Human evidence record · Menotropins (human menopausal gonadotropin)
Highly purified menotropin versus recombinant FSH in IVF/ICSI
Ongoing pregnancy rates were similar (about 25% with HP-hMG vs 22% with recombinant FSH in the per-protocol analysis).
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Human evidence record
What this study tells us
This was a human pharmacology or physiology study. It can show what the compound does to measured biological signals, but it may not establish a meaningful clinical benefit.
Who was studied?
Women undergoing IVF/ICSI
How many?
n=781
What happened?
Ongoing pregnancy rates were similar (about 25% with HP-hMG vs 22% with recombinant FSH in the per-protocol analysis).
What stops us overclaiming?
Fertility-specialist population and protocol; not general endocrine use.
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Key result
Ongoing pregnancy rates were similar (about 25% with HP-hMG vs 22% with recombinant FSH in the per-protocol analysis).
Study details
Study designMultinational randomized parallel-group Phase III comparative trial
PhasePhase III
PopulationWomen undergoing IVF/ICSI
Sample size781
RouteInjection
Regimen / exposureControlled ovarian stimulation with highly purified hMG or recombinant FSH per protocol
DurationOne treatment cycle
ComparatorRecombinant FSH
Primary endpoint / questionOngoing pregnancy and safety
Safety resultOHSS, miscarriage, adverse events and injection-site reactions were broadly similar between groups.
Key limitationsFertility-specialist population and protocol; not general endocrine use.
Registry / identifierPMID 12215327