Randomized, controlled, open-label, non-inferiority study of the CONSORT algorithm for individualized dosing of follitropin alfa.
Reprod Biomed Online
; 30(3): 248-57, 2015 Mar.
Article
em En
| MEDLINE
| ID: mdl-25596910
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.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Contexto em Saúde:
1_ASSA2030
Base de dados:
MEDLINE
Assunto principal:
Indução da Ovulação
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Fertilização in vitro
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Síndrome de Hiperestimulação Ovariana
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Hormônio Foliculoestimulante Humano
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Medicina de Precisão
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Fármacos para a Fertilidade Feminina
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Infertilidade Feminina
Tipo de estudo:
Clinical_trials
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Incidence_studies
/
Prognostic_studies
Limite:
Adolescent
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Adult
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Female
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Humans
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Pregnancy
País/Região como assunto:
America do sul
/
Chile
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Europa
Idioma:
En
Revista:
Reprod Biomed Online
Ano de publicação:
2015
Tipo de documento:
Article