Is Omnitrope (recombinant human growth hormone) recommended for use in In Vitro Fertilization (IVF)?

Omnitrope (Growth Hormone) in IVF: Evidence-Based Recommendations

Omnitrope (recombinant human growth hormone) is not recommended as a standard adjuvant treatment in IVF cycles due to uncertain effects on live birth rates and limited high-quality evidence supporting its use.

Current Evidence on Growth Hormone in IVF

For General IVF Populations:

• The evidence regarding growth hormone supplementation for routine use in IVF is very uncertain, with no clear benefit on live birth rates 1
• Meta-analyses show that while GH may increase the number of oocytes retrieved in some populations, there is no conclusive evidence of improved live birth rates 2

For Poor Responders to IVF:

• Low-dose growth hormone supplementation may slightly increase clinical pregnancy rates in poor responders to previous IVF cycles 3
• In poor responders, GH appears to:
  • Slightly increase pregnancy rates (19-31% vs 15% without GH)
  • Result in a small increase in mean number of oocytes retrieved
  • Reduce the amount of gonadotropins needed for stimulation 1
• However, the evidence is of low to very low certainty due to risk of bias, imprecision, and heterogeneity in studies 1

Safety Considerations

• Omnitrope (somatropin) appears to be generally well-tolerated when used according to prescribing information 4
• Most adverse events reported with Omnitrope are mild to moderate in intensity 4
• There are no specific safety guidelines for Omnitrope use in IVF, as this is not an FDA-approved indication 2

Clinical Decision-Making Algorithm

1. Initial Assessment:

   • Determine if patient meets criteria for "poor responder" to IVF
   • Evaluate previous IVF cycle outcomes

2. For Standard IVF Patients:

   • Omnitrope is not recommended as there is insufficient evidence of benefit
   • Focus on optimizing standard IVF protocols instead

3. For Poor Responders to IVF:

   • Consider Omnitrope as an adjunct only after standard approaches have failed
   • Discuss with patient that:
     • Evidence for improved live birth rates is uncertain
     • May provide modest benefits in oocyte yield and pregnancy rates
     • Not FDA-approved for this indication

4. If Proceeding with IVF:

   • Follow guidelines for embryo transfer regardless of adjuvant treatments:
     • Elective single embryo transfer (eSET) is recommended for most patients 5
     • Do not transfer more than two embryos due to risks of multiple pregnancies 5

Important Caveats

• The dose and regimen of GH used in clinical trials has been variable, making standardized recommendations difficult 1
• Most studies on GH in IVF are small with significant bias and imprecision 1
• Growth hormone is not mentioned in the AUA/ASRM guidelines for treatment of infertility, suggesting it is not considered a standard treatment 5
• Cost-effectiveness should be considered, as GH adds significant expense to IVF cycles

In conclusion, while Omnitrope may offer modest benefits for poor responders to IVF, it should not be considered a standard treatment for all IVF patients. For those with repeated IVF failures, a trial of GH supplementation could be considered, but patients should be informed about the uncertain evidence regarding live birth outcomes and that this represents an off-label use of the medication.