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

Nyboe Andersen, A., Nelson, S. M. , Fauser, B. C.J.M., García-Velasco, J. A., Klein, B. M., Arce, J.-C. and , - (2017) Individualized versus conventional ovarian stimulation for in vitro fertilization: a multicenter, randomized, controlled, assessor-blinded, phase 3 noninferiority trial. Fertility and Sterility, 107(2), 387-396.e4. (doi:10.1016/j.fertnstert.2016.10.033) (PMID:27912901)

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Abstract

Objective: 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. Design: Randomized, multicenter, assessor-blinded, noninferiority trial (ESTHER-1). Setting: Reproductive 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.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Nelson, Professor Scott
Authors: Nyboe Andersen, A., Nelson, S. M., Fauser, B. C.J.M., García-Velasco, J. A., Klein, B. M., Arce, J.-C., and , -
College/School:College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing
Journal Name:Fertility and Sterility
Publisher:Elsevier
ISSN:0015-0282
ISSN (Online):1556-5653
Published Online:29 November 2016
Copyright Holders:Copyright © 2017 The Authors
First Published:First published in Fertility and Sterility 107(2):387-396.e4
Publisher Policy:Reproduced under a Creative Commons License

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