Individualized follitropin delta dosing reduces OHSS risk in Japanese IVF/ICSI patients: a randomized controlled trial

REPRODUCTIVE BIOMEDICINE ONLINE

卷:42

Article

Ishihara, Osamu¹  Arce, Joan-Cartes² 

[1] Saitama Med Univ, Dept Obstet & Gynaecol, Saitama, Japan

[2] Ferring Pharmaceut Reprod Med & Maternal Hlth, Copenhagen, Denmark

关键词: Anti-M?llerian hormone;    Follitropin delta;    Individualized dosing;    Japan;    Live birth;    Ovarian hyperstimulation syndrome;   

DOI  :  10.1016/j.rbmo.2021.01.023

来源: Elsevier

【 摘 要 】

Research question: This study aimed to establish the efficacy and safety of ovarian stimulation with a follitropin delta individualized fixed-dose regimen based on serum anti-M & uuml;llerian hormone (AMH) concentration and body weight versus conventional follitropin beta dosing in Japanese women. Design: This randomized, controlled, assessor-blind, multicentre, non-inferiority trial was conducted in 347 Japanese IVF/intracytoplasmic sperm injection patients. They were randomized to individualized follitropin delta (AMH <15 pmol/l: 12 & micro;g/day; AMH >= 15 pmol/l: 0.10-0.19 & micro;g/kg/day; minimum 6 & micro;g/day; maximum 12 & micro;g/day) or conventional follitropin beta (150 IU/day for the first 5 days, with potential subsequent dose adjustments). The primary end-point was the number of oocytes retrieved with a pre-specified non-inferiority margin (& minus;3.0 oocytes). Results: The primary trial objective was met, as non-inferiority was established for number of oocytes retrieved for individualized follitropin delta dosing compared with conventional follitropin beta dosing (9.3 versus 10.5; lower boundary of 95% confidence interval & minus;2.3). The occurrence of ovarian hyperstimulation syndrome (OHSS) was reduced to approximately half with individualized compared with conventional dosing, with an incidence of 11.2% versus 19.8% (P = 0.021) for OHSS of any grade and 7.1% versus 14.1% (P = 0.027) for moderate/severe OHSS. The live birth rate per started cycle was 23.5% for individualized dosing and 18.6% for conventional dosing. Conclusions: Dosing with individualized follitropin delta in Japanese women is non-inferior to conventional dosing with follitropin beta for number of oocytes retrieved. The individualized approach shows a favourable benefit- risk profile, providing a statistically significant and clinically relevant reduction in the incidence of OHSS, without compromising live birth rates.

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