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

(2017) FERTILITY AND STERILITY. 107(2). p.387-396
Author
Organization
Abstract
Objective: To compare the efficacy and safety of follitropin delta, a new human recombinant FSH with individualized dosing based on serum antimullerian 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 mg/d; AMH >= 15 pmol/L: 0.10-0.19 mu g/kg/d; maximum 12 mg/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 patientswithAMH >= 15pmol/L) (27.9% vs. 35.1% and 10.1% vs. 15.6%, respectively), and fewermeasures 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 mg). 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.
Keywords
ASSISTED REPRODUCTIVE TECHNOLOGY, LIVE BIRTH, HYPERSTIMULATION SYNDROME, PERSONALIZED MEDICINE, HORMONE, CYCLES, IVF, PREDICTORS, NUMBER, ESHRE, Antimullerian hormone, follitropin delta, OHSS, ovarian response, pregnancy

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MLA
Andersen, Anders Nyboe et al. “Individualized Versus Conventional Ovarian Stimulation for in Vitro Fertilization : a Multicenter, Randomized, Controlled, Assessor-blinded, Phase 3 Noninferiority Trial.” FERTILITY AND STERILITY 107.2 (2017): 387–396. Print.
APA
Andersen, A. N., Nelson, S. M., Fauser, B. C. J. M., Garcia-Velasco, J. A., Klein, B. M., Arce, J.-C., ESTHER-1 study group, for the, et al. (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.
Chicago author-date
Andersen, Anders Nyboe, Scott M. Nelson, Bart C. J. M. Fauser, Juan Antonio Garcia-Velasco, Bjarke M. Klein, Joan-Carles Arce, for the ESTHER-1 study group, and Petra De Sutter. 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.
Chicago author-date (all authors)
Andersen, Anders Nyboe, Scott M. Nelson, Bart C. J. M. Fauser, Juan Antonio Garcia-Velasco, Bjarke M. Klein, Joan-Carles Arce, for the ESTHER-1 study group, and Petra De Sutter. 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.
Vancouver
1.
Andersen AN, Nelson SM, Fauser BCJM, Garcia-Velasco JA, Klein BM, Arce J-C, et al. Individualized versus conventional ovarian stimulation for in vitro fertilization : a multicenter, randomized, controlled, assessor-blinded, phase 3 noninferiority trial. FERTILITY AND STERILITY. 2017;107(2):387–96.
IEEE
[1]
A. N. Andersen et al., “Individualized versus conventional ovarian stimulation for in vitro fertilization : a multicenter, randomized, controlled, assessor-blinded, phase 3 noninferiority trial,” FERTILITY AND STERILITY, vol. 107, no. 2, pp. 387–396, 2017.
@article{8541623,
  abstract     = {Objective: To compare the efficacy and safety of follitropin delta, a new human recombinant FSH with individualized dosing based on serum antimullerian 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 mg/d; AMH >= 15 pmol/L: 0.10-0.19 mu g/kg/d; maximum 12 mg/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 patientswithAMH >= 15pmol/L) (27.9% vs. 35.1% and 10.1% vs. 15.6%, respectively), and fewermeasures 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 mg). 
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.},
  author       = {Andersen, Anders Nyboe and Nelson, Scott M. and Fauser, Bart C. J. M. and Garcia-Velasco, Juan Antonio and Klein, Bjarke M. and Arce, Joan-Carles and ESTHER-1 study group, for the and De Sutter, Petra},
  issn         = {0015-0282},
  journal      = {FERTILITY AND STERILITY},
  keywords     = {ASSISTED REPRODUCTIVE TECHNOLOGY,LIVE BIRTH,HYPERSTIMULATION SYNDROME,PERSONALIZED MEDICINE,HORMONE,CYCLES,IVF,PREDICTORS,NUMBER,ESHRE,Antimullerian hormone,follitropin delta,OHSS,ovarian response,pregnancy},
  language     = {eng},
  number       = {2},
  pages        = {387--396},
  title        = {Individualized versus conventional ovarian stimulation for in vitro fertilization : a multicenter, randomized, controlled, assessor-blinded, phase 3 noninferiority trial},
  url          = {http://dx.doi.org/10.1016/j.fertnstert.2016.10.033},
  volume       = {107},
  year         = {2017},
}

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