Clomiphene, metformin, or both for infertility in the polycystic ovary syndrome - PubMed (original) (raw)
Randomized Controlled Trial
. 2007 Feb 8;356(6):551-66.
doi: 10.1056/NEJMoa063971.
Huiman X Barnhart, William D Schlaff, Bruce R Carr, Michael P Diamond, Sandra A Carson, Michael P Steinkampf, Christos Coutifaris, Peter G McGovern, Nicholas A Cataldo, Gabriella G Gosman, John E Nestler, Linda C Giudice, Phyllis C Leppert, Evan R Myers; Cooperative Multicenter Reproductive Medicine Network
Affiliations
- PMID: 17287476
- DOI: 10.1056/NEJMoa063971
Free article
Randomized Controlled Trial
Clomiphene, metformin, or both for infertility in the polycystic ovary syndrome
Richard S Legro et al. N Engl J Med. 2007.
Free article
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].).
Copyright 2007 Massachusetts Medical Society.
Comment in
- Treating the polycystic ovary syndrome the old-fashioned way.
Guzick DS. Guzick DS. N Engl J Med. 2007 Feb 8;356(6):622-4. doi: 10.1056/NEJMe068295. N Engl J Med. 2007. PMID: 17287483 No abstract available. - Treatment of infertility in the polycystic ovary syndrome.
Panidis D, Farmakiotis D. Panidis D, et al. N Engl J Med. 2007 May 10;356(19):1999; author reply 2000-1. doi: 10.1056/NEJMc070603. N Engl J Med. 2007. PMID: 17494937 No abstract available. - Treatment of infertility in the polycystic ovary syndrome.
Geberhiwot T, Jones AF. Geberhiwot T, et al. N Engl J Med. 2007 May 10;356(19):2000; author reply 1999-2001. N Engl J Med. 2007. PMID: 17506158 No abstract available. - Treatment of infertility in the polycystic ovary syndrome.
Bell DS. Bell DS. N Engl J Med. 2007 May 10;356(19):1999-2000; author reply 2000-1. N Engl J Med. 2007. PMID: 17506159 No abstract available. - Clomiphene or metformin for PCOS infertility?
[No authors listed] [No authors listed] J Fam Pract. 2007 May;56(5):349. J Fam Pract. 2007. PMID: 17607841 No abstract available.
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