Obruca, AndreasAndreasObrucaSchenk, MichaelMichaelSchenkTews, GernotGernotTewsMardešić, TonkoTonkoMardešićMrázek, MilanMilanMrázekMeinertz, HelleHelleMeinertzHedon, BernardBernardHedonBarrière, PaulPaulBarrièreKim, ChunghoonChunghoonKimKoong, MikyoungMikyoungKoongYoon, TaekiTaekiYoonKoziol, KatarzynaKatarzynaKoziolKuczynski, WaldemarWaldemarKuczynskiBernabeu, RafaelRafaelBernabeuRuiz Balda, Jose AntonioJose AntonioRuiz BaldaBergh, ChristinaChristinaBerghHillensjö, TorbjörnTorbjörnHillensjöHuang, Hong-YuanHong-YuanHuangYU-SHIH YANGMauw, Ellemiek VonEllemiek VonMauwElbers, JolandaJolandaElbersWitjes, HanHanWitjesZandvliet, Anthe SAnthe SZandvlietMannaerts, BernadetteBernadetteMannaerts2020-02-172020-02-1720101472-6483https://scholars.lib.ntu.edu.tw/handle/123456789/460292In this double-blind, double-dummy, randomized, equivalence trial (Ensure), 396 women weighing 60 kg or less who underwent controlled ovarian stimulation prior to IVF or intracytoplasmic sperm injection were randomized in a 2:1 ratio to a single dose of 100 μg corifollitropin alfa or daily 150 IU recombinant FSH (rFSH) for the first 7 days of stimulation in a gonadotrophin-releasing hormone antagonist protocol. The mean ± SD number of oocytes retrieved per started cycle was 13.3 ± 7.3 for corifollitropin alfa versus 10.6 ± 5.9 for rFSH. The estimated treatment difference of +2.5 oocytes (95% CI 1.2-3.9) in favour of corifollitropin alfa (P < 0.001) was well within the predefined equivalence margin. The median (range) duration of stimulation was 9 (6-15) days in both groups. In 32.8% of the patients, one injection of corifollitropin alfa was sufficient to reach the human chorionic gonadotrophin criterion. The incidence of moderate and severe ovarian hyperstimulation syndrome was 3.4% for corifollitropin alfa and 1.6% for rFSH. A dose of 100 μg corifollitropin alfa offers a simplified treatment option for potential normal responder patients with a lower body weight. ? 2010, Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.[SDGs]SDG3chorionic gonadotropin; corifollitropin alfa; fertility promoting agent; follistim pen; ganirelix; gonadorelin antagonist; placebo; progesterone; recombinant follitropin; recombinant hormone; unclassified drug; adult; antepartum hemorrhage; article; body weight; clinical protocol; clinical trial; controlled clinical trial; controlled study; double blind procedure; drug blood level; drug dose increase; drug dose reduction; drug efficacy; drug elimination; drug half life; drug hypersensitivity; drug induced headache; drug safety; ectopic pregnancy; embryo transfer; female; female infertility; fertilization in vitro; hormonal regulation; hormonal therapy; human; injection; injection site reaction; intracytoplasmic sperm injection; major clinical study; menstrual cycle; multicenter study; oocyte; oocyte retrieval; ovarian stimulation; ovary hyperstimulation; pelvic discomfort; pelvis pain syndrome; randomized controlled trial; single drug dose; time to maximum plasma concentration; treatment duration; treatment outcomejournal article10.1016/j.rbmo.2010.03.019204836642-s2.0-78650171808