Prednisone for recurrent implantation failure
Trial question
What is the role of prednisone in patients with recurrent implantation failure undergoing IVF?
Study design
Multi-center
Double blinded
RCT
Population
715 female patients.
Inclusion criteria: women who have undergone ≥ 2 embryo transfer cycles with good-quality embryos without achieving a clinical pregnancy.
Key exclusion criteria: autoimmune diseases; receipt of corticosteroids or immunosuppression medications; diagnosed diseases affecting the cavity; history of recurrent pregnancy loss.
Interventions
N=357 prednisone (an oral dose of 10 mg/day).
N=358 placebo (matching placebo once daily).
Primary outcome
Live birth
37.8%
38.8%
38.8 %
29.1 %
19.4 %
9.7 %
0.0 %
Prednisone
Placebo
No significant
difference ↔
No significant difference in live birth (37.8% vs. 38.8%; RR 0.97, 95% CI 0.81 to 1.17).
Secondary outcomes
Significant increase in biochemical pregnancy loss (17.3% vs. 9.9%; RR 1.75, 95% CI 1.03 to 2.99).
No significant difference in biochemical pregnancy (54.9% vs. 50.8%; RR 1.08, 95% CI 0.94 to 1.24).
No significant difference in implantation (42.5% vs. 40.4%; RR 1.05, 95% CI 0.9 to 1.24).
Safety outcomes
No significant differences in neonatal complications, congenital anomalies, other adverse events.
Significant difference in preterm delivery (11.8% vs. 5.5%).
Conclusion
In women who have undergone ≥ 2 embryo transfer cycles with good-quality embryos without achieving a clinical pregnancy, prednisone was not superior to placebo with respect to live birth.
Reference
Yun Sun, Linlin Cui, Yao Lu et al. Prednisone vs Placebo and Live Birth in Patients With Recurrent Implantation Failure Undergoing In Vitro Fertilization: A Randomized Clinical Trial. JAMA. 2023 May 2;329(17):1460-1468.
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