Individualized versus conventional ovarian stimulation for in vitro fertilization: a multicenter, randomized, controlled, assessor-blinded, phase 3 noninferiority trial

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• 作者：Anders Nyboe Andersen ; M.D. ; Ph.D.^a ; Scott M. Nelson ; M.R.C.O.G. ; Ph.D.^b ; Bart C.J.M. Fauser ; M.D. ; Ph.D.^c ; Juan Antonio Garcí ; a-Velasco ; M.D. ; Ph.D.^d ; Bjarke M. Klein ; Ph.D.^e ; Joan-Carles Arce ; M.D. ; Ph.D.^f ; ^{jca@ferring.com} ; the ESTHER-1 study groupHerman Tournaye ; Petra De Sutter ; Wim Decleer ; Alvaro Petracco ; Edson Borges ; Caio Parente Barbosa ; Jon Havelock ; Paul Claman ; Albert Yuzpe ; Hana Vi&scaron ; nová ; Pavel Ventruba ; Petr Uher ; Milan Mrazek ; Anders Nyboe Andersen ; Ulla Breth Knudsen ; Didier Dewailly ; Anne Guivarc'h Leveque ; Antonio La Marca ; Enrico Papaleo ; Waldemar Kuczynski ; Katarzyna Kozioł ; Margarita Anshina ; Irina Zazerskaya ; Alexander Gzgzyan ; Elena Bulychova ; Victoria Verdú ; Pedro Barri ; Juan Antonio Garcí ; a-Velasco ; Manuel Ferná ; ndez-Sá ; nchez ; Fernando Sá ; nchez Martin ; Ernesto Bosch ; José ; Serna ; Gemma Castillon ; Rafael Bernabeu ; Marcos Ferrando ; Stuart Lavery ; Marco Gaudoin ; Scott M. Nelson ; Bart C.J.M. Fauser ; Bjarke M. Klein ; Lisbeth Helmgaard ; Bernadette Mannaerts ; Joan-Carles Arce
• 刊名：Fertility and Sterility
• 出版年：2017
• 出版时间：February 2017
• 年：2017
• 卷：107
• 期：2
• 页码：387-396.e4
• 全文大小：574 K
• 卷排序：107

文摘

To compare the efficacy and safety of follitropin delta, a new human recombinant FSH with individualized dosing based on serum antimüllerian hormone (AMH) and body weight, with conventional follitropin alfa dosing for ovarian stimulation in women undergoing IVF.DesignRandomized, multicenter, assessor-blinded, noninferiority trial (ESTHER-1).SettingReproductive medicine clinics.Patient(s)A total of 1,329 women (aged 18–40 years).Intervention(s)Follitropin delta (AMH <15 pmol/L: 12 μg/d; AMH ≥15 pmol/L: 0.10–0.19 μg/kg/d; maximum 12 μg/d), or follitropin alfa (150 IU/d for 5 days, potential subsequent dose adjustments; maximum 450 IU/d).Main Outcomes Measure(s)Ongoing pregnancy and ongoing implantation rates; noninferiority margins −8.0%.Result(s)Ongoing pregnancy (30.7% vs. 31.6%; difference −0.9% [95% confidence interval (CI) −5.9% to 4.1%]), ongoing implantation (35.2% vs. 35.8%; −0.6% [95% CI −6.1% to 4.8%]), and live birth (29.8% vs. 30.7%; −0.9% [95% CI −5.8% to 4.0%]) rates were similar for individualized follitropin delta and conventional follitropin alfa. Individualized follitropin delta resulted in more women with target response (8–14 oocytes) (43.3% vs. 38.4%), fewer poor responses (fewer than four oocytes in patients with AMH <15 pmol/L) (11.8% vs. 17.9%), fewer excessive responses (≥15 or ≥20 oocytes in patients with AMH ≥15 pmol/L) (27.9% vs. 35.1% and 10.1% vs. 15.6%, respectively), and fewer measures taken to prevent ovarian hyperstimulation syndrome (2.3% vs. 4.5%), despite similar oocyte yield (10.0 ± 5.6 vs. 10.4 ± 6.5) and similar blastocyst numbers (3.3 ± 2.8 vs. 3.5 ± 3.2), and less gonadotropin use (90.0 ± 25.3 vs. 103.7 ± 33.6 μg).Conclusion(s)Optimizing ovarian response in IVF by individualized dosing according to pretreatment patient characteristics results in similar efficacy and improved safety compared with conventional ovarian stimulation.Clinical Trial Registration NumberNCT01956110.