METHODS

Design: Randomised, multicentre, assessor-blinded, non-inferiority trial (ESTHER-1)

Participants: 1,329 women aged 18–40 years undergoing in vitro fertilisation (IVF)/intracytoplasmic sperm injection (ICSI)

Main outcome measures: Ongoing pregnancy and ongoing implantation rates

Comparator agents: Follitropin delta (anti-Müllerian hormone (AMH) <15 pmol/L: 12 μg/d; AMH ≥ 15 pmol/L: 0.10-0.19 μg/d), or follitropin alfa (150 IU/d for 5 days, potential subsequent dose adjustments; maximum 450 IU/d)

RESULTS

Ongoing pregnancy rate: 30.7% vs 31.6%; difference –0.9% [95% CI –5.9% – 4.1%]

Ongoing implantation rate: 35.2% vs 35.8%; difference –0.6% [95% CI –6.1% – 4.8%]

Live birth rate: 29.8% vs 30.7%; –0.9% [95% CI –5.8% – 4.0%]

CONCLUSION

In the ESTHER-1 trial, the incidence of all ovarian hyperstimulation syndrome (OHSS) (any grade) and/or preventive intervention was lower in subjects treated with follitropin delta (5.6%) than with follitropin alfa (8%) (p=0.037). Individualised follitropin delta dosing demonstrated non-inferiority compared to conventional follitropin alpha for primary end point. No adjustment for multiplicity was made on secondary endpoints, and therefore it is not possible to draw any conclusions from these findings.
 

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