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Letrozole improved ovulation, live-birth in women with PCOS
Women with polycystic ovary syndrome could improve their chances for successful conception and birth with treatments of letrozole (Femara, Novartis) according to research published in the New England Journal of Medicine.
The aromatase inhibitor was associated with higher ovulation and live-birth rates compared with the first-line treatment clomiphene in a double-blind, multicenter, randomized trial, but further research is needed, researchers wrote.
Richard S. Legro, MD, of the Department of Obstetrics and Gynecology, Penn State College of Medicine, and colleagues randomized 750 women aged 18 to 40 years with polycystic ovary syndrome, as defined by modified Rotterdam criteria, in a 1:1 ratio to treatment with letrozole or clomiphene for up to five cycles.
Patients had at least one patent fallopian tube and a normal uterine cavity. They had a partner with a sperm concentration of at least 14 million per milliliter who agreed to regular intercourse with the intention to conceive. Ovulation and pregnancy were determined and pregnancies were tracked.
Women had more cumulative live births with letrozole (103 of 374, 27.5%) vs. clomiphene (72 of 376, 19.1%) (P=.007) with a 1.44 rate ratio for live birth (95% CI, 1.10-1.87). No significant differences were observed in overall congenital anomalies; however, four major congenital anomalies were seen with letrozole vs. one with clomiphene.
A higher cumulative ovulation rate occurred with letrozole at 61.7% vs. clomiphene at 48.3% (834 of 1352 treatment cycles vs. 688 of 1425 treatment cycles, respectively; P<.001).
The differences between groups were not significant for pregnancy loss (49 of 154 pregnancies with letrozole, 31.8% vs. 30 of 103 pregnancies with clomiphene, 29.1%) or twin pregnancy (3.4% and 7.4%, respectively).
Clomiphene was associated with more hot flushes, but letrozole with more fatigue and dizziness, according to the study.
“Further study with larger numbers of infants is needed to clarify the safety and teratogenic risks with letrozole relative to those with other infertility therapies,” the researchers wrote.
Disclosures: Please see study for full list of disclosures.