PCOSMIC: a multi-centre randomized trial in women with PolyCystic Ovary Syndrome evaluating Metformin for Infertility with Clomiphene.
Hum Reprod
; 25(7): 1675-83, 2010 Jul.
Article
em En
| MEDLINE
| ID: mdl-20435692
ABSTRACT
BACKGROUND:
Ovulation induction treatment with metformin, either alone or in combination with clomiphene citrate (CC), remains controversial even though previous randomized trials have examined this.METHODS:
A double blinded multi-centre randomized trial was undertaken including 171 women with anovulatory or oligo-ovulatory polycystic ovary syndrome. Women with high body mass index (BMI) > 32 kg/m(2) received placebo ('standard care') or metformin; women with BMI < or = 32 kg/m(2) received CC ('standard care'), metformin or both. Treatment continued for 6 months or until pregnancy was confirmed. Primary outcomes were clinical pregnancy and live birth.RESULTS:
For women with BMI > 32 kg/m(2), clinical pregnancy and live birth rates were 22% (7/32) and 16% (5/32) with metformin, 15% (5/33) and 6% (2/33) with placebo. For women with BMI < or = 32 kg/m(2), clinical pregnancy and live birth rates were 40% (14/35) and 29% (10/35) with metformin, 39% (14/36) and 36% (13/36) with CC, 54% (19/35) and 43% (15/35) with combination metformin plus CC.CONCLUSIONS:
There is no evidence that adding metformin to 'standard care' is beneficial. Pregnancy and live birth rates are low in women with BMI > 32 kg/m(2) whatever treatment is used, with no evidence of benefit of metformin over placebo. For women with BMI < or = 32 kg/m(2) there is no evidence of significant differences in outcomes whether treated with metformin, CC or both. ClinicalTrials.gov number NCT00795808; trial protocol accepted for publication November 2005 Johnson, Aust N Z Journal Obstet Gynaecol 2006;46141-145.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Síndrome do Ovário Policístico
/
Clomifeno
/
Hipoglicemiantes
/
Infertilidade Feminina
/
Anovulação
/
Metformina
Tipo de estudo:
Clinical_trials
/
Etiology_studies
/
Guideline
Limite:
Female
/
Humans
/
Pregnancy
Idioma:
En
Ano de publicação:
2010
Tipo de documento:
Article