRoute study · pharmacokinetics only
Randomized pharmacokinetic crossover study
Mannaerts BM et al. Human Reproduction, 1998.
In 18 healthy pituitary-suppressed women, matched 10,000-unit intramuscular and subcutaneous Pregnyl administrations had comparable total exposure, while variability prevented proof of peak and time-to-peak bioequivalence.
- Participants / model
- Eighteen healthy pituitary-suppressed female volunteers
- Treatment
- Three single Pregnyl administrations in crossover
- Follow-up
- Eight-day sampling after each administration
- Study design
- Randomized, single-center, three-way pharmacokinetic crossover
- Funding
- Organon clinical-development authorship
This study did not test pregnancy or live birth and does not change the current labeled route.
Read the original sourceWhat does hCG do in a female fertility cycle, and which outcome follows?
hCG acts as the LH-like trigger after monitoring shows sufficient follicular development. In one Ovidrel ovulation-induction study, 99 participants received the recombinant product: 91.9% ovulated, 22% had a clinical pregnancy, and 15 had a live-birth outcome. Ovulation therefore cannot be presented as if it were pregnancy or live birth.
- Ovulation
- 91.9%
- Clinical pregnancy
- 22%
- Live birth
- 15.2%
This was a single-cycle product study in selected infertility care. Partner factors, embryo development, implantation, pregnancy loss, and multiple gestation all sit between an ovulatory trigger and a live birth.
Ovidrel label · recombinant trigger
FDA prescribing information
EMD Serono. Ovidrel prefilled syringe prescribing information.
Defines recombinant choriogonadotropin alfa as a subcutaneous female-fertility product and reports the 99-person ovulation-induction study: 91.9% ovulation, 22% clinical pregnancy, and 15 live births.
- Participants / model
- Selected infertile women undergoing ovulation induction or assisted reproduction
- Treatment
- Ovidrel prefilled subcutaneous syringe
- Study design
- Regulatory prescribing information with product clinical-study tables
- Funding
- Product development program
The label separates follicular maturation, ovulation, clinical pregnancy, and live-birth outcomes and requires monitored fertility care.
Read the original sourcePregnyl label · urinary hCG
FDA prescribing information
Organon. Pregnyl prescribing information, revised 2025.
Defines urinary-derived chorionic gonadotropin, intramuscular product handling, selected female and male indications, LH-like biology, the absence of a weight-loss effect, monitoring, and serious fertility-treatment risks.
- Participants / model
- Selected female-infertility and male endocrine populations covered by the label
- Treatment
- Pregnyl chorionic gonadotropin for injection
- Study design
- Regulatory prescribing information
This product label does not make community subcutaneous use a labeled Pregnyl route.
Read the original sourceWhich male uses are actually on current urinary hCG labels?
Pregnyl and Novarel label selected cases of hypogonadotropic hypogonadism caused by pituitary deficiency. They also label prepubertal cryptorchidism without an anatomical obstruction, while noting that testicular descent is often temporary. These are diagnosis-specific uses, not a generic treatment for low testosterone or infertility from any cause.
Primary gonadal failure and a missing pituitary signal are different problems. hCG supplies LH-like receptor stimulation; it cannot make a nonresponsive testis behave as if the upstream signal were the only issue.
Pregnyl label · urinary hCG
FDA prescribing information
Organon. Pregnyl prescribing information, revised 2025.
Defines urinary-derived chorionic gonadotropin, intramuscular product handling, selected female and male indications, LH-like biology, the absence of a weight-loss effect, monitoring, and serious fertility-treatment risks.
- Participants / model
- Selected female-infertility and male endocrine populations covered by the label
- Treatment
- Pregnyl chorionic gonadotropin for injection
- Study design
- Regulatory prescribing information
This product label does not make community subcutaneous use a labeled Pregnyl route.
Read the original sourceNovarel label · urinary hCG
FDA prescribing information
Ferring Pharmaceuticals. Novarel prescribing information.
Defines Novarel's intramuscular route, selected female and male indications, obesity non-efficacy statement, androgen-related reactions, hypersensitivity, and fertility-treatment risks.
- Participants / model
- Selected female-infertility and male endocrine populations covered by the label
- Treatment
- Novarel urinary chorionic gonadotropin powder after reconstitution
- Record date
- Published September 25, 2025
- Study design
- Regulatory prescribing information
Its labeled route is intramuscular; formulation and storage instructions differ from Pregnyl and Ovidrel.
Read the original sourceDoes the small testosterone study prove fertility preservation?
No. It proves a narrower physiologic point. Twenty-nine healthy men received testosterone to suppress gonadotropins and were randomized to saline or one of three hCG groups for three weeks. Intratesticular testosterone fell 94% with testosterone plus saline and changed in a dose-related direction with hCG.
29-man trial · intratesticular surrogate
Randomized physiologic study
Coviello AD et al. Journal of Clinical Endocrinology and Metabolism, 2005.
Twenty-nine healthy men received testosterone plus saline or one of three hCG groups for three weeks. Intratesticular testosterone fell 94% in the saline group and rose linearly with greater hCG exposure.
- Participants / model
- Healthy men with experimentally suppressed gonadotropins
- Treatment
- Weekly testosterone with saline or randomized hCG groups
- Follow-up
- Three weeks
- Study design
- Randomized short physiologic dose-response study
- Funding
- Academic research support
The endpoint was aspirated intratesticular testosterone, not sperm, pregnancy, or live birth.
Read the original sourceWhat did the 26-man testosterone-plus-hCG cohort add?
A retrospective series followed 26 hypogonadal men receiving testosterone plus intramuscular hCG for a mean 6.2 months. Semen measures did not change significantly, no participant became azoospermic, and nine partners became pregnant. There was no untreated or testosterone-only control group.
The uncontrolled chart review did not compare hCG with testosterone alone or identify which patients were most likely to benefit.
26-man cohort · semen preservation
Retrospective case series
Hsieh TC et al. Journal of Urology, 2013.
In 26 hypogonadal men receiving testosterone plus intramuscular hCG, semen parameters did not change significantly, none became azoospermic, and nine partners became pregnant during follow-up.
- Participants / model
- Hypogonadal men using testosterone who desired fertility preservation
- Treatment
- Testosterone plus concomitant intramuscular hCG
- Follow-up
- Mean follow-up 6.2 months
- Study design
- Retrospective uncontrolled case series
Without a control group, this cannot quantify benefit or guarantee fertility.
Read the original sourceDid hCG restore sperm counts while nonprescribed androgens continued?
A 2025 retrospective harm-reduction cohort followed 19 men who continued nonprescribed androgens. After three to six months, mean total sperm count rose from 18.0 million to 146.9 million and mean total motile count from 1.1 million to 66.9 million. Some men remained oligospermic or azoospermic.
The cohort had no control group, used individualized treatment, and reported laboratory outcomes rather than live births.
2025 cohort · 19 men, no control
Retrospective harm-reduction cohort
Smit DL et al. F&S Reports, 2025.
Among 19 men who continued nonprescribed androgens, mean total and motile sperm counts increased after three to six months of individualized hCG treatment, while some men remained oligospermic or azoospermic.
- Participants / model
- Men attending a Dutch harm-reduction clinic who continued nonprescribed androgens
- Treatment
- Continued androgen exposure plus individualized hCG treatment
- Follow-up
- Three to six months
- Study design
- Small retrospective uncontrolled cohort
- Funding
- Doping Authority Netherlands and Spaarne Gasthuis Academy reported
Laboratory improvement in a selected cohort is not a fertility guarantee or a randomized treatment effect.
Read the original sourceDoes hCG improve weight loss, hunger, or fat distribution?
No. A criteria-based review traced eight controlled and 16 uncontrolled obesity studies and found no scientific evidence that hCG improves weight loss, fat distribution, hunger, or well-being. FDA says there are no approved hCG products for weight loss.
The dangerous part of many hCG-diet programs is also the accompanying very-low-calorie diet, which FDA links to gallstones, electrolyte imbalance, and heart-rhythm risk without medical supervision.
Obesity review · no hCG benefit
Criteria-based meta-analysis
Lijesen GK et al. British Journal of Clinical Pharmacology, 1995.
The review traced eight controlled and 16 uncontrolled studies and found no evidence that hCG improved weight loss, fat redistribution, hunger, or well-being.
- Participants / model
- Published obesity-treatment studies
- Treatment
- hCG as an adjunct to calorie restriction
- Follow-up
- Varied across studies
- Study design
- Criteria-based review of controlled and uncontrolled studies
Most included studies were methodologically poor; the better controlled subset did not support the marketed claims.
Read the original sourceFDA · no approved weight-loss hCG
FDA safety and regulatory communication
US Food and Drug Administration. Questions and Answers on HCG Products for Weight Loss.
FDA states that no hCG product is approved for weight loss, evidence does not support obesity efficacy, and very-low-calorie diets marketed with hCG can cause serious complications.
- Participants / model
- Consumers considering prescription or unapproved hCG weight-loss products
- Treatment
- hCG products marketed for weight loss
- Study design
- Regulatory safety communication
FDA distinguishes approved injectable reproductive uses from illegal or unapproved weight-loss products.
Read the original sourcePregnyl label · urinary hCG
FDA prescribing information
Organon. Pregnyl prescribing information, revised 2025.
Defines urinary-derived chorionic gonadotropin, intramuscular product handling, selected female and male indications, LH-like biology, the absence of a weight-loss effect, monitoring, and serious fertility-treatment risks.
- Participants / model
- Selected female-infertility and male endocrine populations covered by the label
- Treatment
- Pregnyl chorionic gonadotropin for injection
- Study design
- Regulatory prescribing information
This product label does not make community subcutaneous use a labeled Pregnyl route.
Read the original sourceWhy does an ovulatory trigger require ultrasound, hormone monitoring, and a treatment team?
hCG can trigger ovarian hyperstimulation syndrome, which may progress rapidly with ovarian enlargement, fluid shifts, breathing problems, kidney effects, and thromboembolism. Labels also warn about ovarian torsion, multiple gestation, ectopic pregnancy, and pregnancy loss in the broader fertility-treatment context.
- Severe pelvic or abdominal pain, rapid weight gain, vomiting, breathing difficulty, or low urine output after stimulation can signal OHSS and needs prompt clinical assessment.
- OHSS may emerge after gonadotropins stop and can be more severe if pregnancy occurs.
- Ultrasound shows follicle number and size; serum estradiol alone does not show both.
Pregnyl label · urinary hCG
FDA prescribing information
Organon. Pregnyl prescribing information, revised 2025.
Defines urinary-derived chorionic gonadotropin, intramuscular product handling, selected female and male indications, LH-like biology, the absence of a weight-loss effect, monitoring, and serious fertility-treatment risks.
- Participants / model
- Selected female-infertility and male endocrine populations covered by the label
- Treatment
- Pregnyl chorionic gonadotropin for injection
- Study design
- Regulatory prescribing information
This product label does not make community subcutaneous use a labeled Pregnyl route.
Read the original sourceOvidrel label · recombinant trigger
FDA prescribing information
EMD Serono. Ovidrel prefilled syringe prescribing information.
Defines recombinant choriogonadotropin alfa as a subcutaneous female-fertility product and reports the 99-person ovulation-induction study: 91.9% ovulation, 22% clinical pregnancy, and 15 live births.
- Participants / model
- Selected infertile women undergoing ovulation induction or assisted reproduction
- Treatment
- Ovidrel prefilled subcutaneous syringe
- Study design
- Regulatory prescribing information with product clinical-study tables
- Funding
- Product development program
The label separates follicular maturation, ovulation, clinical pregnancy, and live-birth outcomes and requires monitored fertility care.
Read the original sourceWhat do male label risks and spontaneous reports actually tell us?
Urinary hCG labels describe gynecomastia, fluid and sodium retention, injection reactions, hypersensitivity, and precocious puberty in pediatric treatment. Spontaneous reports can flag unusual events, but without a known exposed denominator or comparator they cannot provide an incidence rate or prove hCG caused an event.
For athletes covered by the World Anti-Doping Code, chorionic gonadotrophin is prohibited in males at all times under the 2026 list. A medical prescription and a sport therapeutic-use exemption are separate questions.
Pregnyl label · urinary hCG
FDA prescribing information
Organon. Pregnyl prescribing information, revised 2025.
Defines urinary-derived chorionic gonadotropin, intramuscular product handling, selected female and male indications, LH-like biology, the absence of a weight-loss effect, monitoring, and serious fertility-treatment risks.
- Participants / model
- Selected female-infertility and male endocrine populations covered by the label
- Treatment
- Pregnyl chorionic gonadotropin for injection
- Study design
- Regulatory prescribing information
This product label does not make community subcutaneous use a labeled Pregnyl route.
Read the original sourceNovarel label · urinary hCG
FDA prescribing information
Ferring Pharmaceuticals. Novarel prescribing information.
Defines Novarel's intramuscular route, selected female and male indications, obesity non-efficacy statement, androgen-related reactions, hypersensitivity, and fertility-treatment risks.
- Participants / model
- Selected female-infertility and male endocrine populations covered by the label
- Treatment
- Novarel urinary chorionic gonadotropin powder after reconstitution
- Record date
- Published September 25, 2025
- Study design
- Regulatory prescribing information
Its labeled route is intramuscular; formulation and storage instructions differ from Pregnyl and Ovidrel.
Read the original sourceOvidrel label · recombinant trigger
FDA prescribing information
EMD Serono. Ovidrel prefilled syringe prescribing information.
Defines recombinant choriogonadotropin alfa as a subcutaneous female-fertility product and reports the 99-person ovulation-induction study: 91.9% ovulation, 22% clinical pregnancy, and 15 live births.
- Participants / model
- Selected infertile women undergoing ovulation induction or assisted reproduction
- Treatment
- Ovidrel prefilled subcutaneous syringe
- Study design
- Regulatory prescribing information with product clinical-study tables
- Funding
- Product development program
The label separates follicular maturation, ovulation, clinical pregnancy, and live-birth outcomes and requires monitored fertility care.
Read the original sourceWADA 2026 · hCG prohibited in males
International sport rule
World Anti-Doping Agency. 2026 Prohibited List, effective January 1, 2026.
Section S2.2.1 prohibits chorionic gonadotrophin and luteinizing hormone and their releasing factors in males at all times in covered sport.
- Participants / model
- Male athletes covered by the World Anti-Doping Code
- Treatment
- Chorionic gonadotrophin and related prohibited substances
- Follow-up
- Effective January 1, 2026
- Study design
- Governing prohibited-substance list
Therapeutic-use-exemption rules are separate and sport specific.
Read the original sourceWhy can one hormone affect both ovulation and testicular androgen production?
hCG binds the LH/hCG receptor. In the ovary, LH-like signaling supports final follicular maturation, ovulation, and corpus-luteum steroid production. In the testis, it stimulates Leydig-cell androgen production. The same receptor action produces different clinical outcomes because the organ, baseline diagnosis, companion gonadotropins, and treatment stage differ.
This mechanism explains why hCG can substitute for an LH signal. It does not support fat mobilization, and it does not mean that an androgen rise equals restored spermatogenesis or pregnancy.
Pregnyl label · urinary hCG
FDA prescribing information
Organon. Pregnyl prescribing information, revised 2025.
Defines urinary-derived chorionic gonadotropin, intramuscular product handling, selected female and male indications, LH-like biology, the absence of a weight-loss effect, monitoring, and serious fertility-treatment risks.
- Participants / model
- Selected female-infertility and male endocrine populations covered by the label
- Treatment
- Pregnyl chorionic gonadotropin for injection
- Study design
- Regulatory prescribing information
This product label does not make community subcutaneous use a labeled Pregnyl route.
Read the original sourceOvidrel label · recombinant trigger
FDA prescribing information
EMD Serono. Ovidrel prefilled syringe prescribing information.
Defines recombinant choriogonadotropin alfa as a subcutaneous female-fertility product and reports the 99-person ovulation-induction study: 91.9% ovulation, 22% clinical pregnancy, and 15 live births.
- Participants / model
- Selected infertile women undergoing ovulation induction or assisted reproduction
- Treatment
- Ovidrel prefilled subcutaneous syringe
- Study design
- Regulatory prescribing information with product clinical-study tables
- Funding
- Product development program
The label separates follicular maturation, ovulation, clinical pregnancy, and live-birth outcomes and requires monitored fertility care.
Read the original source29-man trial · intratesticular surrogate
Randomized physiologic study
Coviello AD et al. Journal of Clinical Endocrinology and Metabolism, 2005.
Twenty-nine healthy men received testosterone plus saline or one of three hCG groups for three weeks. Intratesticular testosterone fell 94% in the saline group and rose linearly with greater hCG exposure.
- Participants / model
- Healthy men with experimentally suppressed gonadotropins
- Treatment
- Weekly testosterone with saline or randomized hCG groups
- Follow-up
- Three weeks
- Study design
- Randomized short physiologic dose-response study
- Funding
- Academic research support
The endpoint was aspirated intratesticular testosterone, not sperm, pregnancy, or live birth.
Read the original sourceStudies and sources
Pregnyl label · urinary hCG
FDA prescribing information
Organon. Pregnyl prescribing information, revised 2025.
Defines urinary-derived chorionic gonadotropin, intramuscular product handling, selected female and male indications, LH-like biology, the absence of a weight-loss effect, monitoring, and serious fertility-treatment risks.
- Participants / model
- Selected female-infertility and male endocrine populations covered by the label
- Treatment
- Pregnyl chorionic gonadotropin for injection
- Study design
- Regulatory prescribing information
This product label does not make community subcutaneous use a labeled Pregnyl route.
Read the original sourceNovarel label · urinary hCG
FDA prescribing information
Ferring Pharmaceuticals. Novarel prescribing information.
Defines Novarel's intramuscular route, selected female and male indications, obesity non-efficacy statement, androgen-related reactions, hypersensitivity, and fertility-treatment risks.
- Participants / model
- Selected female-infertility and male endocrine populations covered by the label
- Treatment
- Novarel urinary chorionic gonadotropin powder after reconstitution
- Record date
- Published September 25, 2025
- Study design
- Regulatory prescribing information
Its labeled route is intramuscular; formulation and storage instructions differ from Pregnyl and Ovidrel.
Read the original sourceOvidrel label · recombinant trigger
FDA prescribing information
EMD Serono. Ovidrel prefilled syringe prescribing information.
Defines recombinant choriogonadotropin alfa as a subcutaneous female-fertility product and reports the 99-person ovulation-induction study: 91.9% ovulation, 22% clinical pregnancy, and 15 live births.
- Participants / model
- Selected infertile women undergoing ovulation induction or assisted reproduction
- Treatment
- Ovidrel prefilled subcutaneous syringe
- Study design
- Regulatory prescribing information with product clinical-study tables
- Funding
- Product development program
The label separates follicular maturation, ovulation, clinical pregnancy, and live-birth outcomes and requires monitored fertility care.
Read the original sourceRoute study · pharmacokinetics only
Randomized pharmacokinetic crossover study
Mannaerts BM et al. Human Reproduction, 1998.
In 18 healthy pituitary-suppressed women, matched 10,000-unit intramuscular and subcutaneous Pregnyl administrations had comparable total exposure, while variability prevented proof of peak and time-to-peak bioequivalence.
- Participants / model
- Eighteen healthy pituitary-suppressed female volunteers
- Treatment
- Three single Pregnyl administrations in crossover
- Follow-up
- Eight-day sampling after each administration
- Study design
- Randomized, single-center, three-way pharmacokinetic crossover
- Funding
- Organon clinical-development authorship
This study did not test pregnancy or live birth and does not change the current labeled route.
Read the original source29-man trial · intratesticular surrogate
Randomized physiologic study
Coviello AD et al. Journal of Clinical Endocrinology and Metabolism, 2005.
Twenty-nine healthy men received testosterone plus saline or one of three hCG groups for three weeks. Intratesticular testosterone fell 94% in the saline group and rose linearly with greater hCG exposure.
- Participants / model
- Healthy men with experimentally suppressed gonadotropins
- Treatment
- Weekly testosterone with saline or randomized hCG groups
- Follow-up
- Three weeks
- Study design
- Randomized short physiologic dose-response study
- Funding
- Academic research support
The endpoint was aspirated intratesticular testosterone, not sperm, pregnancy, or live birth.
Read the original source26-man cohort · semen preservation
Retrospective case series
Hsieh TC et al. Journal of Urology, 2013.
In 26 hypogonadal men receiving testosterone plus intramuscular hCG, semen parameters did not change significantly, none became azoospermic, and nine partners became pregnant during follow-up.
- Participants / model
- Hypogonadal men using testosterone who desired fertility preservation
- Treatment
- Testosterone plus concomitant intramuscular hCG
- Follow-up
- Mean follow-up 6.2 months
- Study design
- Retrospective uncontrolled case series
Without a control group, this cannot quantify benefit or guarantee fertility.
Read the original source2025 cohort · 19 men, no control
Retrospective harm-reduction cohort
Smit DL et al. F&S Reports, 2025.
Among 19 men who continued nonprescribed androgens, mean total and motile sperm counts increased after three to six months of individualized hCG treatment, while some men remained oligospermic or azoospermic.
- Participants / model
- Men attending a Dutch harm-reduction clinic who continued nonprescribed androgens
- Treatment
- Continued androgen exposure plus individualized hCG treatment
- Follow-up
- Three to six months
- Study design
- Small retrospective uncontrolled cohort
- Funding
- Doping Authority Netherlands and Spaarne Gasthuis Academy reported
Laboratory improvement in a selected cohort is not a fertility guarantee or a randomized treatment effect.
Read the original sourceObesity review · no hCG benefit
Criteria-based meta-analysis
Lijesen GK et al. British Journal of Clinical Pharmacology, 1995.
The review traced eight controlled and 16 uncontrolled studies and found no evidence that hCG improved weight loss, fat redistribution, hunger, or well-being.
- Participants / model
- Published obesity-treatment studies
- Treatment
- hCG as an adjunct to calorie restriction
- Follow-up
- Varied across studies
- Study design
- Criteria-based review of controlled and uncontrolled studies
Most included studies were methodologically poor; the better controlled subset did not support the marketed claims.
Read the original sourceFDA · no approved weight-loss hCG
FDA safety and regulatory communication
US Food and Drug Administration. Questions and Answers on HCG Products for Weight Loss.
FDA states that no hCG product is approved for weight loss, evidence does not support obesity efficacy, and very-low-calorie diets marketed with hCG can cause serious complications.
- Participants / model
- Consumers considering prescription or unapproved hCG weight-loss products
- Treatment
- hCG products marketed for weight loss
- Study design
- Regulatory safety communication
FDA distinguishes approved injectable reproductive uses from illegal or unapproved weight-loss products.
Read the original sourceWADA 2026 · hCG prohibited in males
International sport rule
World Anti-Doping Agency. 2026 Prohibited List, effective January 1, 2026.
Section S2.2.1 prohibits chorionic gonadotrophin and luteinizing hormone and their releasing factors in males at all times in covered sport.
- Participants / model
- Male athletes covered by the World Anti-Doping Code
- Treatment
- Chorionic gonadotrophin and related prohibited substances
- Follow-up
- Effective January 1, 2026
- Study design
- Governing prohibited-substance list
Therapeutic-use-exemption rules are separate and sport specific.
Read the original sourceWhy is hcg in S tier?
S reflects approved reproductive uses and direct human evidence. Products and routes are not interchangeable, testosterone add-on studies do not establish live-birth benefit, and controlled trials found no weight-loss efficacy.
read hCG in the reptides guide, chapter 13: 13 pages, free to read.