title: Randomized, controlled, open-label, non-inferiority study of the CONSORT algorithm for individualized dosing of follitropin alfa.
abstract: In this randomized, controlled, open-label, phase IV study, ovarian response after a follitropin alfa starting dose determined by the CONSORT calculator was compared with a standard dose (150 IU). Normo-ovulatory women (aged 18-34 years) eligible for assisted reproductive techniques were recruited (23 centres: nine European countries and Chile); 200 women were randomized (CONSORT [n = 96]; standard dosing [n = 104]). Significantly lower mean daily (121.5 versus 167.4 IU; P < 0.001) and total (1288.5 versus 1810.0 IU; P < 0.001) doses of follitropin alfa were administered in the CONSORT group. Clinical pregnancy rates were CONSORT (36.0%) and standard dosing (35.5%); estimated difference (confidence interval 0.6%; -13.5 to 14.6). Ovarian hyperstimulation syndrome occurred in 6.3% and 12.5% of patients in the CONSORT and standard-dosing groups, respectively. The primary efficacy analysis found a significantly lower mean [SD] number of oocytes retrieved in the CONSORT (10.0 [5.6]; P = 0.037) versus standard-dosing group (11.8 [5.3]). Although the CONSORT calculator was statistically inferior to standard dosing in the number of oocytes retrieved, clinical pregnancy rates (fresh embryo transfers) were similar in both groups, and incidence of ovarian hyperstimulation syndrome was lower in the CONSORT group.
authors.affiliation: Centre d'Assistance Médicale à la Procréation Eylau-La Muette, Paris, France. Electronic address: francois.olivennes@gmail.com.
authors.forename: F
authors.initials: F
authors.lastname: Olivennes
authors.affiliation: Hammersmith Hospital, London, UK.
authors.forename: G
authors.initials: G
authors.lastname: Trew
authors.affiliation: TECNOBIOS Procreazione, Center for Reproductive Health, Bologna, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Borini
authors.affiliation: Department Reproductive Medicine, Female and Baby Division, University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: F
authors.initials: F
authors.lastname: Broekmans
authors.affiliation: Abbott, Allschwil, Switzerland.
authors.forename: P
authors.initials: P
authors.lastname: Arriagada
authors.affiliation: Consultant, Geneva, Switzerland.
authors.forename: D W
authors.initials: DW
authors.lastname: Warne
authors.affiliation: ARIES Consulting Sarl, Geneva, Switzerland.
authors.forename: C M
authors.initials: CM
authors.lastname: Howles
mesh_terms: D000293:Adolescent; D000328:Adult; D000465:Algorithms; D002677:Chile / Q000453:epidemiology; D054796:Drug Dosage Calculations; D004624:Embryo Transfer; D005060:Europe / Q000453:epidemiology; D005260:Female; D005300:Fertility Agents, Female / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D005307:Fertilization in Vitro; D043373:Follicle Stimulating Hormone, Human / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D015994:Incidence; D007247:Infertility, Female / Q000503:physiopathology / Q000628:therapy*; D057194:Intention to Treat Analysis; D054315:Oocyte Retrieval; D016471:Ovarian Hyperstimulation Syndrome / Q000139:chemically induced / Q000453:epidemiology / Q000517:prevention & control*; D010062:Ovulation Induction / Q000009:adverse effects*; D057285:Precision Medicine; D011247:Pregnancy; D018873:Pregnancy Rate; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D005300:Fertility Agents, Female; D043373:Follicle Stimulating Hormone, Human; D011994:Recombinant Proteins; C571801:follitropin alfa
keywords: algorithm; anti-Müllerian hormone; antral follicle count; assisted reproductive technology; recombinant human follicle-stimulating hormone