Clomiphene, metformin, or both for infertility in the polycystic ovary syndrome.
N Engl J Med
; 356(6): 551-66, 2007 Feb 08.
Article
in En
| MEDLINE
| ID: mdl-17287476
ABSTRACT
BACKGROUND:
The polycystic ovary syndrome is a common cause of infertility. Clomiphene and insulin sensitizers are used alone and in combination to induce ovulation, but it is unknown whether one approach is superior.METHODS:
We randomly assigned 626 infertile women with the polycystic ovary syndrome to receive clomiphene citrate plus placebo, extended-release metformin plus placebo, or a combination of metformin and clomiphene for up to 6 months. Medication was discontinued when pregnancy was confirmed, and subjects were followed until delivery.RESULTS:
The live-birth rate was 22.5% (47 of 209 subjects) in the clomiphene group, 7.2% (15 of 208) in the metformin group, and 26.8% (56 of 209) in the combination-therapy group (P<0.001 for metformin vs. both clomiphene and combination therapy; P=0.31 for clomiphene vs. combination therapy). Among pregnancies, the rate of multiple pregnancy was 6.0% in the clomiphene group, 0% in the metformin group, and 3.1% in the combination-therapy group. The rates of first-trimester pregnancy loss did not differ significantly among the groups. However, the conception rate among subjects who ovulated was significantly lower in the metformin group (21.7%) than in either the clomiphene group (39.5%, P=0.002) or the combination-therapy group (46.0%, P<0.001). With the exception of pregnancy complications, adverse-event rates were similar in all groups, though gastrointestinal side effects were more frequent, and vasomotor and ovulatory symptoms less frequent, in the metformin group than in the clomiphene group.CONCLUSIONS:
Clomiphene is superior to metformin in achieving live birth in infertile women with the polycystic ovary syndrome, although multiple birth is a complication. (ClinicalTrials.gov number, NCT00068861 [ClinicalTrials.gov].).
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Database:
MEDLINE
Main subject:
Polycystic Ovary Syndrome
/
Clomiphene
/
Fertility Agents, Female
/
Infertility, Female
/
Metformin
Type of study:
Clinical_trials
/
Etiology_studies
Limits:
Adult
/
Female
/
Humans
/
Pregnancy
Language:
En
Year:
2007
Type:
Article