Document Type
Article
Original Publication Date
2014
Journal/Book/Conference Title
The New England Journal of Medicine
Volume
371
DOI of Original Publication
10.1056/NEJMoa1313517
Date of Submission
December 2014
Abstract
BACKGROUND
Clomiphene is the current first-line infertility treatment in women with the polycystic ovary syndrome, but aromatase inhibitors, including letrozole, might result in better pregnancy outcomes.
METHODS
In this double-blind, multicenter trial, we randomly assigned 750 women, in a 1:1 ratio, to receive letrozole or clomiphene for up to five treatment cycles, with visits to determine ovulation and pregnancy, followed by tracking of pregnancies. The polycystic ovary syndrome was defined according to modified Rotterdam criteria (anovulation with either hyperandrogenism or polycystic ovaries). Participants were 18 to 40 years of age, had at least one patent fallopian tube and a normal uterine cavity, and had a male partner with a sperm concentration of at least 14 million per milliliter; the women and their partners agreed to have regular intercourse with the intent of conception during the study. The primary outcome was live birth during the treatment period.
RESULTS
Women who received letrozole had more cumulative live births than those who received clomiphene (103 of 374 [27.5%] vs. 72 of 376 [19.1%], P=0.007; rate ratio for live birth, 1.44; 95% confidence interval, 1.10 to 1.87) without significant differences in overall congenital anomalies, though there were four major congenital anomalies in the letrozole group versus one in the clomiphene group (P=0.65). The cumulative ovulation rate was higher with letrozole than with clomiphene (834 of 1352 treatment cycles [61.7%] vs. 688 of 1425 treatment cycles [48.3%], P
CONCLUSIONS
As compared with clomiphene, letrozole was associated with higher live-birth and ovulation rates among infertile women with the polycystic ovary syndrome. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and others; ClinicalTrials.gov number, NCT00719186.)
Rights
From The New England Journal of Medicine, Legro, R. S., Btyzski, R. G., Diamond, M. P. et al., Letrozole versus Clomiphene for Infertility in the Polycystic Ovary Syndrome, Vol. 371, Page 119, Copyright © 2014 Massachusetts Medical Society. Reprinted with permission.
Is Part Of
VCU Obstetrics and Gynecology Publications
Supplementary Appendix
nejmoa1313517_protocol.pdf (3368 kB)
Protocol
nejmoa1313517_disclosures.pdf (739 kB)
Disclosure Forms
Comments
Originally Published at http://dx.doi.org/10.1056/NEJMoa1313517