hMG Dosage: The FDA Label Schedule and the Off-Label Male Regimen
hMG dosage from the FDA-approved Menopur label - starting dose, adjustment steps, reconstitution - plus the off-label male regimen sources describe.
The short version
The FDA-approved Menopur label gives one dosing schedule, for women in an ART fertility cycle: a 225 IU starting dose, adjusted in small steps, capped at 450 IU a day. There is no approved dose for men. Off-label, published studies describe hMG paired with hCG in men with hypogonadotropic hypogonadism. This page gives those doses as common practice in that research, not as an established protocol.
- Approved starting dose: 225 IU per day, subcutaneous, adjusted after day 5 in steps of up to 150 IU.
- Maximum approved dose is 450 IU per day; treatment should not exceed 20 days.
- Each 75 IU vial is mixed with a specific diluent volume the label states; see reconstitution below.
- No FDA-approved male dose exists. Studies describe 150 IU hMG with hCG, several times weekly, as one regimen.
Human Menopausal Gonadotropin dosage chart
The FDA-approved Human Menopausal Gonadotropin product is dosed as its label directs and a prescriber sets the dose. For vials that need mixing, this is each label dose in units on a U-100 insulin syringe, by vial size.
75 IU vialwith 3 mL water
| Dose | Units | Volume | Doses per vial |
|---|
Full 75 IU vial page: other water volumes, mixing, storage →
U-100 insulin syringe (100 units = 1 mL), to the nearest half unit. Arithmetic only. Other numbers: peptide calculator.
hMG dosage means two different things depending on who is asking. The FDA-approved label gives one precise schedule, for women in an ART fertility cycle. Off-label use in men has no approved dose, only what published studies report using. This page states each separately and does not blend them. For what hMG is and its full warnings, see the hMG guide.
US legal status - FDA-approved · prescription only
Menotropins for injection is FDA-approved by prescription for the schedule below in women. The male regimen further down is off-label common practice reported in research, not an FDA-reviewed dose.
Approved dose: follicle development in women
| Step | Dose |
|---|---|
| Starting dose (cycle day 2 or 3) | 225 International Units per day, subcutaneous |
| First adjustment (after day 5) | Up to 150 IU higher or lower, based on ultrasound and estradiol monitoring |
| Further adjustments | No more often than every 2 days, by no more than 150 IU each time |
| Maximum daily dose | 450 International Units |
| Maximum treatment length | 20 days |
Dosing is individualized to each woman’s ovarian response, monitored by ultrasound, serum estradiol, or both. Once follicles are adequately developed, hMG stops and a separate hCG dose is given to trigger ovulation. The label states hCG “must be given” at that point, since hMG alone does not cause ovulation.
hMG may also be combined with a related FSH product (urofollitropin). The label caps that combined starting dose at 225 IU as well. Full mechanism and approved use: hMG guide.
How it’s reconstituted
Each 75 IU vial (75 IU FSH activity and 75 IU LH activity) is a lyophilized powder. It comes with its own diluent vial containing 2 mL of 0.9% Sodium Chloride Injection, USP. The label-based patient instructions say the usual amount used to mix one vial is 1 mL, not the full 2 mL the diluent vial holds.
To reach a dose larger than one vial provides, the same 1 mL of mixed solution is drawn from the first vial. It is then used to dissolve each additional vial in turn. The label allows reconstituting up to several vials this way in the same 1 mL, rather than adding more diluent for each one.
The resulting concentration depends on how many vials are pooled into that 1 mL, so there is no single fixed “units per mL” figure to publish as a table here. A prescriber or fertility pharmacist sets the actual draw for a given IU dose.
Use immediately after mixing and discard any unused solution. Store the unmixed powder refrigerated or at room temperature (3-25°C / 37-77°F), protected from light.
Off-label male dose: what research describes
There is no FDA-approved hMG dose for men, because there is no approved male indication. What follows is what published studies used, stated as common practice in that research. It is not an established protocol, and it is not specific to men who became hypogonadal from testosterone-replacement therapy rather than another cause.
- A 2024 review of fertility management in hypogonadal men on TRT Fink 2024 - Fink J, Ide H, Horie S. Management of Male Fertility in Hypogonadal Patients on Testosterone Replacement Therapy. Medicina (Kaunas). 2024;60(2)., in the references below describes a studied regimen of 150 IU hMG combined with 1,500 IU hCG, given three times weekly.
- A 2019 study of 220 men with hypogonadotropic hypogonadism Lin 2019 - Lin J, Mao J, Wang X et al. Optimal treatment for spermatogenesis in male patients with hypogonadotropic hypogonadism. Medicine (Baltimore). 2019;98(31):e16616., in the references below used combined hCG/hMG therapy over a much longer course. The men were divided between treatments rather than described as randomised.
In the 2019 study, sperm first appeared after an average of 10.9 months, and after more than a year in some men. Sperm appeared in only about a quarter of the men treated. The paper reports 25%, though its stated group sizes do not match that percentage. Treatment was markedly slower and less successful than the study’s GnRH-pump comparison arm.
Across both sources, treatment for fertility restoration in men runs to months rather than the 20-day cap that applies to the approved female protocol above.
Who should not use it
The label lists these contraindications:
- Prior hypersensitivity to menotropins products or their excipients.
- High FSH indicating primary ovarian failure.
- Pregnancy.
- Uncontrolled non-gonadal endocrinopathies (thyroid, adrenal or pituitary disorders).
- Sex-hormone-dependent tumors of the reproductive tract.
- Tumors of the pituitary gland or hypothalamus.
- Abnormal uterine bleeding of undetermined origin.
- An ovarian cyst or enlargement not due to polycystic ovary syndrome.
Full warnings (OHSS, thromboembolic events and multiple pregnancy) are on the hMG guide.
When to stop and get medical care
Seek emergency care (call 911 in the US) for signs of a serious allergic reaction: swelling of the face, lips, tongue or throat, or difficulty breathing. Do the same for sudden, severe abdominal or pelvic pain, rapid weight gain, or abdominal swelling, which can signal ovarian hyperstimulation.
For an accidental extra dose, a suspected overdose, or any exposure that is not a clear emergency, call the US National Poison Control Center at 1-800-222-1222. It is free, confidential and open 24 hours a day.
Related
- hMG: the approved use and off-label context
- hCG dosage: the trigger-dose label schedule
- Peptides and TRT: what has (and has not) been studied
Where to get Human Menopausal Gonadotropin legally
Human Menopausal Gonadotropin is an FDA-approved prescription medicine, so the legal route is a licensed prescriber, in person or by telehealth, and a licensed pharmacy.
How telehealth prescribing works, what it costs and what to check: telehealth peptide prescribing.
Common questions
What is the standard hMG dose for women in IVF?
The label gives a starting dose of 225 International Units per day by subcutaneous injection, beginning cycle day 2 or 3. After day 5 the dose is adjusted based on ultrasound and estradiol monitoring. Steps are no more than 150 IU, no more often than every 2 days, up to a maximum of 450 IU per day. Treatment continues until follicles are ready, then hCG is given to trigger ovulation. Therapy should not exceed 20 days.
How is hMG reconstituted?
Each 75 IU vial ships as a lyophilized powder with its own diluent vial. The label-based patient instructions say the usual amount of 0.9% Sodium Chloride used to mix one vial is 1 mL. The diluent vial supplies 2 mL, and the extra is not injected. To reach a higher dose, the same reconstituted 1 mL is drawn through additional vials in sequence rather than adding more diluent. Full detail is below.
What is the hMG dose for men?
There is no FDA-approved dose, because hMG has no approved male indication. Published research on off-label use in men with hypogonadotropic hypogonadism describes regimens such as 150 IU hMG combined with 1,500 IU hCG, three times weekly. These are reported as what was studied, not as an established protocol, and not in a population defined specifically by testosterone-therapy-induced hypogonadism. See the sourcing below.
How long does hMG treatment last?
For its approved use, the label caps treatment at 20 days per cycle. The published studies of off-label male use ran much longer, months rather than weeks, because restoring sperm production is slower than stimulating follicles for one ART cycle. One 2019 study in men reported an average of roughly 11 months before sperm first appeared.
References (4 sources)
Bibliographic detail is fetched from PubMed, not written by me - so a citation here cannot drift from the paper it names. Study design comes from PubMed's own tags rather than my judgement.
- 1.Lin J, Mao J, Wang X et al. Optimal treatment for spermatogenesis in male patients with hypogonadotropic hypogonadism. Medicine (Baltimore). 2019;98(31):e16616.Randomised trialPMID 31374027full text
- 2.Fink J, Ide H, Horie S. Management of Male Fertility in Hypogonadal Patients on Testosterone Replacement Therapy. Medicina (Kaunas). 2024;60(2).ReviewPMID 38399562full text
- 3.MENOPUR (menotropins for injection) - full prescribing information, including the dosage and administration section, reconstitution instructions, and how-supplied packaging detail.- DailyMed, National Library of Medicinelabel
- 4.National Poison Control Center - 1-800-222-1222, free and confidential poisoning and overdose guidance.- America's Poison Centersother