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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

Standard

Individualized versus conventional ovarian stimulation for in vitro fertilization : a multicenter, randomized, controlled, assessor-blinded, phase 3 noninferiority trial. / Nyboe Andersen, Anders; Nelson, Scott M; Fauser, Bart C J M; García-Velasco, Juan Antonio; Klein, Bjarke M; Arce, Joan-Carles; ESTHER-1 study group.

I: Fertility and Sterility, Bind 107, Nr. 2, 02.2017, s. 387-396.e4.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

Harvard

Nyboe Andersen, A, Nelson, SM, Fauser, BCJM, García-Velasco, JA, Klein, BM, Arce, J-C & ESTHER-1 study group 2017, 'Individualized versus conventional ovarian stimulation for in vitro fertilization: a multicenter, randomized, controlled, assessor-blinded, phase 3 noninferiority trial', Fertility and Sterility, bind 107, nr. 2, s. 387-396.e4. https://doi.org/10.1016/j.fertnstert.2016.10.033

APA

Nyboe Andersen, A., Nelson, S. M., Fauser, B. C. J. M., García-Velasco, J. A., Klein, B. M., Arce, J-C., & ESTHER-1 study group (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. https://doi.org/10.1016/j.fertnstert.2016.10.033

Vancouver

Nyboe Andersen A, Nelson SM, Fauser BCJM, García-Velasco JA, Klein BM, Arce J-C o.a. Individualized versus conventional ovarian stimulation for in vitro fertilization: a multicenter, randomized, controlled, assessor-blinded, phase 3 noninferiority trial. Fertility and Sterility. 2017 feb;107(2):387-396.e4. https://doi.org/10.1016/j.fertnstert.2016.10.033

Author

Nyboe Andersen, Anders ; Nelson, Scott M ; Fauser, Bart C J M ; García-Velasco, Juan Antonio ; Klein, Bjarke M ; Arce, Joan-Carles ; ESTHER-1 study group. / Individualized versus conventional ovarian stimulation for in vitro fertilization : a multicenter, randomized, controlled, assessor-blinded, phase 3 noninferiority trial. I: Fertility and Sterility. 2017 ; Bind 107, Nr. 2. s. 387-396.e4.

Bibtex

@article{22a9eeae24364ca588e922d058fee667,
title = "Individualized versus conventional ovarian stimulation for in vitro fertilization: a multicenter, randomized, controlled, assessor-blinded, phase 3 noninferiority trial",
abstract = "OBJECTIVE: To compare the efficacy and safety of follitropin delta, a new human recombinant FSH with individualized dosing based on serum antim{\"u}llerian 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.CLINICAL TRIAL REGISTRATION NUMBER: NCT01956110.",
keywords = "Adolescent, Adult, Anti-Mullerian Hormone/blood, Biomarkers/blood, Body Weight/drug effects, Brazil, Canada, Embryo Implantation, Embryo Transfer, Europe, Female, Fertility/drug effects, Fertility Agents, Female/administration & dosage, Fertilization in Vitro/adverse effects, Follicle Stimulating Hormone, Human/administration & dosage, Humans, Infertility/diagnosis, Live Birth, Ovarian Hyperstimulation Syndrome/etiology, Ovulation/drug effects, Ovulation Induction/adverse effects, Pregnancy, Pregnancy Rate, Recombinant Proteins/administration & dosage, Treatment Outcome, Young Adult",
author = "{Nyboe Andersen}, Anders and Nelson, {Scott M} and Fauser, {Bart C J M} and Garc{\'i}a-Velasco, {Juan Antonio} and Klein, {Bjarke M} and Joan-Carles Arce and {ESTHER-1 study group}",
note = "Copyright {\circledC} 2016 The Authors. Published by Elsevier Inc. All rights reserved.",
year = "2017",
month = "2",
doi = "10.1016/j.fertnstert.2016.10.033",
language = "English",
volume = "107",
pages = "387--396.e4",
journal = "Fertility and Sterility",
issn = "0015-0282",
publisher = "Elsevier",
number = "2",

}

RIS

TY - JOUR

T1 - Individualized versus conventional ovarian stimulation for in vitro fertilization

T2 - a multicenter, randomized, controlled, assessor-blinded, phase 3 noninferiority trial

AU - Nyboe Andersen, Anders

AU - Nelson, Scott M

AU - Fauser, Bart C J M

AU - García-Velasco, Juan Antonio

AU - Klein, Bjarke M

AU - Arce, Joan-Carles

AU - ESTHER-1 study group

N1 - Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

PY - 2017/2

Y1 - 2017/2

N2 - 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.CLINICAL TRIAL REGISTRATION NUMBER: NCT01956110.

AB - 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.CLINICAL TRIAL REGISTRATION NUMBER: NCT01956110.

KW - Adolescent

KW - Adult

KW - Anti-Mullerian Hormone/blood

KW - Biomarkers/blood

KW - Body Weight/drug effects

KW - Brazil

KW - Canada

KW - Embryo Implantation

KW - Embryo Transfer

KW - Europe

KW - Female

KW - Fertility/drug effects

KW - Fertility Agents, Female/administration & dosage

KW - Fertilization in Vitro/adverse effects

KW - Follicle Stimulating Hormone, Human/administration & dosage

KW - Humans

KW - Infertility/diagnosis

KW - Live Birth

KW - Ovarian Hyperstimulation Syndrome/etiology

KW - Ovulation/drug effects

KW - Ovulation Induction/adverse effects

KW - Pregnancy

KW - Pregnancy Rate

KW - Recombinant Proteins/administration & dosage

KW - Treatment Outcome

KW - Young Adult

U2 - 10.1016/j.fertnstert.2016.10.033

DO - 10.1016/j.fertnstert.2016.10.033

M3 - Journal article

VL - 107

SP - 387-396.e4

JO - Fertility and Sterility

JF - Fertility and Sterility

SN - 0015-0282

IS - 2

ER -

ID: 196878396