FDA-Approved — Specific Indication Only Authoritative Evidence Reference Approved clinical use (assisted reproduction)

Menotropins (hMG)

Human menopausal gonadotropin (FSH and LH activity) purified from urine; MENOPUR is FDA-approved for multiple follicular development in ovulatory women in assisted reproductive technology cycles.

Language: English العربية (Arabic) →
Drug Class Gonadotropin with follicle-stimulating hormone (FSH) and luteinising hormone (LH) activity.
FDA Regulatory Status FDA-Approved — Specific Indication Only
Clinical Stage Approved clinical use (assisted reproduction)
Evidence Verification Active Reference Standards
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60-Second Scientific Briefing

Menotropins, or human menopausal gonadotropin (hMG), is a mixture with follicle-stimulating hormone (FSH) and luteinising hormone (LH) activity purified from urine. MENOPUR is FDA-approved (initial approval 1975) for developing multiple follicles and pregnancy in ovulatory women as part of assisted reproduction (IVF). Its main risks are ovarian hyperstimulation syndrome and multiple pregnancy, and it must be used only by infertility specialists with monitoring.

What is Menotropins (hMG)?

Pharmacological Classification & Molecular Identity

Menotropins (human menopausal gonadotropin, hMG) is a preparation of gonadotropins with FSH and LH activity purified from the urine of postmenopausal women, given by subcutaneous injection. [1] U.S. National Library of Medicine (DailyMed), 2026 ↗

Verified Chemical & Regulatory Registry Identifiers

Documented Aliases & Research Codes:
hMG HMG human menopausal gonadotropin Menopur

Mechanism of Action & Receptor Targets

Biological Pathway and Target Binding

Receptor Selectivity: Activates FSH and LH receptors in the ovary, stimulating the growth and maturation of multiple follicles; ovulation is then triggered separately (usually with hCG). [1] U.S. National Library of Medicine (DailyMed), 2026 ↗

Regulatory & FDA Approval Status

Legal and Regulatory Classifications
⚠️ FDA APPROVED MEDICATION STATUS (SPECIFIC INDICATION ONLY)

MENOPUR (menotropins for injection; initial US approval 1975) is FDA-approved for the development of multiple follicles and pregnancy in ovulatory women as part of an assisted reproductive technology (ART) cycle. Other uses are not approved indications in the US label. [1] U.S. National Library of Medicine (DailyMed), 2026 ↗

MENOPUR (menotropins for injection; initial US approval 1975) is FDA-approved for the development of multiple follicles and pregnancy in ovulatory women as part of an assisted reproductive technology (ART) cycle. Other uses are not approved indications in the US label.

Human Evidence & Clinical Trials

Clinical Study Readouts and Evidence Syntheses

The label describes two randomised, open-label, multinational trials in which 434 ovulatory infertile women received subcutaneous MENOPUR in an IVF cycle. Cochrane 2025 (ovulation induction in PCOS): it is uncertain whether hMG improves or lowers live birth, multiple pregnancy or miscarriage compared with urinary FSH. In males with hypogonadotropic hypogonadism, hMG was one of the gonadotropins used in pubertal induction studies (Eur J Endocrinol 2024, 103 studies). [1] U.S. National Library of Medicine (DailyMed), 2026 ↗ [2] Cochrane Database Syst Rev, 2025 ↗ [3] Eur J Endocrinol, 2024 ↗

Clinical Evidence

The label describes two randomised, open-label, multinational trials in which 434 ovulatory infertile women received subcutaneous MENOPUR in an IVF cycle. Cochrane 2025 (ovulation induction in PCOS): it is uncertain whether hMG improves or lowers live birth, multiple pregnancy or miscarriage compared with urinary FSH. In males with hypogonadotropic hypogonadism, hMG was one of the gonadotropins used in pubertal induction studies (Eur J Endocrinol 2024, 103 studies).

Safety Profile & Clinical Limitations

Documented Adverse Events and Known Uncertainties

Most common adverse reactions (2% or more) in ART: abdominal cramps, abdominal enlargement, abdominal pain, headache, injection-site pain, reaction or inflammation, and ovarian hyperstimulation syndrome (OHSS). The label warns of abnormal ovarian enlargement, OHSS with pulmonary or vascular complications, ovarian torsion, multi-fetal gestation, congenital malformation, ectopic pregnancy, miscarriage and ovarian neoplasms. It is contraindicated in pregnancy, primary ovarian failure and sex-hormone-dependent tumours. [1] U.S. National Library of Medicine (DailyMed), 2026 ↗

ℹ️ Active Research Safety Surveillance

Comparative benefit against other gonadotropins in PCOS is uncertain (Cochrane 2025), and whether any regimen reduces OHSS or ectopic pregnancy is uncertain. [1] Cochrane Database Syst Rev, 2025 ↗

Dose Approval Status

Commercial Dosing Status and Policy Directives
🛑 PRESCRIPTION DOSING INFORMATION (APPROVED PRODUCT ONLY)

Approved US labelling: in the first ART cycle, a starting dose of 225 International Units per day by subcutaneous injection, adjusted after 5 days by no more than 150 IU at each adjustment, up to a maximum of 450 IU per day and a maximum stimulation of 20 days, with monitoring. Dosing is set by the infertility specialist. [1] U.S. National Library of Medicine (DailyMed), 2026 ↗

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 MENOPUR prescribing information: store the powder refrigerated or at room temperature (3–25 °C). [1] U.S. National Library of Medicine (DailyMed), 2026 ↗

What is Known vs. What is Unknown

Evidence Comparison and Clinical Evidence Boundaries

✓ Confirmed Scientific Evidence

  • Menotropins (human menopausal gonadotropin, hMG) is a preparation of gonadotropins with FSH and LH activity purified from the urine of postmenopausal women, given by subcutaneous injection.
  • Targets & Selectivity: Activates FSH and LH receptors in the ovary, stimulating the growth and maturation of multiple follicles; ovulation is then triggered separately (usually with hCG).
  • The label describes two randomised, open-label, multinational trials in which 434 ovulatory infertile women received subcutaneous MENOPUR in an IVF cycle. Cochrane 2025 (ovulation induction in PCOS): it is uncertain whether hMG improves or lowers live birth, multiple pregnancy or miscarriage compared with urinary FSH. In males with hypogonadotropic hypogonadism, hMG was one of the gonadotropins used in pubertal induction studies (Eur J Endocrinol 2024, 103 studies).
  • Safety considerations: Most common adverse reactions (2% or more) in ART: abdominal cramps, abdominal enlargement, abdominal pain, headache, injection-site pain, reaction or inflammation, and ovarian hyperstimulation syndrome (OHSS). The label warns of abnormal ovarian enlargement, OHSS with pulmonary or vascular complications, ovarian torsion, multi-fetal gestation, congenital malformation, ectopic pregnancy, miscarriage and ovarian neoplasms. It is contraindicated in pregnancy, primary ovarian failure and sex-hormone-dependent tumours.

? Unknown / Under Ongoing Investigation

  • Comparative benefit against other gonadotropins in PCOS is uncertain (Cochrane 2025), and whether any regimen reduces OHSS or ectopic pregnancy is uncertain.

Verified Questions & Answers

10 Verified scientific answers with permanent anchor keys
#1

What is Menotropins (hMG) and how is it classified?

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Direct Answer

Menotropins (hMG, MENOPUR) is a urinary gonadotropin preparation with FSH and LH activity, approved to stimulate the ovaries in IVF and other assisted reproduction cycles.

Authoritative Citations:
#2

What is the mechanism of action and receptor profile of Menotropins (hMG)?

§
Direct Answer

It activates FSH and LH receptors in the ovary, making several follicles grow and mature; ovulation is then triggered separately, usually with hCG.

Authoritative Citations:
#3

Is Menotropins (hMG) approved by the US FDA or health authorities?

§
Direct Answer

Yes. MENOPUR is FDA-approved (initial approval 1975) for the development of multiple follicles and pregnancy in ovulatory women as part of an assisted reproductive technology cycle.

Authoritative Citations:
#4

What human clinical evidence and trials exist for Menotropins (hMG)?

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Direct Answer

The approval rests on randomised IVF trials in 434 women described in the label. A 2025 Cochrane review found it uncertain whether hMG is better or worse than urinary FSH for live birth in women with PCOS.

Label: two single-cycle, open-label, multinational, multicentre comparative trials randomised 434 ovulatory infertile women to subcutaneous MENOPUR in an IVF cycle. Cochrane 2025 (gonadotropins for ovulation induction in PCOS): for hMG versus urinary FSH, the reviewers were uncertain whether either improves or lowers live birth, multiple pregnancy, clinical pregnancy or miscarriage, and uncertain whether any regimen reduces OHSS or ectopic pregnancy. In males with hypogonadotropic hypogonadism, hMG was used in 42 of 103 pubertal-induction studies (Eur J Endocrinol 2024).

Authoritative Citations:
#5

What adverse effects and safety risks are documented for Menotropins (hMG)?

§
Direct Answer

Most common in ART: abdominal cramps, bloating and pain, headache, injection-site reactions and ovarian hyperstimulation syndrome. The label also warns of ovarian torsion, multiple pregnancy, ectopic pregnancy and miscarriage; it is contraindicated in pregnancy.

Authoritative Citations:
#6

What are the critical unknown safety aspects and clinical limitations of Menotropins (hMG)?

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Direct Answer

Comparative benefit against other gonadotropins in PCOS is uncertain, and whether any regimen reduces OHSS or ectopic pregnancy is uncertain (Cochrane 2025).

Authoritative Citations:
#7

What is the approved dosing status for Menotropins (hMG)?

§
Direct Answer

Approved US labelling: in the first ART cycle, 225 IU per day under the skin, adjusted after 5 days by no more than 150 IU at a time, up to 450 IU per day for at most 20 days, with monitoring. Dosing is set by the infertility specialist.

Authoritative Citations:
#8

What are the storage and handling requirements for Menotropins (hMG)?

§
Direct Answer

Per the MENOPUR prescribing information: store the powder refrigerated or at room temperature (3–25 °C).

Authoritative Citations:
#9

Is Menotropins (hMG) prohibited in competitive sports by WADA?

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Direct Answer

Menotropins contain luteinising hormone (LH) activity; LH and other gonadotrophins are prohibited at all times for male athletes under section S2.2.1 of the 2026 WADA Prohibited List.

Authoritative Citations:
#10

What is Egypt Peptides' official medical policy regarding Menotropins (hMG)?

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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

MENOPUR (menotropins for injection): prescribing information ↗

Publisher / Registry: U.S. National Library of Medicine (DailyMed) Publication Date: 2026-05-11
Verified Locator: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=22c8db95-c3db-1770-8086-31356fbabe35
Source [2] Tier 1 Regulatory / Academic

Gonadotropins for ovulation induction in women with polycystic ovary syndrome ↗

Publisher / Registry: Cochrane Database Syst Rev Publication Date: 2025-04-07 PubMed PMID: 40193219
Verified Locator: https://pubmed.ncbi.nlm.nih.gov/40193219/
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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