Fertil Steril. 2019 Jan 22. pii: S0015-0282(18)32225-8. doi: 10.1016/j.fertnstert.2018.11.030. [Epub ahead of print]
A randomized controlled trial of combination letrozole and clomiphene citrate or letrozole alone for ovulation induction in women with polycystic ovary syndrome.
Abstract
OBJECTIVE:
To evaluate whether a combination of letrozole and clomiphene citrate (CC) results in higher ovulation rates than letrozole alone in infertile women with polycystic ovary syndrome (PCOS).
DESIGN:
Open-label randomized controlled trial.
SETTING:
Academic medical center using two clinic sites.
PATIENT(S):
Women 18-40 years of age with a diagnosis of infertility and PCOS as defined by the Rotterdam criteria and no other known cause of infertility.
INTERVENTIONS(S):
Participants were randomized in a 1:1 ratio, stratified by age and body mass index, to either 2.5 mg letrozole alone or the combination of 2.5 mg letrozole and 50 mg CC daily on cycle days 3-7 for one treatment cycle.
MAIN OUTCOME MEASURE(S):
Ovulation defined as mid-luteal serum progesterone concentration ≥3 ng/mL.
RESULT(S):
Seventy patients were randomized: 35 to letrozole alone and 35 to letrozole and CC. Results were analyzed according to the intention-to-treat principle. Women who received the combination of letrozole and CC had a statistically higher ovulation rate compared with those who received letrozole alone (27 of 35 women [77%] vs. 15 of 35 women [43%]). There were no serious adverse events or multiple-gestation pregnancies in either group. The side-effects profile was similar in the two treatment groups.
CONCLUSION(S):
The combination of letrozole and CC was associated with a higher ovulation rate compared with letrozole alone in women with infertility and PCOS. Further studies are needed to evaluate the effect on live birth rate.
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