Individualised versus Standard FSH Dosing in Predicted Poor Responders Undergoing IVF: A Randomised Controlled Trial

Abstract

Background: Poor responders usually lead to detrimental effects on IVF outcomes due to low oocyte number and quality which further result in low pregnancy outcomes and increased chance of cycle cancellation. Clinicians often individualise the FSH dose using ovarian reserve tests (ORT), including antral follicle count (AFC). However, it is unclear whether individualised FSH dosing improves clinical outcomes. Aim: To understand if there is a difference in live birth rates between individualised or standard FSH dosing in poor responders? Method: Between March 2019 and April 2020, we performed a single center, parallel, open-label randomised controlled trial. Women referred for their first IVF/ICSI cycle, [Formula: see text]43 years of age, AFC[Formula: see text]10 were approached. Eligible women were randomised either to individualised or standard FSH dosing. In the individualised group, women with AFC 1-6 were assigned to 300IU/day, while women with AFC 7-9 were assigned to 225IU/day. In the standard group, women were assigned 150IU/day. The primary outcome was live birth attributable to the first ART cycle within 18 months of randomization. Results: A total of 661 women were randomised, 328 to the individualised group and 333 to the standard group. The live birth rate (follow up still ongoing) was not significantly different between the two groups [49.1% (161/328) vs 42.3% (141/333), RR: 1.16 (95%CI, 0.98-1.37), P=0.082]. The cumulative ongoing pregnancy rate for individualised versus standard dosing was 53.0% (174/328) versus 47.4% (158/333), respectively [RR: 1.12 (95%CI, 0.96-1.30), p=0.150]. The multiple pregnancy rate also did not differ between individualised and standard dosing [5.49% vs 5.71%, RR: 0.96 (95%CI, 0.51-1.80), p=0.903]. Individualised dosing reduced the occurrence of poor response compared to standard dosing [31.1% vs 48.6%, RR: 0.64 (95%CI, 0.53-0.78), p[Formula: see text]0.001]. Conclusion: The individualised dosing strategy led to lower rates of poor response, but it did not result in significantly higher ongoing pregnancy rates.